![World map of COVID-19 vaccination doses administered per 100 people by country or territory](https://upload.wikimedia.org/wikipedia/commons/7/72/World_map_of_COVID-19_vaccination_doses_administered_per_100_people_by_country_or_territory.png)
, 12.7billion
COVID-19 vaccine
A COVID19 vaccine is a vaccine intended to provide acquired immunity against severe acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2), the virus that causes coronavirus disease 2019 ( COVID19).
Prior to the COVID19 pandemic, an e ...
doses have been administered worldwide, with 67.9 percent of the global population having received at least one dose. While 4.19million vaccines were then being administered daily, only 22.3 percent of people in low-income countries had received at least a first vaccine by September 2022, according to official reports from national health agencies, which are collated by
Our World in Data
Our World in Data (OWID) is a scientific online publication that focuses on large global problems such as poverty, disease, hunger, climate change, war, existential risks, and inequality.
It is a project of the Global Change Data Lab, a re ...
.
During
a pandemic on the rapid timeline and scale of
COVID-19
Coronavirus disease 2019 (COVID-19) is a contagious disease caused by a virus, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The first known case was COVID-19 pandemic in Hubei, identified in Wuhan, China, in December ...
cases in 2020, international organizations like the
World Health Organization
The World Health Organization (WHO) is a specialized agency of the United Nations responsible for international public health. The WHO Constitution states its main objective as "the attainment by all peoples of the highest possible level of h ...
(WHO) and
Coalition for Epidemic Preparedness Innovations
The Coalition for Epidemic Preparedness Innovations (CEPI) is a foundation that takes donations from public, private, philanthropic, and civil society organisations, to finance independent research projects to develop vaccines against emerging ...
(CEPI), vaccine developers, governments, and industry evaluated the distribution of the eventual vaccine(s).
Individual countries producing a vaccine may be persuaded to favor the highest bidder for manufacturing or provide first-service to their own country.
Experts emphasize that licensed vaccines should be available and affordable for people at the frontline of healthcare and having the most need.
In April 2020, it was reported that the UK agreed to work with 20 other countries and global organizations including France, Germany, and Italy to find a vaccine and to share the results and that UK citizens would not get preferential access to any new COVID‑19 vaccines developed by taxpayer-funded UK universities.
Several companies planned to initially manufacture a vaccine at
artificially low pricing, then increase prices for
profitability
In economics, profit is the difference between the revenue that an economic entity has received from its outputs and the total cost of its inputs. It is equal to total revenue minus total cost, including both explicit and implicit costs.
It i ...
later if annual vaccinations are needed and as countries build stock for future needs.
An April 2020 CEPI report stated: "Strong international coordination and cooperation between vaccine developers, regulators, policymakers, funders, public health bodies, and governments will be needed to ensure that promising late-stage vaccine candidates can be manufactured in sufficient quantities and equitably supplied to all affected areas, particularly low-resource regions."
The WHO and CEPI are developing financial resources and guidelines for the global deployment of several safe, effective COVID‑19 vaccines, recognizing the need are different across countries and population segments.
For example, successful COVID‑19 vaccines would be allocated early to
healthcare personnel and populations at greatest risk of severe illness and death from COVID‑19 infection, such as the elderly or
densely-populated impoverished people.
The WHO had set out the target to vaccinate 40% of the population of all countries by the end of 2021 and 70% by mid-2022, but many countries missed the 40% target at the end of 2021.
Distribution
''Note about table in this section: Number and percentage of people who have received at least one dose of a COVID-19 vaccine (unless noted otherwise). May include vaccination of non-citizens, which can push totals beyond 100% of the local population. Table is updated daily by a bot.
[The table data is automatically updated daily by a bot; see Template:COVID-19 data for more information. Scroll down past the table to find the documentation and the main reference. See also: :Automatically updated COVID-19 pandemic table templates.]''
Phased distribution
Many countries have implemented phased distribution plans that prioritize those at highest risk of complications such as the elderly and those at high risk of exposure and transmission such as healthcare workers.
In the United States, the
Advisory Committee on Immunization Practices
The Advisory Committee on Immunization Practices (ACIP) is a committee within the United States Centers for Disease Control and Prevention (CDC) that provides advice and guidance on effective control of vaccine-preventable diseases in the U.S. civ ...
(ACIP) of the
Centers for Disease Control and Prevention
The Centers for Disease Control and Prevention (CDC) is the national public health agency of the United States. It is a United States federal agency, under the Department of Health and Human Services, and is headquartered in Atlanta, Georgi ...
(CDC) voted in December 2020, that the first doses of the vaccine should be prioritized for healthcare workers and residents and staff of nursing homes. ACIP recommended that the second phase of distribution (Phase 1b) include persons aged ≥75 years and non-healthcare frontline essential workers such as those employed in
grocery stores
A grocery store ( AE), grocery shop ( BE) or simply grocery is a store that primarily retails a general range of food products, which may be fresh or packaged. In everyday U.S. usage, however, "grocery store" is a synonym for supermarket, an ...
,
restaurants
A restaurant is a business that prepares and serves food and drinks to customers. Meals are generally served and eaten on the premises, but many restaurants also offer take-out and food delivery services. Restaurants vary greatly in appearanc ...
,
military
A military, also known collectively as armed forces, is a heavily armed, highly organized force primarily intended for warfare. It is typically authorized and maintained by a sovereign state, with its members identifiable by their distinct ...
,
law enforcement
Law enforcement is the activity of some members of government who act in an organized manner to enforce the law by discovering, deterring, rehabilitating, or punishing people who violate the rules and norms governing that society. The term en ...
,
fire department
A fire department (American English) or fire brigade (Commonwealth English), also known as a fire authority, fire district, fire and rescue, or fire service in some areas, is an organization that provides fire prevention and fire suppression se ...
s,
retail
Retail is the sale of goods and services to consumers, in contrast to wholesaling, which is sale to business or institutional customers. A retailer purchases goods in large quantities from manufacturers, directly or through a wholesaler, and t ...
,
sanitation
Sanitation refers to public health conditions related to clean drinking water and treatment and disposal of human excreta and sewage. Preventing human contact with feces is part of sanitation, as is hand washing with soap. Sanitation systems ...
,
schools
A school is an educational institution designed to provide learning spaces and learning environments for the teaching of students under the direction of teachers. Most countries have systems of formal education, which is sometimes compulsor ...
,
public transportation
Public transport (also known as public transportation, public transit, mass transit, or simply transit) is a system of transport for passengers by group travel systems available for use by the general public unlike private transport, typical ...
,
self-storage
Self storage (a shorthand for "self-service storage," and also known as "device storage") is an industry that rents storage space (such as rooms, lockers, containers, and/or outdoor space), also known as "storage units," to tenants, usually o ...
,
hotel
A hotel is an establishment that provides paid lodging on a short-term basis. Facilities provided inside a hotel room may range from a modest-quality mattress in a small room to large suites with bigger, higher-quality beds, a dresser, a ref ...
s,
warehousing
A warehouse is a building for storing goods. Warehouses are used by manufacturers, importers, exporters, wholesalers, transport businesses, customs, etc. They are usually large plain buildings in industrial parks on the outskirts of cities, tow ...
, and
news media
The news media or news industry are forms of mass media that focus on delivering news to the general public or a target public. These include news agencies, print media (newspapers, news magazines), broadcast news (radio and television), and th ...
. However, states control the final plans for prioritization, distribution, and logistics of vaccinating everyone as supply becomes available.
The European Union began phased vaccine rollout on 27 December 2020. Each member state is managing distribution with a common focus on prioritizing healthcare workers, people at high risk of exposure, the elderly, and those with serious health conditions.
The
COVID‑19 vaccination programme in the United Kingdom prioritized elder care facility residents and carers, followed by healthcare workers and those over 80 years of age. Subsequent phases are based largely on age, declining from 75 years in 5-year increments.
Some countries used accelerated dose 1 plans with extended dose 2 intervals after the first dose in order to extend vaccination to as many people as possible until vaccine availability improved. Data suggests that people who have recovered from COVID-19 may only require a single dose of an mRNA vaccine to reach full two dose immunity.
Mixed series
The use of the different vaccines in a two-shot regimen is not widespread; there is no data on the efficacy of mixed series for COVID-19 vaccines but such series are not expected to be unsafe or ineffective. The US
Centers for Disease Control and Prevention
The Centers for Disease Control and Prevention (CDC) is the national public health agency of the United States. It is a United States federal agency, under the Department of Health and Human Services, and is headquartered in Atlanta, Georgi ...
(CDC) recommends the use of a mixed series only in exceptional circumstances, such as where a second dose of the same vaccine cannot be delivered in a reasonable timeframe. In Canada, authorities were investigating the effectiveness of a mixed series and ultimately recommended the use of a first shot consisting of the
Oxford-AstraZeneca COVID-19 vaccine, followed by one of the mRNA vaccines. In June 2021, German authorities recommended using mRNA vaccines as a second shot after an AstraZeneca shot in younger people as a precaution to avoid a
rare blood clotting side effect associated with the AstraZeneca vaccine. Thailand began mixing-and-matching doses of the AstraZeneca and Sinovac vaccines in July 2021 amid concerns about the Sinovac vaccine's long-term protection.
Equitable access
![Covid-Vaccine-67 (50753109591)](https://upload.wikimedia.org/wikipedia/commons/c/cf/Covid-Vaccine-67_%2850753109591%29.jpg)
During 2020, as the COVID‑19 pandemic escalated globally and vaccine development intensified, the World Health Organization (WHO)
COVAX
COVID-19 Vaccines Global Access, abbreviated as COVAX, is a worldwide initiative aimed at equitable access to COVID-19 vaccines directed by the GAVI vaccine alliance, the Coalition for Epidemic Preparedness Innovations (CEPI), and the World Hea ...
facility adopted the motto "No one is safe unless everyone is safe" to emphasize the need for
equitable vaccination.
The facility set a goal of supplying COVID‑19 vaccines to nearly 100 low-to-middle income countries that could not afford them. COVAX sought to fundraise to purchase and deliver vaccines to participating countries in proportion to their populations.
On 18 December 2020, the facility announced agreements with vaccine manufacturers to supply 1.3billion doses for 92 low-middle income countries in the first half of 2021.
Yet, by mid-December, some 16 countries representing only 14% of the world's population had preordered more than 10billion vaccine doses or about 51% of the available world supply.
Specifically, Canada, Australia, and Japan having only 1% of the world's COVID‑19 cases had collectively reserved some 1billion vaccine doses,
while the COVAX facility had reserved only a few hundred million doses.
At the
Group of Seven summit in June 2021, the United States promised to distribute 500million vaccine doses internationally; this distribution began on 17 August.
Preorders from rich countries were made during 2020 with 13 different vaccine manufacturers, whereas those for low-to-middle income countries were made primarily for the
Oxford–AstraZeneca COVID-19 vaccine
The Oxford–AstraZeneca COVID19 vaccine, sold under the brand names Covishield and Vaxzevria among others, is a viral vector vaccine for prevention of COVID-19. Developed in the United Kingdom by Oxford University and British-Swedish comp ...
, which is lowest in cost and has no special refrigeration needs.
![WHO EN - Illustration 3 - Country Readiness - NDVP 19Feb2021](https://upload.wikimedia.org/wikipedia/commons/3/39/WHO_EN_-_Illustration_3_-_Country_Readiness_-_NDVP_19Feb2021.jpg)
The CEPI, the WHO, and charitable vaccine organizations, such as the Gates Foundation and GAVI, raised over during the first half of 2020, to fund vaccine development and preparedness for vaccinations, particularly for children in
under-developed countries.
CEPI, which was created to monitor fair distribution of infectious disease vaccines to low- and middle-income countries,
has recommended considering manufacturing capacity, financing and purchasing, and releasing vaccine developers from liability.
Despite opposition from some vaccine manufacturers,
CEPI revised its February 2020 equitable access policy to apply specifically to its COVID‑19 vaccine funding:
# "prices for vaccines will be set as low as possible for territories that are or may be affected by an outbreak of a disease for which CEPI funding was used to develop a vaccine;
# "information, know-how and materials related to vaccine development must be shared with (or transferred to) CEPI" so that it can assume responsibility for vaccine development if a company discontinues expenditures for a promising vaccine candidate;
# CEPI would have access to, and possible management of, intellectual property rights (i.e., patents) for promising vaccines;
# "CEPI would receive a share of financial benefits that might accrue from CEPI-sponsored vaccine development, to re-invest in support of its mission to provide global public health benefit"; and
# data transparency among development partners should maintain the WHO Statement on Public Disclosure of Clinical Trial Results, and require results to be published in
open-access
Open access (OA) is a set of principles and a range of practices through which research outputs are distributed online, free of access charges or other barriers. With open access strictly defined (according to the 2001 definition), or libre op ...
publications.
International groups, such as the Centre for Artistic Activism and
Universities Allied for Essential Medicines
Universities Allied for Essential Medicines (UAEM) is a student-led organization working to improve access to and affordability of medicines around the world, and to increase research and development of drugs for neglected tropical diseases.
Supp ...
, advocate for equitable access. Scientists have encouraged collaboration between the WHO, CEPI, corporations, and governments to ensure that vaccines are distributed in an evidence-based manner based on infection risk
and to prioritize healthcare workers, vulnerable populations, and children.
By mid-March 2021, 67 countries, mostly in Africa and the Middle East, had not yet reported any vaccinations. Countries that had begun vaccinations were generally prioritizing populations such as health workers or the elderly. It has also been suggested that
elective surgery
Elective surgery or elective procedure (from the la, eligere, meaning to choose) is surgery that is scheduled in advance because it does not involve a medical emergency. Semi-elective surgery is a surgery that must be done to preserve the patien ...
recipients should be prioritized since a patient recovering from surgery would be more vulnerable than average. Some expressed concern over the short shelf-life of the Moderna and Pfizer-BioNTech vaccines, which expire within hours after being removed from the freezer; they argued that, once the vaccine is unfrozen, it is better to apply these doses to anyone who can be found rather than discard the doses.
As of March 2021, the United States had ordered twice the necessary doses to cover its own population, but it remained unclear when it might share surplus doses with other countries. In April 2021, ''
Vanity Fair'' reported that it would be difficult to share surplus doses with other countries because the U.S. government had expressly agreed in its contracts with vaccine manufacturers to use doses only in the United States and its territories.
The manufacturers requested this clause because most other countries do not have liability protections for vaccines as expansive as the
Public Readiness and Emergency Preparedness Act
The Public Readiness and Emergency Preparedness Act (PREPA), passed by the United States Congress and signed into law by President of the United States George W. Bush in December 2005 (as part of ), is a controversial tort liability shield inten ...
.
In late November 2021 the
World Health Organization
The World Health Organization (WHO) is a specialized agency of the United Nations responsible for international public health. The WHO Constitution states its main objective as "the attainment by all peoples of the highest possible level of h ...
published, "it is vitally important that inequities in access to COVID-19 vaccines are urgently addressed to ensure that vulnerable groups everywhere, including health workers and older persons, receive their first and second doses, alongside equitable access to treatment and diagnostics." Inequalities in vaccine distribution facilitate the emergence of new variants like
SARS-CoV-2 Omicron variant
Omicron (B.1.1.529) is a variant of SARS-CoV-2 first reported to the World Health Organization (WHO) by the Network for Genomics Surveillance in South Africa on 24 November 2021. It was first detected in Botswana and has spread to become the ...
.
Concerns
Concerns were raised that wealthy countries may receive their vaccines in 2020–21 while developing countries may be excluded from vaccinations until 2023–24.
Data from April 2021 comports with this expectation since 25% of the population in high income countries have been vaccinated compared to only 0.2% in low income countries.
The head of the World Health Organization said on 4 August 2021 that rich countries had administered about 100 doses per 100 people while poor countries had administered only about 1.5 doses for every 100 people, and therefore, in his estimation, it was important to prioritize vaccination in poor countries before offering booster vaccines in rich countries. The WHO Director General Tedros Adhanom Ghedreyesus raised concerns about rich countries hoarding vaccines at the expense of citizens in poorer nations who wait for vaccines to either become available or are donated. The WHO Regional Office of Africa highlighted vaccine discard in African countries, after Nigeria destroyed about 1 million donated doses of AstraZeneca vaccine after being donated with only a few weeks till expiration. Other countries such as Malawi, and South Sudan have either destroyed expired or close to expiring vaccines or paused donated shipments due to expiration concerns.
Intellectual property
The first
polio vaccine
Polio vaccines are vaccines used to prevent poliomyelitis (polio). Two types are used: an inactivated poliovirus given by injection (IPV) and a weakened poliovirus given by mouth (OPV). The World Health Organization (WHO) recommends all chil ...
was never patented; some have argued that similar treatment of an effective COVID‑19 vaccine could enable fair distribution.
Initially, negotiations at the
World Trade Organization
The World Trade Organization (WTO) is an intergovernmental organization that regulates and facilitates international trade. With effective cooperation
in the United Nations System, governments use the organization to establish, revise, and e ...
(WTO) on the issue of waiving patent rights were blocked for months by resistance by the US, Switzerland, Norway, and the EU. Initially one observer considered the US position unlikely to change,
but as of April 2021 the US administration was discussing the issue and then reversed course and announced its support for a patent waiver for COVID-19 vaccines on 5 May 2021.
400 non-profit organizations and 115 members of the
European Commission
The European Commission (EC) is the executive of the European Union (EU). It operates as a cabinet government, with 27 members of the Commission (informally known as "Commissioners") headed by a President. It includes an administrative body o ...
have signed a letter urging the United States and Europe to side with the WTO members in the global south.
Debate
Some question if patent waiver proposals formulated for
small molecule
Within the fields of molecular biology and pharmacology, a small molecule or micromolecule is a low molecular weight (≤ 1000 daltons) organic compound that may regulate a biological process, with a size on the order of 1 nm. Many drugs ar ...
drugs can be applied to complex
biologics
A biopharmaceutical, also known as a biological medical product, or biologic, is any pharmaceutical drug product manufactured in, extracted from, or semisynthesized from biological sources. Different from totally synthesized pharmaceuticals, th ...
like vaccines.
One vaccine production expert argued that "there is an unrecognized gap in understanding ... nearly all of the people who are providing views on the value of removing patent protections have zero experience in vaccine development and manufacturing."
Indeed, most of the advocacy in favor of patent waivers has come from the
public health
Public health is "the science and art of preventing disease, prolonging life and promoting health through the organized efforts and informed choices of society, organizations, public and private, communities and individuals". Analyzing the det ...
community (which has drawn inspiration from the history of raucous
HIV/AIDS activism
Social activism, Social and Political protest, political activism to raise awareness about HIV/AIDS, as well as to raise funds for treatment of HIV/AIDS, effective treatment and care of people with AIDS (PWAs), has taken place in multiple nations ...
in the 1980s and 1990s),
while most members of the vaccinology community (i.e., actual experts on development and production of vaccines) have effectively refused to lend their credibility to such proposals by either remaining silent or refusing to take any position.
Small molecule drugs are easy to copy and can be quickly brought to market by
generic drug
A generic drug is a pharmaceutical drug that contains the same chemical substance as a drug that was originally protected by chemical patents. Generic drugs are allowed for sale after the patents on the original drugs expire. Because the active ch ...
manufacturers who are not required to run their own full-scale
clinical trial
Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietar ...
s because they can piggyback on
regulatory approvals obtained by original drug manufacturers.
In contrast, "there is no such thing as generic vaccines".
The manufacturer of each independently developed vaccine (including a purported copy of an existing vaccine) must run its own clinical trials to establish safety and efficacy.
Independent copying of an existing first-generation vaccine is so hard that the resulting second-generation vaccine is often a significant improvement over the first-generation technology and is itself patentable.
Although Moderna has stated that it will not seek enforcement of its patents during the pandemic,
a patent waiver (voluntary or involuntary) would not force a vaccine manufacturer to disclose the complete knowledge (i.e.,
know-how
Know-how (or knowhow, or procedural knowledge) is a term for practical knowledge on how to accomplish something, as opposed to "know-what" (facts), "know-why" (science), or "know-who" (communication). It is also often referred to as street smart ...
) for making a vaccine, which is not found in patents.
The World Health Organization (WHO) has promoted the COVID-19 Technology Access Pool to facilitate disclosures, but participation is voluntary and none of the vaccine manufacturers have joined.
Without access to the original vaccine manufacturer's know-how,
reverse engineering
Reverse engineering (also known as backwards engineering or back engineering) is a process or method through which one attempts to understand through deductive reasoning how a previously made device, process, system, or piece of software accompli ...
the manufacturing process is difficult and expensive with no guarantee of success.
Even if a third party succeeds, they must prove that fact to the satisfaction of
regulatory authorities
A regulatory agency (regulatory body, regulator) or independent agency (independent regulatory agency) is a government authority that is responsible for exercising autonomous dominion over some area of human activity in a licensing and regulatin ...
.
For small molecule drugs, proving
bioequivalence
Bioequivalence is a term in pharmacokinetics used to assess the expected in vivo biological equivalence of two proprietary preparations of a drug. If two products are said to be bioequivalent it means that they would be expected to be, for all i ...
of a generic drug to the original drug costs only about US$1 to $2million; but for biologics, proving
biosimilar
A biosimilar (also known as follow-on biologic or subsequent entry biologic) is a biologic medical product that is almost an identical copy of an original product that is manufactured by a different company. Biosimilars are officially approved ...
ity of a third-party product to the original product requires clinical trials, with costs ranging from US$100 to $250million.
One
financial analyst
A financial analyst is a professional, undertaking financial analysis for external or internal clients as a core feature of the job.
The role may specifically be titled securities analyst, research analyst, equity analyst, investment analyst, ...
specializing in pharmaceuticals estimated that it would take a minimum of two years after patent waiver for the first independent reproductions of a COVID-19 vaccine to reach the market,
which may be too long to have any net impact on global public health.
While discussing the idea of "open source" COVID-19 vaccine manufacturing,
Bill Gates
William Henry Gates III (born October 28, 1955) is an American business magnate and philanthropist. He is a co-founder of Microsoft, along with his late childhood friend Paul Allen. During his career at Microsoft, Gates held the positions ...
said: "There's not a single additional vaccine that would have come out of that .... no free IP would have improved anything related to this pandemic."
His
foundation
Foundation may refer to:
* Foundation (nonprofit), a type of charitable organization
** Foundation (United States law), a type of charitable organization in the U.S.
** Private foundation, a charitable organization that, while serving a good cause ...
has instead helped other countries reach licensing deals as in the case of the Oxford/AstraZeneca vaccine being produced by India's Serum Institute.
Another concern, raised by Pfizer CEO
Albert Bourla
Albert Bourla ( el, Άλμπερτ Μπουρλά; born ) is a Greek-American veterinarian and the chairman and chief executive officer of Pfizer, an American pharmaceutical company. He joined the company in 1993 and has held several executive ro ...
, is that allowing unauthorized third-party vaccine production would severely disrupt vaccine developers' efforts to ramp up vaccine production when original developers and third-party producers all end up competing for the same scarce raw materials.
This is why some conclude that voluntary
technology transfer
Technology transfer (TT), also called transfer of technology (TOT), is the process of transferring (disseminating) technology from the person or organization that owns or holds it to another person or organization, in an attempt to transform invent ...
s are the superior option for producing more doses
—since the transferor's active assistance can help the transferee bypass time-consuming clinical trials by taking advantage of existing approvals for the transferor's vaccine
—and others describe patent waiver proposals as "more symbolic than practical".
Derek Lowe has characterized the U.S. government's May 2021 announcement of support for patent waiver proposals as "almost as much of a
PR move as anything else".
By November 2021, the prospects for approval of such proposals (which by WTO tradition must be unanimous) looked increasingly remote; participants criticized the United States for not working to bridge the gap between supporters and opponents.
Meanwhile,
Tedros Adhanom Ghebreyesus
Tedros Adhanom Ghebreyesus ( ti, ቴዎድሮስ አድሓኖም ገብረኢየሱስ, sometimes spelt ti, ቴድሮስ ኣድሓኖም ገብረየሱስ, label=none; born 3 March 1965) is an Ethiopian public health official, researcher, and ...
has rejected the dichotomy between waiving patents and initiating technology transfers by including both measures as part of a list of four steps towards increasing vaccine production. He pointed out that the
TRIPS agreement
The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) is an international legal agreement between all the member nations of the World Trade Organization (WTO). It establishes minimum standards for the regulation by nat ...
signed by all members of the
WTO
The World Trade Organization (WTO) is an intergovernmental organization that regulates and facilitates international trade. With effective cooperation
in the United Nations System, governments use the organization to establish, revise, and e ...
already allows for an emergency waiver of intellectual property rights in countries with free manufacturing capacities.
Several observers have noted that the vaccine patent waiver debate involves an issue expected to outlast the COVID-19 pandemic: who will control the broader technology of
RNA therapeutics
RNA therapeutics are a new class of medications based on ribonucleic acid (RNA). Research has been working on clinical use since the 1990s, with significant success in cancer therapy in the early 2010s. In 2020 and 2021, mRNA vaccines have been ...
.
Howard Dean
Howard Brush Dean III (born November 17, 1948) is an American physician, author, lobbyist, and retired politician who served as the 79th governor of Vermont from 1991 to 2003 and chair of the Democratic National Committee (DNC) from 2005 to 200 ...
has accused
Narendra Modi
Narendra Damodardas Modi (; born 17 September 1950) is an Indian politician serving as the 14th and current Prime Minister of India since 2014. Modi was the Chief Minister of Gujarat from 2001 to 2014 and is the Member of Parliament from ...
of trying to gain access to such technology by promoting the "disingenuous" claim that patent waivers will accelerate vaccine production.
Josh Rogin
Josh Rogin is an American journalist who serves as a foreign policy columnist for the Global Opinions section of ''The Washington Post'' and as a political analyst for CNN. He is the author of the book ''Chaos Under Heaven: Trump, Xi, and the B ...
has pointed out that control of mRNA technology has "
national security implications" for the United States, and that its development was initially funded by U.S. taxpayers through
DARPA
The Defense Advanced Research Projects Agency (DARPA) is a research and development agency of the United States Department of Defense responsible for the development of emerging technologies for use by the military.
Originally known as the Adv ...
for that reason.
Central to the debate is whether profits from strong
intellectual property
Intellectual property (IP) is a category of property that includes intangible creations of the human intellect. There are many types of intellectual property, and some countries recognize more than others. The best-known types are patents, cop ...
rights are necessary to ensure that someone will conduct the
applied research
Applied science is the use of the scientific method and knowledge obtained via conclusions from the method to attain practical goals. It includes a broad range of disciplines such as engineering and medicine. Applied science is often contrasted ...
which turns promising laboratory experiments into marketable drugs and vaccines. Such research is dauntingly expensive (on average, $3billion per successful drug) and nearly always fails (only 12 percent of drugs which enter clinical trials ultimately obtain
FDA
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...
approval),
and "governments have neither the money nor the
risk tolerance
In economics and finance, risk aversion is the tendency of people to prefer outcomes with low uncertainty to those outcomes with high uncertainty, even if the average outcome of the latter is equal to or higher in monetary value than the more ...
to take over the role of businesses in developing pharmacy-ready medicines".
Moderna co-founder
Robert S. Langer has argued that early private investors deserve "a lot of credit" for its successful COVID-19 vaccine since they "put the money in way before" the U.S. federal government got involved, and thereby laid the foundation for the company's success many years later.
The risk of waiving patents for COVID-19 vaccines is that it sets a precedent which may discourage the private sector from future investments in vaccines and other lifesaving technologies, and in turn, future technologies not yet developed will never come to market when the public sector fails to pick up the slack.
As one financial analyst explained: "It would be intensively counterproductive, in the extreme, because what it would say to the industry is: 'Don't work on anything that we really care about, because if you do, we're just going to take it away from you.
The "most depressing" worst-case outcome is that pharmaceutical firms give up on saving lives and focus on inventing
quality of life
Quality of life (QOL) is defined by the World Health Organization as "an individual's perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards ...
treatments which are more profitable and less likely to be expropriated;
the most notorious examples of such treatments are Pfizer's
Viagra
Sildenafil, sold under the brand name Viagra, among others, is a medication used to treat erectile dysfunction and pulmonary arterial hypertension. It is unclear if it is effective for treating sexual dysfunction in women. It is taken by ...
and
Allergan's Botox
Botulinum toxin, or botulinum neurotoxin (BoNT), is a neurotoxic protein produced by the bacterium '' Clostridium botulinum'' and related species. It prevents the release of the neurotransmitter acetylcholine from axon endings at the neuromus ...
.
The "threat of losing developers is real" in the vaccine sector, which had withered away to only a handful of companies by the turn of the 21st century and by 2021 had only recently begun to grow again.
However,
Peter Bach
Peter B. Bach is a physician and writer at Memorial Sloan-Kettering Cancer Center where he is Director of the Center for Health Policy and Outcomes. His research focuses on healthcare policy, particularly as it relates to Medicare, racial disp ...
has argued that whether this risk might be worth it deserves to be frankly debated: "If this action allows for more access and more people to have their lives saved today in 2021 and the consequence is down the road we may not have some new gene therapy for 100 kids, then that's the trade-off worth discussing".
Sovereignty
Favored distribution of vaccines within one or a few select countries, called "vaccine sovereignty", is a criticism of some of the vaccine development partnerships,
such as for the AstraZeneca-University of Oxford vaccine candidate, concerning whether there may be prioritized distribution first within the UK and to the "highest bidder" – the United States, which made an
advance payment An advance payment, or simply an advance, is the part of a contractually due sum that is paid or received in advance for goods or services, while the balance included in the invoice will only follow the delivery. Advance payments are recorded as a ...
of to secure 300million vaccine doses for Americans, even before the AstraZeneca-Oxford vaccine or a
Sanofi
Sanofi S.A. is a French multinational pharmaceutical and healthcare company headquartered in Paris, France. Originally, the corporation was established in 1973 and merged with Synthélabo in 1999 to form Sanofi-Synthélabo. In 2004, Sanofi-Syn ...
vaccine was proved safe or effective.
Concerns exist about whether some countries producing vaccines may impose
protectionist controls by export restrictions that would
stockpile a COVID‑19 vaccine for their own population.
The Chinese government pledged in May 2020, that a successful Chinese vaccine would become a "global, public good", implying enough doses would be manufactured for both national and global distribution. Unlike mRNA vaccines, which have to be stored at subzero temperatures, inactivated vaccines from Sinovac and Sinopharm require ordinary refrigeration and may have more appeal in developing countries. In November 2021, the Chinese government pledged to donate in 2022 a further 600 million vaccine doses to Africa, and supply another 400 million through other routes including production by Chinese companies in Africa.
In June 2020, the
Serum Institute of India
Serum Institute of India (SII) is an Indian biotechnology and biopharmaceuticals company, based in Pune. It is the world's largest manufacturer of vaccines. It was founded by Cyrus Poonawalla in 1966 and is a part of Cyrus Poonawalla Group.
...
(SII) – a major manufacturer of global vaccines – reached a licensing agreement with AstraZeneca to make 1billion doses of vaccine for low-and-middle income countries,
of which half of the doses would go to India.
Similar preferential homeland distribution may exist if a vaccine is manufactured in Australia.
Illegal distribution
In the United States, the vaccine distribution line, while varying by state, has placed healthcare workers and senior citizens high on the list for
COVID-19
Coronavirus disease 2019 (COVID-19) is a contagious disease caused by a virus, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The first known case was COVID-19 pandemic in Hubei, identified in Wuhan, China, in December ...
vaccination, while less essential workers are secondary recipients. Due to the long process of distribution, some individuals tried to secure a more favorable position on the vaccination list, such as by
bribery
Bribery is the Offer and acceptance, offering, Gift, giving, Offer and acceptance, receiving, or Solicitation, soliciting of any item of value to influence the actions of an official, or other person, in charge of a public or legal duty. With reg ...
or making donations to hospitals. In response, state governments imposed large fines and other penalties for violation of federal vaccine distribution guidelines. A COVID-19 vaccine
black market
A black market, underground economy, or shadow economy is a clandestine market or series of transactions that has some aspect of illegality or is characterized by noncompliance with an institutional set of rules. If the rule defines the se ...
enabled some individuals to buy illegal early access to a vaccine.
By mid-February 2021, China had arrested 80 people involved in vaccine contraband, and the Colombian government intercepted a freezer with 70 doses of a Chinese-manufactured vaccine that a traveler brought with her into the airport without any accompanying paperwork.
Vaccine tourism
In the later half of February 2021, it was reported that wealthy and influential people from
Canada
Canada is a country in North America. Its ten provinces and three territories extend from the Atlantic Ocean to the Pacific Ocean and northward into the Arctic Ocean, covering over , making it the world's second-largest country by tot ...
and European countries flew to the
United Arab Emirates
The United Arab Emirates (UAE; ar, اَلْإِمَارَات الْعَرَبِيَة الْمُتَحِدَة ), or simply the Emirates ( ar, الِْإمَارَات ), is a country in Western Asia (The Middle East). It is located at th ...
to secure early access to the vaccine. The UAE has been promoting
Dubai
Dubai (, ; ar, دبي, translit=Dubayy, , ) is the most populous city in the United Arab Emirates (UAE) and the capital of the Emirate of Dubai, the most populated of the 7 emirates of the United Arab Emirates.The Government and Politics of ...
as a vaccine holiday hub for the wealthy, who can pay a hefty amount to get inoculated before they become eligible. Some
Canadians who maintained second homes in the United States were able to get vaccines earlier.
As restrictions on vaccine eligibility were lowered in the United States, wealthier individuals from other countries with slower vaccination rates were reportedly travelling to the United States to be vaccinated. The U.S. state of
Alaska
Alaska ( ; russian: Аляска, Alyaska; ale, Alax̂sxax̂; ; ems, Alas'kaaq; Yup'ik: ''Alaskaq''; tli, Anáaski) is a state located in the Western United States on the northwest extremity of North America. A semi-exclave of the U.S., ...
announced in April 2021 that it would intentionally offer free vaccinations to tourists at
major Alaskan airports starting 1 June 2021. In an effort to guard against vaccine tourism, Greece restricted its eligibility to those with a social security number. However, this had the effect of excluding part of the elderly or immigrant population as well as some Greek citizens who worked abroad before the pandemic.
In the European Union, several travel agencies are offering "vaccine vacations". The
Maldives
Maldives (, ; dv, ދިވެހިރާއްޖެ, translit=Dhivehi Raajje, ), officially the Republic of Maldives ( dv, ދިވެހިރާއްޖޭގެ ޖުމްހޫރިއްޔާ, translit=Dhivehi Raajjeyge Jumhooriyyaa, label=none, ), is an archipelag ...
are also offering vaccines as part of holiday travel packages.
Cost
An effective vaccine for COVID‑19 could save
trillion
''Trillion'' is a number with two distinct definitions:
* 1,000,000,000,000, i.e. one million million, or (ten to the twelfth power), as defined on the short scale. This is now the meaning in both American and British English.
* 1,000,000,000,0 ...
s of dollars in global economic impact, according to economists Arnab Acharya and Sanjay Reddy who advocate suspending patent protections for vaccines temporarily and compensating the affected companies. Any price tag in the billions would therefore look small in comparison. In early stages of the pandemic, it was not known if it would be possible to create a safe, reliable and affordable vaccine for this virus, and it was not known exactly how much the vaccine development could cost.
Even with several vaccines on the market, the antigenicity changes in
new variants of the virus mean that the billions of dollars could still be invested without success.
Before an effective vaccine was developed, it was clear that billions of doses would need to be manufactured and distributed worldwide. In April 2020, the Gates Foundation estimated that manufacturing and distribution could cost as much as . Gates also admitted "Ideally, there would be global agreement about who should get the vaccine first, but given how many competing interests there are, this is unlikely to happen".
From Phase I clinical trials, 84–90%
of vaccine candidates fail to make it to final approval during development, and from Phase III, 25.7% fail
the investment by a manufacturer in a vaccine candidate may exceed and end with millions of useless doses given advanced manufacturing agreements.
In the case of the
Oxford-AstraZeneca COVID-19 vaccine, 97% of this came from taxpayer money.
As of November 2020, companies subsidized under the United States' Operation Warp Speed program have set initial pricing at to per dose, in line with the
influenza vaccine
Influenza vaccines, also known as flu shots, are vaccines that protect against infection by influenza viruses. New versions of the vaccines are developed twice a year, as the influenza virus rapidly changes. While their effectiveness varies fr ...
. In December 2020, a Belgian politician briefly published the confidential prices agreed between vaccine producers and the EU:
Supply chain
Deploying a COVID‑19 vaccine may require worldwide transport and tracking of 10–19billion vial doses, an effort readily becoming the largest
supply chain
In commerce, a supply chain is a network of facilities that procure raw materials, transform them into intermediate goods and then final products to customers through a distribution system. It refers to the network of organizations, people, acti ...
challenge in history.
As of September 2020, supply chain and logistics experts expressed concern that international and national networks for distributing a licensed vaccine were not ready for the volume and urgency, due mainly to deterioration of resources during 2020 pandemic lockdowns and downsizing that degraded supply capabilities. Globally, supplies critical to vaccine research and development are increasingly scarce due to international competition or national sequestration.
Addressing the worldwide challenge faced by coordinating numerous organizations – the COVAX partnership, global pharmaceutical companies, contract vaccine manufacturers, inter- and intranational transport, vaccine storage
Vaccine storage relates to the proper vaccine storage and handling practices from their manufacture to the administration in people. The general standard is the 2–8 °C cold chain for vaccine storage and transportation. This is used for all ...
facilities, and health organizations in individual countries – Seth Berkley
Seth Franklin Berkley (born October 18, 1956) is an American medical epidemiologist, the CEO of Gavi, the Vaccine Alliance and a global advocate of the power of vaccines. He is the founder and former president and CEO of the International AIDS ...
, chief executive of GAVI, stated: "Delivering billions of doses of vaccine to the entire world efficiently will involve hugely complex logistical and programmatic obstacles all the way along the supply chain."
As an example highlighting the immensity of the challenge, the International Air Transport Association
The International Air Transport Association (IATA ) is a trade association of the world's airlines founded in 1945. IATA has been described as a cartel since, in addition to setting technical standards for airlines, IATA also organized tariff ...
stated that 8,000 Boeing 747
The Boeing 747 is a large, long-range wide-body airliner designed and manufactured by Boeing Commercial Airplanes in the United States between 1968 and 2022.
After introducing the 707 in October 1958, Pan Am wanted a jet times its size, t ...
cargo planes, equipped for precision vaccine cold storage, would be needed to transport one dose for the entire population in the more than 200 countries experiencing the COVID‑19 pandemic. GAVI states that "with a fast-moving pandemic, no one is safe, unless everyone is safe."[
In contrast to the multibillion-dollar investment in vaccine technologies and early-stage clinical research, the post-licensing supply chain for a vaccine has not received the same planning, coordination, security or investment.] A major concern is that resources for vaccine distribution in low- to middle-income countries, particularly for vaccinating children, are inadequate or non-existent, but could be improved with cost efficiencies if procurement and distribution were centralized regionally or nationally. In September, the COVAX partnership included 172 countries coordinating plans to optimize the supply chain for a COVID‑19 vaccine, and the United Nations Children's Fund joined with COVAX to prepare the financing and supply chain for vaccinations of children in 92 developing countries.
Logistics
Logistics vaccination services assure necessary equipment, staff, and supply of licensed vaccines across international borders. Central logistics include vaccine handling and monitoring, cold chain management, and safety of distribution within the vaccination network. The purpose of the COVAX facility is to centralize and equitably administer logistics resources among participating countries, merging manufacturing, transport, and overall supply chain infrastructure.[ Included are logistics tools for vaccine forecasting and needs estimation, in-country vaccine management, potential for wastage, and stock management.][
Other logistics factors conducted internationally during distribution of a COVID‑19 vaccine may include:]
* visibility and traceability by barcode
A barcode or bar code is a method of representing data in a visual, machine-readable form. Initially, barcodes represented data by varying the widths, spacings and sizes of parallel lines. These barcodes, now commonly referred to as linear or o ...
s for each vaccine vial
* sharing of supplier audits
* sharing of chain of custody
Chain of custody (CoC), in legal contexts, is the chronological documentation or paper trail that records the sequence of custody, control, transfer, analysis, and disposition of materials, including physical or electronic evidence. Of particular ...
for a vaccine vial from manufacturer to the individual being vaccinated
* use of vaccine temperature monitoring tools
* temperature stability testing and assurance
* new packaging and delivery technologies
* stockpiling
* coordination of supplies within each country (personal protective equipment
Personal protective equipment (PPE) is protective clothing, helmets, goggles, or other garments or equipment designed to protect the wearer's body from injury or infection. The hazards addressed by protective equipment include physical, elec ...
, diluent
A diluent (also referred to as a filler, dilutant or thinner) is a Concentration, diluting agent. Certain fluids are too Viscosity, viscous to be pumped easily or too density, dense to flow from one particular point to the other. This can be prob ...
, syringes, needles, rubber stoppers, refrigeration fuel or power sources, waste-handling, among others)
* communications technology
* environmental impacts in each country
A logistics shortage in any one step may derail the whole supply chain, according to one vaccine developer. If the vaccine supply chain fails, the economic and human costs of the pandemic may be extended for years.[
]
Manufacturing capacity
By August 2020, when only a few vaccine candidates were in Phase III trials and were many months away from establishing safety and efficacy, numerous governments pre-ordered more than 2billion doses at a cost of more than .[ Pre-orders from the British government for 2021 were for five vaccine doses per person, a number dispiriting to organizations like the WHO and GAVI which are promoting fair and equitable access worldwide, especially for developing countries.][ In September, CEPI was financially supporting basic and clinical research for nine vaccine candidates, with nine more in evaluation, under financing commitments to manufacture 2billion doses of three licensed vaccines by the end of 2021.][ Before 2022, 7–10billion COVID‑19 vaccine doses may be manufactured worldwide, but the sizable pre-orders by affluent countries – called "vaccine nationalism" – threaten vaccine availability for poorer nations.][
The ]RNA vaccine
An mRNA vaccine is a type of vaccine that uses a copy of a molecule called messenger RNA (mRNA) to produce an immune response. The vaccine delivers molecules of antigen-encoding mRNA into immune cells, which use the designed mRNA as a blueprin ...
s from Moderna and Pfizer-BioNTech are unusually difficult to produce because they rely upon encapsulation of mRNA in lipid nanoparticles, a novel technology which has never been scaled up before for mass production. As of February 2021, this was thought to be the primary bottleneck in the manufacturing of such vaccines. In November 2021, Moderna CEO Stéphane Bancel claimed that the company had a backlog of tens of millions of doses of its vaccine destined for Africa because COVAX
COVID-19 Vaccines Global Access, abbreviated as COVAX, is a worldwide initiative aimed at equitable access to COVID-19 vaccines directed by the GAVI vaccine alliance, the Coalition for Epidemic Preparedness Innovations (CEPI), and the World Hea ...
or individual governments could not take delivery. He cited delays with dose administration, a shortage of refrigerator space, and delays getting customs documents.
Vaccines must be handled and transported according to international regulations, be maintained at controlled temperatures that vary across vaccine technologies, and be used for immunization before deterioration in storage.[ The scale of the COVID‑19 vaccine supply chain is expected to be vast to ensure delivery worldwide to vulnerable populations.][ Priorities for preparing facilities for such distribution include temperature-controlled facilities and equipment, optimizing infrastructure, training immunization staff, and rigorous monitoring.][ ]RFID
Radio-frequency identification (RFID) uses electromagnetic fields to automatically identify and track tags attached to objects. An RFID system consists of a tiny radio transponder, a radio receiver and transmitter. When triggered by an electromag ...
technologies are being implemented to track and authenticate a vaccine dose from the manufacturer along the entire supply chain to the vaccination.
In September 2020, Grand River Aseptic Manufacturing agreed with Johnson & Johnson
Johnson & Johnson (J&J) is an American multinational corporation founded in 1886 that develops medical devices, pharmaceuticals, and consumer packaged goods. Its common stock is a component of the Dow Jones Industrial Average and the company i ...
to support the manufacture of its vaccine candidate, including technology transfer
Technology transfer (TT), also called transfer of technology (TOT), is the process of transferring (disseminating) technology from the person or organization that owns or holds it to another person or organization, in an attempt to transform invent ...
and fill and finish
In the pharmaceutical industry, fill and finish (also referred to as fill finish, fill-finish or fill/finish) is the process of filling vials with vaccine , biological and pharmaceutical Drug Substances (DS) and finishing the process of packaging t ...
manufacturing. In October 2020, it was announced that the Moderna vaccine candidate will be manufactured in Visp
Visp (french: Viège) is the capital of the district of Visp in the canton of Valais in Switzerland.
Geography
Visp lies in the Rhône valley, at the confluence of the Vispa and the Rhône, west of Brig-Glis.
Visp has an area, , of . Of ...
, Switzerland
). Swiss law does not designate a ''capital'' as such, but the federal parliament and government are installed in Bern, while other federal institutions, such as the federal courts, are in other cities (Bellinzona, Lausanne, Luzern, Neuchâtel ...
by its partner Lonza Group
Lonza Group is a Swiss multinational manufacturing company for the pharmaceutical, biotechnology and nutrition sectors, headquartered in Basel, with major facilities in Europe, North America and South Asia. Lonza was established under that name in ...
, which plans to produce the first doses in December 2020. The newly built 2,000-square-metre facility will ramp up production to 300million doses annually. The ingredient will be shipped frozen at −70°C to Spain's Laboratorios Farmacéuticos Rovi SA for the final stage of manufacturing.[ Lonza's site in ]Portsmouth, New Hampshire
Portsmouth is a city in Rockingham County, New Hampshire, United States. At the 2020 census it had a population of 21,956. A historic seaport and popular summer tourist destination on the Piscataqua River bordering the state of Maine, Portsmou ...
, aimed to start making vaccine ingredients exclusively for the U.S. by November 2020.[ Compounding the concerns over massive pre-orders by wealthy countries, manufacturing capacity is also limited by the fact that most vaccines are patented by companies in those countries. India and South Africa proposed a waiver to the ]TRIPS Agreement
The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) is an international legal agreement between all the member nations of the World Trade Organization (WTO). It establishes minimum standards for the regulation by nat ...
which would remove exclusivity agreements as a barrier to setting up new facilities but the measure is being blocked by the G7.
Cold chain
Different vaccines have different shipping and handling requirements. For example, the Pfizer-BioNTech COVID‑19 vaccine must be shipped and stored between , must be used within five days of thawing, and has a minimum order of 975 doses, making it unlikely to be rolled out in settings other than large, well-equipped hospitals. The Moderna vaccine vials require storage above and between . Once refrigerated, the Moderna vaccine can be kept between for up to 30 days.
Vaccines (and adjuvants) are inherently unstable during temperature changes, requiring cold chain
A cold chain is a low temperature-controlled supply chain network. An unbroken cold chain is an uninterrupted series of refrigerated production, storage and distribution activities, along with associated equipment and logistics, which maintain qu ...
management throughout the entire supply chain, typically at temperatures of . Because COVID‑19 vaccine technologies are varied among several novel technologies, there are new challenges for cold chain management, with some vaccines that are stable while frozen but liable to heat, while others should not be frozen at all, and some are stable across temperatures. Failure to maintain cold chain temperature stability results in damage that can reduce or even eliminate vaccine efficacy. Sinopharm
China National Pharmaceutical Group Corporation (CNPGC), commonly referred to as Sinopharm, is a Chinese state-owned enterprise. The corporation was the indirect major shareholder of publicly traded companies Sinopharm Group (, via a 51–49 j ...
and Sinovac
Sinovac Biotech Ltd. () is a Chinese biopharmaceutical company based in Haidian District, Beijing that focuses on the research, development, manufacture, and commercialization of vaccines that protect against human infectious diseases. The comp ...
's vaccines are examples of inactivated vaccine
An inactivated vaccine (or killed vaccine) is a vaccine consisting of virus particles, bacteria, or other pathogens that have been grown in culture and then killed to destroy disease-producing capacity. In contrast, live vaccines use pathogens ...
s which can be transported using existing cold chain systems at .
modRNA vaccine technologies in development may be more difficult to manufacture at scale and control degradation, requiring ultracold storage and transport.[ As examples, Moderna's RNA vaccine candidate requires cold chain management just above freezing temperatures between with limited storage duration (30 days), but the Pfizer-BioNTech RNA candidate requires storage between ,] or colder throughout deployment until vaccination. In February 2021, Pfizer and BioNTech asked the U.S. Food and Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...
(FDA) to update the emergency use authorization (EUA) to permit the vaccine to be stored at between for up to two weeks before use. , Walvax is conducting Phase III trials for its mRNA vaccine which could be stored at room temperature for six months.
After a vaccine vial is punctured to administer a dose, it is viable for only six hours, then must be discarded, requiring attention to local management of cold storage and vaccination processes. Because the COVID‑19 vaccine will likely be in short supply for many locations during early deployment, vaccination staff will have to avoid spoilage and waste, which typically are as much as 30% of the supply.[ The cold chain is further challenged by the type of local transportation for the vaccines in rural communities, such as by motorcycle or ]delivery drone
A delivery drone is an unmanned aerial vehicle (UAV) used to transport packages for use cases that include medical supplies, fresh food, live ammunition, or other goods. Delivery drones are typically autonomous and electric, and operated as a pa ...
, need for booster doses, use of diluents, and access to vulnerable populations, such as healthcare staff, children and the elderly.
Air and land transport
Coordination of international air cargo
Air cargo is any property carried or to be carried in an aircraft. Air cargo comprises air freight, air express and airmail.
Aircraft types
Different cargo can be transported by passenger, cargo or combi aircraft:
* Passenger aircraft use the ...
is an essential component of time- and temperature-sensitive distribution of COVID‑19 vaccines, but, as of September 2020, the air freight network is not prepared for multinational deployment. "Safely delivering COVID‑19 vaccines will be the mission of the century for the global air cargo industry. But it won't happen without careful advance planning. And the time for that is now. We urge governments to take the lead in facilitating cooperation across the logistics chain so that the facilities, security arrangements and border processes are ready for the mammoth and complex task ahead," said IATA's Director General and CEO, Alexandre de Juniac
Alexandre de Juniac (born 10 November 1962) is a French businessman.
Career
He previously served as the chairman and CEO of Air France (2011–2013) and CEO of Air France–KLM (2013–2016). He became Director General and CEO of the Internati ...
, in September 2020.[
For the severe reduction in passenger air traffic during 2020, airlines downsized personnel, trimmed destination networks, and put aircraft into long-term storage.][ As the lead agencies for procurement and supply of the COVID‑19 vaccine within the WHO COVAX facility, GAVI and UNICEF are preparing for the largest and fastest vaccine deployment ever, necessitating international air freight collaboration, customs and border control, and possibly as many as 8,000 cargo planes to deliver just one vaccine dose to multiple countries.][
Two of the first approved vaccines, Pfizer and BioNTech's Pfizer-BioNTech COVID‑19 vaccine and Moderna's mRNA-1273, must be kept cold during transport. Keeping the temperatures sufficiently low is accomplished with specially-designed containers and ]dry ice
Dry ice is the solid form of carbon dioxide. It is commonly used for temporary refrigeration as CO2 does not have a liquid state at normal atmospheric pressure and sublimates directly from the solid state to the gas state. It is used primarily a ...
, but dry ice is only allowed in limited quantities on airplanes as the gases released via sublimation may be toxic. In the United States, the Federal Aviation Administration
The Federal Aviation Administration (FAA) is the largest transportation agency of the U.S. government and regulates all aspects of civil aviation in the country as well as over surrounding international waters. Its powers include air traffic m ...
(FAA) limits the amount of dry ice on a Boeing 777
The Boeing 777, commonly referred to as the Triple Seven, is an American long-range wide-body airliner developed and manufactured by Boeing Commercial Airplanes. It is the world's largest twinjet.
The 777 was designed to bridge the gap bet ...
-224 to , but it temporarily allowed United Airlines
United Airlines, Inc. (commonly referred to as United), is a major American airline headquartered at the Willis Tower in Chicago, Illinois. to transport up to —nearly 1million doses—between Brussels
Brussels (french: Bruxelles or ; nl, Brussel ), officially the Brussels-Capital Region (All text and all but one graphic show the English name as Brussels-Capital Region.) (french: link=no, Région de Bruxelles-Capitale; nl, link=no, Bruss ...
and Chicago. The Centers for Disease Control and Prevention
The Centers for Disease Control and Prevention (CDC) is the national public health agency of the United States. It is a United States federal agency, under the Department of Health and Human Services, and is headquartered in Atlanta, Georgi ...
(CDC) has tasked McKesson with vaccine distribution in the US; the company will handle all major vaccines except Pfizer's. American Airlines
American Airlines is a major airlines of the United States, major US-based airline headquartered in Fort Worth, Texas, within the Dallas–Fort Worth metroplex. It is the Largest airlines in the world, largest airline in the world when measured ...
, Boeing
The Boeing Company () is an American multinational corporation that designs, manufactures, and sells airplanes, rotorcraft, rockets, satellites, telecommunications equipment, and missiles worldwide. The company also provides leasing and product ...
, and Delta Air Lines
Delta Air Lines, Inc., typically referred to as Delta, is one of the major airlines of the United States and a legacy carrier. One of the List of airlines by foundation date, world's oldest airlines in operation, Delta is headquartered in Atla ...
are also working to increase dry ice transportation capacity, and American, Delta, and United each operate their own cold storage networks in the US. FedEx
FedEx Corporation, formerly Federal Express Corporation and later FDX Corporation, is an American multinational conglomerate holding company focused on transportation, e-commerce and business services based in Memphis, Tennessee. The name "Fe ...
and UPS
UPS or ups may refer to:
Companies and organizations
* United Parcel Service, an American shipping company
** The UPS Store, UPS subsidiary
** UPS Airlines, UPS subsidiary
* Underground Press Syndicate, later ''Alternative Press Syndicate'' or ...
have installed ultra-cold freezers at air cargo hubs in Europe and North America, and UPS can manufacture of dry ice per hour.
Security and corruption
Medicines are the world's largest fraud market, worth some $200billion per year, making the widespread demand for a COVID‑19 vaccine vulnerable to counterfeit
To counterfeit means to imitate something authentic, with the intent to steal, destroy, or replace the original, for use in illegal transactions, or otherwise to deceive individuals into believing that the fake is of equal or greater value tha ...
, theft, scams
A confidence trick is an attempt to defraud a person or group after first gaining their trust. Confidence tricks exploit victims using their credulity, naïveté, compassion, vanity, confidence, irresponsibility, and greed. Researchers have de ...
, and cyberattack
A cyberattack is any offensive maneuver that targets computer information systems, computer networks, infrastructures, or personal computer devices. An attacker is a person or process that attempts to access data, functions, or other restricted ...
s throughout the supply chain. The vaccine has been referred to as "the most valuable asset on earth"; Interpol called it "liquid gold" and warned of an "onslaught of all types of criminal activity". Anticorruption, transparency, and accountability safeguards are being established to reduce and eliminate corruption of COVID‑19 vaccine supplies. Absence of harmonized regulatory frameworks among countries, including low technical capacity, constrained access, and ineffective capability to identify and track genuine vs. counterfeit vaccines, may be life-threatening for vaccine recipients, and would potentially perpetuate the COVID‑19 pandemic.[ ]Tracking system
A tracking system, also known as a locating system, is used for the observing of persons or objects on the move and supplying a timely ordered sequence of location data for further processing. It is important to be aware of human tracking, fur ...
technologies for packaging are being used by manufacturers to trace vaccine vials across the supply chain,[ and to use digital and ]biometric
Biometrics are body measurements and calculations related to human characteristics. Biometric authentication (or realistic authentication) is used in computer science as a form of identification and access control. It is also used to identify in ...
tools to assure security for vaccination teams. In December 2020, Interpol
The International Criminal Police Organization (ICPO; french: link=no, Organisation internationale de police criminelle), commonly known as Interpol ( , ), is an international organization that facilitates worldwide police cooperation and cri ...
warned that organized crime
Organized crime (or organised crime) is a category of transnational, national, or local groupings of highly centralized enterprises run by criminals to engage in illegal activity, most commonly for profit. While organized crime is generally th ...
could infiltrate the vaccine supply chain, steal product through physical means, and data theft Data theft is a growing phenomenon primarily caused by system administrators and office workers with access to technology such as database servers, desktop computers and a growing list of hand-held devices capable of storing digital information, su ...
, or even offer counterfeit vaccine kits. Further, vaccines which require constant freezing temperatures are also susceptible to sabotage.
GPS devices will be used in the United States to track the vaccines. In Colorado
Colorado (, other variants) is a state in the Mountain West subregion of the Western United States. It encompasses most of the Southern Rocky Mountains, as well as the northeastern portion of the Colorado Plateau and the western edge of t ...
, the vaccine shipments will be escorted by Colorado State Patrol
The Colorado State Patrol (CSP) (originally known as the Colorado State Highway Courtesy Patrol), based in Lakewood, Colorado, is a division of the Colorado Department of Public Safety, and is one of the official state patrol agencies of Colorad ...
officers from Denver International Airport
Denver International Airport , locally known as DIA, is an international airport in the Western United States, primarily serving metropolitan Denver, Colorado, as well as the greater Front Range Urban Corridor. At , it is the largest airport in ...
to the state's eight distribution points; the exact plans are confidential and law enforcement will "maintain a low-key profile".
Peripheral businesses may also be affected. An IBM security analyst told ''The New York Times
''The New York Times'' (''the Times'', ''NYT'', or the Gray Lady) is a daily newspaper based in New York City with a worldwide readership reported in 2020 to comprise a declining 840,000 paid print subscribers, and a growing 6 million paid ...
'' that petrochemical companies are being targeted by hackers due to their central role in producing dry ice.
On 21 May 2020, the FDA made public the cease-and-desist notice it had sent to North Coast Biologics, a Seattle-based company that had been selling a purported "nCoV19 spike protein vaccine". On 21 January 2021, its founder, Johnny Stine, was arrested on a federal warrant charging him with introducing misbranded drugs into interstate commerce, a misdemeanor. Stine pleaded guilty in August 2021. On 8 March 2022, he was sentenced to five years' probation and ordered to pay $246,986 in restitution.
National infrastructure
The WHO has implemented an "Effective Vaccine Management" system, which includes constructing priorities to prepare national and subnational personnel and facilities for vaccine distribution, including:
* Trained staff to handle time- and temperature-sensitive vaccines
* Robust monitoring capabilities to ensure optimal vaccine storage and transport
* Temperature-controlled facilities and equipment
* Traceability
* Security
Border processes for efficient handling and customs clearance within individual countries may include:[
* Facilitating flight and landing permits
* Exempting flight crews from ]quarantine
A quarantine is a restriction on the movement of people, animals and goods which is intended to prevent the spread of disease or pests. It is often used in connection to disease and illness, preventing the movement of those who may have been ...
requirements
* Facilitating flexible operations for efficient national deployment
* Granting arrival priority to maintain vaccine temperature requirements
Tailored vaccination strategies
During a pandemic wave, rapid vaccination of those driving virus dissemination (the socially active) and vaccination of those at highest risk (the elderly, often socially less active) are two desirable goals that are at odds in the setting of limited vaccine supply. However, the recent study on the national COVID-19 vaccination schedules published in 2021 in 29 countries (EU, UK, and Israel) shows that all researched schedules prioritized criteria referring to higher risk (being over 65 years old and/or having coexisting health conditions) over the criteria referring to virus dissemination (occupation and/or housing conditions). Postponing a second vaccine dose (the first is more important for avoiding a severe disease course) to allow faster access to the first dose for more persons has been chosen as deployment strategies in some countries. Using a reduced mRNA vaccine dose in the younger, who have a lower disease risk, a stronger immune response to the vaccination but are key drivers of pandemic waves, may allow reaching more persons faster, with vaccination strategy models predicting a significant reduction of nation-wide case load and deaths. On the other side, protection of some groups, e.g. the elderly or the immunosuppressed may require additional booster doses.
Liability
On 4 February 2020, US Secretary of Health and Human Services Alex Azar
Alex Michael Azar II (; born June 17, 1967) is an American attorney, businessman, lobbyist, and former pharmaceutical executive who served as the United States secretary of health and human services from 2018 to 2021. Azar was nominated to his p ...
published a notice of declaration under the Public Readiness and Emergency Preparedness Act
The Public Readiness and Emergency Preparedness Act (PREPA), passed by the United States Congress and signed into law by President of the United States George W. Bush in December 2005 (as part of ), is a controversial tort liability shield inten ...
for medical countermeasures against COVID‑19, covering "any vaccine, used to treat, diagnose, cure, prevent, or mitigate COVID‑19, or the transmission of SARS-CoV-2 or a virus mutating therefrom", and stating that the declaration precludes "liability claims alleging negligence by a manufacturer in creating a vaccine, or negligence by a health care provider in prescribing the wrong dose, absent willful misconduct". The declaration is effective in the United States through 1 October 2024.
In the European Union, the COVID‑19 vaccines are licensed under a Conditional Marketing Authorisation which does not exempt manufacturers from civil and administrative liability claims. While the purchasing contracts with vaccine manufacturers remain secret, the manufacturers remain liable even for side-effects not known at the time of licensure.
Pfizer has been criticised for demanding far-reaching liability waivers and other guarantees from countries such as Argentina and Brazil, which go beyond what was expected from other countries such as the US (above).
See also
Notes
References
{{DEFAULTSORT:Deployment Of Covid-19 Vaccines
Medical research