A global effort is underway to develop and mass-produce an effective vaccine to counter the new, deadly, and highly infectious coronavirus disease, COVID-19. Many governments have warned that daily life cannot return to normal until their populations have built up antibodies to fend off the virus. Accelerated clinical trials are already underway, but vaccine development typically takes years.
More From Our Experts
The Clean Network Program: Digital Age Echoes of the “Long Telegram”?
Developing a successful vaccine is not enough. Many countries also face the looming challenge of producing quantities necessary to provide immunity to all their citizens, and competition is growing over who will have access once a vaccine is ready.
What is the status of a COVID-19 vaccine?
Pharmaceuticals and Vaccines
Public Health Threats and Pandemics
There are more than one hundred vaccines in preclinical development by pharmaceutical companies, academic institutions, government agencies, and others that are being tracked by the World Health Organization (WHO).
Tens of vaccine candidates, across more than a dozen countries, are already undergoing clinical trials.
Read a complete list of vaccine candidates undergoing clinical trials in the appendix.
More From Our Experts
The Clean Network Program: Digital Age Echoes of the “Long Telegram”?
Nearly half of these potential vaccines are being developed by firms and research groups in China and the United States. The first human trial in the United States began in Seattle in March with a vaccine by Moderna Inc., which is now undergoing large-scale trials involving tens of thousands of participants. Other U.S.-based candidates include ones by pharmaceutical giants Johnson & Johnson, Merck, and Pfizer. In November, Pfizer and partnering German firm BioNTech announced that their vaccine appeared highly effective in early results from large-scale trials. In China, Beijing has already approved several of its vaccine candidates for limited use. Russia has also approved vaccines—before testing them in large trials, moves that drew censure from scientists around the globe.
Additionally, several candidates each are being developed in Australia, Germany, and the United Kingdom. The UK’s University of Oxford and British-Swedish company AstraZeneca are working on a vaccine that is undergoing large-scale trials in Brazil, India, South Africa, the UK, and the United States. In September, AstraZeneca paused its trials after a volunteer suffered a serious reaction; they have since resumed. While some of these candidates are already spurring hope, experts warn that it’s too early to determine which, if any, will be successful on a large scale.
Pharmaceuticals and Vaccines
Public Health Threats and Pandemics
Who is involved?
Vaccines are frequently collaborative efforts across sectors of society, with private pharmaceutical firms teaming up with public health agencies or university labs. For instance, a recently approved Ebola vaccine was ultimately developed by multinational pharmaceutical company Merck but also involved Canadian and U.S. public health agencies, a tiny Iowa-based biotech firm, U.S. Defense Department researchers, and the WHO. Here are snapshots of some of the major players in the COVID-19 vaccine search.
Daily News Brief
A summary of global news developments with CFR analysis delivered to your inbox each morning. Most weekdays.
Governments. Public health agencies play critical roles in vaccine research, supplying funds to develop a COVID-19 vaccine. In the United States, President Donald J. Trump’s administration launched a project known as Operation Warp Speed aimed at developing an effective vaccine and manufacturing enough doses for all three hundred million Americans by early 2021. The effort, which has pledged billions of dollars to companies with promising vaccine candidates, brings together agencies within the Department of Health and Human Services (HHS)—including the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), and the Food and Drug Administration (FDA)—and the Department of Defense. The European Commission is also funding several candidates; and in a virtual summit hosted by the European Union, world leaders, organizations, and banks pledged $8 billion for vaccine research. In China, the government is closely overseeing efforts on its territory, with state-owned firms making up about two-fifths of the country’s vaccine industry.
International institutions. The WHO and other multilateral institutions such as the World Bank are focused on financing and manufacturing a COVID-19 vaccine for global use, in particular to ensure fair allocation among all countries. Also at the forefront of multilateral efforts is the Coalition for Epidemic Preparedness Innovations (CEPI), a global alliance that was founded by Norway, India, the Bill & Melinda Gates Foundation, the UK-based Wellcome Trust, and the World Economic Forum. Gavi, the Vaccine Alliance—also founded by the Gates Foundation—is a public-private partnership focused on improving vaccine access for lower-income countries. In June, the WHO, CEPI, and Gavi launched COVAX, a global initiative seeking more than $18 billion in funding to procure two billion doses of a vaccine by the end of 2021. By October, more than 170 countries had joined COVAX, with Russia and the United States absent.
Private sector. The pharmaceutical industry is driving much of the push toward a vaccine. Companies ranging from biotech start-ups to giants such as Johnson & Johnson and China-based Sinopharm have rapidly shifted their research and development (R&D) efforts to focus on COVID-19. While early research into a vaccine candidate typically receives government funding, such as NIH grants in the case of the United States, the bulk of financing for clinical development generally comes from private sources.
Research institutions and nonprofits. Many of the COVID-19 vaccine candidates involve a university or college assisting in preclinical research or clinical trials. In the case of the University of Oxford’s candidate, the research team was already working on vaccines for an unknown disease that could cause a pandemic; then, in January, the group zeroed in on COVID-19. The Gates Foundation has been the leading nonprofit funding COVID-19 vaccine efforts.
How does a vaccine work?
Traditionally, vaccines are dead or weakened virus molecules—known as antigens—that trigger defensive white blood cells in the immune system to create antibodies that bind to the virus and neutralize it.
There are four main types of conventional vaccines:
live vaccines use a weakened form of the virus to prompt the creation of antibodies; inactivated vaccines use a dead version of the virus; toxoid vaccines use toxins made by the virus to produce immunity to the part of the virus that causes disease; and subunit, recombinant, polysaccharide, and conjugate vaccines use proteins or other pieces of the virus.
There are also several new types of vaccines that use the virus’s genetic material—DNA or RNA—to prompt the body to create antibodies. Scientists are still investigating these types for wide use in humans.
When most of a population has been vaccinated and is immune to a particular disease, even those who are not immune are considered protected because the likelihood of an outbreak is small. This is known as herd immunity. Chickenpox, measles, mumps, and polio are all examples of diseases for which the United States has achieved herd immunity due to vaccines. Scientists are divided about how much of a population must have COVID-19 antibodies to prevent new outbreaks, with estimates ranging from less than half to over 80 percent.
How is a vaccine developed?
There are many stages involved in the development and production of a vaccine, from initial academic research to distribution to hospitals and doctor’s offices.
Clinical trials are crucial indicators of whether a vaccine is effective. Potential vaccines, as with other drugs, are commonly tested in animals first. Human trials are broken up into three phases, progressively increasing the number of volunteers. If a vaccine candidate appears to be ineffective, has harmful side effects, or is too similar to existing vaccines, it won’t move on. Trials are often carried out “blind,” by which some groups are administered the vaccine and some receive a placebo.
If a vaccine candidate is considered successful in human trials, the developers can seek approval by a national regulatory agency, such as the FDA or the European Medicines Agency. In the United States, less than 10 percent of all drugs that go into clinical trials make it past this part of the process. In the case of the new coronavirus, the FDA has said that a vaccine would need to prevent or reduce the severity of COVID-19 in at least 50 percent of patients to be approved. Prior to approval, a vaccine maker can ask the FDA for an emergency use authorization (EUA), which allows the sale of unapproved medical products. Pfizer has said it will seek an EUA for its vaccine after it completes the recommended two months of safety data collection in late November.
Additionally, while the WHO does not approve drugs, the vaccine maker can request prequalification by the WHO—a process to determine quality assurance. Many low- and middle-income countries rely on WHO prequalification [PDF] when buying medicines. Finally, the vaccine must be approved by national regulators in other countries to be distributed abroad.
Following approval, the vaccine can be manufactured for broad use. However, with the need for billions of doses of a COVID-19 vaccine, experts warn that many more production plants will be needed to fulfill the global demand. COVAX estimated it will require $5.3 billion to scale up vaccine manufacturing, including by building specialized production plants. The U.S. Biomedical Advanced Research and Development Authority (BARDA), part of HHS, has also pledged to help scale up manufacturing in the United States.
Can vaccine development be sped up?
Many experts say that the timeline of twelve to eighteen months stated by U.S. officials for a COVID-19 vaccine is extremely optimistic. Under normal circumstances, during which the stages of vaccine development occur sequentially, a vaccine on average takes eight to fifteen years to get from the lab into the hands of health-care providers. The fastest a vaccine has ever been developed is five years. Amid this pandemic, however, researchers around the globe are accelerating the process for COVID-19 by carrying out stages of development simultaneously and by looking to new vaccine technologies. “What’s different in this context is that you have such an enormous global effort being undertaken,” says CFR’s Thomas J. Bollyky. “Any entity working in this field broadly is pursuing a COVID-19 vaccine.”
The accelerated Operation Warp Speed timeline hinges on overlapping stages of development; mass production is already starting for strong candidates even while clinical trials are ongoing. In a deal under Warp Speed, Pfizer and BioNTech signed a $1.95 billion contract to manufacture and distribute one hundred million doses by the end of 2020 at no cost to Americans if their candidate receives an EUA. (Pfizer executives said they have not accepted any U.S. federal funding for the development of their vaccine.) But in September, CDC Director Robert Redfield told a Senate committee that a vaccine likely would not be widely available until mid-2021, testimony that Trump rejected as a “mistake.”
Clinical trials are difficult to speed up because antibodies take time to develop in the body. So-called challenge trials, in which patients are purposefully exposed to a disease, are another way to cut time out of the process, but they are ethically controversial. Typically, challenge trials are only done with curable diseases, such as typhoid fever, and there is no known cure for COVID-19 yet.
Another way researchers are seeking to quicken the process is by focusing on new vaccine approaches. RNA- and DNA-based vaccines can be developed far faster than conventional vaccines, which require months at a time of growing antigens in animal or insect cells. However, none has ever been approved for commercial use in humans. Thirteen of the COVID-19 candidates in clinical trials are RNA- or DNA-based.
How could a COVID-19 treatment help?
Dozens of treatments—which would not prevent someone from being infected with COVID-19 but could help reduce the severity and duration of illness—are being developed or repurposed to mitigate the health crisis in the interim. Among the most promising treatment candidates is the antiviral drug remdesivir, which was developed by U.S.-based Gilead Sciences and already approved by the FDA. An NIAID trial of remdesivir that involved dozens of sites in the United States, Europe, and Asia showed faster rates of recovery from the virus. Some health experts are also optimistic about the use of dexamethasone, a common steroid, which was found to reduce the risk of death in severely ill COVID-19 patients in the UK. In August, the FDA announced an EUA for convalescent plasma, or blood plasma of previously infected people who have created COVID-19 antibodies. Though plasma donations have already been used in tens of thousands of patients, there have not been robust studies to determine the treatment’s effectiveness.
President Trump has promoted the use of another drug, hydroxychloroquine, as a treatment for COVID-19. The drug is typically used to treat malaria and autoimmune diseases such as arthritis. Trump said in May that he himself was taking the drug preventively, despite warnings from scientists that it is not proven to be an effective COVID-19 treatment and could lead to harmful side effects.
Can a vaccine end the coronavirus pandemic?
Public officials worldwide have stressed that the pandemic likely will not end until there is an effective vaccine. Even after a vaccine is approved, however, there remains the tremendous challenge of producing enough of it for the world’s population. An estimated one billion doses would need to be manufactured just to vaccinate workers in health care and other essential industries globally, and that is if only a single dose is required for each person.
This task has both motivated countries to prepare for large-scale production, as well as pitted them against one another amid fears of a potentially limited vaccine supply. While Brazil, China, and India all have large vaccine industries, they also have among the largest populations, and they could reserve their vaccine supplies for their own citizens before opening them up to others. Some countries have sought monopoly agreements with vaccine manufacturers to avoid domestic shortages. Brazil, the United States, and the European Union have all struck deals with AstraZeneca for hundreds of millions of doses of the University of Oxford vaccine. Experts including CFR’s Bollyky have warned that bidding wars over a vaccine will lead to inequitable distribution and, ultimately, fail to eliminate the risk of new outbreaks.
On top of these challenges are the public’s concerns about a sped-up vaccine. In a September poll by the Pew Research Center, almost half of Americans surveyed said they would not get a coronavirus vaccine if it were currently available. Moreover, scientists are still investigating how this new coronavirus behaves and trying to answer the many questions people have about the risk it poses and how much protection a vaccine will provide. This includes how effective a vaccine will be against a mutating coronavirus, though researchers point out that mutations do not necessarily mean different strains of the virus or changes in its infectiousness or lethality. Uncovering such details about the virus, they say, will only help in the development of a successful vaccine.