The FDA has granted emergency use authorization to Pfizer’s COVID-19 vaccine for kids ages five to 11. Before the U.S. can begin to roll out shots, however, the CDC will weigh in at its meeting next week.
An FDA advisory committee had recommended the authorization during a meeting held earlier this week. The New York Times reports that members of the FDA committee questioned whether the jabs are necessary for all children in the age group or if it should be limited to those with underlying conditions who are more at risk of severe COVID-19. However, they ultimately voted to authorize the vaccine because of their concern for the nearly two million children in that age group who have been infected.
Pfizer says its COVID-19 vaccine is 90.7 percent effective at preventing symptomatic disease in kids ages five to 11. An analysis of Pfizer’s clinical trials of 2,268 participants, released by the FDA on Friday, also showed that none of the participants reported cases of severe disease or the COVID-19-related multi-inflammatory syndrome that has been seen in children.
The White House has made clear its intentions to deliver the vaccines for kids as quickly as possible once they have been authorized. Last week, the Biden administration announced its plan to roll out the vaccine for kids by working with pediatricians, children’s hospitals, school clinics, and other health care centers.
COVID-19 vaccines have reached consumers in record time. Though the process can typically take 10 to 15 years, the U.S. Food and Drug Administration has granted emergency authorization to vaccines made by Pfizer, Moderna, and Johnson & Johnson in less than a year. Before now, the fastest-ever vaccine—for mumps—took four years to develop in the 1960s.
Even after a vaccine is authorized or fully licensed, it faces potential roadblocks when it comes to scaling up production and distribution, which also includes deciding which populations should get it first—and at what cost.
Yet several efforts are underway to help produce and distribute the vaccines more quickly. Here’s everything you need to know—including primers on how vaccines and clinical trials work, the latest news on vaccine distribution and safety, and a detailed breakdown of each of the candidates that have reached phase three and beyond.
Vaccines and clinical trials
More than 60 vaccines are still going through a three-stage clinical trial process that’s required before they are sent to regulatory agencies for approval. Given the urgent need, some vaccine developers have compressed the clinical process for SARS-CoV-2 by running trial phases simultaneously.
VACCINE CLINICAL TRIAL PROCESS
Phase one: Checks the safety of a vaccine and determines whether it triggers an immune response in a small group of healthy humans.
Phase two: Widens the testing pool to include groups of people who may have the disease or be more likely to catch it, to gauge the vaccine’s effectiveness.
Phase three: Expands the pool up to the thousands to make sure the vaccine is safe and effective among a wider array of people, given that immune response can vary by age, ethnicity, or by underlying health conditions.
The COVID-19 candidates, like all vaccines, essentially aim to instruct the immune system to mount a defense, which is sometimes stronger than what would be provided through natural infection and comes with fewer health consequences.
To do so, traditional vaccines use the whole coronavirus, but in a killed or weakened state. Others use only part of the virus—whether a protein or a fragment. Some transfer the instructions for coronavirus proteins into an unrelated virus that is unlikely or even incapable of causing disease. Finally, cutting-edge vaccines under development rely on deploying pieces of the coronavirus’s genetic material, enabling our cells to temporarily make coronavirus proteins needed to stimulate our immune systems. (Find out more about vaccines and how they work.)
TYPES OF VACCINES
Nucleic acid: Relies on injecting snippets of a virus’s genetic material, either DNA or messenger RNA (mRNA), into human cells. It spurs the production of viral proteins that mimic features of the coronavirus, training the immune system to recognize its presence.
Knocked-out virus: Uses a non-infectious form of the coronavirus that can no longer cause full-blown disease but can still provoke an immune response. The virus can either be fully inactivated or weakened. These modes are considered the most classic ways to make vaccines.
Viral vector: Essentially a “Trojan horse” presented to the immune system. One type involves introducing a piece of DNA from SARS-CoV-2 into another unrelated germ—for example, an adenovirus, which typically causes the common cold. When this modified adenovirus is injected into humans, the hope is that it will instruct cells to make coronavirus proteins and will trigger an immune response.
Protein: These vaccines are typically made from coronavirus proteins, which can be synthesized or brewed in labs like beer. Some versions involve coating a carrier—such as nanoparticles—with proteins to better aid delivery and uptake by cells.
U.S. vaccine rollout
Latest news
In the United States, more than 66 percent of the population has received at least one dose, and more than 57 percent are fully vaccinated. As of October 29, the U.S. had administered more than 417 million shots of the authorized vaccines and had distributed more than 510 million doses.
On October 29, the FDA authorized Pfizer’s COVID-19 vaccine for emergency use in children ages five to 11. The decision came days after an FDA advisory committee voted to recommend emergency use authorization. Before the shots can begin to roll out, the CDC will weigh in on the matter in a meeting next week.
The FDA panel’s vote in favor of the recommendation was near-unanimous, with one abstention. However, the New York Times reports that some committee members questioned whether all children in the age group need to be vaccinated and suggested authorizing shots only for those with underlying conditions that made them more susceptible to severe COVID-19. However, they concluded that the benefits outweigh the risks given the nearly two million children who have been infected so far.
The news comes a week after the FDA released Pfizer’s analysis of its clinical trials of 2,268 participants showing that the vaccine is 90.7 percent effective at preventing symptomatic disease in kids in this age group. The analysis also showed that none of the participants reported cases of severe disease or the COVID-19-related multi-inflammatory syndrome that has been seen in children.
The company had previously announced that its analysis shows the vaccine is safe and elicits “robust” neutralizing antibodies. The vaccine follows a two-dose regimen of 10 milligram doses—a third of the dosage that is given to adults.
The White House has announced its plans to roll out the vaccines to children by working with more than 25,000 pediatricians and other primary care sites, children’s hospitals, pharmacies, school clinics, and more.
On October 21 CDC director Rochelle Walensky issued a ruling that clears the way for booster shots of the Moderna and Johnson & Johnson vaccines to begin rolling out immediately. Anyone 18 and older will be able to get a second dose of the Johnson & Johnson vaccine at least two months after their first dose. Meanwhile, U.S. regulators’ recommendation for the Moderna vaccine is narrower: A third dose can be administered at least six months after the second one to people age 65 and older and to those ages 18 to 64 who are at high risk of severe COVID-19 due to underlying conditions. It also includes people ages 18 to 64 who are at high risk of exposure because of where they work or live, such as health-care workers or incarcerated people. These guidelines are the same as those approved for Pfizer’s booster doses.
The CDC also endorsed a “mix and match” approach to booster doses, which will, for example, allow people who received a Johnson & Johnson jab to seek a Pfizer or Moderna booster instead. Only people who are eligible for booster doses will be authorized to mix and match. U.S. regulators based the decision on evidence from a new National Institutes of Health study suggesting that booster doses of the Moderna or Pfizer vaccines are more effective for people who originally received the Johnson & Johnson shot.
The CDC’s recommendations align with the FDA emergency use authorization that had been issued the previous day.
U.S. regulators have already authorized a third dose of Pfizer’s vaccine for certain populations. On September 24, CDC director Rochelle Walensky overruled her agency’s advisory committee to endorse administering booster shots to people in occupational or institutional settings that put them at high risk for disease, such as health-care workers or teachers. U.S. regulators have also granted emergency use authorization of booster shots to people who are age 65 and older, those in long-term care facilities, and people ages 50 to 64 with conditions that make them more vulnerable to severe disease. The CDC has said that people ages 18 to 49 can receive booster shots only if their personal benefits outweigh the risks of vaccination, which can include rare side effects like myocarditis.
The decision roughly aligns with earlier recommendations from the FDA advisory committee, which expressed skepticism that Pfizer had provided adequate data supporting the need for the boosters in the general population. They also didn’t think there was enough data on the safety of boosters among younger people, who are more susceptible to side effects from the vaccines such as myocarditis. Instead, the panel indicated their support for a limited use of boosters among populations that are more at risk of breakthrough infections.
Vaccines still remain effective at preventing most severe illness, even for breakthrough infections of the Delta variant. But there's concern over the potential for transmission. On July 30, the CDC published preliminary data from a Massachusetts COVID-19 outbreak that suggests vaccinated individuals who are infected with the Delta variant may carry similar viral loads as an unvaccinated infected individual. On September 29, a preprint study showed that vaccination reduces transmission of the Delta variant but that impact dwindles over time, indicating that boosters could help control transmission.
Walensky said in August that the Biden administration wanted to roll out booster shots in an attempt to stay ahead of the virus. Although the data shows that the vaccine still offer strong protection against severe disease, Walensky said the data consistently demonstrate a waning effectiveness against mild and moderate disease as well as declining efficacy against the Delta variant. Walensky pointed to data from other countries—including Israel—indicating that protections against severe disease “could decrease in the months ahead.”
On September 2, White House adviser Anthony Fauci said in a press briefing that it’s likely that people will need three doses of the mRNA vaccines for full protection against COVID-19. He cited recent studies from Israel showing a decline in infections among people who received a third dose.
However, the WHO called for a moratorium on booster shots through September to help efforts to vaccinate at least 10 percent of people in every country. The organization asked wealthy nations to share their doses instead of administering boosters. “We cannot and should not accept countries that have already used most of the global supply of vaccines using even more of it while the world’s most vulnerable people remain unprotected,” WHO Director General Tedros Adhanom Ghebreyesus said in a press conference.
Vaccine mandates and masking
On September 9, the White House announced a plan to impose broad new COVID-19 vaccine mandates aimed at the nearly 80 million Americans who have not yet gotten a shot. One key element is a new Department of Labor rule that will require all companies with more than 100 employees to ensure employees are either vaccinated or regularly tested for COVID-19. The Biden administration has also issued executive orders requiring vaccination of all federal employees and government contractors. Healthcare facilities that receive funding from Medicare and Medicaid will also be required to vaccinate staff. The Washington Post reports that businesses that ignore the new policy could face penalties of up to $14,000 per violation. They will also be required to give employees paid time off to get vaccinated.
The urgent need to vaccinate more Americans was buttressed by a trio of studies released by the Centers for Disease Control and Prevention on September 10. As the Washington Post reports, the studies show that people who are not fully vaccinated are more than 10 times more likely to be hospitalized and 11 times more likely to die of COVID-19. Hospitalizations are also 10 times higher among unvaccinated adolescents compared to the fully vaccinated. A real-world study also showed that Moderna’s vaccine is slightly more effective in preventing hospitalization.
The FDA granted full approval to Pfizer’s vaccine on August 23, making it the first COVID-19 vaccine to reach that milestone. The decision cleared the way for companies and schools to enact vaccine mandates and may persuade the vaccine-hesitant to finally get a shot. Public health experts say it also allows physicians the latitude to prescribe the vaccine as they see fit, including as a third dose booster shot for vulnerable patients. However, the CDC has since warned physicians against these off-label uses.
State and local governments are also implementing vaccine mandates among their employees. On August 11, California became the first state to require all teachers and school staff to either get a vaccine or undergo weekly COVID-19 testing. The mandate goes into effect on October 15. California also plans to mandate vaccines for all schoolchildren once regulators have fully approved the vaccine for younger age groups.
On July 27, the Centers for Disease Control and Prevention updated its recommendations on masks. The agency now urges their universal use in indoor public spaces by people living in regions with at least “substantial” COVID-19 transmission, where 50 or more new cases per 100,000 people have been reported over the past seven days.
The CDC also recommends indoor masking in public spaces for vaccinated people who live with anyone vulnerable to the disease, such as unvaccinated children and immunocompromised individuals. All teachers, students, and staff in schools, whether vaccinated or not, should also wear masks, according to the new CDC guidance.
Unvaccinated individuals likely still account for the greatest viral transmission, since the total number of breakthrough cases is relatively low, CDC director Rochelle Walensky, stressed during the July 27 briefing.
Global vaccine rollout
The World Health Organization is also coordinating global efforts to administer vaccines, with an eye toward delivering two billion doses by the end of 2021. It is leading an initiative through the COVAX Facility to ensure that all countries have equitable access. COVAX has distributed more than 406 million doses to 144 participants. The WHO has approved the Pfizer-BioNTech, AstraZeneca-Oxford, Johnson & Johnson, Moderna, Sinopharm, and Sinovac vaccines for emergency use.
On October 29, Moderna announced that it has agreed to supply more than 56 million doses of its vaccine to COVAX, to be delivered in the second quarter of 2022. These doses are in addition to the 60 million jabs that the company has already promised for low- and middle-income countries.
On September 22, the U.S. announced that it will purchase another 500 million doses of the Pfizer vaccine to donate to low- and middle-income countries. The Associated Press reports that this brings the country’s total commitment to 1.1 billion doses through 2022. The news arrives as the nation faces scrutiny for considering the use of booster doses even as other countries lag behind in vaccination due to supply issues.
COVAX had previously acknowledged a shortfall of 190 million doses. In a joint statement released in May, COVAX administrators said the consequences of that shortfall “could be catastrophic.” They called on world leaders to share more doses and commit additional funding to the global effort.
On June 13, national leaders at the G7 summit announced plans to donate 870 million doses to the global vaccination effort, with the aim to deliver at least half of them by the end of 2021. Pfizer, Moderna, and Johnson & Johnson have also pledged to collectively provide around 3.5 billion doses of their vaccines to low- and middle-income countries by the end of 2022. The European Union also said it would donate at least 100 million doses by the end of 2021. On August 6, China pledged to provide two billion doses of its COVID-19 vaccines this year and donate $100 million to COVAX.
Vaccine safety
On July 13, the U.S. Food and Drug Administration added a warning label to Johnson & Johnson’s vaccine after it was linked to rare cases of Guillain-Barré Syndrome, a rare autoimmune disorder that can lead to paralysis. There have been 100 preliminary reports of the syndrome among the approximately 12.5 million people who have received the vaccine. The FDA said that the benefits of receiving the vaccine outweigh the risks.
The FDA has also added a warning label to the Pfizer and Moderna vaccines about rare cases of heart inflammation in adolescents and young adults. The news comes after the CDC’s Advisory Committee on Immunization Practices announced that it has identified more than 300 cases of myocarditis and pericarditis that it acknowledged are likely linked to the vaccines. The agency says these cases are rare but higher than expected. It also said the benefits of the shots outweigh the risks.
An earlier CDC report released February 19 revealed that severe reactions to the Pfizer-BioNTech and Moderna COVID-19 vaccines are rare. The report documented only 4.5 cases of anaphylaxis per million doses of vaccine administered during the reporting period, which the CDC notes is comparable with rates for other types of vaccines. U.K. regulators have also published safety data for the Pfizer-BioNTech vaccine showing that most side effects are mild and consistent with what is typical of other vaccines. Still, as a precautionary measure, U.K. officials have advised people with a history of serious allergic reactions not to get the Pfizer-BioNTech vaccine.
In April, the European Medicines Agency issued statements saying that unusual blood clots should be listed as a very rare but possible side effect of both the AstraZeneca and Johnson & Johnson vaccines. In a review of 86 reported cases related to the AstraZeneca vaccine, the EMA’s safety committee found a potential link between it and the clots, with most known cases occurring in women under age 60 within two weeks of receiving the first dose. The EMA continues to stress that the odds of developing a clot after vaccination are extremely low, and that the benefits of getting vaccinated outweigh the risks. They also recommend that people seek immediate medical attention if they experience symptoms related to clotting, including persistent pain, shortness of breath, and headaches or blurred vision.
On August 27, a study published in the British Medical Journal affirmed the EMA’s risk-benefit analysis, showing that there’s a much higher risk of developing blood clots after SARS-CoV-2 infection than after immunization with the AstraZeneca or Pfizer vaccines.
On August 11, the CDC officially recommended that people who are pregnant, breastfeeding, or may become pregnant get a COVID-19 vaccine. A new analysis of data from the vaccine rollout found no increased risk of miscarriage among people who received an mRNA vaccine before 20 weeks of pregnancy. Earlier studies also showed that the vaccine is safe later in pregnancy as well—for both pregnant people and their babies. The CDC emphasized the urgency of vaccination among these groups in a health alert issued on September 29, reporting new data showing a rise in COVID-19-related deaths among pregnant people.
Vaccine prospects
Here are some of the vaccines that have made it to phase three and beyond:
Pfizer
Name: BNT162b2
Who: One of the world’s largest pharmaceutical companies, based in New York, in collaboration with German biotech company BioNTech.
What: A nucleic-acid vaccine that requires two doses taken 21 days apart.
Latest news: On October 29, the FDA authorized Pfizer’s vaccine for emergency use in kids ages five to 11. The agency’s advisory committee had recommended authorization earlier that week on the heels of releasing ananalysis of Pfizer’s clinical trials showing that its COVID-19 vaccine is 90.7 percent effective in preventing symptomatic disease among kids in this age group. Before the U.S. can begin rolling out the shots to kids, however, the CDC is expected to weigh in early next week.
Pfizer has also said that an analysis of its clinical trials of 2,268 participants shows the vaccine is safe and elicits “robust” neutralizing antibodies. The vaccine follows a two-dose regimen of 10 milligram doses—a third of the dosage that is given to adults.
Approval status: On December 2, the U.K. became the first Western country to approve any COVID-19 vaccine when it authorized the Pfizer-BioNTech candidate—making the drug the first mRNA vaccine in history allowed for human use. The FDA granted emergency use authorization to this vaccine on December 11, 2020, and fully approved it on August 23, 2021. The vaccine has also been granted emergency approval in Canada, the European Union, and other countries.
On May 12, the CDC approved Pfizer’s vaccine for emergency use in adolescents ages 12 to 15. U.K. regulators have also approved this vaccine for use in the same age group, while the European Union granted conditional authorization.
On August 23, the FDA granted full approval to Pfizer’s vaccine, making it the first COVID-19 vaccine to reach that milestone. Public health experts say the decision could lead to a substantial increase in vaccination rates among the hesitant as well as an influx of vaccine mandates from businesses and schools across the country. The decision also provides doctors more latitude in prescribing booster doses.
As of September 24 U.S. regulators granted emergency use authorization of a third dose of Pfizer’s vaccine—but only for certain subgroups of the national population, including older people and those with underlying conditions.
The FDA authorized boosters for people age 65 and older as well as those who are at risk of severe disease. The CDC later refined that recommendation, ruling that all adults over 65 and those ages 50 to 64 with conditions that put them at higher risk of disease should get the shot. CDC director Rochelle Walensky also endorsed boosters for people in occupational or institutional settings that put them at high risk of infection, such as health-care workers and teachers.
Distribution: Pfizer and BioNTech have signed several contracts with the U.S. government to provide 300 million doses by July 31, 2021.
The European Union said on April 14 that it has begun negotiations with Pfizer-BioNTech for 1.8 billion doses of their vaccines for 2022 and 2023. The move is part of the bloc’s plans to pivot away from the AstraZeneca and Johnson & Johnson vaccines in favor of the mRNA vaccines.
Globally, Pfizer expects to be able to produce up to 50 million vaccine doses in 2020 and 1.3 billion doses by the end of 2021. Questions have been raised over the vaccine’s storage, which requires ultra-cold freezers set at minus 70 degrees Celsius (-94 degrees F). On February 19, however, Pfizer and BioNTech said that their vaccine can remain stable for two weeks at temperatures between minus 25℃ and minus 15℃ (-13℉ to 5℉), a common range in pharmaceutical freezers and refrigerators. The finding would allow for easier distribution of the vaccine in communities where ultra-cold storage requirements present a challenge. The companies say they have submitted the new data to the FDA for review.
Efficacy: On September 20, Pfizer announced that a study of its clinical trials shows its vaccine is safe and highly effective in children ages five to 11. Researchers determined that two low doses administered three weeks apart elicit high levels of neutralizing antibodies among children, with side effects comparable to those seen in people ages 16 to 25. The 10-milligram doses of vaccine are a third of what has been approved among older age groups.
Pfizer also expects to release data soon on how well its vaccine works among children ages six months to five years, according to CEO Albert Bourla. In a public forum, he said the data could be available as early as the end of October.
On August 25, Pfizer announced new data showing that a third dose of its vaccine generates robust quantity of neutralizing antibodies that is more than three times higher than what was observed one month after the second dose.
A preprint study out of the United Kingdom shows that the Pfizer and AstraZeneca vaccines remain protective against the Delta variant but that their efficacy wanes over time. Among study participants, Pfizer’s vaccine waned more rapidly. Within four to five months after a second dose, the vaccine’s efficacy was on par with the AstraZeneca shot. The study emphasizes, however, the both vaccines still significantly reduce the risk of infection.
On July 8, a study published in Nature demonstrated that people who have received both doses of the Pfizer or AstraZeneca vaccines remain fully protected against severe disease, hospitalization, and death from the Delta and Beta variants. However, a single dose of either vaccine was not as protective.
The findings corroborate an earlier study published in Nature showing that the Pfizer and Moderna vaccines elicit “robust and prolonged” immune responses. As the New York Times reported at the time, the findings suggested that people who are immunized with these vaccines may not need booster shots as protection may last for years so long as the virus doesn’t mutate to evade it.
On June 10, a study published in the journal Nature showed that two doses of the Pfizer vaccine protects against several virus variants, including the Delta and Eta variants. The news came a few days after the CDC announced that the Pfizer and Moderna vaccines reduce the risk of infection by 91 percent for fully vaccinated people.
In April, the CDC has released a study of the U.S. vaccine rollout showing that the Pfizer-BioNTech and Moderna vaccines are 90 percent effective in preventing symptomatic COVID-19 in real-world conditions. The study analyzed the efficacy of the two mRNA vaccines among nearly 4,000 health-care workers, first responders, and other frontline workers who were the first to receive the jab in the U.S. It also showed the vaccines are 80-percent effective after one dose. The findings confirmed earlier studies from the U.K. and Israel.
On December 10, the New England Journal of Medicine published the results of Pfizer’s phase three study, showing the vaccine was safe and 95-percent effective in protecting against COVID-19 in people 16 and older. Pfizer and BioNTech have also announced that a phase three trial shows that their vaccine is safe and 100 percent efficacious among children between the ages of 12 and 15, and that it elicited robust antibody responses.
Safety: On June 23, the U.S. Food and Drug Administration said it plans to add a warning label to the Pfizer and Moderna vaccines about rare cases of heart inflammation in adolescents and young adults. The news comes after the CDC convened an emergency meeting of its advisory committee to discuss “rare but higher-than-expected” cases of myocarditis and pericarditis among young people who have received the vaccines. The committee acknowledged that these cases are likely linked to the vaccines but that the benefits of the shots outweigh the risks.
Severe allergic reactions following immunization with the Pfizer-BioNTech vaccine have been reported in many countries. White House advisor Anthony Fauci told CNBC in December that some adverse reactions are expected when a vaccine is distributed to a wider population. Regulators in the U.S. and U.K. have also released reports offering reassurances that severe reactions are rare.
Clinical trials status: On November 18, Pfizer and BioNTech announced the conclusion of their phase three trials. The trials launched in July, enrolling a diverse population in areas with significant SARS-CoV-2 transmission. Pfizer has expanded the trial to include 44,000 people across multiple countries.
On February 18, Pfizer and BioNTech announced the launch of a phase two/three clinical trial to study the vaccine’s safety and efficacy among 4,000 pregnant women over the age of 18. The companies have also launched a phase 1/2/3 study in children between the ages of six months and 11 years.
On June 8, Pfizer said that it will expand its clinical trials to a larger group of children under age 12. After a phase one study showed that the vaccine was safe and effective in a group of 144 children, the clinical trials will now enroll up to 4,500 children at more than 90 sites in the U.S., Finland, Poland, and Spain. Pfizer will test a dose of 10 micrograms in children ages 5 to 11, and three micrograms for children from six months to five years old.
The company expects to have data for the older group in September and will likely file for emergency authorization for that group later that month. Data for children ages two to five will likely come soon afterward, while data for the youngest age group is not expected until October or November.
On July 8, Pfizer and Biotech announced that they are developing an updated version of the vaccine that specifically targets the Delta variant. They anticipate clinical trials will begin in August.
Johnson & Johnson
Name: JNJ-78436735
Who: One of the world’s largest multinational corporations, based in New Jersey, specializing in healthcare and pharmaceutical products.
What: A single-dose vector vaccine. (Here’s how the Johnson & Johnson vaccine works.)
Latest news: On October 21 the CDC cleared the way for the U.S. to begin rolling out booster shots of Johnson & Johnson’s vaccine. The agency endorsed the FDA’s emergency use authorization of a second dose of the vaccine for all people ages 18 and older at least two months after a first dose.
U.S. regulators also authorized mixing and matching vaccines—such as administering booster doses of the either Moderna or Pfizer vaccine to people who originally received the Johnson & Johnson vaccine. A preprint analysis of a National Institutes of Health study shows that a booster dose of the mRNA vaccines elicit a stronger immune response than another dose of the Johnson & Johnson shot.
The news comes just weeks after Johnson & Johnson announced results of its studies of booster doses. When administered two months after the first jab, the booster is 100 percent effective against severe disease and causes antibody levels to rise four to six times higher than after the first shot. The second dose was also shown to be 75 percent effective against all symptomatic disease globally and 94 percent effective in the U.S. The company said that a booster shot administered six months after the first dose produced a 12-fold increase in antibody levels.
The company also said that real-world evidence and data from its clinical trials show that its single-dose vaccine remains effective against COVID-19. The press release cited a study published to a preprint server, which shows that the vaccine remains 79 percent effective in preventing COVID-19 and 81 percent effective in preventing hospitalizations. Johnson & Johnson said these data are consistent with findings from its clinical trials, which showed 75 percent efficacy against severe disease and 89 percent efficacy against hospitalization.
Approval status: Approved for use in the U.S., Bahrain, Canada, and the European Union.
Distribution: On March 2, the U.S. announced that Johnson & Johnson has partnered with its competitor Merck to increase the supply of its COVID-19 vaccine. Merck will dedicate two facilities to producing the vaccine, which could double the amount of available doses. Biden said that the additional doses will allow the U.S. to vaccinate all adults by the end of May.
On June 11, the New York Times reported that the FDA has told Johnson & Johnson to throw out 60 million doses made at its plant in Baltimore. The news came a day after CNN reported that the U.S. hasn’t sent any shipments of the vaccine since the first week of May due to a lack of supply caused by earlier issues at the plant. On June 10, Johnson & Johnson also announced that the FDA has approved an extension of the shelf life of its vaccine from three to four and a half months.
Efficacy: On July 20, the New York Times reported on a preliminary study showing that Johnson & Johnson’s vaccine is less effective against the Delta and Lambda variants than it was against the original virus strain. The paper notes that the results were obtained in a lab experiment and may not reflect the vaccine’s real-world efficacy.
The results are also at odds with an earlier study conducted by Johnson & Johnson showing that its vaccine offers strong protection against Delta. Those studies showed a slight drop in efficacy compared to the original virus, but say it is more effective against Delta than the Beta variant of concern. The studies also showed that the protections last for at least eight months.
On February 24, an FDA analysis confirmed Johnson & Johnson’s earlier report that its vaccine is safe and effective in preventing COVID-19. The report found the vaccine is 72-percent effective in preventing COVID-19 based on U.S. trials, and 85-percent effective in preventing severe disease across all regions. It also shows that the vaccine was 64-percent effective in preventing disease in the company’s South African trials, which is higher than had previously been reported.
On June 9, a study published in the journal Nature showed that Johnson & Johnson’s vaccine is effective in protecting against virus variants, including the Beta and Gamma variants of concern. The study showed that the vaccine elicits neutralizing antibodies and a T-cell response among people who live in areas where the variants are widely circulating, including Brazil and South Africa.
Safety: On July 13, U.S. regulators added a warning to Johnson & Johnson’s vaccine in response to rare reports linking the shot to Guillain-Barré Syndrome, a disorder in which the body’s immune system attacks the nerves. The FDA said there have been about a hundred preliminary reports of the syndrome among the 12.8 million people who have received the Johnson & Johnson vaccine. It added that the benefits of receiving the vaccine still outweigh the risks.
CDC officials told the Washington Post that the cases have mostly been reported about two weeks after vaccination among men, many aged 50 or older, and that these cases will be discussed during an upcoming meeting of the CDC’s advisory committee.
In the spring, the vaccine’s rollout was briefly halted in the U.S. and across Europe as regulators investigated reports of blood clotting among people who have received the shot. The FDA and CDC reviewed 15 cases of blood clots. The cases—which the agencies noted are “extremely rare”—occurred in women between the ages of 18 and 48 within six to 13 days after vaccination. The Europeans Medicines Agency also said that the cases it reviewed occurred in people under 60—mostly women—within three weeks of vaccination.
On April 23, the U.S. FDA and CDC lifted the pause on Johnson & Johnson’s vaccine and said that immunizations can resume immediately. The agencies said that the risk of blood clots is “very low” and that the benefits of getting the vaccine outweigh the risks. It will add information about the increased risk of blood clots to the vaccine’s label. The decision came days after the European Medicines Agency said that blood clots should be listed as a “very rare” side effect of Johnson & Johnson’s COVID-19 vaccine.
Clinical trials status: On September 23, 2020, Johnson & Johnson announced the launch of its phase three “ENSEMBLE” trial to evaluate the safety of the vaccine—and how well it works—among up to 60,000 adults from a variety of countries. The trial will include “significant representation” from older populations and those with underlying conditions that make them more susceptible to COVID-19.
On October 12, 2020, Johnson & Johnson announced that it paused phase three trials for an independent safety review due to an unexplained illness in a participant. The company didn’t provide any details, in part to protect the patient’s privacy, but said that illnesses and accidents are expected in large clinical studies. What’s more, study pauses are routine for clinical trials and aren’t typically reported. Later that month, the company announced it would resume trials, which were fully enrolled with 45,000 participants by December 17.
On April 2, Johnson & Johnson announced that it has begun vaccinating children age 12 to 17 as part of its phase 2a clinical trial. The company said it will initially test the vaccine in adolescents age 16 to 17 before expanding it to younger children.
Moderna Therapeutics
Name: mRNA-1273
Who: A Massachusetts-based biotech company, in collaboration with the National Institutes of Health.
What: A nucleic-acid vaccine that requires two doses.
Latest news: On October 21 the CDC cleared the way for some people to get booster shots of the Moderna vaccine. The agency endorsed the FDA’s emergency use authorization of booster doses forall people ages 65 and older as well as those ages 18 to 64 who are at risk of severe COVID-19 because of their underlying conditions. It also includes people ages 18 to 64 who are at high risk of exposure because of where they work or live, such as health-care workers or incarcerated people.
Moderna has previously said that its phase two clinical trials showed that a third dose administered six months after the second “induce robust antibody responses” and increased protections against the variants of concern. It has also said that a study of the phase two clinical trials of its three booster candidates produced robust antibody responses against the virus, including the Gamma, Beta, and Delta variants of concern.
Approval status: On December 18, the FDA granted emergency approval to Moderna’s COVID-19 vaccine, a day after an advisory panel decided 20-0, with one abstention, that the benefits of the vaccine outweigh the risks, such as the mild side effects reported in their clinical trial. The vaccine has also been approved in the European Union, Canada, the U.K., Israel, and by the WHO.
On June 1, Moderna announced that it has applied for full FDA approval of its COVID-19 vaccine for use in people age 18 and older. The company also plans to file for emergency use authorization for teens ages 12 to 17. A study of clinical trials among adolescents in this age group shows that its vaccine is safe and 100 percent effective. The study also showed the vaccine is 93 percent effective among participants in this age group two weeks after the first dose.
On October 5, Moderna announced that European Union regulators have authorized a third dose of its COVID-19 vaccine for “severely immunocompromised” people age 12 and older.
Distribution: Moderna’s candidate was the second vaccine to receive emergency authorization in the U.S., joining Pfizer’s candidate. On December 11, the Trump administration purchased an additional 100 million doses of Moderna’s vaccine. Two months later, the Biden administration procured an additional 100 million doses, for a total of 300 million by the end of July.
On April 2, Moderna announced that the FDA has authorized it to increase the number of doses in its vials from 10 to 11. Regulators are also permitting the company to use new vials that allow for 15 doses. The FDA also said that Moderna’s vaccine can now be kept at room temperature for up to a day. The vaccine can otherwise be safely stored on ice or in a normal refrigerator for 30 days. These changes are expected to help the company distribute its vaccine more quickly.
The company also says it remains on track to deliver at least 500 million doses globally per year beginning in 2021, thanks in part to a deal it has struck with Swiss manufacturer Lonza that will allow it to manufacture up to a billion doses a year.
On July 16, the U.S. said it will begin shipping 3.5 million doses of Moderna’s vaccine to Argentina as part of a bilateral deal between the countries. The U.S. has also shared doses of its vaccines with Taiwan, Brazil, El Salvador, Pakistan, and other countries.
Efficacy: On September 10, the CDC released a study of more than 32,000 real-world cases suggesting that Moderna’s vaccine is more effective at preventing hospitalizations than the Pfizer or Johnson & Johnson vaccines. The overall efficacy of Moderna’s vaccine was 95 percent, compared to 80 percent for Pfizer and 60 percent for Johnson & Johnson.
The study backs up earlier studies suggesting that Moderna’s vaccine may provide stronger protection than Pfizer’s jab. A study published on August 30 found that Moderna’s vaccine produces significantly more neutralizing antibodies than Pfizer’s, which might be attributed to the higher dosage or the longer interval between the first and second doses. On August 8, a preliminary Mayo Clinic study of more than 50,000 patients showed that the efficacy of Moderna’s vaccine dropped from 86 percent in early 2021 to 76 percent in July, when the Delta variant was predominant. Meanwhile, the Pfizer vaccine’s efficacy dropped over the same time period from 76 percent to 42 percent.
An earlier preprint analysis of Moderna’s vaccine also suggested that antibody levels can predict the vaccine’s efficacy against COVID-19. The study showed that people with breakthrough infections who had lower levels of antibodies in their blood were more likely to develop symptomatic infections than those with higher levels of antibodies. The study authors tell Nature that the data doesn’t suggest a threshold of antibodies that ensures protection but it does show a relationship between higher levels of antibodies and lower risk of infection.
On August 12, a study published in the journal Science showed that Moderna’s vaccine protects against COVID-19 for at least six months and is effective against the Delta variant. The findings confirm earlier studies and announcements made by the company that its vaccine remains 93 percent effective for at least six months after administration of the second dose.
However, there is some doubt about whether people who received the Moderna shot will need boosters. A study published in the journal Nature on June 28 showed that the vaccine elicits “robust and prolonged” immune responses—indicating that protection may last for years so long as the virus doesn’t mutate to evade it.
On July 9, Nature reported on a study showing that two quarter-doses of Moderna’s vaccine generates long-lasting neutralizing antibodies and T cells. The results suggest that it might be possible to administer fractional doses to help stretch the world’s vaccine supply, particularly in low- and middle-income countries that are facing shortages.
On February 17, the New England Journal of Medicine published a preliminary report showing that Moderna’s vaccine remains effective in protecting against the virus variant found in the U.K. However, it may be less effective in protecting against the South African variant—although researchers noted that further study is needed.
In December 2020, an FDA analysis of the phase three study of Moderna’s vaccine confirmed that it is 94.1-percent effective in preventing mild cases of COVID-19 and 100-percent effective at preventing severe cases after taking two doses.
Safety: On June 23, the U.S. Food and Drug Administration said it plans to add a warning label to the Pfizer and Moderna vaccines about rare cases of heart inflammation in adolescents and young adults. The news comes after the CDC convened an emergency meeting of its advisory committee to discuss “rare but higher-than-expected” cases of myocarditis and pericarditis among young people who have received the vaccines. The committee acknowledged that these cases are likely linked to the vaccines but that the benefits of the shots outweigh the risks.
Clinical trials status: Moderna announced on December 17 that it is launching clinical trials to evaluate the vaccine’s safety in children and people with cancer; it will also establish a “pregnancy registry” to track the vaccine’s safety in people who are pregnant.
The company started the third phase of its clinical trials in July 2020. Preliminary findings from its phase one trials showed that healthy subjects—including elderly patients—produced coronavirus antibodies and a reaction from T cells, another part of the human immune response. Phase three is testing the vaccine in 30,000 U.S. participants. The company also announced plans to test the safety and efficacy of a booster shot that would be delivered a year after the first pair of vaccine doses, according to CNBC. The trial will likely begin in July 2021.
On February 24, Moderna announced that it has shipped doses of a booster vaccine to the U.S. National Institutes of Health for clinical trials. The phase one trial will determine whether the booster can improve immunity against the South Africa variant. Moderna is also investigating using a third dose of its approved vaccine to protect against variants.
AstraZeneca—University of Oxford
Name: ChAdOx1 nCoV-19
Who: The U.K. university, in collaboration with the biopharmaceutical company AstraZeneca.
What: A viral vector vaccine that requires two doses.
Latest news: A preprint study out of the United Kingdom shows that the Pfizer and AstraZeneca vaccines remain protective against the Delta variant but that their efficacy wanes over time. Among study participants, Pfizer’s vaccine waned more rapidly. Within four to five months after a second dose, the vaccine’s efficacy was on par with the AstraZeneca shot. The study emphasizes, however, the both vaccines still significantly reduce the risk of infection.
Approval status: Approved for use in the United Kingdom, the European Union, Argentina, India, and other countries.
Efficacy: On July 8, a study published in Nature demonstrated that people who have received both doses of the AstraZeneca of Pfizer vaccines remain fully protected from the Delta and Beta variants. However, a single dose of either vaccine was not as protective.
On June 25, preliminary results from a British study showed that mixing doses of the AstraZeneca and Pfizer vaccines provides strong protection against COVID-19. Researchers told the New York Times that the protection is strong regardless of the order in which the vaccines are administered. The findings will be useful for those who are unable to get a second AstraZeneca vaccine due to production delays and safety concerns, although researchers say it’s still best to get two doses of the same vaccine for now.
On March 24, AstraZeneca released the primary analysis of its U.S. phase three clinical trials showing that its vaccine is 76 percent effective at preventing COVID-19, slightly lower than the 79 percent efficacy it had announced two days earlier based on a partial analysis of the data. It is also 85 percent effective in people 65 and older and 100 percent effective at preventing severe cases of the disease.
U.S. health officials had taken the unusual step of questioning the decision to release the interim results, describing them as “outdated and potentially misleading.” In a letter obtained by the Washington Post, an independent panel of experts at the National Institutes of Health that oversees U.S. clinical trials said that it had recommended the company release a later analysis instead, showing the vaccine may be 69 to 74 percent effective.
On February 3, AstraZeneca and Oxford released a preprint study of a phase three trial showing that their vaccine is 76-percent effective at preventing COVID-19 after one dose, with no severe cases or hospitalizations reported. The data also suggest that the vaccine may reduce asymptomatic transmission of the virus. Weekly swabs of participants testing for the presence of the virus found a 67-percent reduction in positive swabs after the first dose.
The companies also said that the vaccine’s efficacy increased to 82 percent when the second dose was taken after 12 weeks or longer, rather than the originally recommended four-week interval. The British government has recommended the longer gap in its rollout of the vaccine to prioritize getting the first shot to as many at-risk people as possible.
On February 7, South Africa halted its use of the AstraZeneca-Oxford vaccine after preliminary laboratory studies showed it offered only minimal protection against the virus variant that is dominant in that country. The finding was later confirmed by a study published in the New England Journal of Medicine showing that the vaccine does not protect against mild to moderate cases of COVID-19 caused by the South African variant. Early data suggested that the vaccine will still effectively protect against the variant that is prevalent throughout the U.K.
Safety: On June 9, a study published in the journal Nature Medicine found that people who have received the AstraZeneca vaccine have a slightly increased risk of a bleeding disorder. The analysis of 2.53 million people who received the vaccine found an incidence of 1.13 cases per 100,000 vaccines. Researchers said the benefits of getting the vaccine outweigh the risks. The study echoes and earlier safety review conducted by the European Medicines Agency.
In Canada, meanwhile, on June 29 regulatory officials advised people with a history of capillary leak syndrome against receiving the AstraZeneca vaccine. Health Canada is also updating the vaccine’s label to add the syndrome as a potential side effect.
Distribution: Project members say their candidate can be stored at temperatures seen in common refrigeration. Oxford and AstraZeneca expect to produce up to three billion doses of the vaccine in 2021.
On December 30, the U.K. announced changes to its vaccine delivery plan: With COVID-19 infections spreading rapidly, the country said it would prioritize delivering the first dose of either vaccine to as many at-risk people as possible, based on data provided to and released by health regulators. It will do so by delaying administration of the second dose of the AstraZeneca-Oxford drug. A similar rule was issued for the Pfizer-BioNTech vaccine, but regulators didn’t provide data to back the new regimen. Overall, the U.K. still recommends that recipients receive two doses of either vaccine for maximum benefit.
On February 15, the WHO listed the AstraZeneca-Oxford vaccine for emergency use, which will allow the agency to begin rolling out the vaccine in low-income countries through the COVAX Facility. Reuters reports that COVAX plans to deliver nearly two billion doses to more than 90 low- and middle-income countries by the end of the year.
On April 26, the Associated Press reported that the U.S. plans to share its AstraZeneca vaccine stockpile with the rest of the world—up to 60 million doses. The U.S. has not yet authorized the company’s vaccine for use.
The European Union also said on April 26 that it is suing AstraZeneca over the delays in shipping hundreds of millions of doses of its vaccine. According to the New York Times, AstraZeneca has said it will only be able to deliver a third of the 300 million doses it had promised Europe by the end of June. The lawsuit will hinge on whether AstraZeneca can prove it has made its “best efforts” to deliver the doses on time, according to the terms of the contract.
Clinical trials status: On December 11, AstraZeneca and Russia’s Gamaleya Institute announced plans to work together to study the possibility of combining Oxford’s vaccine with Gamaleya’s Sputnik V vaccine. Since both use the same adenovirus, researchers will investigate whether a combination of the two will improve efficacy.
The AstraZeneca-Oxford vaccine’s phase three trial aims to recruit up to 50,000 volunteers in Brazil, the U.K., the United States, and South Africa. On September 8, AstraZeneca paused the trials for a safety review due to an adverse reaction in one participant in the U.K., which the company described as a “routine action.” After an investigation by independent regulators, the trials resumed in the U.K., Brazil, South Africa, and India in September and resumed in the U.S. a month later.
Novavax
Name: NVX-CoV2373
Who: A biotechnology company based in Gaithersburg, Maryland.
What: A protein vaccine that involves a nanoparticle carrier to better aid delivery and uptake by cells.The vaccine is administered in two doses, 21 days apart.
Latest news: On August 5, Novavax said that it will hold off on submitting its vaccine to the FDA for emergency use authorization until the fourth quarter of 2021 rather than the third quarter as the company had previously announced. Reuters reports that Novavax also said that it will file a separate application for booster shots once the emergency use authorization submission is processed; the company said its booster shot given six months after the two-dose regimen elicited a 4.6-fold increase in antibodies. The company has filed for authorization from regulators in India, Indonesia, and the Philippines.
The New York Times also reported that the federal government will not fund further production of the Novavax vaccine until the company resolves regulators’ concerns about its lagging production process.
Approval status: Not approved for use.
Efficacy and safety: On June 14, Novavax announced that its vaccine is safe and 90.4 percent effective in protecting against COVID-19—including the more contagious virus variants that are circulating. The vaccine is also 100 percent effective at preventing moderate and severe disease among 29,960 clinical trial participants age 18 and older in the U.S. and Mexico.
On March 11, Novavax announced that a final analysis of its phase three clinical trials in the U.K. shows that its vaccine is 96.4-percent effective in preventing COVID-19. It also announced the findings of its phase 2b clinical trial in South Africa, which showed the vaccine was only 48.6-percent effective against the strains circulating there. Both trials showed the vaccine is 100-percent effective at preventing severe cases of the disease.
On January 28, Novavax had announced preliminary results of its phase three trials in the U.K., which showed at the time that its vaccine is 89.3-percent effective in preventing COVID-19. On September 2, a study of the company’s phase one trial published in the New England Journal of Medicine found that the vaccine was safe and produced coronavirus antibodies at a higher level than is seen among those who have recovered from COVID-19. It also stimulated T cells, another arm of the human immune response.
Clinical trials status: On September 24, Novavax announced the launch of its phase three trial in the United Kingdom, which will evaluate the vaccine in up to 10,000 people, both with and without underlying conditions. Up to 400 participants will also be vaccinated against the seasonal flu as part of a sub-study that will help determine whether it is safe to give patients both vaccines at the same time. On November 30, Novavax said it had completed enrollment in its phase three trial in the U.K.
On December 28, Novavax announced the launch of a phase three study in the U.S. and Mexico, which will evaluate the safety and efficacy of its vaccine in up to 30,000 adults.
Sinopharm
Name: None
Who: China’s state-run pharmaceutical company, in collaboration with the Wuhan Institute of Biological Products.
What: Two inactivated SARS-CoV-2 vaccines.
Latest news: On July 19, preliminary results from a study conducted in Sri Lanka found that Sinopharm’s vaccine was less effective against the Delta variant than the original SARS-CoV-2 strain. As Reuters reported, the study showed that the vaccine elicited a 1.38-fold reduction in antibody levels against the variant.
Distribution: Authorities in China have set a goal to vaccinate 50 million people by Lunar New Year in mid-February, despite the lack of evidence that their available vaccines are safe and effective. Chinese officials have said the vaccine will be free for Chinese citizens, and that they will prioritize immunizations for high-risk groups such as the elderly and people with underlying conditions.
On January 13, Hungary’s government announced that it had reached a deal with Sinopharm to buy the company’s vaccine, following Hungary’s criticisms of the pace of the European Commission’s vaccine rollout.
Approval status: China has approved one of the company’s vaccines for general use and another for limited use. One of the Sinopharm vaccines has also been approved by the World Health Organization as well as in Bahrain, the United Arab Emirates, and other countries.
Sinopharm filed for final regulatory approval from China in late November, two months after the New Yorker reported that hundreds of thousands of Chinese civilians have already been vaccinated under the government’s emergency-use approval. China began to inoculate medical workers and other high-risk groups with the Sinopharm trial vaccines in July, making it the first experimental vaccine available to civilians beyond clinical volunteers.
Efficacy and safety: On May 7, the World Health Organization estimated the Sinopharm vaccine’s efficacy to be 79 percent among all age groups, affirming the company’s earlier announcement of the results of its phase three study.
Preliminary findings from two randomized trials, published in the Journal of the American Medical Association, have shown the vaccine can trigger an antibody response with no serious adverse effects. The study did not measure T cell-mediated immune responses. These results are significant, though, as they are the first published data from human clinical trials for a COVID-19 vaccine that uses a whole, inactivated virus.
Clinical trials status: Sinopharm launched its first phase three trial in July 2020 among 15,000 volunteers—aged 18 to 60, with no serious underlying conditions—in the UAE. The company selected the UAE because it has a diverse population made up of approximately 200 nationalities, making it an ideal testing ground. Sinopharm will also undertake phase three trials in locations such as Peru and Bahrain.
Sinovac
Name: CoronaVac
Who: A Chinese biopharmaceutical company, in collaboration with Brazilian research center Butantan.
What: An inactivated vaccine.
Latest news: On July 15, Reuters reported that the leaders of a Chilean study have recommended administering a third dose of Sinovac’s vaccine as its efficacy has waned in the face of the Delta variant. The vaccine’s level of protection is lower than others—late-stage trials found that it is 51 percent effective in preventing COVID-19. Still, Nature reports that it is 100 percent effective at preventing severe disease and therefore is key to helping curb the pandemic.
Approval status: Approved for limited use by the WHO as well as in China, Indonesia, Brazil, and other countries.
Efficacy and safety: Reports released in early January place CoronaVac’s efficacy below that of other authorized vaccines. Results from a late-stage clinical trial released on January 13 found that CoronaVac had an efficacy of 50.4 percent, slightly more than the 50-percent minimum recommended by the World Health Organization. The difference comes down to the earlier estimate’s exclusion of trial participants who got “very mild infections” but did not require clinical assistance.
On April 7, a preliminary study of CoronaVac’s vaccine rollout in Brazil showed that the vaccine is about 50 percent effective in protecting against COVID-19 in a region where the highly transmissible P.1 variant is circulating.
Clinical trials status: CoronaVac entered phase three trials in July, with plans to recruit nearly 9,000 healthcare professionals in Brazil, in addition to phase three trials in Indonesia. A planned trial in Bangladesh was delayed, after Bangladesh refused in October to co-finance a late-stage trial.
Center for Genetic Engineering and Biotechnology
Name: Abdala
Who: A government-run research institute in Cuba.
What: A protein subunit vaccine that’s administered in three doses.
Latest news: On June 22, Cuba announced that the Abdala vaccine is 92.28 percent effective against COVID-19. Data has not yet been released, but Reuters reports that Cuban regulators are expected to grant emergency use authorization to both the Abdala and Soberana-02 vaccines. However, the country has already begun administering the two vaccines among health workers as part of an “intervention study.”
Clinical trials: In March Cuba launched phase three clinical trials for the Abdala vaccine among 48,000 volunteers.
Finlay Institute for Vaccines
Name: Soberana-02
Who: A government-run research institute in Cuba.
What: A conjugate vaccine that uses part of the virus spike protein.
Latest news: On June 22, the New York Times reported that the Soberana-02 vaccine was 62 percent effective at preventing COVID-19 after two of its three required doses. Results for all three doses is expected within weeks.
Clinical trials: On March 4, Cuba became the first country in Latin America to announce the launch of a phase three clinical trial for one of its COVID-19 vaccines, the Miami Herald reported. The Cuban government hasn’t released any data from early-stage trials but said the phase three trial will be conducted in Havana among 44,000 volunteers.
CureVac
Name: CVnCoV
Who: A German biopharmaceutical company in partnership with Bayer, a German multinational pharmaceutical company.
What: An mRNA vaccine that’s administered in two doses taken 28 days apart.
Latest news: On June 16, CureVac reported disappointing results from a study of its clinical trials showing its vaccine is 47 percent effective in preventing COVID-19, falling short of the company’s own criteria for success. CureVac attributed its results to the virus variants that are now circulating. It sequenced 124 cases of COVID-19 among clinical trial participants and found only one case was caused by the original SARS-CoV-2 virus and more than half were caused by variants of concern.
The New York Times reports that CureVac still intends to apply for approval from the European Medicines Agency. The company has a deal to provide 405 million doses to the European Union if its vaccine is authorized.
Approval status: Not approved for use.
Efficacy and safety: On January 11, CureVac announced that preliminary results show its vaccine prompted robust antibody and T-cell responses in rhesus macaques.
Clinical trials status: On December 14, CureVac announced it had begun enrolling participants in a phase 2b/3
