The benefits of Pfizer-BioNTech’s COVID-19 vaccine outweigh its risks for emergency use in people over 16 in the United States, a panel of vaccine experts told the Food and Drug Administration on Dec. 10.
The recommendation followed an all-day meeting of the panel, the Advisory Committee on Vaccines and Related Biological Products, held to discuss data collected from vaccine clinical trials that included more than 40,000 people. The panel voted overwhelmingly to allow emergency use of the vaccine, with some members voting no, on the grounds that there is not enough data on 16- and 17-year-olds to say whether the vaccine has more benefits than risk for teens. who have a relatively low risk of serious illness and death.
Although not binding, the FDA usually takes the panel’s recommendations. The agency must now decide whether to authorize the vaccine for emergency use, a decision that could be made as soon as the next few days.
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In clinical trials, the vaccine was 95 percent effective in preventing vaccinated people from getting sick, Pfizer reported, confirming data the company has already published. The company also indicated that the vaccine could protect against serious illness.
But there were not enough serious cases in the trials to make that determination, some experts who did not participate in the trials said at the meeting. Others have argued that other vaccines that prevent milder illnesses also prevent serious illnesses and that the data suggest that the Pfizer vaccine may also help prevent the worst complications.
It is not yet known to what extent the vaccine can also prevent infection or prevent infected people from transmitting the virus to others (SN: 8/12/20). Pfizer said Dec. 10 that it measures antibodies in the participant's blood to determine if there were asymptomatic infections among the vaccinated group, which could help answer those questions.
If the vaccine is released to the public, the company also plans to conduct studies in health workers and military families to reveal more about how the vaccine works.
Vaccine clinical trial data indicate that the vaccine is safe. Several side effects include fever, headache, arm pain, pain at the injection site, and a feeling of being deteriorated, which can be unpleasant, but are common reactions to vaccines approved for other diseases.
Given the potential mortality of COVID-19, “the vaccine is very good compensation in terms of benefits and risks,” says Marm Kilpatrick, an infectious disease researcher at the University of California, Santa Cruz, who did not attend the meeting. .
“But the side effects (which are seen in the trials) are substantial enough that it is very important to communicate clearly about them before giving the vaccine or else many people will not want a second dose and some will be scared to hear experiences from peoples ".
In the UK, two people have had severe allergic reactions after taking the vaccine since its implementation there, which began on 8 December. This has led health officials there to recommend that people with “significant allergies” that trigger anaphylaxis not get the vaccine.
FDA analysis showed that people in the Pfizer-vaccinated group were slightly more likely to have allergic reactions than those in the placebo group, officials said at the meeting. In the trial, 137 people in the vaccine group reported an allergy-like reaction, while 111 in the placebo group. The agency asked Pfizer for more data and additional allergy control.
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Another possible concern is that four people in the vaccine group developed a neurological condition called Bell's palsy, while there were no cases in the placebo group. The incidence of the disorder, which causes temporary weakness or paralysis in the muscles of the face, was not higher than in the general population. But the FDA said they would be closely monitoring that potential side effect if the vaccine got the go-ahead.
These unusual reactions raise questions about whether the vaccine can cause very rare side effects that have not been seen in clinical trials. Some side effects may come to light only once millions have been vaccinated instead of thousands of people.
The committee also debated whether to vaccinate people in clinical trials who received a placebo. In its report released Dec. 8, the FDA said people who received the placebo would not be eligible to receive the vaccine now while it is still under emergency use authorization. This is because administering the vaccine would erase the comparison group and make it difficult to determine whether the vaccine is effective and safe in the long run.
But withholding the vaccine from people at risk for COVID-19 complications may be considered unethical or irresponsible. Pfizer proposed to continue the trial, but offer the vaccine to participants in the placebo group over time when they would normally be eligible for it, subject to availability, if they did not join the study.
A CDC advisory panel recommended that health care workers and people living in nursing homes be the first to be vaccinated, if authorized (SN: 01/12/20). But it will be up to the states to work out the details of who gets it exactly and when.
The committee also looked at possible pitfalls with vaccine implantation. It is known that the vaccine, which requires two doses, must be kept frozen at -70 ° C to maintain its effectiveness (SN: 20/11/20). That unique requirement could make for complicated logistics when it comes to distributing the vaccine (SN: 03/12/20).
But the vaccine also needs to be mixed differently from other vaccines and should be given within six hours after dilution, said during the meeting Anita Patel, senior advisor to the CDC's pandemic health care and countermeasures program. This can have a learning curve and can lead to the loss of some doses if the vaccine is not handled properly.
Medical personnel must also receive special training on how to open and close the containers to prevent premature thawing of the vaccine. A minimum order for the vaccine, which includes 975 doses, could cause problems in rural areas that are not prepared to distribute that vaccine quickly, Patel said.
The committee’s guidance comes as the number of COVID-19 cases, hospitalizations and deaths increase at an alarming rate in the country. The United States recorded more than 3,000 deaths from COVID-19 on December 9, a new daily record.
A similar vaccine manufactured by Modern Biotechnology Company will be reviewed by the advisory committee on December 17th.
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