Side effects seen in the rollout of the Covid-19 vaccine from
Pfizer and the U.S.
Two people in Alaska who received the Pfizer-BioNTech vaccine suffered reactions, which have also been seen in a few U.K. vaccine recipients. The advisory panel meeting, called to consider whether to recommend
“At this point, we and CDC are continuing to investigate these cases and consider data,” Fink said in the online panel meeting. “As we continue to evaluate and investigate the data, we will determine whether additional recommendations need to be made.”
Pfizer and BioNTech’s vaccine was cleared first in the U.K. earlier this month, where there were two reports of reactions following administration of the shot. Health officials there warned anyone who has a history of anaphylactic reactions to food, medicine or a vaccine shouldn’t get the shot.
The FDA didn’t take such a step, but told facilities where the vaccine would be administered to have medication on hand to treat possible allergic reactions, information which will now be reflected in the fact sheets for the vaccine.
Moderna’s vaccine isn’t yet approved in any other countries and hasn’t yet been used on anyone outside of a clinical trial. But like Pfizer and BioNTech, the company didn’t report any serious allergic reactions in its research. Both the Moderna and Pfizer products are based on messenger RNA technology that hasn’t been previously used in human vaccines. Both are two-dose vaccines.
Advisers also discussed the provision of vaccine to trial volunteers who initially received a placebo. Pfizer has already begun giving the vaccine to placebo recipients who are prioritized to get shots, such as health-care workers. Moderna is considering giving the vaccine to anyone in its trial that got a placebo, according to an FDA report prepared for the meeting. Moderna hopes to start offering the vaccine to those volunteers within one to two weeks of emergency authorization, according to a
Vaccine trial investigators give placebo randomly to participants, without knowing which, to minimize bias while they measure effectiveness and safety. Reducing the size of the placebo group may make it more difficult to detect side effects and raise trust issues.
“The images of young low-risk trial participants being knowingly vaccinated before much higher-risk community members could adversely affect trust in the fairness of the vaccine testing and allocation system,” Steven Goodman, associate dean of clinical and translational research at Stanford University School of Medicine, said in a presentation at the meeting.
One person died from Covid-19 that received the placebo earlier in the study.
“How many more severe illnesses in the placebo group will we have, and we have about two to three per week, do we need to convince ourselves of the short-term efficacy,” said Lindsey Baden, a co-principal investigator on Moderna’s final-phase clinical trial and assistant professor at Harvard Medical School.
In a report ahead of the meeting, FDA staff determined Moderna’s vaccine is 94.1% effective against symptomatic Covid-19. The report listed side effects like headache, fatigue and muscle aches typical of a vaccine.
Moderna’s vaccine is expected to get a positive overall assessment from the advisory panel though there could be a more thorough discussion of side effects given the allergic reactions.
The advisory panel met a week ago on Pfizer and BioNTech’s vaccine and voted 17 to 4, with one abstention, that the shot’s benefits outweigh its risks. The FDA does not have to follow its advisers’ recommendations, though it often does and did in this case, authorizing the vaccine on Friday, a day later. It’s likely the FDA will move at the same pace for Moderna.
Once the U.S. grants authorization for Moderna’s vaccine, advisers to the CDC must meet, as they did last week on Pfizer’s vaccine, to give Moderna’s shot the green light and provide specific recommendations for use and monitoring.
Health and Human Services Secretary
Between Pfizer and Moderna, up to 20 million people in the U.S. are expected to get their first shots by year-end. The government is holding vaccines in reserve to ensure those people get their second dose.
The companies will need to file for full FDA approval once they have assessed clinical trial participants for longer than the two months of follow up they compiled for emergency authorization. Pfizer expects to file for full approval in April.
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