FDA meeting (part 2)
Second half report. A little late (#workingmom).
The second half of the FDA meeting started off with public comment. There was one major theme: vaccine hesitancy. A legitimate concern public health officials need to consider while rolling out the vaccine campaign.
Then Pfizer had its time on the stand. They basically took a victory lap. But did report a few surprises...
1. They are already started a DART study. This is an animal study (in this case rats) that evaluates any signs a vaccine might hurt a developing fetus or pose a threat to the pregnancy. This is an FDA requirement before going into clinical trials with pregnant and/or lactating women. We should get results in the next week or so. Although, with our knowledge of RNA and the human system, we do not hypothesize anything negative will come up (see my previous post on vaccine and fertility). Nonetheless, an important step.
2. Also, Pfizer reported that data on how well the vaccine protects against asymptomatic infection is expected in early January.
Then came the fun part...An important discussion amongst the committee before voting. There were three main talking points:
1. Severe allergic reactions reported in the UK. Pfizer didn’t report severe reactions in their trial because people with a history of allergic reactions to vaccines were excluded from the beginning. So, in short, the committee was not surprised that two people had severe allergic reactions in the UK. They were “more worried about perception than reality”. In other words, the committee was more worried that the allergic reactions were surprising to the public and that it will add to vaccine hesitancy. Even though it’s still not even clear if the allergic reactions were due to the vaccine. The committee asked for future studies on allergies but that this won’t stand in the way of emergency approval. The FDA said they warned about allergic reactions with vaccine ingredients a few weeks ago. The FDA also stated that their independent review pointed to the possibility of some volunteers in the trial having minor allergic reactions that researchers had not caught.
2. Pfizer wasn’t excited about the plan for placebo participants (discussed in the first half). This was driven by concerns of feasibly vaccinating 44,000 people again and moral obligations to “courageous volunteers who made a personal and important choice to help make a difference during this pandemic”. Pfizer has said they are NOT doing the crossover design and plan to unblind the study.
3. Inclusion of teenagers. There was a lot of disagreement about whether there was enough data to include 16-17 year olds in the emergency authorization. Some committee members argued that there was just not enough people to make a meaningful decision on safety.
Then the committee voted...Do the benefits of the Pfizer vaccine outweigh its risks for those aged 16+? 17 “Yes”, 4 “No”, 1 “abstention”. The “No’s” were likely driven by the age disagreement above.
This vote is a recommendation to the FDA. The FDA doesn’t have to approve for emergency use, but most likely will in the next couple days. The FDA will have final say on the groups that can be vaccinated (like age and breastfeeding) under the emergency order. TBD.
If the FDA approves, the initial shipment of 6.4 million doses will leave warehouses within 24 hours.
Then, if all goes as planned, Pfizer will apply for full approval in April of 2021 (six months of safety data).
Phew, what a day.
Love, YLE