Many Americans say they’re waiting until a vaccine is approved (not just emergency authorized) to get vaccinated. With so many still unvaccinated and Delta sparking exponential growth and increases in hospitalizations and deaths (see Dr. Gerald’s Sobering Epidemiology & Hospital Capacity Update), there’s growing pressure for the FDA to approve one or more of the authorized vaccines. In addition to getting hesitant folks off the fence, approval would make universities, governments and employers feel more comfortable implementing vaccine requirements.
It has been disappointing to see the FDA be so opaque about where the vaccines are in the approval pipeline and what still remains to be completed before they will entertain approval. After all, the highly effective mRNA vaccines by Pfizer-BioNTech and Moderna have been administered to tens of millions of people in the United States and worldwide without significant problems.
Pfizer and BioNTech submitted their request for full approval way back on May 7, and Moderna began a rolling submission in June. The emergency use authorization for Pfizer was based on clinical trial data of 21,700 people with a 2 month follow-up (and an equal number of placebo folks). Many placebo people have since received the vaccine, and the follow-up for everyone is at least six months, which is now complete.
We finally got a little info from FDA last week when they said that one of the hold-ups has been the manufacturing approval process which is much more detailed than it is for EUA. They also need to do additional inspections of facilities, and with lots of facilities involved in different countries, that entails a lot of travel and legwork.
The FDA still hasn’t given an estimated date for approval of either Pfizer or Moderna. .
On the vaccine front for younger kids… Pfizer says they expect to ask the FDA for emergency use authorization for kids 5-11 years old in September or October and for the 6 month to 4 year old group the month after that.
Those clinical trials are using lower doses, with 5-11 year-olds getting a 10 microgram dose and kids under 5 getting 3 micrograms. Those trials started back in March. The FDA is asking for 6 months of follow up for these pediatric trials both because of the lower doses and to make sure they have a clear picture of the rare myocarditis events. That extra follow-up time is partly why authorization in the younger kid group is taking longer.
It would be nice if the FDA would be more transparent about where they are in the process and were to communicate that clearly. Good communication can provide confidence in the process and the vaccines. By being so opaque, they have really been missing opportunities to build more public confidence.
Honestly, I think it’s time for HHS Secretary Becerra to nominate a new permanent FDA Commissioner – and preferably one that’s good at communication.
