Covid Vaccine for the Youngest?
Kudos to the FDA
On Friday the FDA announced they would be delaying a decision on allowing PFZ’s COVID vaccine to be made available to the 6 mo- 5 yo age group, pending further data on disease prevention and further safety data. This was a wise decision. The overall situation was certainly unusual since PFZ had announced just a few weeks ago that the 2x dose regimen they were testing had failed to be as immunogenic as anticipated, and that they were modifying the trial to include a third dose. Despite that, the FDA apparently requested PFZ to submit the data they had available for review. Scott Gottlieb, former FDA Commissioner and now a Pfizer Board member, and Albert Bourla, CEO and Chairman of Pfizer, both proclaimed publicly that they were confident that the three dose regimen would be effective, and that the FDA would green light starting to vaccinate young children with two doses. To say that this situation was very unusual would be an understatement, but these are unusual times. What seems clear to me is these two individuals should have recused themselves from public comment about the FDA’s likely decision. Given the extremely contentious nature of the vaccine debate in the United States and around the world, the message likely to be received is top executives of the the drug company saying, “Two doses of this vaccine developed for the Wuhan stain of the virus didn’t work, but we think three will do the trick, and we want to start injecting the kids now with the first doses in case we are right. Don’t worry we will be very careful about letting you know all the safety issues, as soon as we figure it out.” So Kudos to the FDA so far on this issue.
One of the biggest issues for the FDA apparently was not just the lower than expected peak antibody levels in a certain age range, but the lack of data on vaccine efficacy in disease prevention. That brings up an important issue. We are using the wrong vaccine for the current Omicron virus, which right now is the only one that counts. The currently available RNA vaccines have maintained good effectiveness in preventing severe disease and death, but they have been of much diminished valued in preventing disease. That’s why the mantra has finally changed from, “Take the vaccine and you won’t get COVID”, to “Take the vaccine and you won’t end up in the ICU or the morgue”. Pfizer will likely be able to obtain data on vaccine effectiveness in disease prevention in the youngest age group in a relatively short time. I won’t make a prediction on that result. I do think it will take much longer to collect data on severe disease or death in this pediatric group, which has an incredibly low risk of either to begin with. The question is, will the FDA eventually make a decision then based on vaccine efficacy in disease prevention, which we already know is pretty poor. If they do, will they use a much lower bar, or will they stick with the (app. 70%) metric which Dr. Fauci told us at the beginning of vaccine development would be necessary for the vaccine to be truly useful?
Will decisions around the rest of the developed Western world have an influence on a vaccination program here for the youngest? The history of the Pandemic so far suggests it won’t. Denmark announced Friday that they are planning to wind down their vaccination program in the spring, citing high vaccine uptake and very high population immunity from both vaccine and natural immunity. This is in the face of declining but still intense disease transmission. They are basing that decision on the current level of severe disease which is manageable for the healthcare system. The Danes are not going to give boosters to the 5-15yo age group, and have stopped giving fourth doses to high risk groups. Although not specifically addressing the issue it sounds like they won’t be pursuing vaccination of the youngest children at least for now.