Just now, the FDA has announced they will postpone an advisory meeting to discuss whether kids 6 months to 4 years could receive 2 doses of Pfizer vax at 3 micrograms. This dose was insufficient to meet the primary endpoint of the study: non-inferior Ab titers. In a normal world, the company might have attempted a dose of 6 micrograms x 2. Instead, they added a 3rd dose and plowed ahead. While that was ongoing, an analysis suggested that there was some signal of reduction in sars-cov-2 acquisition. The administration pushed the narrative that we could authorize 2 doses for now, with possibly a third to come.
Data was trickled out slowly in the media, and the Times reported that with ~4 k participants, there were 50 events there might be a 57% reduction in sars cov 2 acquisition. Privately, many scrambled to calculate confidence intervals, and reached the conclusion these data were sparse. Moreover, when you look at endpoints beside the primary endpoint, and are allowed to look as many times as you wish, you can often find such deviations, which fail to meet the statistical rigor of clinical trials that demand pre-specified looks at data and adjustment for multiplicity. At the time I made a video about what I was going to look for in the data
Now it appears the administration is walking back this EUA, and will wait for more information.
Let me just say: This is a colossal screw up.
The administration is spending the FDA’s vaccine credibility like monopoly money. They make Donald Trump look hands off on vaccines!
First, they pushed so hard on boosting young people. Gruber and Krause resigned from FDA over this. Next, they lost Paul Offit, who has penned a number of op eds critical of boosters. Meanwhile employers & colleges latched on to booster mandates, and forced young people to do it, at peril of being fired or expelled.
This was terrible management. We should have boosted old people, and worked on getting just one dose in adults who lacked natural immunity. Those who survived covid already could have been left alone.
We seem to be aggressively pursuing kids vaccination so we can take them out of masks, but we don’t need to vaccinate them to remove masks. We could just remove masks.
Next, came this back and forth about kids vaccines 6mo - 4 years old. Everything I learned about the data came from leaks on TV shows, and coverage in newspapers. That is not how scientists are supposed to learn trial data. Now, facing the prospect of a negative advisory vote, the FDA walks back the meeting itself.
What are they thinking? We have far more at stake than just this vaccine— we have the fate of all vaccines on the line. What will the American people think about this vaccine with these flip flops? If a vaccine is ultimately approved at these ages, a huge chunk of Americans may never trust it. Worse, many may stop trusting all the vaccines we have had to protect from childhood illnesses for many years. Already some states are floating regulations to remove all vaccine mandates. That would not be good. Finally, trust in the FDA may crater entirely as it appears the White House is controlling the day to day decisions of the agency.
If a kids vaccine is someday approved, what will the uptake be? We currently have ~20% uptake in 5 to 11, this vaccine is poised to do even poorer given all this drama. Mandates like the one proposed in California are even more ill conceived and will add fuel to the fire.
Americans need clear, simple, consistent vaccine advice. The advice should be honest and acknowledge scientific truth. For COVID19, it is a more important to vaccinate the old than the young. You don’t have to worry about people with natural immunity. Vaccine makers have billions of dollars and can run large randomized trials in kids measuring clinical endpoints (severe disease) and not merely antibody levels. You don’t have to resurrect failed trials to push through EUAs in young kids.
This is all very bad. It will end poorly. There are no winners here, just losers.