Pfizer has a lot of good news this week.
First, of course, is the news that the FDA is likely to issue an expansion of the Emergency Use Authorization by next week to include 12-15 year olds (16+ are already approved). This is huge news at a time when the pace of vaccination is slowing among adults and there are growing concerns about our ability to reach a herd immunity level of vaccinations in the US. This will add a new pool of vaccine recipients and while it’s only a modest slice of the population, every shot counts.
Second, Pfizer has announced it plans to seek an expansion of its EUA to include 2 to 11 year olds in September (Phase 3 trials for this age group are currently underway). This, again, is huge, not only for adding much more to the pool of potential vaccine recipients but also the timing. Most people had been expecting that approvals for children that young would not be forthcoming until very late in the year, or possibly even not until early next year. A November approval timeframe was considered optimistic.
If Pfizer’s expectation of a September timeframe is realistic, it means we could start vaccinating those young children relatively early in the school year. Since schools and daycares are a pretty well-known source of spread of illness (hence the news on occasion when a severe influenza outbreak will close a school down for a few days), this will go a long way toward closing off a potential avenue of spread of the disease. And it will hopefully allow the 2021-22 school year to be a normal one for both our kids and our nation’s teachers.
Third, Pfizer is filing for FULL FDA approval of its vaccine. That means it will no longer “just” be under an Emergency Use Authorization, but rather have the FDA’s full approval as a vaccine. This may seem like an issue of semantics, but having full approval may have the effect of getting a few vaccine-hesitant fence-sitters to get the jab. Also, I am not by any means versed in all the in-and-outs of such things, but it may also give firmer legal footing to schools and employers that want to require vaccinations as a condition of employment, or, in the case of students, attending school in person. Because you just know the legal challenges from the anti-vaxxers will be coming fast and furious once some big employers start requiring such a thing for their employees. And finally, it means that Pfizer would be able to directly market their vaccine to consumers. Normally, I take a rather dim view of the US’s lax laws allowing pharma companies to bombard us all with nonstop advertising for their drugs, but in this case… every little bit helps, and if a big company like Pfizer can turn their their marketers loose on the task of convincing people to get vaccinated — good on them.