The editors of the Washington Post have what appears to me to be a very measured commentary on whether children younger than 5 should be vaccinated against COVID-19. Here’s the meat of their remarks:
Pfizer said Dec. 17 that a two-dose vaccine worked well to stimulate antibodies in children from 6 months to 2 years old in a clinical trial, but did not work in children from 2 years old to under 5. The company said it would attempt a clinical trial with a third dose, to see if that got better results, and if successful, it would seek an emergency-use authorization from the FDA for a three-dose regimen. At issue is not vaccine safety or tolerance but whether it is effective.
On Tuesday, Pfizer announced the FDA has requested that it submit information for an emergency-use authorization of the first two doses, leaving the third for later. This raises the question: What has changed since the December announcement that those two didn’t work? We might learn more when the matter comes before an FDA advisory committee soon. Pfizer said results on the third dose would only be available in “the coming months.â€
In statements, the FDA and Pfizer both pointed to the omicron surge as the reason for the unusual process. An FDA spokesperson said the new variant “has rapidly facilitated the collection of important additional clinical data impacting the potential benefit-risk profile of a vaccine for the youngest children.†FDA officials felt it was “prudent†to get the data from Pfizer now instead of waiting, especially because of “notable increase in reports of children experiencing covid-19 long haul symptoms, including in some cases children developing autoimmune diseases and Type 1 diabetes after having had covid-19.â€
The company and the FDA are right to feel a sense of urgency. But parents will be asking: Should they start with two doses, given Pfizer’s statement that in the earlier trial, they didn’t work for children from 2 to under 5? Should parents be comfortable starting a vaccine series — which Pfizer calls “a planned three-dose primary series†— without knowing anything about the effectiveness of the third dose?
The context for these measures may be that recent studies of the prevalence of COVID-19 among children younger than 5 have suggested that it may be greater than had previously been thought. Shorter: kids under 5 get COVID-19.
My own view is that the FDA should have high confidence that the vaccine is effective among children 2-5 before granting emergency use authorization for that age group. At this point there is still a lot we don’t know.







