Selected Opinion/Editorial

The Washington Post
February 2, 20220
The Post’s View
Opinion: The smallest kids still lack a vaccine. The FDA must leave no uncertainty.
By Editorial Board
In considering whether to give emergency-use authorization to the Pfizer-BioNTech vaccine for children under 5 years old, it is imperative that the Food and Drug Administration retains public trust and protects the integrity of the process. Many parents are eager for their children to get this vaccine, but many others might be hesitant. The FDA is taking an unusual route in considering the merits and must not leave any doubts in the air.

The anxiety of parents about children under 5 is acute: These are the only Americans not yet eligible for a vaccine. Overall, in billions of doses, the mRNA vaccines have proved safe and effective. Although children represent a small percentage of pandemic hospitalizations, and deaths are rare, the case numbers have spiked during the omicron wave.

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.”

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.”

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?

Everyone must hope the vaccines will work for those who have most of their lives ahead of them. But parents are already displaying reluctance to get children from 5 to 12 years old vaccinated. For the next step, the FDA must be crystal clear and leave no gaps or uncertainties. A vaccine should never be a shot in the dark.