Pfizer is widely expected to ask the FDA for an emergency-use authorization of its COVID-19 vaccine in infants and young children as early as today. Pfizer, together with BioNTech, its German partner in the production of its COVID vaccine, hopes to begin administering the shots to infants as young as 6 months worldwide, starting in the United States later this month.
1. Pfizer and the FDA are moving forward DESPITE the failure its drug trials on children under 5
Pfizer and BioNTech already reported in December that,
“two doses of the pediatric vaccine failed in 2-, 3- and 4-year-olds to trigger an immune response comparable to what was generated in teens and older adults.”
The company did claim then, though, to have achieved an, “adequate immune response in children 6 months to 2 years old.”
2. A third dose is already planned
Due to the disappointing results from the trials of the two-shot regimen in children under 5, Pfizer immediately began testing a third dose on those children, amending its study to provide for a third injection to each of the participating children eight weeks after their second shot.
An anonymous administration official reported that a briefing of federal health officials by Pfizer, which included Dr. Anthony Fauci, the White House’s chief medical adviser for its response to the coronavirus, included,
“a ‘robust conversation’ that three doses were likely to be much better than two shots [in children under 5] … But to get to three, you have to get two shots first … There’s interest in seeing this move forward.”
3. The third dose may already be added to the scheduled dosing of infants and young children by April
Pfizer announced in January that it expects data on this third shot to be available by April. The Washington Post added that, according to “knowledgeable individuals” the submission of this new data is expected to lead to its addition to the vaccine schedule for young children:
“Once that information is submitted, regulators are expected to authorize a third dose of the pediatric vaccine. ‘We know that two doses isn’t enough, and we get that,’ said one of the people familiar with the situation. ‘The idea is, let’s go ahead and start the review of two doses. If the data holds up in the submission, you could start kids on their primary baseline months earlier than if you don’t do anything until the third-dose data comes in.’” [Emphasis added].