Fauci confirms parents’ nightmare: FDA may delay COVID vaccines for kids under 5

The FDA is considering holding off on reviewing Moderna's vaccine for children under the age of 5 until it has data from Pfizer and BioNTech. The plan would push back the earliest possible authorization for a vaccine in the age group from May to June, another blow to parents who are anxious to protect their young children as the rest of the country ditches precautions.

The FDA was going to delay the review of Moderna's vaccine because they were worried about approving it, but just a few weeks later they found out that Pfizer's vaccine was superior to Moderna's, according to sources.

Anthony Fauci, a top infectious disease expert, said in an interview with CNN that the regulators may wait until summer to authorize vaccines for kids under 5. Fauci explained that he was not involved in the regulators decisions and could not explain their thinking further.

Hunt, the parent of a young child, expressed the frustration many parents are feeling, asking Fauci if Moderna is ready to apply for that Emergency Use Authorization and if we can have the vaccine in May.

Fauci apologized for not having an answer to that.

Moderna is expected to apply for FDA authorization by the end of the month, and the possibility of an authorization as early as May. Moderna announced top-line results of a clinical trial last month, which found that the company's two-dose vaccine was safe for children ages 6 months to under 6 years. The efficacy against an infection with the omicron variant was fairly low, but it is unsurprising given omicron's ability to evade vaccine-derived protection from the first-generation vaccines. Protection from severe disease is expected to be strong based on the protection seen in adults. Even if additional shots are needed later, the company is moving forward with an authorization request for the two-dose regimen.

Rollercoaster

The progress of Pfizer and BioNTech toward a vaccine for young children has been a roller coaster. The companies said in December that the two-dose vaccine did not produce the same levels of antibodies in children as in adults. The vaccine failed to meet the primary objective of the study, which dashed the hopes of parents for a vaccine authorization. The companies said they would continue the trial with a third dose if they were granted FDA approval.

Pfizer and BioNTech said they would seek FDA authorization for their two-dose regimen after the huge wave of omicron cases in January. The companies collected data indicating that the two doses were preventing COVID-19, as a result of the massive surge of cases. The two-dose regimen was abandoned by the companies by mid-February. They decided to go back to their previous plan of waiting for the data on the third dose. The move implied that the benefit of the two doses the companies may have initially seen in a small group of children had evaporated as more children became infections. The third-dose data is expected in June.

The FDA wants to delay reviewing Moderna's vaccine because it wants independent experts on its advisory panel to vote on authorizations before it makes a final decision. The dates that advisers were asked to set aside in May have been scrapped. The plans could change if cases of COVID-19 continue to rise in the US.