Fauci says vaccine approval for those under 5 likely not until June

A COVID-19 vaccine for children under five might not be approved for emergency use until June, Anthony Fauci said on Thursday.

Fauci, the chief medical adviser for President Biden, told CNN’s Kasie Hunt that health regulators were concerned because vaccine makers Moderna and Pfizer were creating slightly different products, which required additional scrutiny.

“You have two separate companies, one of which has a dose a little bit different than the other, and the other one has a regiment a little bit different,” Fauci said.

The health adviser also raised concerns to Hunt about the virus’s highly transmissible omicron variant. Pfizer is planning for a two-dose regiment for children under five, but the emergence of omicron means Americans need an extra dose for immunity, Fauci said.

“You need three doses of a vaccine to really get good protection,” he added.

Hunt tweeted that Fauci had confirmed a delay until this summer for regulators’ approval of the vaccines for young children, which she reported he said will likely come in June.

The Food and Drug Administration (FDA) has authorized the emergency use of the Pfizer vaccine for those aged five and up. In February, it appeared that vaccine may be moving toward emergency use authorization for children under five, but the companies said they were delaying completing their request until they had more data on the efficacy of a third dose.

Moderna said last month it would apply to the FDA for emergency use of its two-dose vaccine for children six years old and under.

Moderna has reported that its vaccine was able to produce a similar immune response in children as in adults. The effectiveness of the vaccine in preventing any infection was found to be fairly low, though Fauci said the results were comparable to other vaccine results seen against omicron.

Politico reported on Thursday that Moderna would formally apply for its vaccine at the end of the month, meaning it could be ready for emergency use by mid-May.

But administration officials expressed multiple concerns to the outlet about approving it then, including fears of receiving backlash from parents if they were to authorize the Moderna vaccine for young children vaccine, only to find out later that Pfizer’s has more positive results.

Hunt pressed Fauci on why the FDA might delay emergency use of Moderna’s vaccine if it was ready for use in children under six in May. He replied the data was confidential.

“I’d like to give you a straight answer, but I’ll be honest with you, I don’t have an answer,” he said.