FDA takes a rare step and asks Pfizer to submit a Covid-19 vaccine EUA for the youngest children
What does the FDA know that we don’t? Hopefully a lot.
Without offering much detail, the FDA yesterday afternoon asked Pfizer to send over a rolling submission to amend its Covid-19 vaccine EUA to include children 6 months to under 5 years of age.
The tricky part in making such a request is that last month, Pfizer announced that its vaccine (a 3 µg dose for the youngest population) demonstrated non-inferiority for the 6- to 24-month-old population, when compared to the 16- to 25-year-old population in which high efficacy was demonstrated, but not for the 2- to under 5-year-old population.
The company said it would continue to study the vaccine in these youngest children with a third dose, and doesn’t seem to be changing its tune even with this latest FDA request.
“Ultimately, we believe that three doses of the vaccine will be needed for children 6 months through 4 years of age to achieve high levels of protection against current and potential future variants. If two doses are authorized, parents will have the opportunity to begin a COVID-19 vaccination series for their children while awaiting potential authorization of a third dose,” Pfizer CEO Albert Bourla said in a statement.
No safety concerns were identified in that prior analysis of the 3 µg dose data among children 6 months to under 5 years of age, Pfizer said.
While the FDA often requests that companies provide additional safety or efficacy data (usually before a new drug or vaccine is approved or authorized), the agency rarely requests a specific submission, but acting FDA commissioner Janet Woodcock said this is a priority right now for the agency.
Having a safe and effective vaccine available for children in this age group is a priority for the agency, and we’re committed to a timely review of the data, which the agency asked Pfizer to submit in light of the recent Omicron surge. https://t.co/hXGSImQCJu
— Dr. Janet Woodcock (@DrWoodcockFDA) February 1, 2022
“I don’t think authorizing two doses in children ages 2 to 4 years of age where effectiveness in this age group hasn’t been confirmed is going to convince the majority of parents to vaccinate their children,” Norman Baylor, president and CEO of Biologics Consulting and a former head of the FDA’s vaccine office, told STAT News. “If the vaccine in this age cohort is a three-dose vaccine, FDA should review the data from the three-dose series before authorizing the vaccine.”
On Feb. 15, the FDA will convene its VRBPAC, an adcomm of outside advisors to discuss this application. The committee kicked off the Covid-19 vaccine booster season last fall by pledging to not require boosters for all, and then boosters were recommended for all, and have proven to be helpful in reducing cases and hospitalizations in this latest Omicron surge.
For Omicron cases, January 2022
>50% reduced by 2-shot vaccination
Another ~50% reduced by 3-shot vaccination
Which goes along with all recent datahttps://t.co/9bHYdKxz8u
The "vaccines don't work with Omicron" is off-base pic.twitter.com/lceIOQVESx
— Eric Topol (@EricTopol) February 1, 2022
Another big question, as has been the case for the entire pandemic, is uptake in this youngest population. The FDA notes that as of Dec. 19, the Centers for Disease Control and Prevention said just 8.7 million Covid-19 vaccinations have been given to kids 5 through 11 years of age, which is only about one-third of the 24 million US kids this age range. There are about 23 million children less than 5 years of age in the US, the FDA estimated.
Hesitancy has been a big issue nationwide, with the US trailing behind the vaccination rates of other wealthy nations around the globe. But Woodcock previously told Endpoints News that this fight might be about more than just vaccines.
“Well the loss of trust seems to be a general anti-authority, anti-science thing,” she wrote. “Very strong streak of this in the US over the centuries. Sure, it would be fine to have another traditional type voice making public health statements, but this may need to be fought out in the social media and other current info sources, otherwise you are just preaching to the converted. FDA would need more comms staff — our people are pretty exhausted and mostly have the traditional skillset.”
FDA’s top vaccine official Peter Marks said in a recent keynote, reflecting on some of the things that keep him up at night, “The lack of trust in a basic public health measure that saves lives is catastrophic in this country.”