Pfizer has postponed its rolling application to the Food and Drug Administration (FDA) requesting authorization for use of the company's COVID-19 vaccine on children under five-years-old, due to insufficient data at the time on a third dose.
The request is slated to be delayed until at least April as Pfizer waits for data on the efficacy of a third dose, while Big Pharma targets kids ages six months to four years.
"Cases continue to accumulate according to the study protocol and more data are being generated because rates of infection and illness remain high in children of this age, especially due to the recent Omicron surge," Pfizer said in a statement.
Pfizer said Friday that it will wait for its data on a three-dose series of the vaccine, because it believes three doses "may provide a higher level of protection in this age group." Data on the third dose is expected in early April, the company said.
Back in December, the company said that two doses didn't generate a strong enough immune response in its trial testing children ages two to four. For young children, Pfizer's vaccine has a dosage of three micrograms. For children ages five to 11, the dosage is higher, at 10 micrograms, NBC News reported.
Pfizer had asked the FDA to authorize the first two doses with hopes to submit additional data in the coming weeks on a third dose. The full vaccine series would be a three-dose vaccination, according to NBC News.
The FDA was expected to publish an analysis of the Pfizer data on Friday, ahead of next week's advisory committee meeting, but the federal agency said on the expected analysis date that the upcoming meeting has been postponed.
Two sources familiar with the FDA's plans said there had been a lot of initial pushback on the agency from outside experts who had concerns that Pfizer's data wasn't sufficient, NBC News reported. The experts felt, according to one of the souces, that concerns were "falling on deaf ears" within the federal agency.
Pfizer CEO Albert Bourla told CNBC on Thursday that the chances are "very high" that the FDA would authorize the COVID-19 vaccine for young children.
"I think that they will be pleased with the data and they will approve," Bourla told CNBC's Meg Tirrell, while noting that the regulatory process still has to play out.
Join and support independent free thinkers!
We’re independent and can’t be cancelled. The establishment media is increasingly dedicated to divisive cancel culture, corporate wokeism, and political correctness, all while covering up corruption from the corridors of power. The need for fact-based journalism and thoughtful analysis has never been greater. When you support The Post Millennial, you support freedom of the press at a time when it's under direct attack. Join the ranks of independent, free thinkers by supporting us today for as little as $1.
Remind me next month
To find out what personal data we collect and how we use it, please visit our Privacy Policy
