The U.S. Food & Drug Administration on Monday granted its full approval to Moderna's COVID-19 vaccine for adults ages 18 and older. Additionally, the agency is reportedly pressuring Pfizer-BioNTech to apply for emergency use authorization for its vaccine to be given to children under 5.
Moderna's vaccine, called Spikevax, is the second mRNA vaccine to be fully approved for U.S. adults, following the full approval for Pfizer's vaccine, Comirnaty, in August. The FDA said that Spikevax had met the agency's "rigorous standards for safety, effectiveness and manufacturing quality required for approval."
“The FDA’s approval of Spikevax is a significant step in the fight against the COVID-19 pandemic, marking the second vaccine approved to prevent COVID-19. The public can be assured that Spikevax meets the FDA’s high standards for safety, effectiveness and manufacturing quality required of any vaccine approved for use in the United States,” acting FDA Commissioner Janet Woodcock said.
The vaccine is a two-dose regimen, with doses delivered one month apart. Individuals who have received the primary doses can get a third booster dose five months after their second shot. The FDA has authorized the third Spikevax shot as a "mix and match" single booster dose for individuals age 18 and older who have completed primary vaccination with a different available COVID-19 vaccine, the FDA said.
“The approval was based on a comprehensive submission package including efficacy and safety data approximately six months after the second dose,” Moderna said after the FDA's announcement.
Meanwhile, the Washington Post reported that Pfizer and its partner, BioNTech, will submit an application to the FDA as soon as Tuesday for emergency use authorization to give its vaccine to children ages 6 months to 5 years old.
FDA officials told the Post that the agency has "urged" the companies to apply for an EUA even though tests have shown that a two-dose regimen of Pfizer's vaccine for young children did not provide a strong enough immune response to protect from COVID-19.
In December, the companies announced they would begin testing three doses of their COVID-19 vaccine after preliminary research indicated that while the vaccine is safe, the immune response in 2- to -4-year-olds after two doses was weaker compared to the vaccines approved for adults. Pfizer and BioNTech said at the time they would apply for an EUA once the three-dose regimen was shown to be effective. But that data won't be ready until March.
The Biden administration appears impatient to have a vaccine approved for young children and is asking Pfizer and BioNTech to submit their EUA application before the data on the third dose is ready.
“We know that two doses isn’t enough, and we get that,” one of the officials that spoke to the Post said. "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.”
Another official reportedly said there is a consensus in the Biden administration on "seeing this move forward," referring to the EUA application.
The Washington Post's reporting matches what White House chief medical adviser Dr. Anthony Fauci said about pediatric COVID-19 vaccines last week.
Asked by reporters when the vaccine would be ready for children 2 to 4 years old, Fauci said that initial trials found the two-dose regimen of Pfizer-BioNTech's vaccine "did not yet reach the level of non-inferiority" in young children.
"It looks like it will be a three-dose regimen," Fauci said. "I don’t think we can predict when we will see an [emergency use authorization] with that, because the company is still putting the data before the FDA."
The Post reported that the FDA has faced pressure from some parents who want the agency to approve the vaccines for their children more quickly. Protect Their Future, a grassroots organization of physicians, parents, and advocates, has collected more than 5,700 signatures on a petition asking the FDA to approve a COVID-19 vaccine for younger children.
However, some doctors have cautioned that any actions taken by the federal government to rush approval of the COVID-19 vaccines could further undermine confidence in the safety and efficacy of the shots.