FDA’s High-Stakes Plan On Child Vaccines Raises Concerns
Asking Pfizer and BioNTech to submit an authorization request is an unusual move by the FDA and reflects the dangers covid poses to unvaccinated kids under 5. But experts worry that if the plan backfires that it could suppress adoption of the covid shot.
Stat:
Experts Question Authorization Plan For Covid Vaccine For Kids Under 5
The Food and Drug Administration’s willingness to consider authorizing a Covid-19 vaccine developed by Pfizer and BioNTech for children under the age of 5 — without evidence yet that it would be protective — is raising concerns among some vaccine experts who fear the plan could backfire and undermine vaccine uptake in this group. Pfizer and BioNTech confirmed Tuesday that they had been asked by the FDA to submit an application for the use of a two-dose vaccine in children 6 months to 4 years old. Data on a third shot would be submitted to regulators once they became available in the spring — ostensibly clearing the way for the agency to authorize a three-shot regimen for the youngest children who can get vaccinated. (Branswell, 2/2)
USA Today:
'Not Typical': FDA Takes Unusual Step In Urging Pfizer To Seek Approval For Child Vaccine
In a move that highlights rising concerns about the risks of COVID-19 to young children, Pfizer-BioNTech on Tuesday asked for federal authorization for its vaccine for children 6 months to 4 years old. Companies usually make the decision to submit a request to Food and Drug Administration on their own, but in this instance it was made at the urging of the federal agency. "That’s not typically the way the federal government works. Usually, they wait and let the company decide when it wants to submit," said Dr. Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia. (Weise, 2/2)
AP:
Pfizer Asks FDA To Allow COVID-19 Vaccine For Kids Under 5
Pfizer on Tuesday asked the U.S. to authorize extra-low doses of its COVID-19 vaccine for children under 5, potentially opening the way for the very youngest Americans to start receiving shots as early as March. In an extraordinary move, the Food and Drug Administration had urged Pfizer and its partner BioNTech to apply earlier than the companies had planned — and before it’s settled if the youngsters will need two shots or three. (Neergaard and Perrone, 2/1)
In related news about young children —
KHN:
The Advice To ‘Vaccinate And Test’ Isn’t Much Help To Parents With Kids Under 5
Just before my son’s 9-month checkup, my wife and I debated whether to postpone it. It was a “well baby visit,” but the potential threats to his health felt real. The last time he went to the pediatrician, in November, the air inside the office was stuffy, and the waiting room was crowded with children from schools in and around St. Louis, all waiting to get their covid shots. By showing up to get their children vaccinated, the families were all following the guidance from the Centers for Disease Control and Prevention for children ages 5 to 11. But we were trying to follow the CDC guidance too, and for children too young for the vaccine. That means avoiding crowded or poorly ventilated places — like the pediatrician’s waiting room. (Sable-Smith, 2/2)
In other news about Pfizer —
NPR:
Pfizer's Paxlovid Contract With The Government Has Some Surprises
The United States is spending about $530 for each 5-day course of Pfizer's COVID-19 pill, Paxlovid. But the contract for the first 10 million doses would allow the government to get a lower price if one of a handful of other wealthy countries gets a better deal on the drug. It's part of a purchase agreement that seems to be more favorable to the federal government overall compared to the COVID-19 vaccine contracts, says Robin Feldman, a professor at the University of California Hastings College of the Law, who focuses on the pharmaceutical industry and drug policy. (Lupkin, 2/1)
