Pfizer may be the only booster shots available in Sept, feds say

0
33
Pfizer may be the only booster shots available in Sept, feds say

Only COVID-19 booster shots from Pfizer may be available this month despite President Joe Biden’s plan to start offering third jabs from Moderna too, according to a report.

Two of the nation’s top health officials have urged the White House to delay unrolling the booster shots the week of Sept. 20 — in part because Moderna may have missed its Food and Drug Administration application deadline, a federal official told the New York Times.

While Pfizer completed its FDA booster shot application last week, Moderna only recently started the process and has insufficient data about a proper dosage, officials told the paper.

FDA director Janet Woodcock and Centers for Disease Control and Prevention director Rochelle Walensky on Thursday warned White House pandemic coordinator Jeffrey Zients that the agencies may need more time to approve and recommend the boosters — and possibly only to some of the people who originally got Pfizer shots.

Zients later told the Times she plans to “follow the science” and get “full review and approval” by the FDA.

Centers for Disease Control and Prevention Director Dr. Rochelle Walensky
CDC Director Dr. Rochelle Walensky argued the FDA needs more time to evaluate COVID-19 booster shots.
AP
Janet Woodcock, director of the Food and Drug Administration's Center for Drug Evaluation and Research
FDA director Janet Woodcock admitted President Joe Biden’s boost shot rollout needs to be delayed.
Getty Images

Last month, the White House announced plans to start offering booster shots to adults who had received their second dose of the Pfizer or Moderna vaccines at least eight months ago — and have also considered administering them after five months — pending FDA approval, to combat the highly contagious Delta strain of COVID-19.

But Woodcock argued privately that it was risky to set a firm date for the booster shot rollout before health officials had a chance to thoroughly review the data, according to the Times.

The public health holdup comes just days after two senior FDA officials resigned over frustrations with the Biden Administration’s plan to move forward with recommending COVID-19 booster shots without their prior approval.

A nurse reaches for a vial of Pfizer-BioNTech Covid-19 vaccine.
Under the White House plan, third COVID-19 booster shots will only be available to those who received their second shot eight months ago.
AFP via Getty Images
A woman prepares a Pfizer COVID-19 vaccine vial.
The White House hopes introducing third COVID-19 booster shots will combat the Delta strain variant.
Los Angeles Times via Getty Imag

The officials, Marion Gruber and Phil Krause, felt they’d been sidelined on major decisions and that the White House’s plan for boosters was jumping the gun.

On Friday, officials said the FDA wants to see more data about the waning efficacy the Pfizer vaccine to ensure it backs up the Israeli government’s previous study before green-lighting the boosters, according to the Times.

Source link