The U.S. COVID-19 reinforcement campaign will begin only with Pfizer – source

WASHINGTON, Sept. 3 (Reuters) – A White House plan to offer COVID-19 booster shots will likely begin this month only with the vaccine made by Pfizer Inc. (PFE.N) and BioNTech (22UAy.DE), an initiative narrower than expected, a source familiar with the matter said Friday.

President Joe Biden had hoped to launch a campaign to administer 100 million booster shots on September 20th.

Moderna Inc. (MRNA.O) only began sending data for regulatory approval of a booster shot and said Friday it had ended its filing.

A panel of experts advising the Food and Drug Administration (FDA) on vaccines is scheduled to meet Sept. 17 to discuss additional doses of the Pfizer shot.

Dr. Anthony Fauci, Biden’s chief medical adviser, told MSNBC on Friday that it did not appear that the information needed for Moderna was available in time for the Sept. 20 presentation.

“It may be a few weeks late. We don’t know,” Fauci said.

Johnson & Johnson (JNJ.N) has not yet asked regulators to approve a booster for its single-dose shot and last week said it was in discussions with the FDA on the issue.

Earlier, the New York Times reported that officials told the White House on Thursday to cut a plan to offer booster shots to the general public later this month.

As Delta variant infections increase, Biden administration is concerned that COVID infections among fully vaccinated individuals are a sign that vaccine protection is declining. It has boosted boosters as a way to rebuild immunity.

“We are awaiting a full review and approval by the FDA” and advisors from the Centers for Disease Control and Prevention (CDC), White House spokesman Chris Meagher said.

“When this approval and recommendation is made, we will be prepared to implement the plan developed by the best doctors in our nation so that we stay ahead of this virus.”

FDA Acting Commissioner Janet Woodcock and CDC Director Dr. Rochelle Walensky told White House COVID coordinator Jeffrey Zientz on Thursday that their agencies could recommend enhancers in late September only for to some recipients of the Pfizer-BioNTech vaccine, a source familiar with the discussions that were said.

U.S. health officials had said in August that a third shot would be widely available on Sept. 20 for Americans who received two doses of Pfizer-BioNTech or Moderna vaccines at least eight months earlier.

The U.S. reinforcement plan depends on the FDA determining that a third dose of two-dose vaccines is safe and effective and a favorable recommendation from CDC advisors.

FDA and CDC spokesmen referred questions to the White House.

Reports by Ahmed Aboulenein; Additional reports by Michael Erman in New Jersey, Julie Steenhuysen in Chicago and Doina Chiacu and Jeff Mason in Washington; edited by Steve Orlofsky, Caroline Humer, David Gregorio, Cynthia Osterman and Sandra Maler

Our standards: the principles of trust of Thomson Reuters.