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Pfizer Makes Case for Vaccine Booster in FDA Presentation

Pfizer on Friday will make a presentation on its coronavirus booster to advisers to the U.S. Food and Drug Administration.

Pfizer  (PFE) - Get Pfizer Inc. Report is bringing its case for Covid-19 vaccine booster approval to the U.S. Food and Drug Administration, using data from the U.S. and Israel that it says prove that vaccine effectiveness is waning. 

Prizer will deliver a presentation to a meeting of outside advisers to the FDA on Friday, Bloomberg reported. 

The FDA has the presentation up on its website on Wednesday. 

"Recent data from Israel and the United States in the context of the delta variant of concern predominant circulation suggest that vaccine protection against Covid-19 infection wanes approximately 6 to 8 months following the second dose," Pfizer will say in its presentation. 

The company said side effects from its booster shots are similar to those experienced after the second dose and more likely to arise in younger people.

The company cites a study conducted by Kaiser Permanente suggesting that the erosion of vaccine effectiveness probably is due mainly to waning vaccine efficacy rather than due to delta escaping vaccine protection. 

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Pfizer shares at last check were up 0.4% at $44.89. 

The White House in August signaled that it intended to sanction booster shots for all Americans who took a two-dose mRNA vaccine. That plan was reportedly set to begin the week of Sept. 20.

But the White House's plan reportedly ruffled feathers at the FDA with officials fearing that political pressures would interfere with its own assessment on boosters. 

Earlier this week an international group of scientists published an opinion piece in the Lancet, saying that the average person does not yet need a Covid-19 booster shot. 

Phil Krause and Marion Gruber, two top scientists at the FDA who announced their resignation from the agency two weeks ago, were two of the 16 authors of the Lancet article. 

“The limited supply of these vaccines will save the most lives if made available to people who are at appreciable risk of serious disease and have not yet received any vaccine," the Lancet piece said, according to the Financial Times. 

"Even if some gain can ultimately be obtained from boosting, it will not outweigh the benefits of providing initial protection to the unvaccinated."