Documents published by the FDA show Pfizer has asked regulators to approve a booster shot six months after people receive their second jab.
In a separate assessment of data from Pfizer’s vaccine, the FDA said waning antibody levels among vaccinated people might have been linked to the jump in cases seen over the summer as the Delta variant has spread.
But officials said that the data was not conclusive on whether the vaccine’s ability to stop symptomatic infection declined, a sign of internal frictions within the regulator about whether boosters are needed.
“Overall, data indicate that currently US-licensed or authorized COVID-19 vaccines still afford protection against severe COVID-19 disease and death in the United States,” the agency said in a briefing document also published on Wednesday.
The Biden administration has said it wants to begin rolling out a vaccine booster program next week alongside a dozen other nations that are concerned about a rise in breakthrough infections among vaccinated people.
The plan has proved controversial and attracted criticism from two top U.S. scientists, who recently announced their retirement from the U.S. drugs watchdog.
Those scientists, Philip Krause and Marion Gruber co-authored a report this week that concluded there was not enough evidence to justify a booster program at a time when vaccine supplies remain tightly constrained in other parts of the world.
Angela Hwang, president of Pfizer Biopharmaceuticals Group, said that available data supported a booster program to protect the public and help bring an end to the pandemic sooner rather than later.
“Big picture, boosting is important, boosting is necessary. It is the way that we need to protect individuals and the public,” she said at the BofA Global Healthcare investor conference on Wednesday.
While the Biden administration prepares to decide on whether to give the final go-ahead to the booster plan, the U.S. president is also trying to jump-start the country’s flagging vaccination rate.
Biden is due to meet business leaders at the White House on Wednesday as he looks to drum up corporate support for his administration’s new vaccine mandates.
The meeting is intended to display strong backing for his move to require medium-sized and large businesses to insist their staff are either vaccinated or get tested for COVID-19 at least once a week.
Attendees include Bob Chapek, chief executive of Disney; Brad Smith, president of Microsoft, and Joshua Bolten, head of the Business Roundtable.
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Article Source: Regina Leader-Post