FDA aiming to give full approval to Pfizer’s Covid jab by Labor Day to inspire more ‘vaccine confidence’ – reports

The US Food and Drug Administration hopes to grant full authorization for Pfizer’s coronavirus vaccine by early September, the New York Times reported, putting the agency slightly ahead of the president’s estimate of “early fall.”

The regulator will look to complete the approval process by the beginning of next month, “multiple people familiar with the plan” told the Times on Tuesday, while the FDA added in comments elsewhere that upgrading authorization from emergency use could “bring additional confidence” in the Pfizer jab.

“Acknowledging the urgency related to the current state of the pandemic, we have taken an all-hands-on-deck approach… in order to complete our review to help combat this pandemic surge,” the agency told the Hill in a statement, though added it “cannot comment” on a specific timeframe.

The Labor Day deadline, the most detailed reported yet, comes after President Joe Biden said last week that he expects full authorization by “early fall,” suggesting the FDA could make a decision even sooner.

With more than 88 million Americans fully vaccinated with the Pfizer shot, it remains by far the most widely used immunization in the country, followed by Moderna’s at 63 million. The latter vaccine wasn’t given emergency approval until about a week after Pfizer’s, and continues to lag behind in the process for full authorization. While Moderna filed for final FDA approval on June 1, the company is still sending in data and hasn’t said how long that could take. 

Pfizer has also asked the FDA to approve a third booster shot for its vaccine, even as US health officials insist additional doses aren’t yet needed. Data out of Israel, however, suggests the immunization is quickly losing effectiveness against the more contagious Delta mutation, prompting officials there to roll out a booster drive for older and immunocompromised residents. The US Centers for Disease Control and Prevention (CDC) is now studying a similar move

A number of American institutions, including hospitals, universities, government agencies and even the city of San Francisco, have signaled they will institute various levels of vaccine mandates once the jabs receive full-blown FDA approval. The military, for example, has said it would not compel its 1.3 million active duty members to be vaccinated unless the regulator gives its rubber stamp, while San Francisco officials say the city’s 44,500 public employees would need to take the jab within 10 weeks of full authorization. 

While Biden has insisted that he would not issue a federal vaccine mandate for all Americans regardless of approval status, his administration made a rapid reversal after he vowed much the same for federal employees, who are now required to take the shot in order to work, or else be forced to undergo regular coronavirus tests. His CDC Director Rochelle Walensky also set off alarm bells last week after telling Fox’s Bret Baier that the feds were “looking into” a universal mandate, though she quickly walked back the comment.

According to CDC data, just over 70% of American adults have been fully vaccinated with one of the three emergency-approved shots as of Monday, finally reaching a goal Biden had hoped to hit by July 4. In total, more than 165 million are fully immunized, or just under 50% of the US population, though currently no Covid vaccine is approved for children under the age of 12.

Via https://www.rt.com/usa/531065-fda-pfizer-full-approval-reports/