Pressure mounts for full FDA vaccine approval

Pressure is mounting for the Food and Drug Administration (FDA) to fully approve the COVID-19 vaccine, a step that could lead to more warrants and help overcome hesitation.

The last warrant arrived on Monday, when the Secretary of Defense Lloyd AustinLloyd Austin The Hill’s Sustainability Report: This plastic additive is ecstasy for hermit crabs. Next Overnight Defense Budget Package: COVID-19 Vaccine Mandate for Upcoming Troops by Mid-September MORE said he would take steps to make the vaccine mandatory for troops by mid-September, but would act “immediately” if fully approved before then.

Antoine FauciAnthony FauciOvernight Health Care: How a GOP Governor and Union Leader Changed Their Minds on COVID | DC to Require COVID-19 Vaccine or Regular Testing for City Employees | Fauci Supports Teacher Vaccination Mandates Twitter Temporarily Suspends Greene After She Says Vaccines ‘Fail’ Fauci Supports Teacher Vaccination Mandates MORE, the government’s top infectious disease expert, added to the chorus on Sunday, when he expressed hope that approval would move quickly.

“I’m hoping, I’m not predicting, but hopefully it will be in the next few weeks,” Fauci said on NBC’s “Meet the Press”. “I hope it’s August.

The vaccines are currently under emergency FDA clearance. The agency has gone through a rigorous process to issue this clearance, and the vaccines are widely considered by experts to be extraordinarily safe and effective, especially after having already been given to hundreds of millions of people.

But the official FDA seal of full approval could make the difference for some hesitant people. And while companies are free to mandate the vaccine at this time, this seal of approval should also make many employers more willing to issue warrants, following in the footsteps of large entities such as the Department of Defense.

The spike in cases fueled by the delta variant adds to the urgency of doing everything to get more people vaccinated. Cases in children are also on the rise, prompting the FDA to speed up its clearance for children under 12, who currently have no access to vaccines.

Drew Altman, president of the Kaiser Family Foundation, said full approval could be an “opportunity to restart messaging about vaccines” if President BidenJoe BidenBiden pushes to support Florida schools amid DeSantis Cuomo mask dispute resigns after investigation found he harassed divided female GOP governors over response to COVID-19 PLUS outbreak, health officials and governors benefit.

The move could give companies “new cover” to feel comfortable with their employees’ mandates and require proof of vaccination for customers, he said.

A Kaiser poll at the end of June found that 31% of unvaccinated people said full approval would make them more likely to get the vaccine, higher than the percentage who said the same to get one. chance to win a million dollars or a mobile clinic coming to their neighborhood.

Some experts have been asking the FDA for months to move faster.

“Delay in full @US_FDA approval of #mRNA vaccines is costing thousands of lives,” tweeted Carlos del Rio, executive associate dean of the Emory School of Medicine.

“A full approval will be void if it is seen as anything but comprehensive,” Ashish Jha, dean of the Brown University School of Public Health wrote in a Time op-ed last week calling on the FDA to act faster. “But there is a rigor in the science compared to the rigor in the paperwork. The science of these vaccines has been thoroughly verified. “

Eric Topol, professor of molecular medicine at Scripps Research, tweeted in late July that full FDA approval “should have been done now” and “could have prevented a lot of Delta’s success.”

As pressure has grown in recent weeks, the FDA has ensured approval is a top priority, although it has not given a specific timeline.

Biden told a CNN town hall last month that in speaking with science experts he expects full approval to come “maybe early in the school year.”

Peter Marks, a senior FDA official, appeared last week to refer to the comments when he said, “I hope I don’t disappoint the President at all.

“We are very determined to move this forward as quickly as possible,” Marks added, speaking at an event hosted by the COVID-19 Vaccine Education and Equity Project. But he said the agency must also be able to “say wholeheartedly that we have done all the exams that we would normally do.”

“Recognizing the urgency of the current state of the pandemic, we have taken a comprehensive approach,” added an FDA spokesperson, saying the agency had transferred staff and other resources from the whole agency towards the task.

The Pfizer vaccine is most advanced in the process and is expected to be the first to gain full approval.

For children under 12, no COVID-19 vaccine is currently available.

Lee Savio Beers, president of the American Academy of Pediatrics, wrote to the FDA last week asking it to act “aggressively” to clear vaccines for children under 12 “as soon as possible.”

“In our opinion, the rise of the Delta variant is changing the risk-benefit analysis to allow vaccines in children,” Beers wrote.

Marks said at the event last week that the data for children aged 5 to 11 could arrive “in early fall” but that “it will take at least a few weeks to review it” and maybe longer if there are security issues that need to be addressed. discussed.

As the number of COVID-19 cases per day reaches over 100,000 and hospital capacity is strained in areas with low vaccination rates, the urgency to vaccinate more people has become even clearer .

Biden, in making a plea for unvaccinated people to get vaccinated on Tuesday, referred to the full FDA approval, saying he hoped it would happen within a “reasonable”, “God willing” time frame. .