Pressure builds for full FDA approval of vaccines

Pressure builds for full FDA approval of vaccines
© Greg Nash

Pressure is building for the Food and Drug Administration (FDA) to fully approve the COVID-19 vaccine, a step that could lead to more mandates and help address hesitancy.

The latest mandate came Monday, when Defense Secretary Lloyd AustinLloyd AustinTop Senate Armed Service Republican wants DOD to suspend vaccine mandate Trump criticizes media for treating Powell 'beautifully' in death Biden holds Trump's line when it comes to China MORE announced he would move to make the vaccine mandatory for troops by mid-September but would act “immediately” if it received full approval before then. 

Anthony FauciAnthony FauciMore than 40 Texas hospitals face ICU bed shortages FDA mulling to allow 'mix and match' COVID-19 vaccine booster shots: report The Hill's 12:30 Report - Presented by Altria - Remembrances flow in after Powell's death MORE, the government’s top infectious diseases expert, added to the chorus on Sunday, when he expressed hope that the approval would move quickly. 

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“I hope, I don’t predict, but I hope that it will be within the next few weeks,” Fauci said on NBC’s “Meet the Press.” “I hope it’s within the month of August.”

The vaccines are currently under an emergency authorization from the FDA. The agency went through a rigorous process to issue that authorization, and the vaccines are widely seen among experts as extraordinarily safe and effective, especially after their record of having been given to hundreds of millions of people already. 

But the official stamp of full approval from the FDA could make a difference for some hesitant people. And while businesses are free to mandate the vaccine at the moment, that stamp of approval is also expected to make many employers more willing to issue mandates, following in the footsteps of large entities such as the Department of Defense. 

The spike in cases fueled by the delta variant is adding to the urgency to pull out all the stops to get more people vaccinated. Cases among children are also rising, leading to calls for the FDA to speed up its authorization for children under 12, who currently have no access to vaccines at all. 

Drew Altman, president of the Kaiser Family Foundation, said full approval could be an “opportunity for a restart on vaccine messaging” if President BidenJoe BidenWhite House: Window for finalizing sweeping budget package 'closing' Jayapal says tuition-free community college 'probably won't' be in spending plan Jan. 6 panel votes to hold Bannon in contempt MORE, health officials and governors take advantage. 

The move could give “new cover” to businesses to feel comfortable about mandates for their employees, and requiring proof of vaccination for customers, he said. 

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Polling from Kaiser at the end of June found that 31 percent of unvaccinated people said full approval would make them more likely to get the shots, higher than the percentage who said the same for a chance to win a million dollars or a mobile clinic coming to their neighborhood. 

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

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

“A full approval will be empty if it is perceived as anything but thorough,” Ashish Jha, dean of the Brown University School of Public Health wrote in a Time op-ed last week calling on the FDA to move faster. “But there is thoroughness on the science versus thoroughness in the paperwork. The science of these vaccines has been thoroughly vetted.”

Eric Topol, professor of molecular medicine at Scripps Research, tweeted at the end of July that full FDA approval “should have been done by now” and “could have prevented much of Delta’s hit.”

As the pressure has built in recent weeks, the FDA has offered reassurances that the approval is a top priority, though it has not given a specific timeline. 

Biden said at a CNN town hall last month that from talking with scientific experts, he expects the full approval could come “sometime maybe in the beginning of the school year.”

Peter Marks, a top FDA official, last week seemed to reference those comments when he said, “I’m hoping not to disappoint the president at all.”

“We are very committed to moving that as quickly as we can,” Marks added, speaking at an event hosted by the COVID-19 Vaccine Education and Equity Project. But he said the agency also needed to be able to “say wholeheartedly that we’ve done all of the review that we normally would.”

“Acknowledging the urgency related to the current state of the pandemic, we have taken an all-hands-on-deck approach,” an FDA spokesperson added, saying the agency has shifted personnel and other resources from across the agency to the task. 

The Pfizer vaccine is furthest along in the process and is expected to be the first to get full approval. 

For children under 12, no COVID-19 vaccines are currently available at all. 

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

“In our view, the rise of the Delta variant changes the risk-benefit analysis for authorizing vaccines in children,” Beers wrote. 

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

As the number of COVID-19 cases per day climbs to more than 100,000, and hospital capacity is stressed in areas with low vaccination rates, the urgency of getting more people vaccinated has come into even clearer view. 

Biden, in making a pitch for unvaccinated people to get the shots on Tuesday, referenced full approval from the FDA, saying he hoped it would come in a “reasonable” amount of time, “God willing.”