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Why some scientists say the FDA should stop dragging its feet on the COVID-19 vaccines

Polls find full approval could address hesitancy
Vaccine
Posted at 4:12 PM, Jul 14, 2021
and last updated 2021-07-15 00:31:59-04

SAN DIEGO (KGTV) -- As COVID-19 vaccinations slow to a trickle in the U.S., a growing chorus of scientists is calling on the Food and Drug Administration to stop delaying what they consider the single best solution for vaccine hesitancy: full approval of the mRNA vaccines.

As of Tuesday, the U.S. had the slowest pace of COVID-19 vaccinations of any large, developed country, according to Our World in Data.

The pace of daily vaccinations has steadily plummeted since its peak in mid-April. Since June 18, the rate of doses per 100 people has dropped by more than half. Thirty-five percent of eligible Americans remain unvaccinated.

States have tried a wide range of freebies and giveaways to win over vaccine holdouts, including lotteries and free admission to state parks. Some have even given away free cannabis, “joints for jabs.” A new study on Ohio’s vaccine lottery found it didn’t have an impact.

“The number one thing in the U.S. right now that would help the COVID pandemic would be for the FDA to fully approve the Moderna and Pfizer vaccines,” said Dr. Shane Crotty, a professor at the La Jolla Institute for Immunology.

Dr. Crotty said many unvaccinated people are wary of the shots’ conditional status. The vaccines only have an emergency use authorization.

A poll by the Kaiser Family Foundation in May found nearly one-third of unvaccinated Americans said they would be more likely to get a shot once regulators fully approve it.

Several high-profile scientists now contend the FDA has had more than enough time to review and approve the mRNA shots. Pfizer and Moderna’s vaccines have been administered hundreds of millions of times and scrutinized by scientists worldwide.

“The data are done. They’ve been submitted. The safety profiles look great. And the fact that it normally takes four-plus months for the paperwork to go through, it’s just not acceptable,” Crotty said.

Calls for full approval gained significant momentum this month after Dr. Eric Topol of the San Diego-based Scripps Research Institute published an op-ed in the New York Times.

Dr. Topol pointed out that even though Pfizer and Moderna officially applied for approval in May and June, they started submitting their applications months earlier. The companies began rolling submissions in late 2020.

The messenger RNA vaccines from Pfizer and Moderna have now been administered 321 million times in the U.S. alone, according to the Centers for Disease Control and Prevention. The shots have been examined in far-reaching clinical trials and reviewed by teams across the globe in leading medical journals, Topol noted.

“In the history of medicine, few if any biologics have had their safety and efficacy scrutinized to this degree,” Topol wrote.

The FDA now has clinical trial data for 40,000 people for each vaccine for at least six months. “That’s better than pretty much any other medicine you ever take,” Crotty said.

The director of the FDA’s Center for Biologics Evaluation and Research, Dr. Peter Marks, responded by saying the review process is “one of the highest priorities” for the agency.

However, he said the FDA collected an “extensive additional amount of manufacturing and clinical information” after the agency granted emergency authorization for the shots in December that needs to be reviewed.

On its website, the FDA said it typically takes up to six months to review and approve a high-priority drug. That means it could take until November to approve Pfizer’s vaccine.

“I would like them to be approved, but I also really appreciate the FDA taking a close look,” said Dr. Davey Smith, the chief of Infectious Diseases at the UC San Diego School of Medicine

Dr. Smith said the FDA is trying to reassure the public the process has been independent and thorough. Amid the high stakes of the pandemic, he said there’s an added element of pressure: these would be the first-ever approved vaccines to use messenger RNA technology.

“Any time there is a new drug in a new class or a new vaccine in a new class, the scrutiny is just a little higher level,” he said. “It will be setting the stage for other mRNA vaccines that will surely come.”

Full approval may not persuade every vaccine holdout, but experts say it’s not just about persuasion.

According to leaked documents obtained by the Army Times, the military is planning a vaccine mandate once the shots get full approval.

Other employers are likely to follow suit. A poll in May found as many as one in four companies could mandate the vaccines once approved.