Why the FDA Hasn't Approved a COVID Shot yet When Millions Are Vaccinated

On August 11, eight months will have passed since the Food and Drug Administration (FDA) granted its first emergency use authorization (EUA) for a COVID vaccine.

Since December 11, 2020, 164.8 million U.S. citizens have been fully vaccinated with either both doses of the Pfizer or Moderna COVID vaccines, or one of Johnson & Johnson's to help protect them from the disease.

Yet the FDA still has not approved any of the currently available COVID vaccines for use. The U.S.' vaccine rollout has relied, and continues to rely, upon the FDA's speedy but temporary EUA process. An EUA is a mechanism that the FDA can use to allow a non-approved medical product to be used in the event of a public health emergency such as the COVID pandemic.

So what's taking approval so long?

Approval is coming

Newsweek contacted the FDA to ask if and when it believes COVID vaccines will be approved.

The agency pointed Newsweek to a series of tweets shared by acting FDA commissioner Dr. Janet Woodcock, where she said a goal date of January 2022 for FDA approval of the Pfizer vaccine had been set, and that the agency intended to complete its review of Pfizer's application "far in advance" of this.

As Pfizer announced, FDA has formally accepted the company’s Biologics License Application (BLA) requesting licensure (approval) of the Pfizer-BioNTech COVID-19 Vaccine. https://t.co/UCGEp2qUhQ

— Dr. Janet Woodcock (@DrWoodcockFDA) July 16, 2021

The Pfizer vaccine is being reviewed as a priority, meaning a decision on its approval application is expected within six months or less of the application being accepted—in this case, July 16.

Herschel Nachlis, a policy fellow at the Rockefeller Center for Public Policy at Dartmouth College in New Hampshire, told Newsweek: "Many people feel like the FDA is taking a long time to fully approve COVID vaccines.

"But it's worth recognizing that most vaccines usually take many years if not decades to develop and get approved."

An FDA approval requires pharmaceutical companies to produce rigorous scientific data in support of their approval applications.

For some, the FDA's approval process for drugs is too slow while others have actually argued it's too fast, Nachlis said. But the FDA's approach to approval is internationally seen as the gold standard, and the agency wants to get things right.

Adam I. Muchmore, professor of law at Pennsylvania State University, told Newsweek: "There are a lot of 'i's' to be dotted and 't's' to be crossed, and these are not simple bureaucratic requirements.

"Both producing this data, and reviewing it, requires the work of multiple experts in a wide range of scientific fields."

When will the EUA be revoked?

By their nature, EUAs like the ones granted to COVID vaccines in the U.S. are temporary.

This means the EUAs will have to come to an end at some point, and this will usually happen when the emergency that justified their use—in this case the COVID pandemic—comes to end, or when the FDA grants approval for the drug, making the EUA unnecessary.

According to Muchmore, the FDA's grounds for EUA revocation are not strict and the agency can also pull an EUA if it no longer believes the drug is effective or if the benefits no longer outweigh the risks—an unlikely outcome for COVID vaccines, Nachlis said.

Examples of drugs the FDA has revoked EUAs for include chloroquine phosphate and hydroxychloroquine sulfate as treatments for COVID.

The agency granted an EUA for the drugs as COVID treatments in March 2020, but cancelled it June 2020 after deciding they were "unlikely to be effective in treating COVID-19" and because serious side effects meant their benefits no longer outweighed the risks.

Experts told Newsweek they do not believe that the FDA will remove the vaccines' EUA before regular approval is granted.

Susan S. Ellenberg, professor of biostatistics, medical ethics and health policy at the University of Pennsylvania, said it is "very difficult to imagine such an eventuality."

Echoing the point, Muchmore said: "All reports I have seen indicate that the safety and efficacy data FDA relied on in granting the EUAs was extraordinarily strong.

"I don't think it is likely that the FDA will revoke the EUA for any of the current vaccines before the agency grants regular approval to at least one of them."

What does this mean for mandates?

Over the weekend, Centers for Disease Control and Prevention (CDC) director Rochelle Walensky was forced to clarify the government's stance on federal vaccine mandates after she told Fox News that the Biden administration was "looking into" a mandate requiring people to get a shot. Her comments come as the government tries to get a handle on the more transmissible Delta variant that has become the dominant form of COVID in the country.

She later said she was "referring to mandates by private institutions and portions of the federal government. There will be no federal mandate."

The U.S. government's tactic so far has been to try to persuade people to get their shots and leave requiring that customers or employees get fully vaccinated to private businesses or institutions.

But with less than half of the U.S. population fully vaccinated and hesitancy a very real issue facing health agencies in the U.S. and elsewhere, would an FDA approval speed things up?

Nachlis thinks so. He told Newsweek: "In my view there are two groups of unvaccinated people: one group is probably impossible to persuade using either carrots or sticks, but I don't think that group is huge.

"Another and larger group will probably eventually get vaccinated once access is made easier, once there's even more evidence of broad based use and safety and efficacy, and once employers issue more mandates after the vaccines are fully approved."

For both Ellenburg and Muchmore, full FDA approval will probably lead more organizations to mandate vaccination and further increase vaccine acceptance, providing a boost to the number of people vaccinated in the country.

On vaccine mandates, Ellenburg said: "Those that rage against limiting their freedom don't seem to remember that their freedom is limited in many ways in order to protect others—they can't drive drunk, they have to use seat belts, they can't go into many restaurants without shirts or shoes, they can't buy and sell heroin. [There are] lots of restrictions in order to protect public health."

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A stock image shows a man receiving his COVID vaccine. The FDA is in the process of deciding whether or not to grant approval to the Pfizer, Moderna and Johnson & Johnson COVID vaccines. Getty Images