Emergency Use vs. Full Approval: Key differences as the FDA reviews vaccine trial data

Coronavirus

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(WETM) – Once administering millions of vaccine doses per day, the United States is lagging behind where it was earlier this spring. According to the New York Times, the U.S. was administering more than three million doses per day and now it is just more than 500,000 per day, which is an 85 percent decline.

In May, Pfizer applied for full authorization, but Forbes reported that the company and FDA set a goal of approval in 2022. Moderna also filed for full approval in June. Now medical experts are weighing in.

Dr. Ashish Jha, dean of the Brown University School of Medicine, tweeted, “The data is in…it is time for full approval.”

Former Surgeon General Jerome Adams agreed, saying on Twitter he is not sure why it took the Food & Drug Administration so long to announce the approval timeline.

The three approved vaccines went through a rigorous, but quick review process after the Secretary of Health and Human Services declared a public health emergency that could threaten national security in February 2020.

As the Title 21 of the Food and Drug Safety Act states, the FDA may approve an unapproved drug or unauthorized use of the approved drug only if the Secretary of Health and Human Services declares an emergency use is appropriated. The Secretary must find one of four factors:

  1. Director of Homeland Security detects a substantial risk of chemical or biological attack or threat.
  2. Director of Homeland Security detects a threat that affects national security.
  3. Secreatary of Defense detects a military threat from biological or chemical attack.
  4. Determination by Secretary of Health and Human Services that it is a public health emergency, which threatens national security.

Under the Trump Administration, Secretary Alex Azar declared the COVID-19 pandemic is a public health emergency, which threatens national security. He also declared a health emergency under the Public Health Service Act.

The two declarations grant emergency use authorization powers to the FDA, which is how the Pfizer, Moderna, and Johnson & Johnson vaccines are classified at this time.

“Emergency use authorization does let the FDA respond quicker than normal. When faced with certain types of public health emergencies,” Megan Collins, Esq. of Welch, Donlon & Czarples, PLLC. said.

What does emergency use of a COVID-19 vaccine mean?

It’s when regulators allow shots to be given to certain people while studies of safety and effectiveness are ongoing.

Before any vaccine is permitted in the U.S., it must be reviewed by the Food and Drug Administration, which requires study in thousands of people. Normally, the process to approve a new vaccine can take about a decade. But the federal government is using various methods to dramatically speed up the process for COVID-19 vaccines.

During a health crisis, the FDA can loosen its normal scientific standards to allow emergency use of experimental drugs, devices, vaccines, and other medical products. Created in 2004, the EUA has been used for other drugs during similar health crises like the Zika Virus, H1N1, and Ebola, according to Collins.

Instead of the usual requirement of “substantial evidence” of safety and effectiveness for approval, the FDA can allow products onto the market as long as their benefits are likely to outweigh their risks. It has already used its emergency powers to authorize hundreds of coronavirus tests and a handful of treatments during the pandemic.

“For EUA, companies need at least two months of safety data on average and for full licensure, you need at least six months,” Dr. Ann Falsey, co-director of the University of Rochester Medical Center Vaccine Treatment and Evaluation Unit, said.

What is holding the FDA back from full approval?

Two of the three companies have filed for full approval, but the process will be much slower than the emergency authorization review. Because of the quick-moving clinical trial and EUA process, many Americans are left wondering when the drug will be fully authorized, which is increasing vaccine hesitancy.

“While that’s true, that doesn’t mean that corners were cut,” Steuben County Health Director Darlene Smith added.

Some Americans remain hesitant because of the vaccine approval status, saying the process was rushed. Health experts claim the data is there and the vaccines are safe.

“It doesn’t make sense to my mind for people to not take a vaccine solely because the FDA hasn’t completed its traditional approval process. It really doesn’t matter,” Dr. John Moore, infectious disease expert, and professor at Weill Cornell Medicine, concluded.

The experts also added that vaccines are readily available and clinics are happening daily in the Twin Tiers. They also said this is quickly becoming a pandemic of the unvaccinated because the majority of COVID-19 patients right now are those who have not received their shot.

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