How full FDA approval would impact COVID-19 vaccine mandates, competition

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Posted at 10:37 AM, Apr 12, 2021

Pfizer could apply for full FDA approval of its COVID-19 vaccine as early as this month, and Moderna could follow soon after.

If regulators sign off, that status change would have significant impacts on vaccine mandates in workplaces and other experimental vaccine candidates still in development.

Currently, the three vaccines on the market only have an Emergency Use Authorization (EUA), meaning they are “authorized” by the Food and Drug Administration but not “approved.”

“It's a much faster process,” explained consumer advocate and regulatory expert Dr. Sidney Wolfe, the co-founder of Public Citizen's Health Research Group.

An EUA is a shortcut that allows drugmakers to submit less safety data during an emergency than they otherwise would when seeking full approval. In this case, companies had to track volunteers for about two months after vaccination.

To get full approval, known as a Biologics License, companies will need to submit six months of data. That’s the same standard the FDA has had for years, Dr. Wolfe said, one he thinks will make a difference for people who may still feel hesitant about the vaccine.

“I think that these concerns would be lessened if they were told, we now have six months of follow up on his vaccine, which means we're more comfortable with how long it lasts, how effective it is and how safe it is,” Dr. Wolfe said.

Both Pfizer and Moderna say they now have six months of data.

Companies want full approval for several reasons. Once the pandemic is no longer officially designated as an emergency, only fully approved products can remain on the market.

And the stamp of approval from the FDA carries valuable credibility, Wolfe said.

“Aside from what benefit for marketing it does in this country, it will clearly have an international benefit,” he said.

There is a lot of legal debate about whether companies or colleges and universities can require people to get a vaccine that only has emergency authorization. But it becomes clear cut once a vaccine has full approval: they can.

Some employers already require the flu vaccine. Courts have upheld the authority of states to fine people who refuse vaccination.

The status change could also affect the experimental vaccines still under development from companies like San Diego-based Arcturus Therapeutics or Inovio Pharmaceuticals.

Federal law says companies can only get an emergency authorization if “there is no adequate, approved and available alternative.” Translation: once a vaccine gets approved, competitors have to clear a higher bar.

“There are a lot of vaccines still in the pipeline and it may be harder for those ones that are early in development to eventually get EUA authorization if there is an approved option,” said Dr. Christian Ramers of Family Health Centers of San Diego.

To get new vaccines on the market on an emergency basis, companies would need to show their candidates were better at tackling variants or better for certain populations, like people with drug allergies.

Dr. Ramers said he doesn’t expect the change to affect companies like AstraZeneca or NovaVax because of the time it takes the FDA to review a Biologics License Application.

Typically it takes the FDA about six months to review a licensure application for a high-priority drug. Pfizer said it expects to apply in the first half of 2021, and it expects a decision from the FDA in the second half of the year.

Although Pfizer and Moderna may have enough data for full approval in the coming months for adult use, approval in kids will take longer because those studies started later, Dr. Wolfe said.

This story was originally published by Derek Staahl at KGTV.