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FDA Will 'Fast Track' 2 COVID-19 Vaccines

FDA fast tracks vaccines

Ellen Lindner / Verywell

Key Takeaways

  • Two mRNA-based vaccines have received fast track designation from the FDA.
  • While the fast track status will accelerate the development and potential approval process, Pfizer and BioNTech have declined any federal funding for a COVID-19 vaccine.
  • If clinical trials are successful, initial doses could be ready by the end of the year.

Pfizer and BioNTech announced Monday that two of their coronavirus vaccine candidates have received "fast track" designation from the Food and Drug Administration (FDA).

Pfizer—a U.S. pharmaceutical company—and BioNTech—a German biotech firm—teamed up back in March to pursue vaccines against SARS-CoV-2, the virus that causes COVID-19. Specifically, they are creating vaccines with different combinations of messenger RNA (mRNA), a method the pair has been working on together for influenza vaccines since 2018.

What Does Fast Track Mean?

The FDA fast track process facilitates the expedited development and review of drugs—or vaccines—intended "to treat serious conditions and "fill an unmet medical need."

Several drugs receive fast track designation each year. As of June, 20 drugs were approved for fast track in 2020, in development for conditions ranging from metastatic triple negative breast cancer to thyroid eye disease.

Drug companies must be the ones to request fast track designation. If approved, the drug company can expect more frequent meetings, communication, and support from the FDA, as well as eligibility for accelerated approval and priority review.

On background, an FDA spokesperson told Verywell that the organization is prohibited from disclosing any information contained in an investigational new drug application, so little public information is available as to why these particular candidates were chosen. However, a press release issued by Pfizer and BioNTech says the fast track designation followed "preliminary data from Phase 1/2 studies that are currently ongoing in the United States and Germany as well as animal immunogenicity studies."

Fast track will help Pfizer and BioNTech in their goal of manufacturing up to 100 million vaccine doses by the end of 2020, pending the results of ongoing studies and regulatory approval. After that, they'll potentially manufacture over 1.2 billion doses by the end of 2021.

What About Other Vaccines Receiving U.S. Funding?

Pfizer and BioNTech are notably not on the list of vaccine candidates receiving funding from U.S. government, which includes names like AstraZeneca, Moderna, and Johnson & Johnson. While they were selected as part of the Trump administration's "Operation Warp Speed" COVID-19 vaccine initiative, Pfizer chairman and CEO Albert Bourla says they declined federal funding in order to move faster.

“When you take money, the people that are giving the money want to know how you spent them and what exactly you are doing,” Bourla said, according to Pharma Intelligence coverage of a Milken Institute virtual briefing in June. “Speed was of essence right now. I wanted to make sure that we give to our people autonomy to move fast and run and be able to produce a vaccine.”

How Will These Vaccines Work?

Both vaccine candidates, referred to as BNT162b1 and BNT162b2, use a vaccine platform reliant on mRNA, a molecule that helps DNA make protein.

In theory, the introduction of non-infectious viral mRNA will prompt the body to create the spike proteins that cover the SARS-CoV-2 virus. On their own, these spikes are harmless, but they'll still elicit the immune response necessary to create antibodies that protect against SARS-CoV-2.

In recent years, mRNA vaccines have proven safer, more potent, and more efficient to produce than other types of vaccines, making the technology a good option for the billion doses intended.

Pfizer and BioNTech plan to move to Phase 2b/3 trials as soon as later this month with up to 30,000 subjects.

What This Means For You

Fast track means that, if one or both of the vaccines proves safe and effective, the FDA approval process will move faster. That means the vaccine availability to the general public may happen faster too.

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