Story at a glance
- Last week, Pfizer and BioNTech’s vaccine was given emergency use authorization from the FDA.
- This week, the agency will decide if Moderna’s vaccine will also receive emergency use approval.
- These vaccines were made possible in record time because they were made a high priority, giving them access to unprecedented levels of funding.
Last week, the Pfizer and BioNTech coronavirus vaccine was approved for emergency use by the U.S. Food and Drug Administration (FDA), and the first recipients have started receiving their shots. Later this week, the Moderna vaccine could similarly get emergency approval. Here we take a look at how all this was made possible in record time.
First of all, when the coronavirus pandemic became serious in the U.S. it became a top priority for vaccine developers. This brought to the table unprecedented amounts of funding to develop and manufacture vaccines for SARS-CoV-2, the virus causing COVID-19. For example, Pfizer received $1.95 billion from the U.S. government with the promise to deliver 100 million doses for people in the U.S.
“The fact that governments pre-bought the vaccines meant that people could take greater risks with what they did at an earlier stage without having to take one step at a time,” says Stephen Evans, who is a professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine, to The Guardian.
Before the coronavirus pandemic, vaccine developers relied on raising funds with investors and grants from federal agencies.
Besides funding, companies have shown that vaccines can be developed quickly using new technologies like messenger RNA (mRNA). The mRNA serves as a platform for delivering coronavirus genetic material to cells in the body. The cells then make a protein according to the instructions in the genetic material and the immune system responds to the protein.
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Prior to the novel coronavirus, there were no mRNA vaccines approved and on the market, although several companies were working on the technology. Vaccines have traditionally come in the form of the whole virus that is deactivated or in an attenuated form that is not as strong as the original.
Another reason why the vaccines are able to reach people so quickly is that the manufacturing of the vaccines began while the clinical trials were ongoing. This is made possible because of Operation Warp Speed and its goal to “produce and deliver 300 million doses of safe and effective vaccines with the initial doses available by January 2021,” according to the U.S. Department of Health and Human Services. The website states, “To accelerate development while maintaining standards for safety and efficacy, OWS has been selecting the most promising countermeasure candidates and providing coordinated government support.”
Typically, a vaccine developer would not risk wasting its funds by manufacturing a product that they were not sure would get FDA approval. Most products that go through clinical trials do not end up getting the whole way through to FDA approval. Phase 3 trials usually take one to four years to complete, and only about 25 to 30 percent make it to that stage, according to the FDA.
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Keep in mind, the recent FDA approval for the Pfizer coronavirus vaccine is an emergency use authorization. This means that when the conditions for the emergency have passed, then the vaccine would no longer be approved for general use. It would need official approval from the FDA to be administered after the emergency.
The Pfizer/BioNTech vaccine is now being delivered to throughout the United States. Each state will decide how the vaccine will be distributed to its population.
On Monday, Sandra Lindsay, a nurse in the New York metro area, got the first dose outside of a clinical trial. “I have seen the alternative, and do not want it for you,” she says to The New York Times. “I feel like healing is coming. I hope this marks the beginning of the end of a very painful time in our history.”
For both vaccines, there are still a lot of questions that need answers. “The outstanding questions that remain include the long-term durability of protection: weeks, months, years?” says Peter Hotez of Baylor College of Medicine to The Guardian. “Is manufacturing robust enough to get sufficient vaccine to the public, or will we need additional vaccines and technologies?”
For up-to-date information about COVID-19, check the websites of the Centers for Disease Control and Prevention and the World Health Organization. For updated global case counts, check this page maintained by Johns Hopkins University or the COVID Tracking Project.
You can follow Chia-Yi Hou on Twitter.
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