From bench to arm: How COVID-19 vaccines were born
Last week, the Pfizer and BioNTech coronavirus vaccine was approved for emergency use by the United States Food and Drug Administration (FDA), and the first recipients began receiving their vaccines. Later this week, the Moderna vaccine could also get emergency approval. Let’s see here how it was all made possible in record time.
First, when the coronavirus pandemic got serious in the United States, it became a top priority for vaccine developers. This has brought unprecedented amounts of funding to develop and manufacture vaccines against SARS-CoV-2, the virus that causes COVID-19. For example, Pfizer received $ 1.95 billion from the US government with pledge to deliver 100 million doses to people in the US
“The fact that governments bought the vaccines in advance meant that people could take more risks with what they had done at an earlier stage without having to take it one step at a time,” says Professor Stephen Evans. of Pharmacoepidemiology at the London School. of Hygiene & Tropical Medicine, at The Guardian.
Before the coronavirus pandemic, vaccine developers relied on raising funds from investors and grants from federal agencies.
Besides funding, companies have shown that vaccines can be developed quickly using new technologies such as Messenger RNA (MRNA). 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 of the genetic material, and the immune system responds to the protein.
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Before the new coronavirus, there were no mRNA vaccines approved and on the market, although several companies were working on the technology. Vaccines traditionally come as the whole virus that is inactivated or in an attenuated form that is not as strong as the original.
Another reason that vaccines can reach people so quickly is that vaccine production began while clinical trials were underway. This is made possible by Operation Warp Speed and its goal of “producing and delivering 300 million doses of safe and effective vaccines with the initial doses available by January 2021,” according to the US Department of Health. . Health and social services. The website states, “To accelerate development while maintaining safety and efficacy standards, OWS selected the most promising countermeasure candidates and provided coordinated government support. “
Generally, a vaccine developer would not risk wasting their funds making a product that they were not sure would get FDA approval. Most products that go through clinical trials do not end up being approved by the FDA. Phase 3 trials typically take one to four years, and only about 25 to 30 percent make it to this point, according to the FDA.
Keep in mind that the recent FDA approval for the Pfizer coronavirus vaccine is a emergency use authorization. This means that when the conditions of the emergency have passed, the vaccine will no longer be approved for general use. It would require official approval from the FDA to be administered after the emergency.
The Pfizer / BioNTech vaccine is now delivered across the United States. Each state will decide how the vaccine will be distributed to its population.
Monday, Sandra Lindsay, a nurse in the New York metro area, received the first dose outside of a clinical trial. “I saw the alternative and I don’t want it for you,” she said to The New York Times. “I feel like the healing is coming. I hope this marks the beginning of the end of a very painful period in our history.
For both vaccines, there are still many questions that need answers. “The remaining unanswered questions include the long-term durability of the protection: weeks, months, years? Peter Hotez of Baylor College of Medicine told The Guardian. “Is the manufacturing robust enough to deliver enough vaccines to the public, or will we need additional vaccines and technology?” “
For up-to-date information on COVID-19, visit the websites of the Centers for Disaster Control and Prevention and the World Health Organization. For updated global case counts, see this page maintained by Johns Hopkins University or the COVID follow-up project.
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