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How Is a COVID-19 Vaccine Approved?

Close-up medical syringe with a vaccine.
By Ashley Ravid on November 23, 2020 12:16 PM

People across the world have been waiting for news of a vaccine since the start of the pandemic. The recent announcement that pharmaceutical companies Pfizer and Moderna have each developed vaccines with high success rates is certainly welcome, but the vaccine approval process is far from over. Here's what comes next.

Phase 3 Trials

In the United States, approval and certification of drugs falls under the jurisdiction of the FDA, whose Center for Biologics Evaluation and Research (CBER) is responsible for approving vaccinations. The process typically takes years in total, making it difficult to predict when a COVID-19 vaccine may be ready, even though the search for a vaccine is a worldwide focus.

In order to meet FDA approval, a drug or vaccine must undergo three gradually larger trials, though CBER may halt the process or require additional testing phases depending on results. Both the Pfizer and Moderna vaccines, delivered in two injections a few weeks apart, are well into their third clinical trials.

These trials will continue until a certain number of people in the trial groups contract COVID-19. Back in June, the FDA said that a vaccine would have to be at least 50% effective in order for it to be distributed. Both of the current options have hit this target, with Pfizer and Moderna reporting over 90% and 94.5% efficacy, respectively.

Next Steps

One of the concerns with rushing a vaccine is the possibility of long-term side effects. According to USA Today, "About half the trial participants must be two months past their second shot, to prove that the candidate vaccines are safe. If someone were to develop a severe vaccine reaction, it's likely to happen within six weeks of receiving it."

Both Pfizer and Moderna are reported to be close to passing these timelines. The rest of the approval process involves a series of applications, inspections, and review committees from both the FDA and independent boards. This can take time, but given the nature of the pandemic we can likely expect an expedited process once a vaccine is determined to be safe.

When Will People Get It?

After all the above, one last challenge remains: manufacturing and distributing the vaccine itself. Part of the FDA approval process includes verifying that a lab has the capacity to safely and reliably manufacture a vaccine.

Moderna says it will have 20 million doses ready by the end of 2020, with Pfizer claiming it will ready 50 million in that time. Both companies have said that they could manufacture hundreds of millions to billions of doses in 2021.

Much talk has surrounded early doses being given to at-risk groups including healthcare workers and the elderly, among others who are particularly vulnerable to the virus. With the United States population nearing 330 million, the vaccine will likely take time to make it to the general population.

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