How is the COVID-19 vaccine approved? – FindLaw

Close up of a medical syringe with vaccine.

People all over 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 are developing vaccines with high success rates is certainly welcome, but the vaccine approval process is far from over. Here’s what to come next.

Stage 3 trials

In the United States, approval and certification of drugs are subject to the jurisdiction of the Food and Drug Administration, whose Center for Biological Evaluation and Research (CBER) approves vaccinations. The process typically takes years in total, making it difficult to predict when a COVID-19 vaccine may be ready, although the search for a vaccine is a global focus.

In order to meet FDA approval, The drug or vaccine must undergo three progressively larger trials, although CBER may halt the process or require additional testing phases depending on the results. Vaccines Pfizer and Moderna, delivered in two injections a few weeks apart, went well into the third clinical trials.

These experiments will continue until a certain number of people in trial groups have contracted COVID-19. Back in June, the FDA said a vaccine should be so Efficiency of at least 50% In order to distribute it. Both current options achieved this goal, with Pfizer and Moderna reporting efficacy of over 90% and 94.5%, respectively.

Next steps

Among the fears of rushing to get a vaccine is the potential for long-term side effects. According to USA Today, “About half of the trial participants must have passed two months since the second vaccine, to prove that the candidate vaccines are safe. If someone is going to develop a severe reaction to the vaccine, it will likely occur within six weeks of receiving it.”

Both Pfizer and Moderna are reported to be close to exceeding these timelines. The rest of the approval process includes a series of requests, inspections, and audit committees from both the FDA and independent boards. This may take time, but given the nature of the pandemic, we can likely expect a quick process once a vaccine is determined to be safe.

When will people get it?

After all of the above, the final challenge remains: to manufacture and distribute the vaccine itself. Part of the Food and Drug Administration (FDA) approval process includes verifying that the laboratory has the ability to manufacture a vaccine safely and reliably.

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

There has been much talk about early doses being given to high-risk groups, including healthcare workers and the elderly, among others, who are particularly vulnerable to the virus. With the US population approaching 330 million, the vaccine will likely take some time to reach the general population.

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