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Many things are different when you are in the middle of a global pandemic. One such example: how federal regulators review and authorize new vaccines.
The US Food and Drug Administration ushered in a new phase in the fight against COVID-19 on Friday by giving its blessing to a vaccine made by Pfizer Inc. and BioNTech. It is the first vaccine of its kind to receive a green light from the FDA and immunizations will begin in a matter of days.
There are many reasons why the test passed. Data from clinical trials indicate that:
• Was 95% effective in preventing COVID-19 cases in both Latinos and non-Latinos.
• It was 100% effective in black people.
• It was 94% effective in people who were at least 56 years old. (The older you get, the greater the risk of a severe case of COVID-19.)
• It was 95% effective in those who had at least one medical condition that made them more likely to develop a severe case of COVID-19.
• It was 96% effective for obese people, another condition that makes people more vulnerable to COVID-19.
However, none of this was sufficient for the vaccine to gain official FDA approval. What he got instead was a more limited emergency use authorization.
Why?
Blame it on the pandemic.
During a public health emergency, it is imperative to develop new drugs and vaccines as quickly as possible. But even when speed is of the essence, the FDA still takes the time to make sure patients are not subjected to unproven therapies that do more harm than good.
So the agency uses an alternative screening process that is designed to examine things more quickly than the usual FDA approval regime. If a drug or vaccine passes the test, it is granted an emergency use authorization, or EUA.
An EUA can be used on a new medical product or an existing one that has already been approved for another purpose. They are not limited to vaccines: In the right circumstances, an EUA can be awarded to anything that is used to “diagnose, treat, or prevent serious or life-threatening diseases or conditions,” the FDA explains.
What are those conditions?
To begin with, the country must be in a specific and official type of public health emergency. Health and Human Services Secretary Alex Azar stated that the coronavirus triggered a nationwide public health emergency that began on January 27, but that statement does not count because it was issued under the Public Health Service Law.
The legislation that matters is the Federal Food, Drug, and Cosmetic Act, a law passed in 1938 that empowered the FDA to regulate drugs, among other things. Azar issued a public health emergency under this law that went into effect on February 4.
Another important condition for issuing an EUA is that “there are no suitable, approved and available alternatives” to the product being authorized. That is certainly the case with vaccines against COVID-19, a disease that only appeared on the scene in late 2019.
An experimental vaccine that is being considered for emergency use authorization has yet to be tested in multiple rounds of clinical trials. In Phase 1, the vaccine candidate is given to a small number of healthy people in gradually increasing doses to ensure that it is safe and well tolerated. A phase 1 trial could also provide preliminary information on ideal dosages.
Then comes a Phase 2 study, involving more volunteers testing various doses. At this point, the study will branch out to include people with a variety of health conditions, not just those who are in good shape. This is also when a vaccine is first compared to a placebo.
If no safety concerns arise, proceed to Phase 3. Thousands of study volunteers from a variety of backgrounds are randomly assigned to receive the vaccine or placebo. This type of study helps researchers measure the effect of the vaccine. For example, in phase 3 trials of the Pfizer-BioNTech vaccine, eight of the 17,411 people who received the vaccine ended up becoming ill with COVID-19, compared with 162 of the 17,511 who received the placebo. Using that and other data, the researchers determined that the vaccine was 95% effective in preventing COVID-19.
To be considered for an UAE, a Phase 3 vaccine trial must include “more than 3,000” participants, and at least half of them must be tracked for at least two months after receiving their final dose.
Once sufficient data is available, the FDA can decide whether emergency use authorization is warranted. Doctors and scientists on the agency’s staff carefully analyze the results of the study. So do independent scientists and health experts on the agency’s Vaccines and Related Biologics Advisory Committee.
In the case of a vaccine, authorization can be granted if “the known and potential benefits outweigh the known and potential risks,” says the FDA.
The agency also assesses the company’s ability to consistently produce high-quality doses of its vaccine.
Granting emergency use authorization is not the end of the story. Once a licensed vaccine goes public, its manufacturer must keep track of any serious side effects that happen to those who take it, especially adverse events that result in hospitalization or even death.
The FDA, the Centers for Disease Control and Prevention, and other government agencies will also do their own safety monitoring. If the FDA ever determines that the benefits of the vaccine no longer outweigh the harms, the emergency use authorization may be revoked.
A USA can only last as long as a public health emergency is in effect. But scientists anticipate that the coronavirus will continue to circulate in humans even after the COVID-19 pandemic ends. In that case, vaccine manufacturers that want to keep their products on the market will need regular FDA approval and will need to continue their Phase 3 clinical trials to get it.
And that’s probably what they will do. The FDA said it hopes vaccine manufacturers that receive emergency use authorizations “will continue to collect placebo-controlled data on any ongoing trials for as long as possible” so that they can apply for regular approval.
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