The first COVID-19 vaccines distributed in the United States could receive the green light from the competent authorities under a so-called authorization procedure for their emergency use.
Before a vaccine is allowed in the country, it must be evaluated by the Food and Drug Administration (FDA), which requires it to be studied in thousands of people. Typically, the approval process for a new vaccine can take about a decade. However, the federal government uses a variety of methods to dramatically speed up the process of COVID-19 vaccines.
During a health crisis, the FDA may relax its normal scientific criteria to allow emergency use of investigational drugs, devices, vaccines, and other medical products. The first vaccines to get the interim green light in the United States will almost certainly be available through this process, known as emergency use authorization.
Instead of the standard requirement of “substantial evidence” of safety and efficacy to be approved, the FDA can authorize the release of products if their benefits outweigh the risks. The FDA has already cleared its emergency powers to allow hundreds of coronavirus tests and a reduced number of treatments during the pandemic.
However, the agency has almost no experience in authorizing emergency vaccine use and has set additional criteria that it will use when making decisions about upcoming COVID-19 vaccines.
In October, FDA officials told vaccine makers they had to monitor half of those enrolled in their studies for two months for safety reasons before seeking emergency clearance. This information is expected to be sufficient for the FDA to approve vaccines for certain risk groups, such as healthcare workers caring for people with COVID-19 and residents of nursing homes.
Full approval of a vaccine may require a six-month safety follow-up, as well as extensive inspections of the factories of the companies that manufacture them. Major vaccine makers don’t plan to complete the process until next summer. Only then is the FDA expected to grant full clearance, which would allow the general population to be vaccinated.
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