What does the emergency use of an antiviral vaccine mean?

The first COVID-19 vaccines to be distributed in the United States could receive the green light from the competent authorities in accordance with a process known as authorization for their emergency use.What does the emergency use of a coronavirus vaccine mean?

Before a vaccine is authorized in the country, it must be evaluated by the Food and Drug Administration (FDA), which requires that it be studied in thousands of people. Typically the approval process for a new vaccine can take about a decade. However, the federal government is using a variety of methods to dramatically speed up the process for COVID-19 vaccines.

During a health crisis, the FDA may relax its normal scientific criteria to allow the emergency use of experimental drugs, devices, vaccines, and other medical products. The first vaccines to get the provisional green light in the United States will almost certainly be available through this process, known as authorization for emergency use.

Instead of the standard requirement of “substantial evidence” of safety and effectiveness to endorse, the FDA may authorize the release of products if their benefits outweigh the risks. The FDA has already authorized its emergency powers to authorize hundreds of coronavirus tests and a reduced number of treatments during the pandemic.

However, the agency has almost no experience in authorizing the emergency use of vaccines and has laid out additional criteria that it will use to make decisions about upcoming COVID-19 vaccines.

In October, FDA officials told vaccine manufacturers that they needed to monitor half of the people enrolled in their studies for two months for safety before applying for an emergency clearance.

That information is expected to be sufficient for the FDA to authorize vaccines for certain risk groups, such as healthcare workers caring for people with COVID-19 and for residents of nursing homes.

Full approval of a vaccine may require a six-month safety follow-up, as well as extensive inspections of the plants of the companies that make them. The major vaccine manufacturers do not plan to complete the process until next summer. Only then is the FDA expected to grant its full authorization, which would allow the general population to be vaccinated.