DETROIT – The Food and Drug Administration could issue an emergency use authorization for the Pfizer COVID-19 vaccine as early as this Thursday.
Even after the first vaccine is given the green light there will still be a considerable follow-up to monitor safety. That is standard practice to continue to monitor new vaccines and new drugs after they are granted an emergency use authorization or full approval.
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There can be certain rare side effects that don’t show up until a vaccine or drug is given to large numbers of people. In this case, there will be extra emphasis on detecting any of those rare complications as quickly as possible.
Government officials are hoping to put minds at ease when it comes to safety. Part of that includes a new tool called V-SAFE, it’s a smartphone-based active surveillance program for COVID-19. It’s a way for the Centers for Disease Control and Prevention to monitor vaccine recipients for any health problems through text messages and online surveys in the first week after a person receives the vaccine and then weekly thereafter for six weeks.
If any adverse events are reported, the program will help submit a report to the U.S. Department of Health and Human Services. During the early phase of distributing a COVID-19 vaccine, initial doses may be given to specific groups, such as healthcare personnel and other essential workers -- so they would likely be the first to use V-SAFE.
The people who will be able to get the vaccine first are those with the highest risk from COVID-19. By the time the general public will be able to get vaccinated we can expect to have several months of data from the people in clinical trials and millions of health care workers and nursing home residents who have been vaccinated.
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