October 07, 2020
The U.S. Food and Drug Administration is asking COVID-19 vaccine makers to collect at least two months of safety data before submitting a vaccine for authorization.
New guidance released Tuesday instructs pharmaceutical companies to monitor Phase 3 study participants for possible adverse reactions for a couple months after they complete the vaccine regimen.
That makes it unlikely that a vaccine will be authorized before Election Day.
Pfizer and Moderna began their Phase 3 trials in the U.S. in late July. Their vaccines candidates each require participants receive two doses several weeks apart.
Johnson & Johnson's vaccine only requires a single shot, but the company didn't begin enrolling participants until late September. And AstraZeneca's U.S. trial is still halted after a potential adverse reaction in a study participant in the U.K.
The guidance also states that drugmakers should have at least five severe cases of COVID-19 in the placebo arm of their trials before they submit the vaccines for authorization.
The criteria for emergency use authorization were expected to be published much earlier, but the White House wanted to review the guidance first. The development of a COVID-19 vaccine has become politicized as President Trump continues to push for a speedy process.
The goal of the guidelines is a "balance" between speed and safety, Peter Marks, director for the FDA's Center for Biologics Evaluation and Research, said during a virtual symposium hosted by Johns Hopkins University and the University of Washington. He noted about 1,000 people are dying each day of COVID-19.
There will be less safety data available compared to previous vaccine candidates, but Marks said there should be enough time to determine the risk of potential adverse events like spinal cord injury or Guillain-Barré syndrome.
Federal health agencies and the Department of Defense have laid out plans for vaccine distribution to begin in January – or sooner – depending on how the clinical trials go.
The FDA said it made its guidance public due to concerns over the eroding public confidence in a safe and effective COVID-19 vaccine.
The fear of adverse reactions may prevent some people from becoming vaccinated. An Associated Press poll in May indicated that only half of Americans plan to get the vaccine once it is available.
In September, executives of nine of the pharmaceutical companies with a COVID-19 vaccine candidate pledged to ensure their vaccine is safe and effective before submitting for emergency authorization.
The FDA guidance was published as an appendix to the FDA briefing document for the upcoming Vaccines and Related Biological Products Advisory Committee Meeting on Oct. 22. It also is posted on the agency's website.