How the FDA Is Helping Expedite Vaccine Boosters For COVID-19 Variants

The Food and Drug Administration (FDA) issued new guidance this week for developers of vaccines, diagnostic tests, and medications specifically aimed at coronavirus variants. 

In a February 22 reporter briefing about the guidance, FDA staff said that if any vaccines with emergency use authorization are changed to better target COVID-19 variants, they will not need to repeat full-fledged clinical trial testing. In an effort to save time, only hundreds—rather than tens of thousands—of participants will be included in trials. Testing will need to compare the immune response to the modified vaccine against the immune response to the currently-authorized vaccine.

What We Know About Vaccines and the Variants 

Several variants, or variations, of COVID-19 have emerged over the last few months. Health experts worry they could elude vaccines and treatments. These include variants identified in the U.K. (B.1.1.7), South Africa (B1.351), and Brazil (P.1). 

In a briefing for reporters last week, William Hanage, PhD, an associate professor of epidemiology at the Harvard T.H. Chan School of Public Health, acknowledged concern about the variants’ ability to elude antibodies produced by vaccines. But he explained that the vaccines from Pfizer and Moderna are relatively easy to change and update. 

“For now, the hope is that the current vaccines can protect against severe disease and deaths even if they can’t keep everyone from getting the virus caused by a variant,” Hanage said.  

Anthony Fauci, MD, chief medical adviser to President Biden, continually stresses at thrice-weekly White House COVID-19 briefings that swift vaccination can keep variants at bay. 

But tens of millions of people in the U.S. still remain unvaccinated, and the country faced weather-related delays in many states last week. So the risk of infection remains high.

What the FDA Says

The FDA had already been in touch with individual companies about evaluating the effectiveness of products against the COVID-19 variants. 

“The FDA is committed to identifying efficient ways to modify medical products that either are in the pipeline or have been authorized for emergency use to address emerging variants,” said acting FDA commissioner Janet Woodcock, MD in a statement on Monday. 

“We want the American public to know that we are using every tool in our toolbox to fight this pandemic, including pivoting as the virus adapts,” she said. “We need to arm healthcare providers with the best available diagnostics, therapeutics, and vaccines to fight this virus. We remain committed to getting these life-saving products to the frontlines.”

The guidance also offers recommendations on how to efficiently test and create monoclonal antibody treatments that better target the variants, as well as how to evaluate the impact of variants on COVID-19 tests. The FDA says it will monitor publicly-available genomic databases to stay abreast of potential variations of SARS-CoV-2—something the U.K. has excelled at.

The information in this article is current as of the date listed, which means newer information may be available when you read this. For the most recent updates on COVID-19, visit our coronavirus news page.