FDA Addresses Impacts of New Variant, Urges COVID-19 Vaccinations

December 02, 2021 - FDA is working with federal partners and regulators to address potential impacts of the new Omicron variant and urges everyone to receive COVID-19 vaccinations or booster shots, according to an official statement from Janet Woodcock, MD, Acting FDA Commissioner. 

FDA is working to evaluate the potential impact of the variant on currently available diagnostics, therapeutics, and vaccines. The agency will disclose any information to the public.

“Historically, the work to obtain the genetic information and patient samples for variants and then perform the testing needed to evaluate their impact takes time. However, we expect the vast majority of this work to be completed in the coming weeks,” Woodcock said.

Since early in the pandemic, FDA has monitored the possible emergence of a COVID-19 variant and worked with medical product developers when a new variant emerges that could impact product performance. 

FDA has also taken steps to adapt to the variants, including requiring companies to monitor for and evaluate the impact of variants on their products as a condition of authorization. 

Previously, the agency limited the scope of use of certain monoclonal antibodies depending on variants circulating in certain areas and updated fact sheets for healthcare providers with information about how known variants impact specific therapeutics.

Now, FDA anticipates having more information from the ongoing evaluation about how well current vaccines and therapeutics work against the Omicron variant within the next few weeks. 

“On preliminary review, we believe high-volume polymerase chain reaction and antigen tests widely used in the US show low likelihood of being impacted and continue to work. However, the FDA will continue to closely review and adjust course as needed,” Woodcock explained. 

Current vaccines remain highly effective at preventing COVID-19 and serious clinical outcomes associated with infection, including hospitalization and death. 

Last December, FDA issued an emergency use authorization for both the Pfizer-BioNTech and Moderna COVID-19 vaccines. Then in March 2021, the agency authorized Johnson & Johnson’s single-dose COVID-19 vaccine. 

In October, FDA authorized a booster dose of the Modern and Johnson & Johnson COVID-19 vaccine. And in November 2021, the agency expanded the September authorization of the Pfizer-BioNTech vaccine booster dose to all adults. 

Woodcock stressed that the best thing anyone can do right now is get vaccinated or receive a booster to help protect themselves, family, and friends.