Acting FDA Commissioner Janet Woodcock

Acting FDA Commissioner Dr. Janet Woodcock

Acting FDA Commissioner Dr. Janet Woodcock thinks many COVID-19 tests will continue to work with the new Omicron variant — with information coming soon on vaccine efficacy.

In a statement posted yesterday, Woodcock said she thought the agency is well-positioned to work with companies to address the potential impact of viral mutations on COVID-19 tests, therapeutics, and vaccines.

“Getting vaccinated or receiving a booster with one of the currently available vaccines is the best thing that you can do right now (in addition to standard precautions like wearing a mask) to help protect yourself, your family and friends,” Woodcock said.

Discovered in late November in South Africa, the Omicron variant has more than 30 changes to the SARS-CoV-2 spike protein. The variant has enough mutations to raise concerns worldwide, even though it is still unknown whether the mutations cause greater transmissibility or vaccine evasion.

Companies including Abbott, BD, Hologic, PerkinElmer, Thermo Fisher and Quidel have said they think their present tests will detect the Omicron variant. Woodcock thinks the tests will continue to work, too.

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

When it comes to vaccines, top executives at Pfizer and Moderna have said that they think their vaccines will continue to protect — even though efficacy may go down. If needed, they will create new versions of their vaccines.

“We anticipate having more information from the ongoing evaluation regarding if and how well the current vaccines work against this variant in the next few weeks,” Woodcock said. “If a modification to the current vaccines is needed, the FDA and companies will work together to develop and test such a modification quickly.”