FDA investigating possible impacts of Omicron variant, urges vaccination and boosters

Photo: seksan MonKhonkhamsao/Getty Images

As with previous variants of the COVID-19 virus, The U.S. Food and Drug Administration has signaled its intent to actively work with federal partners, international regulators and medical product companies to quickly address any potential impacts of the new Omicron variant on the tools being used to fight the pandemic.

In an announcement this week, the FDA said it's working quickly to evaluate the potential impact of this variant on currently available diagnostics, therapeutics and vaccines. The agency has promised to communicate this information to the public.

That could take a while. 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. The FDA did, however, say that it expects most of this work to be completed "in the coming weeks."

WHAT'S THE IMPACT?

It will be important for the FDA and other federal agencies to be on high alert for the Omicron variant, as Politico reports that it has been detected for the first time in the U.S., in California. The Centers for Disease Control and Prevention is working with health authorities in the state to track its spread. At this point it's unknown how many cases have been detected.

According to the FDA, it's been actively monitoring for the possible emergence of SARS-CoV-2 variants since early in the pandemic, and has worked with medical product developers when a new variant emerges that could impact product performance.

With industry guidance laid out in February and contingency plans already in place, the agency considers itself well positioned to address the potential impact of the Omicron and other variants. It also touted a number of steps it has taken to adapt to emerging variants thus far in the pandemic, such as requiring companies to actively monitor for and evaluate the impact of variants on their products as a condition of authorization.

The FDA has previously limited the scope of use of certain monoclonal antibodies depending on variants circulating in certain areas, updated fact sheets for healthcare providers with information about how known variants impact certain therapeutics, and communicated with the public about tests affected by viral mutations.

If a modification to the current vaccines is needed, the FDA and companies will work together to develop and test such a modification quickly, officials said.

On preliminary review, the agency believes high-volume polymerase chain reaction and antigen tests widely used in the U.S. show low likelihood of being impacted, and should continue to work.

Currently, the vaccines that are already available remain highly effective at preventing COVID-19 and serious clinical outcomes associated with an infection, including hospitalization and death, the agency said. 

Plus, currently available data from international partners and vaccine manufacturers suggests that an additional booster shot following the completion of a primary vaccination (six months for Pfizer-BioNTech and Moderna and two months for Johnson & Johnson) provides further protection. Mask wearing aso continues to be effective, the FDA said.

THE LARGER TREND

Over the past weekend, the World Health Organization declared the Omicron variant a "variant of concern."

What is known is that, although the number of infections are small so far, and none have yet been reported in the U.S., the variant has been detected at faster rates than previous surges of infection, suggesting it could spread.

The virus will likely be more transmisible, though officials don't know that for certain, Dr. Anthony Fauci on Saturday told "Today."  Fauci is director of the National Institute of Allergy and Infectious Diseases and chief medical adviser to the president.

Hospitals in the United States are again facing an increase in cases, with its resulting workforce burnout. This is adding to staffing and supply chain shortages and a strain on companies' revenue.

Twitter: @JELagasse
Email the writer: jeff.lagasse@himssmedia.com