FDA Reportedly Preparing Guidelines for Omicron-targeted Vaccine Studies

Dec. 6, 2021 – As the seemingly fast-spreading COVID-19 omicron variant begins to show up in the United States, the Food and Drug Administration (FDA) is taking measures now to meet any potential need for new diagnostics, vaccines and therapeutics to combat the next phase of the pandemic.

On Dec. 2, President Joe Biden announced a new plan that includes policies to help manage this phase of the pandemic, such as ramping up the number of booster shots given and increasing at-home COVID-19 testing. The Wall Street Journal reported on Dec. 3 that “people familiar with the matter” claim the FDA has been meeting with drug companies “and setting guidelines for the studies and data needed to swiftly evaluate products targeting” omicron.

The agency is “actively working with our federal partners, international regulators and medical product companies to quickly address any potential impacts of the new omicron variant,” the FDA stated in a Nov. 30 press release. “The FDA is committed to continuing to use every tool in our toolbox to fight this pandemic, including pivoting as the virus adapts.”

The FDA also notes that it has been “actively monitoring” for the emergence of variants and has worked with medical product developers when a new variant emerges that may impact product performance. Although there are still many unknowns about omicron at this point – including whether or not it causes more severe illness or spreads faster than other variants, or if existing vaccines offer adequate protection from it – the Biden administration already is moving to address omicron, which was first reported last month in South Africa.

“The FDA, criticized in the past over the pace of reviews of the existing COVID-19 vaccine for specific age groups and for use as a booster, is working to get out ahead of the possible need for a modified vaccine to cover the omicron variant,” said Coalition for Healthcare Communication Executive Director Jon Bigelow. “Offering companies guidance early in the process can save valuable time, and also set a model for addressing future variants.”

With time of the essence as omicron begins to take hold in the United States, certainly it makes sense for the FDA to get the ball rolling regarding processes and procedures for new COVID-19 product development – especially if new vaccines will be required. Representatives from Moderna and Pfizer and its partner BioNTech have said they could have a new vaccine ready in roughly 100 days.

In the interim, the FDA advises the public that “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).”