FDA eyes rapid review for omicron vaccines, drugs: report

The Food and Drug Administration (FDA) is reportedly eyeing steps for an expedited review of vaccines and drugs targeting the newly detected omicron variant should such steps be necessary.

The Wall Street Journal, citing people familiar with the matter, reported Friday that data and study guidelines are being established to expedite reviews of drugs and vaccines. The people also told the newspaper that the agency was meeting with drugmakers, too.

The FDA is reportedly setting up parameters around what studies could look like for omicron vaccine and drug approval. In the case of vaccines, drugmakers could be allowed to look at hundreds of subjects and their immune responses compared to vaccine test trials that wait for COVID-19 to be detected and include thousands of participants, according to the Journal.

One person familiar with the matter told the newspaper that the development and testing of new vaccines would only need three months. Following that, the FDA would take between a week or two to make a decision on authorization of the vaccine following a rapid review process.

“We could probably get a good bit of mileage just from boosting with the ancestral strain vaccine that we already have,” White House chief medical adviser Anthony Fauci said Friday. 

But he added the administration is also working with pharmaceutical companies to develop multiple contingency plans, including increasing production of current vaccines, developing a vaccine that’s effective against both the ancestral strain and a new variant, or developing a variant-specific booster.

The FDA pointed to existing guidance for manufacturers, which was last updated in the spring, to understand how the agency will evaluate possible new vaccines. FDA also noted a statement from acting Commissioner Janet Woodcock issued on Monday about the omicron variant.

“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,” she said.

The new reported steps come as health authorities race to learn more about the omicron variant, which has been detected in more than 30 countries including the U.S. after being discovered by scientists in South Africa.

On Monday, the Biden administration began enforcing travel restrictions on eight southern African nations in an effort to curb the spread of the variant.

Officials from the World Health Organization said on Friday that they believed that the same steps taken during the delta wave would be sufficient in tackling the omicron variant, including a renewed push on vaccinating people, wearing facial coverings and social distancing. 

“The positive news in all of this is that none of the information we have currently about omicron suggests we need to change the directions of our response,” WHO regional director for the Western Pacific, Takeshi Kasai, said during a news conference.

— Nathaniel Weixel contributed.