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The head of the Centers for Disease Control and Prevention confirmed on Sunday that the Food and Drug Administration was speeding the approval process for the “omicron” variant of COVID-19, which emerged recently in South African and has since spread to the United States and other countries.
Dr. Rochelle Walensky’s confirmation comes following a report by The Wall Street Journal last week suggesting that the FDA was examing ways to quickly review medications and vaccines that are specific to the omicron variant in the event they would become necessary, The Hill noted on Sunday.
“You know, one of the things about a booster — about a variant-specific booster — I know Moderna, Pfizer, Johnson and Johnson say they can all do this fairly quickly within three months. But then you have FDA approval. Is there any world where you can see that moving much faster given we’ve already been through this?” ABC’s “This Week” co-anchor Martha Raddatz asked Walensky.
“Yeah, you know, much of that I would have to defer to the FDA, but they’re already in conversations about streamlining the authorization of this, of an omicron-specific vaccine, partially because much of the vaccine is actually exactly the same and really, it would just be that mRNA code that would have to change,” Walensky responded.
“So those conversations are ongoing, and certainly, FDA will move swiftly and CDC will move swiftly right thereafter,” the CDC director noted further.
The WSJ said that the FDA is attempting to set up parameters for studies involving an omicron vaccine and drug approval if needed. Regarding shots, pharmaceutical companies may be authorized to study the immune responses of hundreds of people compared to normal vaccine trials that require COVID-19 to be detected in a person and feature thousands of patients.
A person familiar with the situation told the Journal that the process could take as little as three months, after which the FDA would need one to two weeks to make a decision on whether to authorize a new vaccine or medication following the rapid review process.
“We could probably get a good bit of mileage just from boosting with the ancestral strain vaccine that we already have,” noted White House chief medical adviser Anthony Fauci on Friday.
But Fauci went on to note that the Biden administration is currently working with drug makers to develop several contingencies that include boosting production of the current regimen of coronavirus vaccines that are effective against the original strain and the new variant and developing a booster that works well against specific variants.
“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,” acting FDA Commissioner Janet Woodcock said in a statement Monday regarding work on the omicron variant.
“However, we expect the vast majority of this work to be completed in the coming weeks,” she added.
Meanwhile, Surgeon General Vivek Murthy told “Fox News Sunday” that while Americans should remain “more vigilant” about the new variant, there is no reason to panic, noting that existing guidelines and safety protocols are sufficient.
“We do know that the measures that we take to protect ourselves from the spread of COVID, including wearing masks in indoor spaces, being in well ventilated spaces. Those work… and will work against Omicron,” said Murthy.
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Jon is a staff writer for BizPac Review with 30 years' worth of reporting experience, as well as an author and U.S. Army veteran. He has a BA in political science from Ashford University and an MA in national security studies/intelligence analysis from American Military University.
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