FDA Expedites Review Process For Omicron Vaccines And Drugs

[Stone]

FDA Expedites Review Process For Omicron Vaccines And Drugs

ZH |  DEC 03, 2021


It's been one week since the omicron variant first rattled markets and prompted the Federal Reserve's latest rethink of its plans for rolling back its monetary stimulus. And in that time, vaccine-makers have talked their book by sharing plans to produce new omicron-targeted vaccines, while others claim that there are no data suggesting the Pfizer-BioNTech jab is less effective against omicron.

Assuming the world still does care about omicron three months from now (the first cases of the variant have only just been confirmed in the US in recent days), the FDA and its advisors are reportedly working on an expedited approval process that will allow "tweaked" versions of extant vaccines and remedies to be sheperded through in a matter of weeks.

WSJ reports that the FDA has been quietly meeting with drug makers to establish guidelines for expedited approval of the next generation of vaccines, if they're needed (and that's still a big "if"). According to the new rules the FDA is adopting, drugmakers are working on new vaccines and would be expected to meet standards similar to those required for authorization of boosters.

This means vaccine-makers would be spared the effort of conducting massive, time-consuming trials where they monitor a vaccine test group and a placebo group and wait to see which group reports fewer COVID casualties.

Instead, vaccine-makers could study the "immune response" elicited by the new jabs. Companies like Pfizer would have 3 months to create and test the jabs, with two or three weeks for the FDA to approve them.

Pfizer CEO Albert Bourla said this week that the company and its partner BioNTech could have the vaccines ready in 100 days, while Moderna has said the company can advance new candidates to clinical testing in 60 to 90 days.

Only three cases of omicron have been confirmed in the US, and fewer than 300 have been confirmed globally. Scientists are still trying to figure out whether new treatments are necessary to protect people from the variant, especially since South African scientists at the institute that first identified the new variant are saying that it produces milder infections than delta, especially in patients who have already been vaccinated.

A WHO spokesman said Friday that the agency hasn't seen any deaths linked to the omicron variant just yet - a good sign.

Bottom line: while the FDA is doing everything in its power to make sure it's prepared for omicron, at this point it's not yet clear whether the world will still care about this latest "variant of concern" three months from now.