US FDA Eyes Speedy Review Of Omicron Vaccines, Drugs - Reports
Sumaira FH Published December 03, 2021 | 08:38 PM
The US Food and Drug Administration (FDA) is taking steps to expedite a potential review of Omicron-specific vaccines and drugs to ensure prompt delivery of these when needed, The Wall Street Journal reported on Friday, citing sources
WASHINGTON (UrduPoint News / Sputnik - 03rd December, 2021) The US food and Drug Administration (FDA) is taking steps to expedite a potential review of Omicron-specific vaccines and drugs to ensure prompt delivery of these when needed, The Wall Street Journal reported on Friday, citing sources.
The agency has reportedly been meeting with drug manufacturers to set guidelines for the studies and data needed to rapidly evaluate products targeting the new coronavirus variant.
According to the rules the FDA is working on, manufacturers will be required to meet standards similar to those set for the authorization of COVID-19 booster shots, the report said.
They would be relieved of the obligation to conduct large and lengthy trials with thousands of subjects, and could study the immune responses in a few hundred participants.
Development and testing of the new vaccines is expected to take about three months. In an expedited review process, it would take the FDA one to two weeks to decide on their authorization requests.
Pfizer CEO Albert Bourla said this week that the company and its partner BioNTech could have Omicron-specific shots ready in 100 days, while Moderna said it can advance candidates for the new vaccine to clinical testing in 60 to 90 days.
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