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Steps for Quick Review

The US Food and Drug Administration is taking steps to enable the quick review of drugs and vaccines for the Omicron variant of SARS-CoV-2, the Wall Street Journal reports.

The variant — which was only recently identified but has since been spotted in numerous countries, including the US — is highly mutated and has some 30 changes affecting the viral spike protein. These mutations in particular have raised concerns. Stéphane Bancel, the CEO of Moderna, for instance, told the Financial Times this week that he suspects current SARS-CoV-2 vaccines will be less effective against the Omicron variant. However, he and others have said that more time is needed to get a better understanding of Omicron.

The FDA is getting ready in case Omicron-specific vaccines or drugs are needed, the Journal reports. In particular, it says the agency is building off of rules established earlier this year and would allow vaccine makers developing Omicron-specific shots to meet standards set for booster. That way, they would not have to conduct long clinical trials and instead, vaccine makers would need about three months to develop and test vaccines. The Journal adds that the agency would then review the updated vaccines under its expedited review process.

The Journal adds, though, that the FDA is still weighing how much of a drop in effectiveness of current vaccines would warrant a need for an updated one.