FDA Signals Willingness to Quickly Collaborate with Industry to Tackle Omicron

Amid the increasing travel bans, cancelations and worry caused by the new Omicron variant of the SARS-CoV-2 virus, Acting FDA Commissioner Janet Woodcock said yesterday that the FDA is ready to quickly collaborate with industry in whatever way is needed. However, immunogenicity studies would be required if vaccine makers need to modify their vaccines.

Woodcock said that if a modification to the current vaccines is needed, the FDA will work with vaccine makers to develop and test such a modification quickly. It could take weeks to months for vaccine makers to modify their vaccines and get FDA Emergency Use Authorization (EUA).

“As we have with previous emerging COVID-19 variants, the [FDA] is actively working with our federal partners, international regulators and medical product companies to quickly address any potential impacts of the new Omicron variant on the tools to fight the pandemic,” she said.

Citing the industry guidance on EUAs for COVID-19 vaccines the agency laid out in February and contingency plans already in place, Woodcock said the FDA is “well-positioned and committed to working with companies to evaluate and expeditiously address the potential impact of emerging and future viral mutations on COVID-19 tests, therapeutics and vaccines.”

The guidance from February explains how to apply for an amendment to an EUA for an existing COVID-19 vaccine that has been modified to address a new variant of concern. It notes that a determination of effectiveness should be supported by clinical immunogenicity studies comparing immune responses induced by the modified vaccine against the SARS-CoV-2 variant(s) of concern with those induced by the prototype vaccine against the virus upon which the prototype vaccine was based.

Historically, Woodcock said, 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.

Woodcock said the FDA has taken a number of steps to adapt to emerging variants thus far in the pandemic, such as requiring companies to actively monitor for and evaluate the impact of variants on their products as a condition of authorization.

She added that the agency has previously limited the scope of use of certain monoclonal antibodies depending on variants circulating in certain areas, updated fact sheets for healthcare providers with information about how known variants impact certain therapeutics and communicated with the public about tests affected by viral mutations.

Moderna CEO Stéphane Bancel said yesterday that he believes current COVID-19 vaccines won’t be as effective in battling Omicron as they were with the Delta variant, adding that it would take several months to adjust current vaccines to make them effective against Omicron.

Researchers at the University of Oxford, however, begged to differ. They said yesterday that there is no evidence that existing vaccines would not prevent severe disease from Omicron. The university also said that, if necessary, it was ready to rapidly develop an updated version of the vaccine it developed in collaboration with AstraZeneca.

“Despite the appearance of new variants over the past year, vaccines have continued to provide very high levels of protection against severe disease and there is no evidence so far that Omicron is any different,” the university said.

Pfizer told FDAnews this week that the company is beginning to run neutralization tests on the new Omicron variant and expects to have initial data within weeks.  

Pfizer added that in the event that a variant emerges that escapes protection of its vaccine, Pfizer and BioNTech expect to be able to develop and produce a tailor-made vaccine against that variant in approximately 100 days, subject to regulatory approval.

Meantime, preliminary tests indicate the COVID-19 antibody drug cocktail from Regeneron Pharmaceuticals could lose effectiveness against the new variant, the company said yesterday.

“Prior in vitro analyses and structural modeling regarding the individual mutations present in the Omicron variant indicate that there may be reduced neutralization activity of both vaccine-induced and monoclonal antibody conveyed immunity, including the current REGEN-COV antibodies,” the company said, adding that further analyses are ongoing to confirm and quantify this potential impact. — Suz Redfearn