Still Coughing: Now-Dominant COVID-19 Variant Can Elude Current Vaccines, Prompts FDA Action

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Seyfarth Synopsis: Omicron BA5 strain has become dominant and has evolved to render vaccinations and boosters less effective, resulting in many employers revisiting their COVID-19 policies.

According to the Centers for Disease Control and Prevention (CDC), “SARS-CoV-2, the virus that causes COVID-19, is constantly changing and accumulating mutations in its genetic code over time. New variants of SARS-CoV-2 are expected to continue to emerge. Some variants will emerge and disappear, while others will emerge and continue to spread and may replace previous variants.” For instance, a  new version of COVID, omicron is dominant in the U.S. As of last Saturday, the coronavirus subvariant known as Omicron BA.5 accounted for nearly 54% of the country’s COVID cases, according to the CDC. A similar subvariant, BA.4, makes up approximately 17% more. Studies further indicate that COVID-19 reinfections are associated with lasting health effects and long COVID symptoms.

The FDA has noted that vaccines and boosters currently available are significantly less effective against these new variants, and the agency is working with vaccine manufacturers to tailor boosters to address these inadequacies, as well as to anticipate further evolution of the virus. On June 30, 2022, after a June 28 discussion and vote by the Vaccines and Related Biological Products Advisory Committee, the FDA issued a statement explaining that it

advised manufacturers seeking to update their COVID-19 vaccines that they should develop modified vaccines that add an omicron BA.4/5 spike protein component to the current vaccine composition to create a two component (bivalent) booster vaccine, so that the modified vaccines can potentially be used starting in early to mid-fall 2022.

The FDA appears to have based this recommendation on its determination “that vaccines . . . need to be modified to address circulating variants.”

While federal and state OSHA agencies continue to conduct inspections and issue citations relating to COVID-19 hazards, federal OSHA largely has abrogated its leadership in protecting employees from COVID-19, failing to advise employers on how to address new strains or issue employers any updated guidance since August 13, 2021, despite the long-standing promise of an “UPDATE COMING SOON.” The prospect of new strains of COVID-19, reinfections, and lasting health effects have led many employers to revisit their COVID-19 precautions and policies. Employers with vaccination requirements continue to update those policies, including new booster requirements to ensure employee safety from new variants.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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