Legal Update

Jul 19, 2022

Adding to the U.S.’s COVID-19 Vaccine Arsenal, FDA Issues EUA for Novavax – Will it Impact Religious Accommodations?

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Seyfarth Synopsis: On July 13, 2022, the U.S. Food and Drug Administration (“FDA”) issued an emergency use authorization (“EUA”) for the Novavax COVID-19 Vaccine, Adjuvanted.  Beyond adding another vaccination option in the fight against COVID and its evolving variants, reports suggest those with religious-based objections to previously-approved COVID-19 vaccines may be more accepting of the Novavax vaccine.

The FDA’s Announcement

Determining that “[t]he data support that the known and potential benefits of the [Novavax COVID-19 Vaccine, Adjuvanted] outweigh its known and potential risks in people 18 years of age and older, and that this vaccine may be effective in preventing COVID-19,” the FDA announced on July 13, 2022, that it had authorized the vaccine for emergency use.  As with Pfizer and Moderna’s COVID-19 vaccines, Novavax’s version is delivered in a two-dose primary series, with the second shot following the first by three weeks.

The Technology

Using an older technology than its mRNA predecessors, Novavax’s “vaccine contains the SARS-CoV-2 spike protein and Matrix-M adjuvant. Adjuvants are incorporated into some vaccines to enhance the immune response of the vaccinated individual.”  As the CDC explains, “adjuvants help vaccines work better.”  The spike protein in the Novavax vaccine is produced in insect cells – moths specifically.  And the adjuvant contains saponin extracts (plant-derived organic chemicals) from the bark of the Soapbark tree.

Novavax Explains It Did Not Use Fetal Cell Lines

Reputable media sources have reported that Novavax has represented it did not use fetal cell lines to develop its COVID-19 vaccine.  Novavax’s approach has yielded cautious optimism that at least some of those individuals who have declined vaccination to date based on the earlier vaccines’ attenuated relationship with fetal cell lines—cells grown in a laboratory based on aborted fetal cells collected generations ago—may now choose to vaccinate with Novavax. 

However, there are already anti-vaccine sources online purporting to question Novavax’s public statements about fetal cell lines.  Pervasive online misinformation about vaccines has fueled vaccine refusal, and created challenges for employers’ implementation of vaccine policies that aim to keep workplaces safer from the virus during the pandemic.

Different Technology, Different Ingredients

Vaccine skeptics who harbor distrust for mRNA technology—despite repeated assurances from public health officials that the mRNA vaccines are safe and effective—may also prefer Novavax’s more traditional protein-based technology.  Some health care providers report that “Even though Pfizer-BioNTech and Moderna mRNA vaccines are safe and highly effective, “we’ve heard a lot of people say the reason they’ve chosen not to get an mRNA vaccine is because the mRNA technology is relatively new and it hasn't been tried on a wide scale before.”

Also, many individuals who rejected earlier vaccines based on allergies to ingredients within the vaccine may now be able to take Novavax, as it has a different formulation (and does not contain polyethylene glycol (PEG), for instance).

Employer Takeaways

Employers should consider whether to revisit their vaccination policies to determine whether changes are warranted by the FDA’s decision to authorize emergency use of Novavax COVID-19 Vaccine, Adjuvanted.  Educating vaccine-hesitant employees about this new option could assuage concerns, particularly those based on alleged religious objection to use of fetal cell lines.  Employers who approved exemptions to vaccine requirements based on alleged religious objection to the vaccines’ distant relationship to fetal cell lines, or based on vaccine-related allergies that are not applicable with Novavax, could also consider whether to revisit those approvals once Novavax is available. 

More information from the manufacturer and public health authorities about the Novavax vaccine in the coming weeks may also help expand on Novavax’s prior statements that it has not used fetal cell lines in the development, manufacture, or production of the vaccine.  Seyfarth’s vaccine team will continue to monitor these developments.

Please contact your Seyfarth relationship attorney or the authors of this blog for assistance.