Dear USET/USET SPF Family,
On 13 July, 2022, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for Novavax, Inc for the use of its protein-based COVID-19 vaccine. Subsequently, the Centers for Disease Control and Prevention (CDC) have recommended the use of the Novavax vaccine for adults ages 18 and over. The Biden-Harris administration has secured an agreement for an initial 3.2 million doses and distribution should be available shortly.
Background
The Novavax COVID-19 vaccine (NVX-CoV2373) is a recombinant protein vaccine with a naturally derived adjuvant that is designed to prevent COVID-19 in individuals 18 years of age and older. The vaccine is based on the SARS-CoV-2 S protein of the original Wuhan-Hu-1 strain, and uses a saponin (soap bark tree)-based adjuvant to stimulate and strengthen the immune response to the virus. In contrast to other available COVID-19 vaccines, recombinant protein vaccines have been used for decades; currently, they exist for influenza, hepatitis, human papillomavirus (HPV), Meningococcal B (MenB), and shingles. The vaccine is given as a two-dose primary series, with doses given three (3) weeks apart.
Clinical Trials and Effectiveness
The efficacy of the vaccine in preventing COVID-19 was assessed in an ongoing randomized, observer-blind, placebo-controlled Phase 3 Clinical Trial. Of 29,945 participants, 6.7% were American Indian/Alaska Native; reflective of Novavax’s commitment to respectful partnerships with AI/AN Tribal communities. Overall, the vaccine was 90.4% effective at preventing COVID-19, and 100% effective against moderate and severe disease. As with all COVID-19 vaccines, the FDA undertook a rigorous review of any potential safety concerns, concluding that there were no new safety concerns with this vaccine. While there were no anaphylactic reactions observed in the clinical trial, the FDA does advise against receipt of the vaccine for those who have allergies to any of the vaccine ingredients.
Available COVID-19 Vaccines in the U.S.
With the Novavax EUA, there are now four (4) authorized COVID-19 vaccines for use in the US:
- Two mRNA vaccines:
- Pfizer-BioNtech,
authorized for children 6 months through 17 years, and adults 18 years and up
- Moderna, authorized for children 6 months through 17 years, and adults 18 years and up
- One viral vector vaccine: Johnson & Johnson, authorized for adults 18 years and up
- One recombinant protein vaccine: Novavax, authorized for adults 18 years and up
In agreement with the FDA and CDC, the USET TEC recommends the use of the Novavax COVID-19 vaccine for the prevention of COVID-19 in adults ages 18 and up. Importantly, the well-established efficacy and safety of this vaccine technology may be reassuring to those who are reluctant to receive other available COVID-19 vaccines. It is our hope that the availability of this additional vaccine type will improve COVID-19 vaccine uptake in currently unvaccinated populations. Please contact the TEC should you have any questions at usetepi@usetinc.org.
Resources
CDC Recommends Novavax’s COVID-19 Vaccine for Adults - CDC
Coronavirus (COVID-19) Update: FDA Authorizes Emergency Use of Novavax COVID-19 Vaccine, Adjuvanted
Emergency Use Authorization (EUA) of the Novavax COVID-19 Vaccine, Adjuvanted to prevent Coronavirus Disease 2019 (COVID-19) – Fact Sheet for Recipients and Caregivers
Vaccines for COVID-19
FDA Review of Effectiveness and Safety of Novavax COVID-19 Vaccine in Adults >18 Years of Age Emergency Use Authorization Request
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