Gaithersburg, MD—Doses of the Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373), should be available to administer no later than early August, according to the company.

The doses shipped from the Novavax warehouse by late July and were received by the U.S. government's designated distribution center shortly thereafter.

The vaccine, which has FDA Emergency Use Authorization (EUA) for a two-dose primary series to protect adults from SARS-CoV-2, is being allocated to states by the CDC. Receiving the new vaccine will be federal pharmacy partners, state and local distribution centers, and federally qualified health centers.

The ability to order doses began on July 25, according to Novavax.

Information on where to access the Novavax COVID-19 Vaccine, Adjuvanted, will be on the website.

"Importantly, consumers should work with their healthcare providers and local pharmacies to share requests for the vaccine in areas where it is not yet available to help inform additional allocation decisions by the CDC," the company advised. "Novavax is committed to making the first protein-based COVID-19 vaccine option available to the U.S. population and will be working closely with the U.S. Government to ensure consumers have access."

A statement announced that CDC Director Rochelle P. Walensky, MD, MPH, had endorsed the recommendation that Novavax's COVID-19 vaccine be used as another primary series option for adults. Dr. Walensky pointed out that it provides a more familiar type of COVID-19 vaccine technology for adults, adding, "Having multiple types of vaccines offers more options and flexibility for the public, jurisdictions, and vaccine providers."

Some vaccine-hesitant adults had expressed concern about the newer mRNA technology used in vaccines from Pfizer-BioNTech and Moderna.

According to the CDC, "Protein subunit vaccines package harmless proteins of the COVID-19 virus alongside another ingredient called an adjuvant that helps the immune system respond to the virus in the future. Vaccines using protein subunits have been used for more than 30 years in the United States, beginning with the first licensed hepatitis B vaccine. Other protein subunit vaccines used in the United States today include those to protect against influenza and whooping cough (acellular pertussis)."

Dr. Walensky stated, "Today, we have expanded the options available to adults in the U.S. by recommending another safe and effective COVID-19 vaccine. If you have been waiting for a COVID-19 vaccine built on a different technology than those previously available, now is the time to join the millions of Americans who have been vaccinated. With COVID-19 cases on the rise again across parts of the country, vaccination is critical to help protect against the complications of severe COVID-19 disease."

FDA Commissioner Robert M. Califf, MD, made a statement when the EUA was issued, pointing out, "Today's authorization offers adults in the United States who have not yet received a COVID-19 vaccine another option that meets the FDA's rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization. COVID-19 vaccines remain the best preventive measure against severe disease caused by COVID-19 and I encourage anyone who is eligible for, but has not yet received a COVID-19 vaccine, to consider doing so."

The FDA stated that the Novavax COVID-19 Vaccine, Adjuvanted, is administered as a two-dose primary series 3 weeks apart, adding, "The 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. The spike protein in this vaccine is produced in insect cells; the Matrix M-adjuvant contains saponin extracts from the bark of the Soapbark tree that is native to Chile."

The vaccine was assessed in an ongoing randomized, blinded, placebo-controlled study conducted in the U.S. and Mexico prior to the emergence of Delta and Omicron variants. Overall, the vaccine was found to be 90.4% effective in preventing mild, moderate, or severe COVID-19, with 17 cases of COVID-19 occurring in the vaccine group and 79 cases in the placebo group.

The FDA added that no cases of moderate or severe COVID-19 were reported in participants who received the vaccine, compared with nine cases of moderate COVID-19 and four cases of severe COVID-19 reported in placebo recipients. For participants aged 65 years and older, the vaccine was 78.6% effective.

The side effects most commonly reported by vaccine recipients included pain/tenderness, redness, and swelling at the injection site, fatigue, muscle pain, headache, joint pain, nausea/vomiting, and fever. Approximately 21,000 vaccine recipients had at least 2 months of safety follow-up after their second dose.

The Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) includes a warning, however, that clinical-trial data provide evidence for increased risks of myocarditis and pericarditis following administration of Novavax COVID-19 Vaccine, Adjuvanted.

The content contained in this article is for informational purposes only. The content is not intended to be a substitute for professional advice. Reliance on any information provided in this article is solely at your own risk.