Novavax’ protein-based vaccine is engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease.
Novavax’s COVID-19 vaccine (NVX-CoV2373) has received emergency use authorization (EUA) from the FDA for a first booster dose at least six months after completion of primary vaccination. The EUA applies to people 18 years of age and older for whom an mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, and to people 18 years of age and older who elect to receive the Novavax COVID-19 vaccine, Novavax said in a statement.
Stanley C. Erck
“The U.S. now has access to the Novavax COVID-19 Vaccine, Adjuvanted, the first protein-based option, as a booster,” Stanley C. Erck, president and chief executive officer of Novavax, said in a press release. “According to CDC data, almost 50% of adults who received their primary series have yet to receive their first booster dose. Offering another vaccine choice may help increase COVID-19 booster vaccination rates for these adults.”
The vaccine comes at a time when Americans’ pace of receiving COVID-19 booster doses is waning. Only around 5% of eligible Americans have received the updated booster bivalent vaccine, according to the Biden Administration.
The FDA’s EUA decision for the Novavax booster was based on data from the phase 3 Prevent-19 clinical trial and from the UK-sponsored COV-BOOST trial. In the phase 3 trial, antibody levels increased significantly relative to pre-boost levels, rising above levels associated with protection. Neutralizing antibodies also increased by 34- to 27-fold compared with pre-boost levels when boosted at eight or 11 months, Novavax said.
In the COV-BOOST trial, the Novavax COVID-19 vaccine increased antibody titers when used as a third dose following initial dosing with another authorized COVID-19 vaccine. In the trial, the incidence of grade 3 or higher adverse events remained relatively low. Among participants 18 years of age and older, adverse reactions following the booster dose of the vaccine were injection site pain/tenderness (81.1%), fatigue/malaise (63.4%), muscle pain (63.0%), headache (52.9%), joint pain (30.3%), nausea/vomiting (14.7%), injection site swelling (8.4%), injection site redness (6.3%), and fever (6.3%).
The next step for the vaccine is a policy recommendation for use as a first booster from the CDC.
The FDA granted EUA for a two-dose primary series in adults aged 18 and older in July and for adolescents aged 12 through 17 in August. Following those EUAs, the CDC recommended the vaccine for use as a primary series for both age groups.
Get the latest industry news, event updates, and more from Managed healthcare Executive.
PBM-Offered Genomics Testing Could Reshape Prescribing of Medications
July 25th 2025Two PBMs, True Rx Health Strategies and Capital Rx, are using pharmacogenomics — how a person’s DNA affects their response to medications — to reduce the trial-and-error of prescribing medications, saving employers and patients time and money.
Read More
In this episode of the "Meet the Board" podcast series, Briana Contreras, Managed Healthcare Executive editor, speaks with Ateev Mehrotra, a member of the MHE editorial advisory board and a professor of healthcare policy and medicine at Harvard Medical School. Mehtrotra is also a hospitalist at the Beth Israel Deaconess Medical Center in Boston. In the discussion, Contreras gets to know Mehrotra more on a personal level and picks his brain on some of his research interests including telehealth, alternative payment models and price transparency.
Listen
FDA Extends Review of Blenrep Combinations in Multiple Myeloma
July 24th 2025Last week, an FDA advisory committee against the risk-benefit profile of Blenrep in combination with other therapies. Regulators and reviewers were concerned about the ocular side effects and dosing and tolerability. The new action date is Oct. 23, 2025.
Read More
Sarepta to Pause Shipments of the Gene Therapy Elevidys
July 22nd 2025Sarepta officials said the temporary halt in shipments was done to maintain a productive working relationship with regulators while they address a safety labeling update about the risk of acute liver disease related to Elevidys.
Read More