Maryland Produced COVID-19 Vaccine Conducting U.S. Based Booster Study

Maryland-based Novavax, Inc. today announced that its protein-based COVID-19 vaccine (NVX-CoV2373) is included in clinical trials to evaluate its vaccine's safety, immunogenicity, and reactogenicity as a booster dose.

Novavax confirmed on Mar. 25, 2022, it is participating in an ongoing Phase 1/2 trial sponsored by the U.S. National Institute of Allergy and Infectious Diseases to assess homologous and heterologous boosting regimens in participants who received a primary series of a COVID-19 vaccine which has received full approval or Emergency Use Authorization (EUA) from the U.S. FDA.

Participants will be given a third dose (> 12 weeks later) of either NVX-CoV2373 or one of the three COVID-19 vaccines that have already received EUA or Approval from the FDA.

Novavax's vaccine has not been authorized/approved in the U.S.

The Company completed the required data package and submitted it to the FDA on Jan. 31, 2022.

The study is enrolling approximately 1,130 healthy individuals aged 18 years or older, about 180 of whom will receive NVX-CoV2373 as a heterologous booster.

This trial is being conducted at approximately ten clinical research sites in the U.S., and participants will be followed for 12 months, with topline results expected later in 2022 and full results expected in 2023.

"Additional COVID-19 booster studies are important to support vaccine choice for individuals, healthcare providers, and public health authorities," said Filip Dubovsky, M.D., Chief Medical Officer, Novavax, in a related press release.

"Our COVID-19 vaccine has already been recommended by multiple national policy bodies for primary vaccination and booster settings in individuals 18 years of age and older."

"We look forward to adding to this body of evidence to support the expanded use of our protein-based vaccine."

NVX-CoV2373 (Nuvaxovid, CovoVax, TAK-019) was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

NVX-CoV2373 contains purified protein antigen and can neither replicate nor can it cause COVID-19.

Note: This Novavax media release was edited for clarity and manually curated for mobile readers.