In February 2023 Novavax and the US Department of Health and Human Services (HHS) announced a modification to their existing agreement, in collaboration with the Defence Department, to deliver up to 1.5 million doses of the Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373). The agreement will “maintain the US public’s access to Novavax’s vaccine”.
The vaccine
NVX-CoV2373 is a protein-based vaccine engineered from the genetic sequence of the first strain of the COVID-19 virus, SARS-CoV-2. It was developed using Novavax’s “recombinant nanoparticle technology to generate antigen derived from the coronavirus spike protein”.
It is formulated with patented saponin-based Matrix-M adjuvant to “enhance to the immune response and stimulate high levels of neutralising antibodies”. It comes as a ready-to-use liquid formulation and is stored between 2° -8° Celsius.
Vaccine diversity and access
John C. Jacobs, President and CEO of Novavax, suggested that the agreement acknowledges the “need to offer the American people a diverse COVID-19 vaccine portfolio”. Furthermore, it “underscores the importance of Novavax’s partnership with the US government to ensure continuous access to a protein-based option”.
“We look forward to continuing our collaboration with the US government on the development of our COVID-19 vaccine to meet the requirements of the FDA and our commercial customers.”
The contract supports efforts to make the protein-based vaccine freely available to “states, jurisdictions, federal pharmacy partners, and federally qualified health centres”.
Authorisation
The vaccine was granted emergency use authorisation from the US FDA for adults aged 18 and over, adolescents between 12 and 17 as a primary series, and as a first booster dose. The conditions for the use as a booster dose are “six months after completion of primary vaccination with an authorised or approved COVID-19 vaccine” for individuals over 18 who can’t access the mRNA bivalent COVID-19 booster.
“The emergency use of this product is only authorised for the duration of the declaration that circumstances exist justifying the authorisation of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorisation revoked sooner.”
For more on COVID-19 vaccines and to speak to representatives of Novavax, join us at the World Vaccine Congress in Washington this year.
