HQ Team
October 4, 2023: The US Food and Drug Administration has cleared Novavax’s updated Covid-19 vaccine for emergency use in adolescents 12 years of age or above, the regulator announced.
The Emergency Use Authorisation permits individuals, who have not already been vaccinated with a recently updated mRNA COVID-19 vaccine, to receive two doses and a single dose for those previously vaccinated.
“The updated vaccine addresses currently circulating variants to provide better protection against serious consequences of COVID-19, including hospitalization and death,” according to an FDA statement.
Novavax’s vaccine is consistent with the totality of the evidence and input from the FDA’s expert advisors, and the monovalent vaccine has been updated to include the spike protein from the SARS-CoV-2 omicron variant lineage XBB.1.5 (2023-2024 formula).
Sole product
The vaccine is the sole product that Novavax has on the market and its solvency depends on it. The company’s competitors such as Pfizer-BioNTech and ModernaTX Inc., received the authorisations last month.
“As we head into the fall season and transition into 2024, we strongly encourage those who are eligible to consider receiving an updated COVID-19 vaccine to provide better protection against currently circulating variants,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.
The FDA evaluated manufacturing data to support the change to the 2023-2024 formula of the Novavax Covid-19 Vaccine, adjuvanted.
The agency relied on its evaluation of safety and effectiveness data from clinical trials of Novavax Covid-19, vaccine, adjuvanted and investigational monovalent and bivalent Novavax COVID-19 adjuvanted vaccines, as well as postmarketing data.
Protection
“The data accrued with these Novavax Covid-19 vaccines are relevant to Novavax Covid-19 Vaccine, adjuvanted (2023-2024 Formula) as the vaccines are manufactured using a similar process,” according to the FDA. The manufacturing processes, used in previous formulations, suggest that the vaccines are a good match for protecting against the currently circulating COVID-19 variants.
“COVID-19 is once again on the rise with infections and hospitalizations increasing, so it’s important that individuals get vaccinated to protect themselves…,” said John C. Jacobs, President and Chief Executive Officer, Novavax. “Novavax’s authorization today means people will now have the choice of a protein-based non-MRNA option to help protect themselves against COVID-19, which is now the fourth leading cause of death in the US.”
The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product — unless the declaration is terminated or authorization revoked sooner, according to a statement from Novavax.
The death toll from the Covid-19 virus has neared seven million globally, according to the WHO.
