Following a long-awaited submission of information to the Meals and Drug Administration final month, Novavax introduced Monday that it had formally filed a request for emergency use authorization of its protein-based COVID-19 vaccine in america.
If greenlighted by the FDA, Novavax's photographs may very well be the primary COVID-19 doses accessible within the U.S. primarily based on a sort of "protein subunit" expertise that has been used for many years in different routine vaccinations. Officers say having this feature may assist persuade some remaining vaccine holdouts to get the photographs, in addition to enhance the Biden administration's worldwide vaccine donation targets.
"We consider our vaccine affords a differentiated possibility constructed on a well-understood protein-based vaccine platform that may be an alternative choice to the portfolio of obtainable vaccines to assist battle the COVID-19 pandemic," Novavax's president and CEO Stanley Erck stated in an announcement saying the submission.
Novavax's vaccine could be for folks aged 18 and over. However the share of American adults left to vaccinate is shrinking. Near 90% of U.S. adults have already got at the very least one dose of COVID-19 vaccine, in response to the Facilities for Illness Management and Prevention.
The overwhelming majority had been vaccinated with the mRNA-based vaccines developed by Moderna or Pfizer and BioNTech, which have confirmed protected and efficient at curbing COVID-19 circumstances and deaths in hundreds of thousands of Individuals.
Nonetheless, federal well being officers have lengthy stated that protein-based vaccines may nonetheless have a path to authorization, within the hopes of persuading holdouts unwilling or unable to obtain the mRNA photographs.
"There are some folks in america who nonetheless won't take our mRNA vaccines and they're ready for a protein-based vaccine. And for us, something we are able to do to assist get a bigger portion of our inhabitants vaccinated is one thing that we have to do," Dr. Peter Marks, the FDA's high vaccines official, stated at a convention final yr.
A spokesperson didn't touch upon whether or not the FDA would convene a gathering of its outdoors vaccine specialists, the Vaccines and Associated Organic Merchandise Advisory Committee, earlier than deciding whether or not to authorize Novavax's photographs, because it did for the Pfizer-BioNTech, Moderna, and Johnson & Johnson vaccines.
Each the FDA and the Facilities for Illness Management and Prevention should log out on Novavax's COVID-19 vaccine earlier than the primary doses will be rolled out.
Of the portfolio of vaccines whose growth was backed by the Trump administration's Operation Warp Velocity early within the pandemic, two — Novavax's photographs in addition to one other developed by Sanofi Pasteur and GlaxoSmithKline — are protein-based.
Not like conventional vaccines, which depend on injecting a dose of the whole disabled or weakened virus, scientists growing protein subunit vaccines select solely particular fragments of the virus to set off an immune response. The approach has been used for years in vaccines towards hepatitis B, pertussis (whooping cough) and different ailments.
Protein vaccines like Novavax's doses are additionally mixed with elements referred to as adjuvants that may stimulate the physique to coach a greater immune response.
That is totally different from the mRNA vaccines or Johnson & Johnson's Janssen "viral vector" vaccine, which work by getting among the physique's cells to provide a innocent portion of SARS-CoV-2, the virus that causes COVID-19, in an effort to set off an immune response.
Novavax's shot has already received regulatory approvals in a number of nations world wide, together with Australia and South Korea this month. The vaccine has additionally been greenlighted by the World Well being Group, manufactured by websites in Europe and India.
The corporate has touted outcomes displaying the vaccine was protected and efficient at curbing infections — round 90% total — in printed findings of medical trials of its doses in North America and the United Kingdom earlier within the pandemic. Novavax additionally says its vaccine ought to work towards the Omicron variant, citing information from booster and adolescent research.
Nonetheless, the corporate's submission comes later than initially hoped for. Final Might, Novavax informed traders it anticipated to file for the FDA's authorization "within the third quarter of 2021." Over the summer season, the corporate disclosed the Biden administration had paused funding for Novavax's manufacturing till it may strike an settlement with the FDA over "analytic strategies" for its vaccine.
The corporate accomplished submitting its remaining information on its manufacturing efforts to the FDA on the finish of December.
Past its potential use in vaccinating Individuals, State Division officers say they've pushed for scaling up Novavax's manufacturing in hopes of assembly targets for vaccine donations overseas.
"Novavax is one other large, large variable at this level, and I believe if Novavax comes by pretty quickly, that shall be fantastic and that shall be a giant assist as a result of they are a main a part of the COVAX portfolio," Jeremy Konyndyk, head of the U.S. Company for Worldwide Improvement's COVID-19 process power, informed reporters in October.