Following a long-awaited submission of information to the Food 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 within the United States.
If greenlighted by the FDA, Novavax’s pictures could be the primary COVID-19 doses accessible within the U.S. primarily based on a type of “protein subunit” know-how that has been used for decades in different routine vaccinations. Officials say having this selection could assist persuade some remaining vaccine holdouts to get the pictures, in addition to enhance the Biden administration’s worldwide vaccine donation targets.
“We believe our vaccine offers a differentiated option built on a well-understood protein-based vaccine platform that can be an alternative to the portfolio of available vaccines to help fight the COVID-19 pandemic,” Novavax’s president and CEO Stanley Erck stated in a statement asserting the submission.
Novavax’s vaccine could be for folks aged 18 and over. But the share of American adults left to vaccinate is shrinking. Close to 90% of U.S. adults have already got a minimum of one dose of COVID-19 vaccine, according to the Centers for Disease Control and Prevention.
The overwhelming majority had been vaccinated with the mRNA-based vaccines developed by Moderna or Pfizer and BioNTech, which have confirmed secure and efficient at curbing COVID-19 cases and deaths in hundreds of thousands of Americans.
However, federal well being officers have lengthy stated that protein-based vaccines would possibly nonetheless have a path to authorization, within the hopes of persuading holdouts unwilling or unable to obtain the mRNA pictures.
“There are some people in the United States who still will not take our mRNA vaccines and they are waiting for a protein-based vaccine. And for us, anything we can do to help get a larger portion of our population vaccinated is something that we need to do,” Dr. Peter Marks, the FDA’s prime vaccines official, stated at a convention last year.
A spokesperson didn’t touch upon whether or not the FDA would convene a meeting of its outdoors vaccine consultants, the Vaccines and Related Biological Products Advisory Committee, earlier than deciding whether or not to authorize Novavax’s pictures, because it did for the Pfizer-BioNTech, Moderna, and Johnson & Johnson vaccines.
Both the FDA and the Centers for Disease Control and Prevention should log off 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 Speed early within the pandemic, two — Novavax’s pictures in addition to one other developed by Sanofi Pasteur and GlaxoSmithKline — are protein-based.
Unlike conventional vaccines, which depend on injecting a dose of your complete disabled or weakened virus, scientists growing protein subunit vaccines pick solely particular fragments of the virus to set off an immune response. The technique has been used for years in vaccines in opposition to hepatitis B, pertussis (whooping cough) and different illnesses.
Protein vaccines like Novavax’s doses are additionally mixed with components known as adjuvants that may stimulate the physique to coach a higher immune response.
This is totally different from the mRNA vaccines or Johnson & Johnson’s Janssen “viral vector” vaccine, which work by getting a few of the physique’s cells to supply a innocent portion of SARS-CoV-2, the virus that causes COVID-19, with a view to set off an immune response.
Novavax’s shot has already gained regulatory approvals in a number of international locations around the globe, together with Australia and South Korea this month. The vaccine has additionally been greenlighted by the World Health Organization, manufactured by websites in Europe and India.
The company has touted outcomes exhibiting the vaccine was secure and efficient at curbing infections — round 90% general — 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 in opposition to the Omicron variant, citing data from booster and adolescent research.
However, the company’s submission comes later than initially hoped for. Last May, Novavax informed buyers it anticipated to file for the FDA’s authorization “in the third quarter of 2021.” Over the summer time, the company disclosed the Biden administration had paused funding for Novavax’s manufacturing till it could strike an settlement with the FDA over “analytic methods” for its vaccine.
The company accomplished submitting its remaining information on its manufacturing efforts to the FDA on the end of December.
Beyond its potential use in vaccinating Americans, State Department officers say they’ve pushed for scaling up Novavax’s manufacturing in hopes of meeting targets for vaccine donations overseas.
“Novavax is another big, big variable at this point, and I think if Novavax comes through fairly soon, that will be wonderful and that will be a big help because they’re a major part of the COVAX portfolio,” Jeremy Konyndyk, head of the U.S. Agency for International Development’s COVID-19 job pressure, informed reporters in October.
CBS News reporter protecting public well being and the pandemic.