Last month, Novavax submitted a long-awaited data to the Food and Drug Administration, requesting that its protein-based COVID-19 vaccine in the United States be approved for emergency use.
Assuming the FDA approves Novavax’s shots soon, COVID-19 can then be administered in the United States using a type of “protein subunit” technology already in use in some routine vaccinations, CBS News reported.
In addition to helping some vaccine holdouts get shots, this option could boost the Biden administration’s goal of donating vaccines internationally.
“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,” said Stanley Erck, president and CEO of Novavax.
People aged 18 and over are eligible to receive Novavax’s vaccine.
However, the number of American adults still vaccinated is low.
According to the Centers for Disease Control and Prevention, about 90% of U.S. adults have received only one dose of the COVID-19 vaccine.
In most cases, people were vaccinated with mRNA-based vaccines developed by Moderna, Pfizer, and BioNTech, for which millions of Americans have been vaccinated safely and successfully.
However, officials from the government have long suggested that protein-based vaccines might still have a path to authorization in order to convince holdouts who are unwilling to take the mRNA shots.
“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,” said FDA vaccines official Dr. Peter Marks last year.
The FDA representative declined to comment on whether it will convene an advisory committee made up of vaccine experts before deciding whether to approve Novavax’s shots. A similar process was used for Pfizer-BioNTech, Moderna, and Johnson & Johnson vaccines.
Meanwhile, before the first doses of Novavax’s COVID-19 vaccine can be rolled out, it needs approval from both the FDA and the CDC.
Early in the pandemic, Operation Warp Speed supported the development of two protein-based vaccines.
Scientists can create protein subunit vaccines that trigger an immune response without injecting the entire virus, while traditional vaccines rely on injecting an entire virus with diminished or weakened function.
The technique has been used for years in vaccines against hepatitis B, pertussis (whooping cough) and other diseases.
In addition to the protein vaccines, Novavax’s doses contain adjuvants that are capable of stimulating the body to respond better to the vaccine.
Unlike the mRNA vaccines or the Janssen “viral vector” vaccine developed by Johnson & Johnson, this vaccine works by tricking the body into creating harmless versions of the SARS-CoV-2 virus that causes COVID-19, in order to trigger an immune response.
Several countries have already approved Novavax’s shot, including Australia and South Korea this month. The WHO has also approved the vaccine, which is produced in Europe and India.
The vaccine was found to be safe and effective in clinical trials conducted in North America and the United Kingdom earlier in the pandemic, with an overall infection rate of around 90%.
Data from booster and adolescent studies indicate that Novavax’s vaccine should work against the Omicron variant as well.
It is disappointing, however, that the vaccine was submitted so late. Over the summer, Novavax earlier disclosed the Biden administration had halted funding for the manufacturer’s manufacturing until an agreement could be reached with the FDA over “analytic methods”.
End of December, the company submitted its final manufacturing data to the FDA.
Officials from the State Department have pushed for Novavax to scale up its production in order to meet vaccination goals abroad, in addition to potentially vaccinating Americans.
“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. Development Department’s COVID-19 task force, explained in October.