A Centers for Disease Control and Prevention advisory committee recommended approving Novavax’s Covid-19 vaccine for adults on Tuesday, one week after the protein-based vaccine received emergency authorization from the Food and Drug Administration, as the United States contenders with a fast-moving new coronavirus strain.
The CDC Advisory Committee on Immunization Practices’ unanimously recommendation now heads to CDC Director Rochelle Walensky for final approval, possibly setting the stage for Novavax to become the fourth vaccine available for Americans, along with Pfizer/BioNTech, Moderna and Johnson & Johnson.
Like the FDA‘s emergency use authorization, the CDC did not recommend using the vaccine as a booster shot, which could limit its use in the US, where nearly four out of five people have received at least one dose, according to CDC data,
The committee determined the vaccine’s 90% efficacy rate in trials outweighs concerns raised by the FDA last month of potential heart inflammation associated with the shot.
The Novavax vaccine repeatedly performed well in early trials, but has faced manufacturing issues over its two-year development. In a trial Conducted in the US and Mexico, the vaccine proved to be 90.4% effective in preventing mild, moderate or severe infections, with no cases of moderate or severe Covid-19 reported among the 17,200 trial participants who received it. For adults 65 and older, the vaccine was 78.6% effective. Another study in February found an 82.7% rate over a six-month period when used as a booster, although testing was conducted before omicron became the dominant variant. Last month, however, Novavax shares fell roughly 20% after the FDA raised concerns over a potential risk of heart inflammation, and nearly a year after it failed to meet the FDA's quality standards in its production process. The Maryland-based pharmaceutical company hopes the vaccine, which uses a small "spike protein" to trigger an immune system response—a similar structure to long-used vaccines for the flu, hepatitis B and shingles—could convince Americans skeptical of mRNA-based vaccines like Pfizer/BioNTech and Moderna to get vaccinated. Roughly 10.2% of US adults have not received a single vaccine dose, according to data from the CDC.
3.2 million. That's how many Novavax vaccines the Biden Administration secured last week. In a statementthe administration said it would release the doses once the pharmaceutical company completes testing, which the federal government expects to happen in the coming weeks.
Novavax has already been authorized for use in more than 40 countriesincluding Australia, Canada and the United Kingdom, and it received authorization from the European Union and the World Health Organization.
Some 77% of unvaccinated adults said they would not get a protein-based Covid-19 shot if one were authorized in the US, according to a Morning Consult poll released last month, but unvaccinated adults are more likely to trust the safety of protein-based vaccines (28%) than mRNA shots (17%).
What To Watch For
Novavax could enter the US vaccine arsenal as the country contends with a new dominant coronavirus strain. Earlier this month, the highly transmissible BA.5 omicron subvariant became the dominant strain. The subvariant accounted for nearly 80% of Covid-19 infections nationwide last week, up from 29% in the week ending June 18, according to the CDC,
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