Topline
A Facilities for Illness Management and Prevention advisory committee really helpful approving Novavax’s Covid-19 vaccine for adults on Tuesday, one week after the protein-based vaccine acquired emergency authorization from the Meals and Drug Administration, as america contends with a fast-moving new coronavirus pressure.
A CDC advisory committee really helpful the two-shot Novavax Covid-19 vaccine for grownup use as a … [+]
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Key Information
The CDC Advisory Committee on Immunization Practices’ unanimous suggestion now heads to CDC Director Rochelle Walensky for closing approval, probably setting the stage for Novavax to change into the fourth vaccine out there for Individuals, together with Pfizer/BioNTech, Moderna and Johnson & Johnson.
Just like the FDA’s emergency use authorization, the CDC didn’t advocate utilizing the vaccine as a booster shot, which might restrict its use within the U.S., the place almost 4 out of 5 folks have acquired not less than one dose, in line with CDC data.
The committee decided the vaccine’s 90% efficacy fee in trials outweighs issues raised by the FDA final month of potential coronary heart irritation related to the shot.
Key Background
The Novavax vaccine repeatedly carried out nicely in early trials, however has confronted manufacturing points over its two-year growth. In a trial performed within the U.S. and Mexico, the vaccine proved to be 90.4% efficient in stopping gentle, reasonable or extreme infections, with no circumstances of reasonable or extreme Covid-19 reported among the many 17,200 trial contributors who acquired it. For adults 65 and older, the vaccine was 78.6% efficient. One other examine in February discovered an 82.7% fee over a six-month interval when used as a booster, though testing was performed earlier than omicron grew to become the dominant variant. Final month, nevertheless, Novavax shares fell roughly 20% after the FDA raised issues over a possible danger of coronary heart irritation, and almost a 12 months after it failed to fulfill the FDA’s high quality requirements in its manufacturing course of. The Maryland-based pharmaceutical firm hopes the vaccine, which makes use of a small “spike protein” to set off an immune system response—a similar construction to long-used vaccines for the flu, hepatitis B and shingles—might persuade Individuals skeptical of mRNA-based vaccines like Pfizer/BioNTech and Moderna to get vaccinated. Roughly 10.2% of U.S. adults haven’t acquired a single vaccine dose, in line with data from the CDC.
Large Quantity
3.2 million. That’s what number of Novavax vaccines the Biden Administration secured final week. In a statement, the administration mentioned it might launch the doses as soon as the pharmaceutical firm completes testing, which the federal authorities expects to occur within the coming weeks.
Tangent
Novavax has already been approved to be used in more than 40 countries, together with Australia, Canada and the UK, and it acquired authorization from the European Union and the World Well being Group.
Contra
Some 77% of unvaccinated adults mentioned they might not get a protein-based Covid-19 shot if one had been approved within the U.S., in line with a Morning Consult ballot launched final month, however unvaccinated adults usually tend to belief the protection of protein-based vaccines (28%) than mRNA photographs (17%).
What To Watch For
Novavax might enter the U.S. vaccine arsenal because the nation contends with a brand new dominant coronavirus pressure. Earlier this month, the extremely transmissible BA.5 omicron subvariant grew to become the dominant pressure. The subvariant accounted for almost 80% of Covid-19 infections nationwide final week, up from 29% within the week ending June 18, in line with the CDC.
Additional Studying
FDA Authorizes Novavax’s Covid-19 Vaccine For Adults (Forbes)
U.S. Secures 3.2 Million Novavax Covid Vaccines — Providing Different To MRNA Photographs As New Variant Spreads (Forbes)
New Novavax Covid-19 Vaccine: Right here Are 3 Issues Completely different About It (Forbes)
Novavax Inventory Halted Pending FDA Panel Assembly—Right here’s What To Know About The Firm’s Covid Vaccine (Forbes)
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