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Another CoVid Vaccine On The Horizon
Vidcast: https://youtu.be/vb-exoJeCoY
Novavax has submitted its long-awaited application for an Emergency Use Authorization to the FDA. This product that combines purified CoVid spike protein with nanoparticles has the distinct advantage that it only requires refrigeration and storage at temperatures between 36 and 46 degrees Fahrenheit.
As now reported in the New England Journal of Medicine, 29,949 adults in the US and Mexico were randomized in a Phase 3 trial so that twice as many received 2 doses of the vaccine (5 ug of protein antigen and 50 ug of the nanoparticle + Matrix-M adjuvant) 3 weeks apart as received the control placebo vaccination containing no spike protein.
The study data showed that Novavax CoVid was 90% effective at preventing any infection and 100% effective at preventing moderate to severe infection. Reactions to the vaccine were mild to moderate and transient though more notable after the second than after the first dose.
The catch-22 here is that this vaccine was tested during 7 weeks at the beginning of 2021 when the original strain was predominant and when the only variant was the so called Alpha British strain. Furthermore, the median age of study participants was 47 and only 2.6% were 65 years or older. We have no data on the long-tern protection beyond 3.5 months afforded by this vaccine, and it has never been tested against the more challenging variants including Delta and Omicron.
This vaccine was created using spike protein antigens similar to those used in the mRNA vaccines from Pfizer and Moderna. We would hope that this vaccine has the same or better performance against the variants as those, but we simply have no data to prove or disprove it.
Again, the Novavax advantage is that it may be stored and transported at refrigerator temperatures rather than at extreme sub-zero temps.
https://ir.novavax.com/2022-01-31-Novavax-Submits-Request-to-the-U-S-FDA-for-Emergency-Use-Authorization-of-COVID-19-Vaccine
https://www.nejm.org/doi/full/10.1056/NEJMoa2116185
#CoVid #vaccine #storage #stability
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By Howard G. Smith MD, AM
Vidcast: https://youtu.be/vb-exoJeCoY
Novavax has submitted its long-awaited application for an Emergency Use Authorization to the FDA. This product that combines purified CoVid spike protein with nanoparticles has the distinct advantage that it only requires refrigeration and storage at temperatures between 36 and 46 degrees Fahrenheit.
As now reported in the New England Journal of Medicine, 29,949 adults in the US and Mexico were randomized in a Phase 3 trial so that twice as many received 2 doses of the vaccine (5 ug of protein antigen and 50 ug of the nanoparticle + Matrix-M adjuvant) 3 weeks apart as received the control placebo vaccination containing no spike protein.
The study data showed that Novavax CoVid was 90% effective at preventing any infection and 100% effective at preventing moderate to severe infection. Reactions to the vaccine were mild to moderate and transient though more notable after the second than after the first dose.
The catch-22 here is that this vaccine was tested during 7 weeks at the beginning of 2021 when the original strain was predominant and when the only variant was the so called Alpha British strain. Furthermore, the median age of study participants was 47 and only 2.6% were 65 years or older. We have no data on the long-tern protection beyond 3.5 months afforded by this vaccine, and it has never been tested against the more challenging variants including Delta and Omicron.
This vaccine was created using spike protein antigens similar to those used in the mRNA vaccines from Pfizer and Moderna. We would hope that this vaccine has the same or better performance against the variants as those, but we simply have no data to prove or disprove it.
Again, the Novavax advantage is that it may be stored and transported at refrigerator temperatures rather than at extreme sub-zero temps.
https://ir.novavax.com/2022-01-31-Novavax-Submits-Request-to-the-U-S-FDA-for-Emergency-Use-Authorization-of-COVID-19-Vaccine
https://www.nejm.org/doi/full/10.1056/NEJMoa2116185
#CoVid #vaccine #storage #stability