Fast-Track Emergency Use Approval of the NOVAVAX NVX-CoV2373 COVID-19 Vaccine

The Issue

If we want to end the COVID-19 pandemic, we must make more vaccine types available. We cannot simply push the current vaccine options over and over again, as some cannot, due to allergy or autoimmune disease or other recommendations made by a medical professional, take the current available vaccines. Others are unwilling to take the medical risks of new mRNA technologies or simply want to take a vaccine that uses a more traditional protein subunit form. 

Novavax is this vaccine. In Phase 3 trials, it was proven safe and effective: https://www.nejm.org/doi/full/10.1056/NEJMoa2107659

"A two-dose regimen of the NVX-CoV2373 vaccine administered to adult participants conferred 89.7% protection against SARS-CoV-2 infection and showed high efficacy against the B.1.1.7 variant. (Funded by Novavax; EudraCT number, 2020-004123-16. opens in new tab.)"

Side effects were also shown to be milder than the mRNA and viral vector vaccines.

Many who are hesistant about or unable to take the current vaccine options will take Novavax the moment it is available. If we want to see vaccine uptake rise, we must fast-track this option to approval immediately. We do not have any time to waste.

7,673

The Issue

If we want to end the COVID-19 pandemic, we must make more vaccine types available. We cannot simply push the current vaccine options over and over again, as some cannot, due to allergy or autoimmune disease or other recommendations made by a medical professional, take the current available vaccines. Others are unwilling to take the medical risks of new mRNA technologies or simply want to take a vaccine that uses a more traditional protein subunit form. 

Novavax is this vaccine. In Phase 3 trials, it was proven safe and effective: https://www.nejm.org/doi/full/10.1056/NEJMoa2107659

"A two-dose regimen of the NVX-CoV2373 vaccine administered to adult participants conferred 89.7% protection against SARS-CoV-2 infection and showed high efficacy against the B.1.1.7 variant. (Funded by Novavax; EudraCT number, 2020-004123-16. opens in new tab.)"

Side effects were also shown to be milder than the mRNA and viral vector vaccines.

Many who are hesistant about or unable to take the current vaccine options will take Novavax the moment it is available. If we want to see vaccine uptake rise, we must fast-track this option to approval immediately. We do not have any time to waste.

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7,673


The Decision Makers

United States Food and Drug Administration
United States Food and Drug Administration
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