Novavax (NVAX) finally nabs Covid-19 vaccine EUA

a. 6/22:  vol 6.7M; 2, 4, 5, 10, 11, 52, 95

b.  7/1: vol 6.4M; 12, 23, 60, 67, 82, 83

 

 

 

 

Novavax confirms that its COVID-19 vaccine has received EUA from the FDA

• Co announces that the Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373) has received EUA from the FDA to provide a two-dose primary series for active immunization.
• "Today's FDA emergency use authorization of our COVID-19 vaccine provides the U.S. with access to the first protein-based COVID-19 vaccine."
• The FDA EUA was based on data from the pivotal Phase 3 clinical trial, PREVENT-19, which enrolled approximately 30,000 participants.

In the U.S., the fact sheet accompanying the vaccine warns of a heightened risk of inflammation of the heart and tissues surrounding it following administration. That's in line with the same sheets for Pfizer's (PFE) and Moderna's (MRNA) Covid vaccines. On Thursday, regulators in Europe added a warning against the risk of severe allergic reaction to the Novavax shot.

Still, experts hope adding a third vaccine technology to the U.S. coffers will help bolster the number of people vaccinated against Covid. Novavax's jab uses a protein-based technology and a tree bark chemical from Chile to boost the immune response. Pfizer and Moderna use newer messenger RNA platforms. Johnson & Johnson (JNJ) employs an empty virus to deliver its single-shot vaccine.

NVAX Stock: Small Portion Of Unvaccinated People

Novavax is late to the market, however. Pfizer and Moderna won FDA authorization in December 2020 and J&J followed in February 2021. Further, the company tested its vaccine before the emergence of the delta and omicron variants.

Novavax has global authorizations, including in younger people, but in the U.S. it will only be allowed in adults who have yet to receive a Covid shot. The Centers for Disease Control and Prevention estimates that group accounts for just 10% of people in the country.