News Scan for Aug 15, 2022

Novavax applies for COVID booster EUA as UK approves 2-strain boosterFollowing the Food and Drug Administration (FDA) emergency use authorization (EUA) of the Novavax COVID-19 vaccine last month for the primary vaccine series, the company announced today that it has applied for an EUA for the vaccine to also be used as a booster in adults ages 18 and older.In an announcement today, Novavax said if authorized, the vaccine would be the first protein-based COVID-19 booster for adults.

It said its application covers both heterologous (different-brand) and homologous (same-brand) booster strategies.Stanley Erck, Novavax's president and chief executive officer, said, "It's important for people to have a choice as they evaluate how to stay protected against COVID-19, and boosters are an invaluable tool to build upon immunity obtained from previous vaccinations."A phase 3 study found that the third dose produced robust antibody responses that met or exceeded levels seen in the primary series.

The vaccine also prompted a significant antibody response when used as a heterologous booster.Local and systemic responses lasted about 2 days and showed an increasing incidence across all three doses.

Rare instances of myocarditis, pericarditis, and anaphylaxis have been reported outside of clinical trials, and, earlier this month, the European Medicines Agency recommended that the vaccine maker carry a warning about the two heart conditions.Aug 15 Novavax press releaseIn other vaccine developments, the UK Medicines and Healthcare Products Regulatory Agency today approved Moderna's bivalent (two-strain) booster shot, which covers the original SARS-CoV-2 virus plus the Omicron BA.1 variant.