The U.S. Food and Drug Administration has announced significant changes to COVID-19 vaccine requirements, limiting annual booster approvals to older and high-risk Americans while implementing stricter clinical trial requirements for healthy adults.
The agency plans to demand stronger evidence of efficacy for the shots before approval is granted for healthy persons, between the ages of six months and 64 years, with no risk factors for severe COVID-19 infection.
U.S. stock futures were slightly lower on Tuesday after ending largely flat on Monday. Futures of major benchmark indices were trading lower in premarket.
U.S. stocks trimmed early-session losses by midday Monday, as investors showed limited concern after Moody's downgraded U.S. sovereign credit from Aaa to Aa1, effectively stripping the world's largest economy of its last top-tier credit rating.
Novavax CEO John C. Jacobs called the approval a “significant milestone” as the company seeks to make its protein-based COVID-19 vaccine commercially available.
The U.S. Food and Drug Administration has granted limited approval to Novavax Inc.'s COVID-19 vaccine, restricting its use to people 65 and older and those 12 and up with underlying health conditions that increase risk of severe illness.
The pharma company secured FDA clearance to manufacture and distribute its COVID-19 vaccine Nuvaxovid for adults and at-risk groups, with no advisory committee hurdles.
Novavax posts $667 million in Q1 2025 revenue and $2.93 EPS, boosted by Sanofi payments and APA terminations; full-year outlook raised above expectations.
The company raised its full-year revenue guidance to between $975 million and $1.025 billion, up from its previous guidance of between $300 million and $350 million.
