Moderna's Covid-19 Booster Shots Receive FDA Approval with Restricted Eligibility.

The FDA has approved new Covid-19 booster shots from Moderna, Pfizer, and Novavax, but with restricted eligibility. Analysts predict significant potential upside for Moderna Inc (MRNA) despite a "Hold" consensus recommendation. GuruFocus estimates indicate potential downside for Moderna's fair value compared to its current market price.

The U.S. Food and Drug Administration (FDA) has approved updated Covid-19 vaccines from Moderna, Pfizer, and Novavax, targeting strains related to the JN.1 variant. The new vaccines will be available primarily to people 65 and older and those with underlying health conditions that increase their risk from Covid-19. Other individuals over 6 months old can still receive the vaccines with a doctor’s approval [1].

The FDA's decision follows actions by Health and Human Services Secretary Robert F. Kennedy Jr., who earlier this year pledged to end Covid vaccine mandates while keeping vaccines available for vulnerable populations. Kennedy stated that the FDA’s actions accomplished his four goals: ending Covid vaccine mandates, keeping vaccines available for those who want them (especially vulnerable people), demanding placebo-controlled trials from companies, and ending the emergency [1].

The FDA approved updated formulations from Moderna, Pfizer, and Novavax. Moderna announced that its Spikevax is approved for individuals 6 months through 64 years with high-risk conditions and all adults 65 and older. The company’s mNEXSPIKE vaccine received approval for high-risk individuals aged 12 through 64 and all adults 65 and older [1].

Moderna CEO Stéphane Bancel emphasized the importance of protecting vulnerable populations, noting that "COVID-19 was responsible for up to 4 million outpatient visits and nearly half a million hospitalizations last year" [1].

Shares of vaccine manufacturers Moderna (NASDAQ:MRNA), Pfizer (NYSE:PFE), and Novavax (NASDAQ:NVAX) were little changed following the announcement [1].

Analysts predict significant potential upside for Moderna Inc (MRNA) despite a "Hold" consensus recommendation. GuruFocus estimates indicate potential downside for Moderna's fair value compared to its current market price [2].

References:
[1] https://www.investing.com/news/stock-market-news/fda-approves-updated-covid-vaccines-with-restricted-eligibility-93CH-4213193
[2] https://www.stocktitan.net/news/MRNA/moderna-receives-u-s-fda-approval-for-updated-covid-19-vaccines-9pajif1adv8r.html