Moderna’s Bid For Second COVID Vaccine Booster Spans Broader Age Group Than Pfizer/BioNTech

US FDA advisory committee will meet in April to discuss whether and when boosters may be needed and for whom; Moderna seeks authorization for second booster dose in everyone ≥18 years, while Pfizer/BioNTech have limited their request to individuals ≥65 years.

Paint brushes
Moderna is using broad brush strokes in its bid for authorization of a second booster dose, compared to Pfizer/BioNTech's narrower request. • Source: Alamy

Moderna, Inc.’s request for US emergency use authorization of a second COVID-19 vaccine booster shot in the general adult population marks the company’s first bid to move past rivals Pfizer Inc./BioNTech SE in breadth of indication for the competing mRNA products.

On 17 March, Moderna announced it had submitted a request to the Food and Drug Administration for an additional booster dose of mRNA-1273 in adults ≥18 years who have received an

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Vaccines

Legal, Process Problems May Plague New US FDA COVID-19 Vaccine Policy

 

The FDA may have violated laws and regulations along with many norms in how it released its planned changes for COVID-19 vaccine approvals.

Observational, Retrospective Trials Could Retest Vaccines, HHS’ Kennedy Says

 

The Health and Human Services secretary told a Senate appropriations subcommittee that placebo-controlled trials may not be necessary to ensure vaccine safety as the FDA released a framework requiring them for COVID-19 vaccines.

Novavax’s COVID-19 Vaccine Label Narrowed After Political Officials Intervened

 

The label that Novavax's COVID-19 vaccine was slated to receive before political officials held up the approval was broader than was granted 16 May.

US FDA COVID-19 Booster Strategy May Not Be As Controversial As It Seems

 

US FDA Commissioner Martin Makary’s call for placebo-controlled trials to confirm the efficacy of COVID-19 boosters is drawing a lot of criticism, but former Commissioner Robert Califf also supported the idea.

More from Pink Sheet

Darzalex Faspro Gains US FDA AdComm Support For Smoldering Myeloma Claim

 

The use of J&J’s Darzalex Faspro in high-risk smoldering multiple myeloma could result in overtreatment, but the FDA committee voted in favor of the new claim for delay in development of multiple myeloma.

STARGLO Dulled: Genentech’s Columvi Data Not Generalizable To US Patients, FDA Panel Says

 
• By 

The glofitamab trial results are not generalizable due to the small number of enrolled US lymphoma patients and adverse results across multiple endpoints for patients from non-Asian regions, the Oncologic Drugs Advisory Committee said.

Legal, Process Problems May Plague New US FDA COVID-19 Vaccine Policy

 

The FDA may have violated laws and regulations along with many norms in how it released its planned changes for COVID-19 vaccine approvals.