For Recombinants To Approach mRNA Speed, US FDA Urged To Select Monovalent COVID Boosters

US FDA and BARDA ask makers of recombinant protein SARS-CoV-2 vaccines how they could match mRNA vaccines in post-strain-selection turnaround time for annual booster doses. The reply: give them a fighting chance by selecting just one strain instead of two.

vaccine rockets
how recombinant boosters could keep up • Source: Shutterstock

If the US government wants slower options in the COVID-19 vaccine race to play a role with annual boosters now that mRNA vaccines have raised the bar on speed to market, then it should plan on boosting with monovalent vaccines rather than bivalent, several sponsors and independent experts told a 27 April workshop.

There is no downside to such a strategy, they said, because monovalent COVID-19 vaccines are quicker to manufacture and work as well or better than bivalent alternatives.

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

US FDA’s June Approval Forecast: Infection Prevention, Cancer And HAE

 

Upcoming FDA user fee goal dates include novel products from a busy lung cancer pipeline, a single-dose passive immunization against RSV for infants, what could be the first oral HAE acute treatment, and a first-in-class HAE preventive antibody.

Pink Sheet Podcast: US FDA’s Private Pharma CEO Tour, HHS Changes COVID-19 Vaccine Advice

Pink Sheet reporter and editors consider the issues that could emerge during upcoming private FDA forums with pharma CEOs, as well as the impact of the surprising move by HHS Secretary Robert F. Kennedy Jr. to limit the CDC recommendation for annual COVID-19 vaccine boosters.

US FDA Meeting Drought Ends … With A Vengeance

 

The first 100 days of the Trump Administration were notable for an extraordinary decline in the number of public meetings hosted by the US Food and Drug Administration. But the schedule changed quickly.

HHS Rescinds COVID-19 Vaccine Advice, Usurping US CDC Role

 
• By 

By stepping into the role of the Centers for Disease Control and Advisory Committee on Immunization Practices, HHS Secretary Robert F. Kennedy Jr. is causing further confusion and uncertainty about vaccine policy, experts say.

More from Pink Sheet

How Pharma Companies Can Mitigate The Impact Of US Tariffs On The Supply Chain

 
• By 

If US tariffs on pharmaceutical supply chain products come into force they could be disruptive for companies. Ewan Townsend, of the international law firm Arnold & Porter, explains how companies can mitigate issues through negotiating with suppliers and reallocating tariff responsibilities.

‘The Question Is, What’s Going To Happen Next?’ – The Future For Biosimilars In Europe

 
• By 

With European biosimilars developers buoyed by recent regulatory moves, Medicines for Europe’s Isabell Remus and Julie Maréchal-Jamil discuss the next steps forward for the industry.