First African Approvals For Merck’s Ebola Vaccine

A Collaborative Effort Has Secured Rapid Licensing

Regulators have pulled out all the stops in their efforts to get the Ebola vaccine to the marketing authorization stage in Africa. 

Ebola
African countries will soon receive their first doses of licensed Ebola vaccine • Source: Shutterstock

Merck’s Ebola vaccine, Ervebo, has been approved for use in four African countries including the Democratic Republic of Congo, and the first licensed doses are expected to be made available in the third quarter of this year.

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

How States And Courts Could Insulate America From An Anti-Vaccine Executive Branch

 

The mood at the World Vaccines Congress in Washington, D.C. was bleak given Robert F. Kennedy Jr.’s rise to lead the Trump Administration’s Health and Human Services Department, but vaccine lawyers offered an optimistic outlook and ideas for countering his vaccine agenda.

Maybe In May: US FDA Calls Coming On Moderna Next-Gen COVID-19 Vaccine, AbbVie’s Big ADC Bet

 

The 31 May goal date for Moderna’s next-generation COVID-19 vaccine looms over the month, but the US FDA's decision lineup includes three more novel agents, including AbbVie's Teliso-V antibody-drug conjugate, as well as supplemental indications like GSK's bid for Nucala in COPD.

Updated: Makary Backs New Novavax COVID-19 Trial, Political Officials Take Over Product Review

 

In an unusual move, Tracy Beth Høeg, a special assistant to FDA Commissioner Martin Makary, is leading the continued negotiations on Novavax’s delayed COVID-19 vaccine approval.

Postmarketing Surprise Is Latest Plot Twist For Novavax’s COVID-19 Vaccine BLA

 

Three weeks after its user fee goal date, the FDA demanded a postmarketing commitment “to generate additional data,” Novavax said.

More from Pink Sheet

Non-Submissions To UK HTA Body Could Increase Unless Commercial Environment Improves, Warns Industry

 
• By 

Finding ways to lower the rebates paid by the pharmaceutical industry to the UK government and fostering partnerships to make the UK a more attractive launch market could help reduce the number of terminated technology appraisals conducted by NICE, the health technology appraisal institute, says the UK pharmaceutical industry.

Non-Submissions To England’s NICE Surge Across All Disease Areas

 
• By 

Blood cancer therapies were most proportionately impacted by the failure of pharmaceutical companies to submit evidence on their cancer therapies to England’s health technology appraisal body, shows analysis by the Pink Sheet.

PBMs No Longer Profit From Rebates But Plans Benefit; Should Sponsors Push More For Reform?

 
• By 

Employers and other health plan sponsors may need to push for better targeted reforms that lower cost sharing for patients.