J&J COVID Vaccine: Single-Dose Format Will ‘Expedite’ Phase III Trial

Effectiveness can be evaluated more quickly because researchers won’t have to wait for the second dose, company executive notes during briefing on the launch of the Phase III study.

Doctor, nurse, scientist hand in blue gloves holding flu, measles, coronavirus, covid-19 vaccine disease preparing for child, baby, adult, man and woman vaccination shot, medicine and drug concept.
J&J Vaccine Enters Phase III

Johnson & Johnson’s Phase III trial on its investigational vaccine for COVID-19 can proceed on a faster schedule then the other three COVID vaccines currently in Phase III because its single dose regimen will allow for quicker efficacy assessments, J&J chief scientific officer Paul Stoffels pointed out during a media briefing 22 September.

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

Moderna Pivots To Increase Focus On Cancer Amid US Vaccine Policy Changes

 
• By 

During its first quarter earnings call, Moderna avoided criticizing vaccine policy changes, but de-emphasized its flu/COVID-19 vaccine for those under age 50 and prioritized cancer programs.

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.

More from Pink Sheet

Pink Sheet Podcast: Vaccine Review Political Interference, Missed Deadlines A Harbinger Of US FDA Problems?

Pink Sheet reporter and editors discuss FDA Commissioner Martin Makary’s decision to have one of his assistants lead negotiations for Novavax’s delayed COVID-19 vaccine review, as well as some recent missed review deadlines, which may be the result of recent FDA cuts.

Switzerland Simplifies Imports Of Unauthorized Drugs To Tackle Drug Shortages

 

Swiss authorities have introduced temporary measures that will make it easier for health care professionals to import medicines that are either not authorized or not available in Switzerland, which will particularly benefit pediatric drugs, in light of ongoing shortages.

EU ‘Can’t Expect Industry To Give Up Proprietary Insights’ Under Health Data & Clinical Trials Regulations

 

Both the EU Clinical Trials Regulation and the European Health Data Space Regulation have the potential to improve harmonization and be highly valuable for industry – but the importance of protecting company data will be paramount, a life sciences consultant says.