1. Pink Sheet
  2. >>Vaccines

Next Hurdles For COVID-19 Vaccine Development: Selecting Endpoints, Getting Enough Subjects

 
• By Brenda Sandburg

US FDA's Peter Marks and industry execs discuss challenges in moving candidate vaccines to Phase II/III trials, including international regulatory alignment on clinical endpoints and other issues. J&J's Paul Stoffels says it is going to be a 'Herculean task' to conduct placebo-controlled studies in 30,000 to 100,000 people.

COVID-19 Vaccine. Corona Virus SARS-CoV-2, 2019 nCoV virus destruction. A vaccine against coronavirus disease 2019. Breakthrough in the Creating of a COVID-19 Vaccine.
COVID-19 vaccine candidates face new challenges as they move into Phase 2/3 trials

As COVID-19 vaccine candidates move into pivotal trials, developers and regulators are confronting new challenges, from getting a sufficient number of participants, to determining what will be needed to demonstrate safety and efficacy and how to deal with special populations.

The US FDA's Peter Marks, director of the Center for Biologics Evaluation and Research, and executives from companies developing COVID-19 vaccines discussed these issues at a 9 June plenary session...

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
Start Free Trial

Already a subscriber?

More from Vaccines

US FDA Meeting Drought Ends … With A Vengeance

 
• By Michael McCaughan

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 Sue Sutter

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.

Pink Sheet Podcast: US FDA’s Big Vaccine Policy Week

 
• By Derrick Gingery, Sarah Karlin-Smith, Sue Sutter, and Nielsen Hobbs

Pink Sheet reporter and editors discuss the new clinical trial requirements that the FDA announced for COVID-19 vaccines, the updated label for Novavax’s newly approved COVID-19 vaccine, and other vaccine-related events that were part of a busy week for policy in the sector.

US FDA Punts On New COVID-19 Framework’s Impact On Fall Shots

 
• By Sarah Karlin-Smith

The FDA’s advisors split on whether to update COVID-19 vaccines for the fall. The agency refused to discuss the impact of the new vaccine framework on availability.

More from Pink Sheet

PBM Investigation, Enforcement Action ‘Critical Priorities’ At FTC, Chair Says

 
• By Cathy Kelly

The new FTC chair addressed concerns that staffing cuts will undermine the commission’s commitment to pharmacy benefit manager oversight.

Could EU Collective Procurement Counter US Most Favored Nation Policy?

 
• By Francesca Bruce

Joint procurement, if used by member states to respond to potential pricing and access challenges caused by a US most favored nations pricing policy, would cause more uncertainty for pharmaceutical companies, warn industry representatives.

EMA Says Digital Transformation A ‘Fundamental Shift’ In Meeting Regulatory Challenges

 
• By Eliza Slawther

Sponsors can expect faster evaluation processes for key medicines and greater support in mitigating medicines supply shortages this year as part of the European Medicines Agency’s digital transformation overhaul.