Drug Discovery and Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Women in Pharma and Biotech
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • Resources
    • Video features
    • Podcast
    • Voices
    • Views
    • Webinars
  • Pharma 50
    • 2025 Pharma 50
    • 2024 Pharma 50
    • 2023 Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50
  • Advertise
  • SUBSCRIBE

Pfizer shares positive top-line data from Phase 3 study of pneumococcal vaccine

By Brian Buntz | August 12, 2022

Pfizer logoPfizer (NYSE:PFE) said it is planning on filing a supplemental Biologics License Applications (sBLA) for its 20-valent pneumococcal conjugate vaccine candidate in infants by the end of the year.

After announcing positive data from a pivotal U.S. Phase 3 study (NCT04382326), the company said the 20vPnC vaccine candidate, if approved, would offer the broadest serotype coverage of any pneumococcal vaccine in infants.

PFE shares ticked up 3.69% to $50.08 in afternoon trading.

The 20vPnC vaccine candidate would protect against pneumococcal disease (IPD) resulting from 20 Streptococcus pneumoniae (pneumococcus) serotypes.

FDA approved the 20-valent conjugate vaccine for adults 18 and older last year. The vaccine for that demographic is known as Prevnar 20.

Earlier this year, FDA approved Merck’s (NYSE:MRK) Vaxneuvance pneumococcal 15-valent conjugate vaccine for infants and children.

In Pfizer’s Phase 3 study, the 20vPnC yielded strong immune responses for all 20 serotypes.

In addition, the vaccine candidate was statistically non-inferior for the co-primary objective after four doses.

Pfizer also noted that the safety and tolerability profile of 20vPnC was in line with Prevnar 13 vaccine, which won FDA approval for children and infants in 2010.

Prevnar 13 succeeded Prevnar, a pneumococcal 7-valent conjugate vaccine that won approval in 2000.

The Phase 3 study for the 20vPnC vaccine candidate had two co-primary objectives related to the immunogenicity responses one month after the third and fourth doses of the four-dose vaccination series.

Pfizer noted that 14 of the 20 serotypes met the co-primary objective of non-inferiority of the percentage of participants with predefined IgG levels after Dose 3. Of the remaining six, four serotypes narrowly missed or two missed by a wider margin.

Pfizer noted in a news release that it finds the data encouraging. If 20vPnC wins FDA approval, it has “the potential to cover more of the clinically significant remaining burden of infant pneumococcal disease than any other available pneumococcal conjugate vaccine,” noted Annaliesa Anderson, Pfizer’s senior vice president and chief scientific officer, vaccine research and development.

Pfizer won breakthrough therapy designation for 20vPnC in August 2020 and Fast Track designation for pediatric use in May 2017.

The FDA previously granted Fast Track Designation for 20vPnC in May 2017 for the pediatric indication.

Merck is also developing a 21-valent pneumococcal conjugate vaccine.

Last year, the Prevnar family of vaccines brought in $5.3 billion in revenue.


Filed Under: Infectious Disease
Tagged With: Pfizer, pneumococcal vaccine
 

About The Author

Brian Buntz

As the pharma and biotech editor at WTWH Media, Brian has almost two decades of experience in B2B media, with a focus on healthcare and technology. While he has long maintained a keen interest in AI, more recently Brian has made making data analysis a central focus, and is exploring tools ranging from NLP and clustering to predictive analytics.

Throughout his 18-year tenure, Brian has covered an array of life science topics, including clinical trials, medical devices, and drug discovery and development. Prior to WTWH, he held the title of content director at Informa, where he focused on topics such as connected devices, cybersecurity, AI and Industry 4.0. A dedicated decade at UBM saw Brian providing in-depth coverage of the medical device sector. Engage with Brian on LinkedIn or drop him an email at bbuntz@wtwhmedia.com.

Related Articles Read More >

Close-up medical syringe with a vaccine.
Six leading medical organizations sue RFK Jr. over vaccine recommendations
RFK’s new ACIP changed longstanding vaccine recommendations
Secretary of Health removes all current members of the CDC advisory committee on immunization practices
covid-19 vaccine
FDA COVID booster pullback jolts vaccine stocks before gains cool
“ddd
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news and trends happening now in the drug discovery and development industry.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Drug Discovery and Development
  • MassDevice
  • DeviceTalks
  • Medtech100 Index
  • Medical Design Sourcing
  • Medical Design & Outsourcing
  • Medical Tubing + Extrusion
  • Subscribe to our E-Newsletter
  • Contact Us
  • About Us
  • R&D World
  • Drug Delivery Business News
  • Pharmaceutical Processing World

Copyright © 2025 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Drug Discovery & Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Women in Pharma and Biotech
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • Resources
    • Video features
    • Podcast
    • Voices
    • Views
    • Webinars
  • Pharma 50
    • 2025 Pharma 50
    • 2024 Pharma 50
    • 2023 Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50
  • Advertise
  • SUBSCRIBE