Pfizer (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.