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The 20-valent pneumococcal conjugate vaccine candidate 20vPnC from Pfizer (NYSE:PFE) was evaluated in a major EU Phase 3 research for the treatment of pneumonia, acute otitis media, and invasive pneumococcal disease (IPD) (inflammation of the middle ear). This will be interesting as we look at the PFE stock price target for the day. 

The 20vPnC pediatric vaccine candidate is intended to provide protection against seven additional serotypes that cause invasive pneumococcal disease globally, in addition to the 13 serotypes that are presently present in Pfizer’s (NYSE:PFE) Prevnar 13 vaccine.

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Based on immunological responses one month after the second and third doses of the three-dose vaccine regimen, the study assessed three coprimary outcomes and compared it to Prevenar 13 in this regard. One month after receiving doses 3 and 2, respectively, 19 serotypes and 16 serotypes, respectively, achieved the non-inferiority (NI) coprimary objective of immunoglobulin G (IgG) geometric mean concentrations (GMCs).

The third NI coprimary goal of the proportion of individuals with predetermined serotype-specific IgG concentrations was fulfilled one month after Dose 2 by nine of the 20 serotypes. It was discovered that 20vPnC’s safety profile with this vaccination schedule was comparable to Prevenar 13.

PFE intends to submit the results to the European Medicines Agency by the end of 2022 in order to request regional regulatory approval for the vaccine.

With regards to the 20vPnC Phase 3 Pediatric Program

Pfizer (NYSE:PFE) began the Phase 3 clinical research program for the pediatric use of 20vPnC in 2020. To increase our understanding of the safety, tolerability, and immunogenicity of 20vPnC, we will conduct four core pediatric Phase 3 investigations. Approximately 4,700 infants, 800 toddlers, and kids of all ages participated in these investigations, which included:

• A Phase 3 research comparing the immunogenicity of 20vPnC to Prevenar 13® in infants immunized at 2, 4, 6, and 12 to 15 months of age in the United States (NCT04382326)
• A Phase 3 trial evaluating the safety and tolerability of 20vPnC, using Prevenar 13® as the control in infants immunized at 2, 4, 6, and 12–15 months of age in several nations. (NCT04379713)
• Vaccination of infants in Europe and Australia at about 2, 4, and 11–12 months old in a Phase 3 study comparing the immunogenicity of 20vPnC to Prevenar 13®. (NCT04546425)
• A single dosage of 20vPnC was administered to children aged 15 months to 18 years in a Phase 3 study in the United States.

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