First the US, now the EU: Pfizer’s 20-valent pneumococcal jab for infants headed to regulators
About five weeks after Pfizer said its 20-valent vaccine follow-up to Prevnar 13 was effective in infants in a US study, the Big Pharma now has the data from an EU late-stage trial that will send the jab to the continent’s regulators by year’s end.
Both the US and European Medicines Agency are expected to have the filings in hand for 20vPnC for infants before the first babies of 2023 are born. The US greenlit the vaccine, known as Prevnar 20, for adults in June 2021, and for the same population in the EU, where it’s known as Apexxnar, on Valentine’s Day of this year.
The data come in three months after rival Merck secured the FDA approval for the 15-valent Vaxneuvance for kids.
In a study of 1,258 infants in Europe and Australia, between September 2020 and April 2022, Pfizer’s three-dose vaccine series showed that it led to “long-term protection,” Pfizer said Monday morning. Researchers inoculated infants at 2, 4 and 11-12 months of age and compared the vaccine to Prevenar 13.
Researchers looked at three key outcomes, including non-inferiority of immunoglobulin G, or IgG, geometric mean concentrations four weeks after the third dose. Of the 20 serotypes, 19 met that endpoint, Pfizer said.
SVB Securities analysts said the results “should further support” the vaccine’s profile in documents shipped to regulators.
“Recall that in the US study, only 14/20 STs met NI on this endpoint which we saw as concerning because it implied PFE’s 20-valent vaccine didn’t match (cross-trial) MRK’s (OP) 15-valent Vaxneuvance efficacy in children,” SVB Securities analysts wrote in a note shortly after the data drop.
The US study tested four doses. Regarding the differences in number of shots between the two regions, Pfizer said in an email to Endpoints News that Europe’s regulators’ immunization schedule looks at two infant doses and one toddler dose for pneumococcal conjugate vaccines. However, the recommendation for some vulnerable infants remains four overall doses, depending on the country, the spokesperson said. The four dose series in the US reflects the FDA and ACIP recommended schedule, they added.
The study also looked at the same metric at an earlier point: one month after the second dose. Sixteen of the 20 serotypes met non-inferiority. And on the final co-primary outcome — the non-inferiority of the percentage of patients with predefined serotype-specific IgG concentrations one month after dose 2 — nine of the 20 serotypes met the NI criteria.
“Strong functional antibody responses” were seen across all 20 vaccine serotypes, similar to that seen with the first two iterations of Prevenar, Pfizer said. Booster responses also increased after doses 2 and 3.
“Based on the totality of immunogenicity and safety data, we feel confident that 20vPnC is likely to be protective against all vaccine serotypes in a three-dose series,” said Annaliesa Anderson, Pfizer CSO for vaccines R&D and SVP, in a statement.
Safety findings came in “similar to Prevenar 13,” Pfizer said. “Concomitant use with common pediatric vaccines were supported.” Detailed safety and immunogenicity data will be presented “at a future date,” once the analysis has wrapped up.
The goal is to prevent pneumococcal bacteria from spurring pneumonia, invasive pneumococcal disease and acute otitis media so that long-term neurological damage doesn’t occur.
Pfizer and Merck have long been rivals in the pneumococcal vaccine space. Merck had a 23-valent jab approved back in the 1980s, but the pneumococcal polysaccharide vaccine’s efficacy didn’t hold up in younger children, so scientists shifted to conjugated vaccines.
Merck previously agreed to pay Pfizer a small percentage of net sales on all pneumococcal conjugate vaccine shots through 2035.
Editor’s note: This story was updated to include information from a Pfizer spokesperson.