Pfizer (NYSE:PFE) and BioNTech SE (Nasdaq:BNTX) have released positive data regarding two omicron-specific COVID-19 vaccine candidates.
One is monovalent, and the other is bivalent, combining the companies’ original BNT162b5 COVID-19 vaccine with mRNA based on the BA.1 omicron variant.
A Phase 2/3 study found that a booster dose of the next-gen Pfizer-BioNTech vaccine candidates led to a significantly higher immune response against omicron BA.1 than the companies’ original vaccine.
Booster doses of 30 µg and 60 µg generated a robust immune response in the Phase 2/3 study.
In the U.S., the BA.1 variant is responsible for a single-digit percentage of COVID-19 infections.
The company plans on sharing the data with the scientific community and health authorities to accelerate the potential introduction of an omicron-adapted booster “as soon as possible if authorized by regulators,” said Pfizer CEO Dr. Albert Bourla.
“Omicron has newly evolving sublineages that have outcompeted BA.1 and exhibit a trend of increasing potential for immune escape,” said Dr. Ugur Sahin, BioNTech CEO, in a news release. “We will therefore remain vigilant and are prepared to rapidly adapt our Omicron-adapted vaccine candidates to emerging sublineages if epidemiological and laboratory data suggest.”
To conclude that the vaccines were superior to the companies’ existing vaccine, the study used a ratio of neutralizing geometric mean titers (GMT) with the lower bound of the 95% confidence interval >1.
Both next-gen Pfizer-BioNTech vaccine candidates led to significant increases in neutralizing geometric titers. The monovalent candidate provided as a fourth booster dose resulted in a 13.5 and 19.6-fold boost in neutralizing geometric titers against Omicron BA.1 at 30 µg and 60 µg dose levels, respectively. Conversely, the bivalent vaccine candidate led to a 9.1 and 10.9-fold increase against the original omicron sublineage.
The study assessed neutralizing geometric mean titers one month after administration.
Both vaccines had a similar tolerability profile compared to the original BNT162b5 vaccine.
The companies plan on sharing the data with FDA and the European Medicines Agency.
In early afternoon trading, PFE shares were down 1.62% to $48.45. BioNTech saw its shares decrease 1.95% to $149.08.
A handful of other companies are also hoping to launch next-gen COVID-19 vaccines this fall, including Moderna (Nasdaq:MRNA) and CureVac (Nasdaq:CVAC).