The new Omicron-targeting booster from Pfizer Inc. and BioNTech SE, which generated a strong immune response against the Omicron substrains BA.4 and BA.5, has shown signs to curb future surges of COVID-19.
The pharmaceutical companies, Pfizer Inc. and BioNTech SE, gave the report in a news release recently.
An early look at data from ongoing testing in people at least 18 years old found the booster generated higher levels of neutralizing antibodies against the two substrains compared with levels measured before the extra shot, the companies said.
“These early data suggest that our bivalent vaccine is anticipated to provide better protection against currently circulating variants than the original vaccine and potentially help to curb future surges in cases this winter,” Pfizer Chief Executive Albert Bourla said.
The U.S. Food and Drug Administration cleared the new shots from Pfizer-BioNTech and from Moderna Inc. in late August, without waiting for results from the kinds of clinical trials conducted before earlier authorisations. The FDA clearance relied on results from testing experimental vaccines targeting the Omicron variant, animal studies and other data.
FDA officials and many vaccine experts said waiting for trial results wasn’t necessary because the changes simply updated proven shots, similar to the process used for annual flu shots, which are given without testing them in people.
Researchers also found the vaccine, called bivalent because it targets both the Omicron substrains as well as the original strain of the virus, was well-tolerated and worked safely.
In the study, researchers measured antibody responses by examining blood samples taken one week after subjects got the dose. They compared subjects who received the booster with those who got an additional shot of the original vaccine.
Among people 55 years and older, those who received a bivalent shot showed a stronger immune response against the substrains than those in the same age group who received a fourth dose of the original vaccine, the companies said.
The companies didn’t provide comparisons for younger people. They planned to provide more data in the future.
