Pfizer-BioNtech has asked the Food and Drug Administration to authorize an updated version of its COVID booster designed to target the BA.5 omicron subvariant. The drugmaker announced in a release monday.
Pfizer’s release was sparse on new details about the booster’s efficacy, but the company said studies in animals found that the vaccine produced an immune response against several versions of Omicron, including BA.4 and BA.5. Huh. It plans to start clinical trials in people this month, the statement said.
Requests covering people 12 years of age and older will now be considered by the FDA, which will review the data and expected to provide emergency use authorization For the age group sometime in September.
When authorized, the company said it is ready to start distributing the shots immediately.
Harvard epidemiologist Bill Hannez praised the “remarkably quick” turnaround time for the new version of the vaccine, saying the shots usually take years to develop and deliver. BA.5 only began to spread across the US in early June.
The new vaccine will be “crucial”, especially for people most vulnerable to serious infections such as the elderly.
expected to be updated shots Launched as part of the Fall Booster campaign Ahead of a possible winter surge in Covid cases, Dr Ashish Jha, coordinator of the White House COVID, said last week.
Pfizer’s so-called bivalent booster targets the original strain of the virus, along with the Omicron subvariants BA.4 and BA.5, in a single shot. BA.5 is responsible for approximately 90% of new COVID cases in the United States, according to Centers for Disease Control and Prevention,
In June, the company released clinical trial data On a different version of a biconvex shot, which targeted the original Omicron version. That booster was shown to be safe and produced an immune response.
The FDA is allowing Pfizer to submit less data on the shot than on previous COVID vaccines. Agency Guidance issued last year That said modified vaccines that target new, emerging strains of the coronavirus can be authorized without the need for lengthy clinical trials.
Georgetown University’s Jesse Goodman, a former FDA vaccine chief, said it “makes sense” to update vaccines to allow for new variants to circulate.
How effective Pfizer’s new bivalent vaccines are compared to existing vaccines is unclear. Goodman said he specifically wants to see how well the vaccines perform against infection.
It is “likely” that immune responses in people will be similar to those observed in animal studies, but “this is not known until human data are available.”
If the new version of the vaccine offers stronger protection against infection and severe disease, it could reduce future Covid waves and perhaps “put pressure on extended health systems,” said Dr. Isaac Bogoch said.
Still, he noted that the lack of data on the bivalent vaccine could make people more hesitant to get the shot in the near term, slowing down the vaccine.
“If you want a good vaccine and you want public procurement and public trust, you have to have sound data to drive it,” he said.
Moderna is preparing to ask the FDA to authorize its bivalent vaccine that targets B.A.4 and B.5 as well as the original strain.
Monday’s announcement comes as the current booster shots from Pfizer and Moderna have been a poor match for Omicron and its growing family of subvariants. The shots, which target the original coronavirus strain identified in Wuhan, China, in late 2019 still offer strong protection against serious illness.