Pfizer CEO Albert Bourla said during an investor call Tuesday the Food and Drug Administration could authorize the company’s new Covid-19 booster shot by the end of the month—moving closer to a system of regular flu-like vaccinations that keep up with the coronavirus as it evolves and as people’s immunity wanes.
In June, Pfizer, along with its German partner BioNTech, asked the FDA to approve a new version of its Covid-19 vaccine booster designed to protect against XBB.1.5, a coronavirus subvariant that emerged in late 2022.
XBB.1.5 is no longer the dominant strain, having been usurped by XBB.1.6, according to the Centers for Disease Control and Prevention, but experts say the two are similar enough that a new booster should protect against both (XBB.1.5 represented 12.3% of all new cases in late July while XBB.1.6 represented 14.8%, according to CDC data).
Bourla said he and his colleagues expect “a new Covid wave to start in the U.S. this fall” and want the new version of the vaccine to be available prior to that.
However, with only 17% of the U.S. population having received a fall 2022 booster shot that was updated for the Omicron variant, according to the CDC, it’s unclear how many Americans will choose to adopt the latest booster.
WHAT WE DON’T KNOW
The CDC will ultimately recommend who should receive the updated boosters, but that announcement likely won’t come until after the FDA authorizes them. The most recent boosters released in fall 2022 were eventually recommended by the CDC for everyone above the age of six.
The first Covid-19 vaccine booster shots, authorized by the FDA in fall 2021, were meant to help replenish waning immunity to the virus. However, after the coronavirus’ Omicron variant launched a new vicious wave of the pandemic last year, drugmakers released a modified “bivalent” booster shot in fall 2022 that was designed to protect against both the original virus strain as well as Omicron, which was more resistant to the original vaccines. This new booster is attempting to do what that bivalent booster did with Omicron, but with an update for the XBB strains. The news comes as 8,035 people were hospitalized for Covid-19 in the week ended July 22, according to the most recent CDC data available. That’s a 12.1% increase over the week before, but a far cry from the peak in January 2022, when there were around 150,000 hospitalizations a week.
This new booster falls in line with doctors’ long held predictions that the Covid-19 vaccines would likely need to become similar to the influenza vaccine, where a new iteration is released annually to update the formulation to new strains of the virus. Anthony Fauci, former director of the National Institute of Allergy and Infectious Diseases and the leader of the federal government’s response to the pandemic, said at a White House briefing in September 2022: “We likely are moving towards a path with a vaccination cadence similar to that of the annual influenza vaccine, with annual updated Covid-19 shots matched to the currently circulating strains for most of the population.”