The revised COVID-19 boosters from Pfizer should receive FDA approval by the end of the month, said the CEO of Pfizer, Albert Bourla, during a conference call with investors on August 2.
Hospitalizations for COVID-19 are increasing for the first time since the start of 2023. As of August 2, there have been more than 700 million COVID-19 cases all across the globe, and there have been reports of a recent spike in cases.
To ensure safety among nations, the pharmaceutical company requested permission from the FDA in June to use a revised formulation of its COVID-19 booster to combat the XBB.1.5 subvariant. This coronavirus strain became highly prevalent in 2022 winter. The same month, Moderna made a similar request.
A few days before the fall COVID-19 booster campaign, the FDA recommended that drugmakers change the injections to target XBB.1.5. According to the CDC, XBB.1.5 is no longer the prevalent strain, accounting for only 12.3% of all new virus cases through the week ending July 22.
It's been edged out by XBB.1.16, or the 'Arcturus,' which accounts for about 15% of all new cases. The strain was reported first on January 9. Experts said during a June meeting of FDA advisers that they don't expect that will hurt vaccine effectiveness much, as the XBB strains aren't too genetically different from one another.
This comes at a time when hospitalizations are increasing in the United States, despite being lower than at any other time throughout the pandemic, according to Bourla's prognosis on the availability of new boosters. During the call, Bourla stated that they anticipate further COVID-19 cases and hospitalizations as we enter the winter months.
This fall, another COVID-19 wave is anticipated to begin in the U.S., according to Bourla.
In an email to POLITICO, White House spokeswoman Kelly Scully replied that "the Biden-Harris Administration has made historic progress on our nation's ability to manage COVID-19 so that it no longer meaningfully disrupts the way we live our lives."
There is yet to be a clear answer whether everyone in the U.S. will receive the boosters. The CDC will be in charge of making that choice, but it isn't anticipated to do so until after the FDA has given the injections its approval.
The initial coronavirus strain was removed from the formulation, and the injections were updated to target an XBB strain during the June meeting of that committee.