FDA Poised To Authorize Pfizer's Updated COVID-19 Booster Targeting XBB.1.5 Strain

FDA pfizer COVID-19 booster updated version

By E.Baloyo , Parent Herald Aug 02, 03:31 am

Photo: (Photo : Scott Olson / Getty Images )

The Food and Drug Administration (FDA) is expected to greenlight Pfizer's updated COVID-19 booster, specifically designed to counter the XBB.1.5 subvariant.

This announcement comes from Pfizer's CEO, Albert Bourla, who anticipates the authorization to come through by the end of August.

The updated version of the booster could play a crucial role in managing this anticipated surge.

Experts have pointed out that despite XBB.1.5 no longer being the predominant strain, the new Pfizer booster should remain effective against recent mutations, as they are not too genetically different from one another.

The FDA's approval of the updated version will likely align with the ongoing need for COVID-19 vaccinations.

Preparing for Fall's COVID-19 Wave

According to NBC News, Bourla expressed this outlook during a recent investor call, explaining that Pfizer formally requested the FDA in June to authorize this updated version of the booster.

The updated booster's objective is to tackle the XBB.1.5 strain of coronavirus that became widely prevalent last winter. Concurrently, Moderna also made a similar appeal.

These pleas from the drugmakers followed shortly after the FDA's advice to update the shots, focusing on the XBB.1.5 strain in preparation for a potential fall COVID-19 booster campaign.

Despite the XBB.1.5 strain accounting for only 12.3% of all new COVID-19 cases for the week ending July 22, the FDA's push for a booster targeting this subvariant signals an ongoing effort to maintain control over the pandemic's trajectory.

Shifting Vaccine Strategies Amidst Emerging Strains

According to the Centers for Disease Control and Prevention (CDC), the XBB.1.5 strain has been surpassed by the XBB.1.16 strain, which currently accounts for around 15% of all new cases.

Despite this shift, experts at a June FDA adviser meeting stated that vaccine effectiveness would not be overly affected given the relatively minor genetic differences between the two strains.

The unveiling of this updated booster comes as COVID-19 hospitalizations in the U.S. are on an upward trend, with Bourla forecasting an uptick in cases heading into the colder months.

"We expect a new COVID-19 wave to start in the U.S. this fall," Bourla mentioned. He anticipates that the updated Pfizer booster will be pivotal in tackling this predicted surge.

As reported by The Hill, with the federal government ceasing to pay for COVID-19 vaccines, the updated Pfizer booster will only be available on the commercial market.

Only 17% of the U.S. population has received an updated booster, according to the CDC.

The FDA has advised drugmakers to update the shots to target the XBB.1.5 subvariant, even though it only accounts for 12.3% of all new cases.

The newly dominant strain is XBB.1.16, which constitutes about 15% of all new infections.

Path Toward Seasonal COVID-19 Vaccinations

While the FDA's decision on the updated booster is eagerly awaited, the recommendation for nationwide application lies with the CDC.

Notably, the FDA will make the authorization decision without convening its Vaccines and Related Biological Products Advisory Committee, based on sources familiar with the agency's plans.

The anticipated approval of this updated COVID-19 booster aligns with previous predictions of an annual COVID-19 vaccination similar to the influenza vaccine.

Forbes reported that the anticipated authorization of Pfizer's updated COVID-19 booster comes at a critical juncture, with a potential new wave of cases looming in the fall.

The FDA's decision to approve this updated version reflects an adaptive response to the ever-changing nature of the virus.

The move towards an annually updated COVID-19 vaccine may well be the future norm, drawing parallels to the influenza vaccination strategy.

The commercial availability and targeted response to evolving strains demonstrate the ongoing commitment to fight COVID-19, ensuring that the population is armed with the latest protection.