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FDA Considers Authorizing a Second Booster Shot: Report


Image for article titled FDA Is Reportedly Considering Whether to Approve a Second Booster Shot for This Fall

Photo: Scott Olson (Getty Images)

This fall, you may be able to get a second covid-19 booster shot along with your annual flu vaccine.

The U.S. Food and Drug Administration has begun reviewing data to decide whether to authorize a second booster dose of the messenger RNA vaccines from Pfizer and partner BioNTech and from Moderna, the Wall Street Journal reported Saturday, citing people familiar with the matter.

According to the Journal’s report, regulators are also weighing whether this fourth booster could be the start of an annual covid-19 vaccination. As for the fall timeline, the thinking goes that because so many people already get their annual flu shot in the fall, they may be more willing to get a yearly covid-19 vaccine then too. However, a person familiar with the matter told the outlet that no decision is final at this point, and if a new variant crops up, it may be necessary to roll out additional booster shots sooner.

Planning is still in the early stages, and several issues would need to be resolved before health regulators moved forward with the process. Authorization would depend on determinations as to whether the second booster should be authorized for all adults or limited to certain high-risk populations such as the elderly, as well as whether another booster dose should target the Omicron variant or be formulated differently, one of the people familiar with the matter told the Journal.

Among other data, ongoing research would need to show that a fourth dose significantly improved people’s immune defenses that have waned in the months following the first booster and would reduce their risk of developing symptomatic and severe health issues from the virus. Researchers have also been debating whether a fourth dose would be necessary to protect against Omicron and any new, highly transmissible coronavirus variants that may emerge down the line, the Journal reports.

The Israel government has already authorized the use of four vaccine doses for certain age groups, people with underlying health conditions, and healthcare workers. The decision followed promising early results from Israel’s health ministry that a fourth jab greatly increased the number of antibodies in individuals and proved effective against the Omicron variant.

In January, the FDA amended the emergency use authorization for covid-19 vaccines, cutting the interval to get a booster dose after receiving the vaccine to five months, down from six, in a bid to bolster immune defenses against the Omicron variant.

“The country is in the middle of a wave of the highly contagious omicron variant, which spreads more rapidly than the original SARS-CoV-2 virus and other variants that have emerged,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, at the time. “Vaccination is our best defense against covid-19, including the circulating variants, and shortening the length of time between completion of a primary series and a booster dose may help reduce waning immunity.”

To date, the U.S. has reported more than 78 million coronavirus cases and 934,582 deaths, according to researchers at Johns Hopkins. A spike in cases caused by the highly transmissible Omicron variant has finally begun to show signs of relenting in recent weeks, though the daily rate of new cases continues to surpass any prior surge numbers.



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