U.S. Expected To Approve Moderna and J&J COVID-19 Booster Shots

The U.S. Food and Drug Administration (FDA) is expected to approve COVID-19 booster shots from Moderna (NASDAQ:MRNA) and Johnson & Johnson (NYSE:JNJ) when its advisory panel meets on Thursday and Friday of this week.

The FDA’s Vaccines and Related Biological Products Advisory Committee meetings come less than a month after U.S. regulators authorized the booster shot of Pfizer (NYSE:PFE) and BioNTech’s (NASDAQ:BNTX) vaccine for a wide array of Americans, including the elderly, adults with underlying medical conditions, and people who work or live in high-risk settings such as healthcare and grocery workers.

More than seven million Americans have received a booster dose in the U.S., according to the latest data available from the Centers for Disease Control and Prevention (CDC).

Members on independent committees of the FDA said at the time they were frustrated that only Pfizer vaccine recipients would be eligible to get booster shots, leaving out millions of Americans who got Moderna’s or J&J’s vaccine.

The FDA advisory group is scheduled to discuss this week data on the safety and effectiveness of a Moderna booster shot in adults. On Friday, the committee is expected to debate J&J booster shots for adults.

The FDA could make a final decision within days of the meetings, handing it off to the CDC and its vaccine advisory committee to make their own decision. The CDC’s next vaccine advisory meeting is scheduled for October 20 and 21 where it’s expected to discuss the boosters.

The FDA meeting comes after average daily COVID-19 cases in the U.S. fell below 100,000 last week with more than 56% of the population fully immunized against the virus and the pandemic showing signs of easing.

The Biden administration hopes boosting the U.S. population will also continue to ensure long-term and durable protection against severe disease, hospitalization and death from the fast-moving Delta variant spreads.

Last month, Moderna said a third shot at half the dosage used for the first two jabs was safe and produced a stronger immune response than what was seen after the second dose in its phase three clinical trial.