Moderna Expected to Miss Sept 20th Booster Approval Deadline

U.S. regulators don’t expect to meet the Biden administration’s September 20th deadline of making booster shots widely available to those who received the Moderna Covid vaccine. Top health officials informed the White House they will need more time to review the Moderna application because the data the company submitted on September 1st was “found inadequate and needs strengthening,” according to the company. Top U.S. health officials had announced on August 18th that the country plans to start offering Covid-19 booster shots to all Americans beginning the third week of September, citing evidence that protection against infection is waning, as the highly contagious delta variant continues to spread. The missed deadline could mean that only those who received Pfizer’s vaccine can get a booster for at least several more weeks.

There is a legitimate debate about the necessity of boosters for people such as a healthy forty-something, but health officials say that boosters are needed for vulnerable Americans, such as elderly nursing home residents or people who are immunocompromised. But officials believe regulators are still on track to make a decision on boosters for Pfizer’s vaccine by September 20th. The FDA has an advisory committee meeting scheduled to discuss the Pfizer boosters on September 17th.

Brandon Rivera, a Los Angeles County emergency medical technician, gives a second does of Pfizer-BioNTech Covid-19 vaccine to Aaron Delgado, 16, at a pop up vaccine clinic in the Arleta neighborhood of Los Angeles, California, August 23, 2021. – The US Food and Drug Administration on August 23, fully approved the Pfizer-BioNTech Covid shot, triggering a new wave of vaccine mandates as the Delta variant batters the country.
Around 52 percent of the American population is fully vaccinated, but health authorities have hit a wall of vaccine hesitant people, impeding the national campaign. (Photo by Robyn Beck / AFP) (Photo by ROBYN BECK/AFP via Getty Images)

While officials said the timeframe was contingent on the FDA’s review, it was a highly unusual move for the most senior health officials to make such a strong recommendation before the FDA has completed their work. The delay adds to a string of mixed messages from the administration about booster shots that some state health officials say could leave the public confused and delay the deployment of a critical tool.

A source familiar with the administration’s booster shot plan said there is insufficient data about a Moderna booster shot, so it will not be available on 09/20 as planned. Pfizer is still on track for that date, and Moderna is likely “a couple weeks behind.” First on @nytimes

— Weijia Jiang (@weijia) September 3, 2021

In a letter to President Biden in late August, Maryland Governor Larry Hogan urged the federal government to make boosters immediately available to seniors and vulnerable populations, “Inexact and changing guidance at the federal level has a real impact on states’ ability to do the frontline work of fighting this pandemic,” he wrote.

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Biden administration discussing whether it must scale back ambitious Covid-19 vaccine booster plan: key point, not enough data on Moderna. https://t.co/3in7bHFq0p pic.twitter.com/UxysV4PQqU

— andrew kaczynski (@KFILE) September 3, 2021

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