FDA Approves Pfizer Booster Shots for Seniors, High Risk Patients

FDA Approves Pfizer Booster Shots for Seniors, High Risk Patients

The U.S. Food and Drug Administration (FDA) approved Pfizer coronavirus booster shots on Wednesday for senior citizens and those at higher risk for having a severe reaction to the virus.

In a press release, the FDA said that a single booster dose of the Pfizer vaccine can be administered six months after the first two doses for citizens 65 and older, as well as younger citizens with a “high risk of severe” coronavirus:

Today, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to allow for use of a single booster dose, to be administered at least six months after completion of the primary series in:

  • individuals 65 years of age and older;

  • individuals 18 through 64 years of age at high risk of severe COVID-19; and

  • individuals 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19.

The authorization, which comes after the FDA rejected the Biden administration’s plan to have sweeping booster shots for all Americans, applies only to the Pfizer vaccine; potential booster shots for the Moderna and Johnson & Johnson vaccines will be decided on at a later date. The Pfizer booster will also not be recommended for people who received the Moderna or J&J vaccines.

FDA acting commissioner Dr. Janet Woodcock also said in a statement that booster shots will be allowed for health care workers, teachers, grocery workers, people in homeless shelters, and people in prison.

“As we learn more about the safety and effectiveness of COVID-19 vaccines, including the use of a booster dose, we will continue to evaluate the rapidly changing science and keep the public informed,” Woodcock said.

As noted by the Associated Press, the ruling “represents a drastically scaled back version of the Biden administration’s sweeping plan to give third doses to nearly all American adults.”

Originally, the Biden administration had proposed booster shots for all American adults eight months after the first two doses, but back in August, sources in the FDA expressed frustration behind the scenes over the administration’s rushed plan to distribute boosters before the agency’s top scientists could approve.

“It wasn’t the FDA’s booster plan,” Paul Offit, a University of Pennsylvania infectious disease expert, told Politico. “The administration has kind of backed themselves up against the wall a little bit here.”

In August, the HHS released a joint statement with medical health officials announcing the release of coronavirus booster shots by September 20, but senior health officials told Politico that “political appointees within the White House largely steered” the statement instead of the FDA and other medical professionals. According to Politico:

The tension within the administration plus open skepticism from outside experts has fueled finger-pointing and divisions among health agencies. Career scientists, in particular, have been confused and surprised by the process, multiple people involved in the talks said.

In the press release on Wednesday, Woodcock emphasized that the current decision should demonstrate that the agency is carefully following the science.

“Today’s action demonstrates that science and the currently available data continue to guide the FDA’s decision-making for COVID-19 vaccines during this pandemic,” Woodcock said.

U.S. health officials have expressed optimism that booster shots will eventually be approved for all Americans, with Dr. Anthony Fauci saying last week that the FDA’s rejection of the Biden plan is “not the end of the story.”

Originally Posted on: http://feedproxy.google.com/~r/breitbart/~3/nymrAyZ561E/
[By: Paul Bois

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