FDA Panel Rejects Proposal for Widespread COVID Booster Shots

A U.S. government advisory panel rejected a plan for the widespread use of COVID-19 vaccine booster shots, dealing a setback to the Biden administration, which had championed the extra shots for nearly all Americans.

By a vote of 16-2, a U.S Food and Drug Administration (FDA) vaccine advisory panel rejected the widespread use of the boosters, citing a lack of data on their safety as well as a lack of evidence concerning their value.

The independent panel did endorse extra vaccine doses for people who are 65 and older or at high risk of severe illness.

Drugmaker Pfizer had requested full approval for boosters for people 16 and older, a proposal backed by the Biden administration.

The White House announced last month that Americans who received either the Pfizer or Moderna vaccines could get a booster shot eight months after their second dose.

And earlier on Friday, the White House said it was ready to roll out the booster shots if health officials approved them.

Pfizer submitted data to the FDA this week that it says shows that the efficacy of its vaccine diminishes by about 6% every two months following the second dose, making a booster at the six-month mark safe and effective at strengthening protection against the virus that causes COVID-19.

Research has shown that although immunity levels decrease over time in those vaccinated, the Pfizer vaccine still provides strong protection against severe illness and death, even in delta variant cases.

The FDA panel’s recommendation is nonbinding; the FDA is not required to follow the panel’s recommendations, but it generally does.

Next week, an independent advisory panel for the Centers for Disease Control and Prevention will weigh in on who should get a booster and when.

Elsewhere, France suspended 3,000 health care workers who had not been inoculated with a COVID-19 vaccine by a government-mandated Sept. 15 deadline.

Tens of thousands of the country’s 2.7 million health workers were unvaccinated in July, when President Emmanuel Macron announced the Sept. 15 deadline to receive at least one shot of a vaccine.

Health Minister Olivier Veran said most suspended employees worked in support services, while few doctors and nurses were among the suspended.

Johns Hopkins Coronavirus Resource Center said Friday that France has reported more than 7 million cases and more than 116,000 deaths from COVID-19.

In India, a record 22.6 million vaccination shots were given Friday as some areas organized special inoculation drives for the birthday of Prime Minister Narendra Modi, who turned 71.

 

“Every Indian would be proud of today’s record vaccination numbers,” Modi said on Twitter.

India has provided at least one vaccine dose to more than 62% of its adult population and has fully vaccinated about 21% of adults, according to the Health Ministry.

In Switzerland, officials announced that all travelers entering the country who have neither been vaccinated nor have recovered from the disease will need proof of a negative test.

British officials relaxed restrictions on travel into England, which included ending the requirement that fully vaccinated passengers from low-risk countries take COVID-19 tests on arrival.

In the U.S. state of Idaho, hospitals have begun rationing care “because the massive increase of COVID-19 patients requiring hospitalization in all areas of the state has exhausted existing resources,” the Idaho Department of Health and Welfare (DHW) said in a statement Thursday.

“The situation is dire — we don’t have enough resources to adequately treat the patients in our hospitals, whether you are there for COVID-19 or a heart attack or because of a car accident,” DHW Director Dave Jeppesen said in a statement.

The best way to end the rationing “is for more people to get vaccinated,” Jeppesen said. “It dramatically reduces your chances of having to go to the hospital if you do get sick from COVID-19.”

Some information for this report came from The Associated Press and Reuters. 

 


       SJ

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