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The FDA allows the third dose for the immunodeficient

One person receives a COVID-19 vaccine at Floyd’s Family Pharmacy as a cause of coronavirus disease (COVID-19) in Ponchatoula, Louisiana, United States, August 5, 2021. Photo taken August 5, 2021.

Callaghan O’Hare | Reuters

The Food and Drug Administration has authorized Covid-19 vaccine-boosting vaccines for people with weakened immune systems, a much-anticipated move aimed at protecting some of the most vulnerable Americans from the highly contagious delta variant.

“Today’s action allows doctors to boost immunity in certain immunocompromised individuals who need additional protection from COVID-19,” FDA agent commissioner Drs. Janet Woodcock.

The agency said recipients of organ transplants and people who are similarly immunocompromised can receive a third dose of Pfizer-BioNTech or Modern vaccines. The FDA also emphasized that other vaccinated people are “adequately protected” and currently do not need an extra dose.

The FDA OK is not the last step. The vaccine advisory committee of the Centers for Disease Control and Prevention scheduled a meeting Friday to consider vaccines for immunocompromised Americans. If they issue a recommendation and it is approved by the CDC, third parties can begin immediately.

Anthony Fauci, the White House chief medical officer, said last week that federal health officials have stepped up regulatory efforts to cancel third doses for such people, including patients with cancer and HIV or those who have had transplants. of organs. He said new data suggests they do not produce an adequate immune response after receiving two doses of a Covid vaccine.

“Immunocompromised individuals are vulnerable,” Fauci said Thursday. “It’s extremely important for us to move to get those individuals their boosters, and we’re working on that now, and we’ll get it up and running as soon as possible. … It’s a very high priority.”

Such people represent only about 2.7% of the U.S. adult population, but make up about 44% of Covid hospital screening cases, which is when a fully vaccinated individual becomes infected, according to recent data. of an advisory group Centers for Disease Control and Prevention.

Studies suggest that a third shot of vaccine could help patients whose immune system does not respond well to a first or second dose.

Four small studies cited by the CDC last month showed that 16% to 80% of people with weakened immune systems did not have detectable antibodies to fight Covid after two strokes. Among vaccinated patients who had no detectable antibody response, 33% to 50% developed an antibody response after receiving an additional dose, according to the CDC.

With the delta growing in the United States, doctors fear leaving such groups unprotected against the virus could lead to even more dangerous variants.

Fauci, speaking with “CBS This Morning” earlier Thursday, said it is “likely” that everyone will eventually need to receive a booster dose. But the priority now, he said, is to give boosters to people who have compromised immune systems.

Some doctors have long been pushing the United States to allow immunosuppressed populations to receive an extra dose, and many of them have already found additional doses of vaccines alone, medical experts say.

A CDC advisory group met last month to consider whether fully vaccinated Americans with weakened immune systems need a booster dose after the data show they are less likely to have antibodies to fight the disease and more prone to suffer from an advanced infection.

“The most difficult to vaccinate people are those who are immunosuppressed,” said in late June Dr. Dan Barouch, an immunologist at Harvard Medical School. The data suggest that at least a third of them respond well if they get a third dose, he added.

The FDA’s move comes after the World Health Organization urged rich nations last week to temporarily halt the distribution of booster shots, citing vaccine inequities around the globe. However, global health officials have been careful to emphasize that they do not refer to the extra doses that may be needed now for certain groups, such as those with a weakened immune system.

Other countries, such as France, are already giving a third blow to people living with cancer or other immune problems. Israel announced plans last month to offer a reinforcement blow to people over 60, another high-risk population, since the effectiveness of the blow appears to be declining in those people.

In the United States, Mississippi, a state with some of the lowest vaccination rates, advises doctors consider a dose of booster for people with weakened immune systems. Health officials advise us to wait at least four weeks after full vaccination before receiving a booster.

This is a developing story. Please check back for updates.

– CNBC’s Christine Wang contributed to this report.


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