FDA authorizes extra COVID-19 vaccine dose for some immunocompromised Americans

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CBS News 13 August, 2021 - 06:53am 84 views

The late-night announcement by the Food and Drug Administration applies to several million Americans who are especially vulnerable because of organ transplants, certain cancers or other disorders. Several other countries, including France and Israel, have similar recommendations.

It's harder for vaccines to rev up an immune system suppressed by certain medications and diseases, so those patients don't always get the same protection as otherwise healthy people — and small studies suggest for at least some, an extra dose may be the solution.

"Today's action allows doctors to boost immunity in certain immunocompromised individuals who need extra protection from COVID-19," Dr. Janet Woodcock, the FDA's acting commissioner, said in a statement.

The FDA determined that transplant recipients and others with a similar level of compromised immunity can receive a third dose of the vaccines from Pfizer and Moderna at least 28 days after getting their second shot. The FDA made no mention of immune-compromised patients who received the single-dose Johnson & Johnson vaccine.

The announcement comes as the extra-contagious Delta version of the coronavirus surges through much of the country, pushing new cases, hospitalizations and deaths to heights not seen since last winter.

Importantly, the FDA's decision only applies to this high-risk group, estimated to be no more than 3% of U.S. adults. It's not an opening for booster doses for the general population.

Instead, health authorities consider the extra dose part of the initial prescription for the immune-compromised. For example, France since April has encouraged that such patients get a third dose four weeks after their regular second shot. Israel and Germany also recently began recommending a third dose of two-dose vaccines.

Separately, U.S. health officials are continuing to closely monitor if and when average people's immunity wanes enough to require boosters for everyone — but for now, the vaccines continue to offer robust protection for the general population.

The Centers for Disease Control and Prevention is expected to formally recommend the extra shots for certain immune-compromised groups after a meeting Friday of its outside advisers.

Transplant recipients and others with suppressed immune systems know they're at more risk than the average American and some have been seeking out extra doses on their own, even if it means lying about their vaccination status. The change means now the high-risk groups can more easily get another shot — but experts caution it's not yet clear exactly who should.

"This is all going to be very personalized," cautioned Dr. Dorry Segev, a transplant surgeon at Johns Hopkins University who is running a major National Institutes of Health study of extra shots for organ recipients. For some people, a third dose "increases their immune response. Yet for some people it does not seem to. We don't quite know who's who yet."

In May, Segev told CBS News he was "hearing of transplant and other immunosuppressed people who got vaccinated and relaxed their safety behaviors and are now being admitted to hospitals and some are dying because they get COVID-19." 

A study published in May of more than 650 transplant recipients found just over half harbored virus-fighting antibodies after two doses of the Pfizer or Moderna vaccines — although generally less than in otherwise healthy vaccinated people.

"This is really much more of a stark contrast than we had expected," Segev told CBS News at the time.  

Another study of people with rheumatoid arthritis and similar autoimmune diseases found only those who use particular medications have very poor vaccine responses.

There's little data on how well a third dose works, and if it causes any safety problems such as an increased risk of organ rejection. Wednesday, Canadian researchers reported that transplant recipients were more likely to have high levels of antibodies if they got a third dose than those given a dummy shot for comparison. Other small studies have similarly found that some transplant recipients respond to a third dose while others still lack enough protection.

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FDA greenlights COVID-19 booster vaccine for some immunocompromised patients

Fox News 13 August, 2021 - 11:50am

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HIV and cancer patients, organ transplant recipients and those taking immunosuppressant drugs comprise about 2.7% of the U.S. adult population. 

Growing evidence had suggested select immunocompromised patients mount a diminished protective immune response, even after two doses of vaccine. 

Research published in the New England Journal of Medicine on Wednesday among 120 organ transplant recipients who received a third dose of Moderna's vaccine indicated a substantial boost in neutralizing antibodies and T-cell counts, compared to a group receiving saline placebo.

The FDA statement, which was released Thursday night, said the specific individuals impacted are "solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromised." 

Other fully vaccinated individuals do not need an additional vaccine dose right now, the statement said.

"FDA’s approval of the third COVID-19 vaccine dose is excellent news for organ transplant recipients," Anastasia Henry, executive director of the American Transplant Foundation, told Fox News. "This is definitely a needed step to ensure transplant recipients are protected. Transplant patients are excited about this option. We encourage transplant recipients to follow-up with their medical providers promptly to make sure they can get their booster shot and discuss future precautions such as masks and social distancing."

It's harder for vaccines to rev up an immune system suppressed by certain medications or diseases, so those patients don't always get the same protection as otherwise healthy people -- and small studies suggest for at least some, an extra dose may be the solution.

"This action is about ensuring our most vulnerable ... are better protected against COVID-19," Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention, said ahead of the FDA's announcement.

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FDA authorizes extra COVID-19 vaccine dose for some immunocompromised Americans

MSNBC 13 August, 2021 - 06:53am

The late-night announcement by the Food and Drug Administration applies to several million Americans who are especially vulnerable because of organ transplants, certain cancers or other disorders. Several other countries, including France and Israel, have similar recommendations.

It's harder for vaccines to rev up an immune system suppressed by certain medications and diseases, so those patients don't always get the same protection as otherwise healthy people — and small studies suggest for at least some, an extra dose may be the solution.

"Today's action allows doctors to boost immunity in certain immunocompromised individuals who need extra protection from COVID-19," Dr. Janet Woodcock, the FDA's acting commissioner, said in a statement.

The FDA determined that transplant recipients and others with a similar level of compromised immunity can receive a third dose of the vaccines from Pfizer and Moderna at least 28 days after getting their second shot. The FDA made no mention of immune-compromised patients who received the single-dose Johnson & Johnson vaccine.

The announcement comes as the extra-contagious Delta version of the coronavirus surges through much of the country, pushing new cases, hospitalizations and deaths to heights not seen since last winter.

Importantly, the FDA's decision only applies to this high-risk group, estimated to be no more than 3% of U.S. adults. It's not an opening for booster doses for the general population.

Instead, health authorities consider the extra dose part of the initial prescription for the immune-compromised. For example, France since April has encouraged that such patients get a third dose four weeks after their regular second shot. Israel and Germany also recently began recommending a third dose of two-dose vaccines.

Separately, U.S. health officials are continuing to closely monitor if and when average people's immunity wanes enough to require boosters for everyone — but for now, the vaccines continue to offer robust protection for the general population.

The Centers for Disease Control and Prevention is expected to formally recommend the extra shots for certain immune-compromised groups after a meeting Friday of its outside advisers.

Transplant recipients and others with suppressed immune systems know they're at more risk than the average American and some have been seeking out extra doses on their own, even if it means lying about their vaccination status. The change means now the high-risk groups can more easily get another shot — but experts caution it's not yet clear exactly who should.

"This is all going to be very personalized," cautioned Dr. Dorry Segev, a transplant surgeon at Johns Hopkins University who is running a major National Institutes of Health study of extra shots for organ recipients. For some people, a third dose "increases their immune response. Yet for some people it does not seem to. We don't quite know who's who yet."

In May, Segev told CBS News he was "hearing of transplant and other immunosuppressed people who got vaccinated and relaxed their safety behaviors and are now being admitted to hospitals and some are dying because they get COVID-19." 

A study published in May of more than 650 transplant recipients found just over half harbored virus-fighting antibodies after two doses of the Pfizer or Moderna vaccines — although generally less than in otherwise healthy vaccinated people.

"This is really much more of a stark contrast than we had expected," Segev told CBS News at the time.  

Another study of people with rheumatoid arthritis and similar autoimmune diseases found only those who use particular medications have very poor vaccine responses.

There's little data on how well a third dose works, and if it causes any safety problems such as an increased risk of organ rejection. Wednesday, Canadian researchers reported that transplant recipients were more likely to have high levels of antibodies if they got a third dose than those given a dummy shot for comparison. Other small studies have similarly found that some transplant recipients respond to a third dose while others still lack enough protection.

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Copyright © 2021 CBS Interactive Inc. All rights reserved.

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