CDC advisory panel recommends additional vaccines for people with weakened immune systems

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ABC News 13 August, 2021 - 12:24pm 73 views

About 7 million people could get a third shot of the mRNA vaccines.

The Centers for Disease Control and Prevention officially recommended a third dose of an mRNA vaccine for immunocompromised Americans on Friday afternoon, allowing around 7 million Americans who didn't get an optimal immune response to their initial vaccine doses of Pfizer or Moderna to gain more protection.

CDC Director Dr. Rochelle Walensky signed off on the recommendation after a CDC panel voted Friday morning on the specifics of who should get an additional shot and when. The CDC approval was the final step in the process initiated by the Food and Drug Administration's announcement late on Thursday night that immunocompromised Americans will be able to get a third shot.

"Today, I signed CDC’s Advisory Committee on Immunization Practices’ (ACIP) recommendation that endorsed the use of an additional dose of COVID-19 vaccine for people with moderately to severely compromised immune systems after an initial two-dose vaccine series," Walensky said in a statement.

She called the recommendation "an important step in ensuring everyone, including those most vulnerable to COVID-19, can get as much protection as possible from COVID-19 vaccination."

The additional dose will specifically be targeted at cancer patients, transplant recipients, people with HIV and people on immunosuppressant drugs, plus a range of other conditions that similarly left vaccinated people with less immunity than expected.

Instead of the more than 90% protection from the vaccines that's normally found in healthy people, vaccine effectiveness in immunocompromised people can be as low as 59% to 72%, the CDC said.

For example, in one U.S. study, 44% of breakthrough cases that led to hospitalization were in immunocompromised people. An Israeli study found it was around 40%.

But the CDC data shows that a booster shot could increase antibodies in an immunocompromised person by up to 50%.

"COVID-19 disease in immunocompromised people is an important public health problem. The anticipated desirable effects of an additional dose of mRNA vaccine are large, and undesirable effects expected to be minimal, favoring the intervention," Dr. Kathleen Dooling, a medical officer at the CDC, said at the meeting on Friday.

The CDC estimated about 7 million people, or 2.7% of the population, fit into the category of moderate or severely immunocompromised. But there is no plan to require people to prove their conditions before receiving a third shot, either by prescription or a doctor's note -- it will be a matter of "self-attesting."

Immunocompromised people who got the Johnson & Johnson vaccine are not yet eligible for additional shots, but the CDC and FDA said they're doing research and hope to provide more guidance soon.

The CDC also assumes the vast majority of immunocompromised people got mRNA vaccines because only 12 million people nationwide have gotten the Johnson & Johnson vaccine, while 149 million have gotten Pfizer or Moderna shots.

"We think that at least there was a solution here for the very large majority of immunocompromised individuals and we believe that we'll probably have a solution for the remainder in the not too distant future," Dr. Peter Marks, vaccine chief for the FDA, said at the meeting.

Experts and officials have been clear that this third shot for immunocompromised people is separate from booster shots for the general public, which people are expected to need as the protection from the vaccines wane over time. But the FDA and CDC, which are monitoring immunity in multiple groups of people across the country, said the U.S. isn't there yet.

"As we’ve previously stated, other individuals who are fully vaccinated are adequately protected and do not need an additional dose of COVID-19 vaccine at this time," acting FDA Commissioner Dr. Janet Woodcock said in a statement Thursday. "The FDA is actively engaged in a science-based, rigorous process with our federal partners to consider whether an additional dose may be needed in the future."

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Extra COVID vaccine OK'd for those with weak immune systems

KPRC 2 Click2Houston 13 August, 2021 - 05:20pm

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.”

One recent study 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. 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.

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

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CDC officially recommends additional vaccines for people with weakened immune systems

ABC News 13 August, 2021 - 03:56pm

About 7 million people could get a third shot of the mRNA vaccines.

The Centers for Disease Control and Prevention officially recommended a third dose of an mRNA vaccine for immunocompromised Americans on Friday afternoon, allowing around 7 million Americans who didn't get an optimal immune response to their initial vaccine doses of Pfizer or Moderna to gain more protection.

CDC Director Dr. Rochelle Walensky signed off on the recommendation after a CDC panel voted Friday morning on the specifics of who should get an additional shot and when. The CDC approval was the final step in the process initiated by the Food and Drug Administration's announcement late on Thursday night that immunocompromised Americans will be able to get a third shot.

"Today, I signed CDC’s Advisory Committee on Immunization Practices’ (ACIP) recommendation that endorsed the use of an additional dose of COVID-19 vaccine for people with moderately to severely compromised immune systems after an initial two-dose vaccine series," Walensky said in a statement.

She called the recommendation "an important step in ensuring everyone, including those most vulnerable to COVID-19, can get as much protection as possible from COVID-19 vaccination."

The additional dose will specifically be targeted at cancer patients, transplant recipients, people with HIV and people on immunosuppressant drugs, plus a range of other conditions that similarly left vaccinated people with less immunity than expected.

Instead of the more than 90% protection from the vaccines that's normally found in healthy people, vaccine effectiveness in immunocompromised people can be as low as 59% to 72%, the CDC said.

For example, in one U.S. study, 44% of breakthrough cases that led to hospitalization were in immunocompromised people. An Israeli study found it was around 40%.

But the CDC data shows that a booster shot could increase antibodies in an immunocompromised person by up to 50%.

"COVID-19 disease in immunocompromised people is an important public health problem. The anticipated desirable effects of an additional dose of mRNA vaccine are large, and undesirable effects expected to be minimal, favoring the intervention," Dr. Kathleen Dooling, a medical officer at the CDC, said at the meeting on Friday.

The CDC estimated about 7 million people, or 2.7% of the population, fit into the category of moderate or severely immunocompromised. But there is no plan to require people to prove their conditions before receiving a third shot, either by prescription or a doctor's note -- it will be a matter of "self-attesting."

Immunocompromised people who got the Johnson & Johnson vaccine are not yet eligible for additional shots, but the CDC and FDA said they're doing research and hope to provide more guidance soon.

The CDC also assumes the vast majority of immunocompromised people got mRNA vaccines because only 12 million people nationwide have gotten the Johnson & Johnson vaccine, while 149 million have gotten Pfizer or Moderna shots.

"We think that at least there was a solution here for the very large majority of immunocompromised individuals and we believe that we'll probably have a solution for the remainder in the not too distant future," Dr. Peter Marks, vaccine chief for the FDA, said at the meeting.

Experts and officials have been clear that this third shot for immunocompromised people is separate from booster shots for the general public, which people are expected to need as the protection from the vaccines wane over time. But the FDA and CDC, which are monitoring immunity in multiple groups of people across the country, said the U.S. isn't there yet.

"As we’ve previously stated, other individuals who are fully vaccinated are adequately protected and do not need an additional dose of COVID-19 vaccine at this time," acting FDA Commissioner Dr. Janet Woodcock said in a statement Thursday. "The FDA is actively engaged in a science-based, rigorous process with our federal partners to consider whether an additional dose may be needed in the future."

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