Tag: Immunocompromised

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Politics

C.D.C. Panel Recommends Third Vaccine Dose for Immunocompromised

C.D.C. Panel Recommends Third Vaccine Dose for Immunocompromised

Dr. Jose U. Scher, a rheumatologist at NYU Langone Health who has studied the effect of vaccines on the immunocompromised, said that the C.D.C. vote — and the guidance from its experts — would help patients who had been agonizing over whether to seek out a third shot. Previously, he said, when people tested themselves for antibodies after vaccination and came up empty, “there were no tools for us to respond to that.”

Updated 

Aug. 13, 2021, 5:00 a.m. ET

“We now know that this population was being left behind,” he said.

Immunocompromised people will not need a doctor’s permission or a prescription to get a third shot, C.D.C. officials said. They will need only to attest that they meet the eligibility requirements for an additional dose. Anyone else, including people with chronic medical conditions, like diabetes or asthma, should not be getting third shots at this point, they said.

Dr. Scher predicted that this honor-system approach could be messy. “I don’t know if there’s any way of corroborating someone’s claim” of being immunocompromised, he said. Requiring some kind of proof, such as a doctor’s note, would be a better process, he said.

The updated F.D.A. authorizations do not apply to immunocompromised people who received the single-dose Johnson & Johnson vaccine. The C.D.C. panel did not offer recommendations on additional shots for that group, which is believed to be small. But the lack of guidance from either the F.D.A. or C.D.C. has left that group in limbo.

Understand the State of Vaccine and Mask Mandates in the U.S.

    • Mask rules. The Centers for Disease Control and Prevention in July recommended that all Americans, regardless of vaccination status, wear masks in indoor public places within areas experiencing outbreaks, a reversal of the guidance it offered in May. See where the C.D.C. guidance would apply, and where states have instituted their own mask policies. The battle over masks has become contentious in some states, with some local leaders defying state bans.
    • Vaccine rules . . . and businesses. Private companies are increasingly mandating coronavirus vaccines for employees, with varying approaches. Such mandates are legally allowed and have been upheld in court challenges.
    • College and universities. More than 400 colleges and universities are requiring students to be vaccinated against Covid-19. Almost all are in states that voted for President Biden.
    • Schools. On Aug. 11, California announced that it would require teachers and staff of both public and private schools to be vaccinated or face regular testing, the first state in the nation to do so. A survey released in August found that many American parents of school-age children are opposed to mandated vaccines for students, but were more supportive of mask mandates for students, teachers and staff members who do not have their shots.  
    • Hospitals and medical centers. Many hospitals and major health systems are requiring employees to get a Covid-19 vaccine, citing rising caseloads fueled by the Delta variant and stubbornly low vaccination rates in their communities, even within their work force.
    • New York. On Aug. 3, Mayor Bill de Blasio of New York announced that proof of vaccination would be required of workers and customers for indoor dining, gyms, performances and other indoor situations, becoming the first U.S. city to require vaccines for a broad range of activities. City hospital workers must also get a vaccine or be subjected to weekly testing. Similar rules are in place for New York State employees.
    • At the federal level. The Pentagon announced that it would seek to make coronavirus vaccinations mandatory for the country’s 1.3 million active-duty troops “no later” than the middle of September. President Biden announced that all civilian federal employees would have to be vaccinated against the coronavirus or submit to regular testing, social distancing, mask requirements and restrictions on most travel.

“We do understand the challenges here, and because of that we will continue to work very diligently to try to have a solution,” Dr. Peter Marks, the F.D.A.’s top vaccine regulator, said at the panel’s meeting. The F.D.A. is waiting on more data that it expects to receive this month, including Johnson & Johnson’s clinical trial data on the safety and efficacy of two doses.

Dr. Kathleen Dooling, a C.D.C. official, said that patients who qualify for a third dose should ideally seek out the vaccine they already received, but that they could take the other two-dose vaccine if necessary.

Presenting studies that supported giving third doses, Dr. Dooling emphasized that immunocompromised people who receive a third dose should still wear a mask, maintain social distancing with people they do not live with, and avoid crowds and poorly ventilated indoor spaces. She said that people with weakened immune systems had also been shown to be at greater risk of breakthrough infection.

Categories
Health

F.D.A. Authorizes Third Covid Shot for Immunocompromised

F.D.A. Authorizes Third Covid Shot for Immunocompromised

The Food and Drug Administration on Thursday approved the third dose of Pfizer-BioNTech and Moderna’s coronavirus vaccines for some people with compromised immune systems, giving doctors more leeway to protect those who have failed to respond adequately to an initial series of vaccinations .

The approval, in the form of updates to the existing emergency approvals, for the two vaccines is for people who have received solid organ transplants and others with similarly compromised immune systems, the FDA said.

The agency’s decision came a day before the Centers for Disease Control and Prevention’s independent advisory committee was due to review and vote on whether to recommend the move. The committee will likely give its approval, and the CDC would follow suit with its own approval of the additional doses.

“The FDA is particularly aware that immunocompromised people are at particular risk for serious illness,” said Dr. Janet Woodcock, acting FDA commissioner, in a statement. “After a thorough review of the available data, the FDA determined that this small, vulnerable group could benefit from a third dose of the Pfizer BioNTech or Moderna vaccines.”

The approval of the third dose marks a busy next stage for federal vaccine authorities – and a new phase in the country’s vaccination campaign. The agency is expected to approve Pfizer-BioNTech’s vaccine by early next month. This will most likely trigger a wave of vaccination requests from companies and organizations that have waited to be vaccinated until the FDA has fully cleared a vaccine.

At the same time, government scientists and regulators are wrestling over whether more Americans will need booster vaccinations, a hotly debated move that many scientists argue is not yet backed by data. Other countries like Israel and Germany have introduced booster policies.

“Other people who are fully vaccinated are adequately protected and do not currently need an additional dose of the Covid-19 vaccine,” said Dr. Woodcock in her statement on Thursday, adding that the agency is “actively engaged in a science-based, rigorous process with our federal partners to consider whether an additional dose might be required in the future.”

The United States is the youngest country to start offering a third dose to people with weaker immune systems. France has been offering extra doses of vaccine to certain people with weak immune responses since April, and Germany and Hungary have recently followed suit.

About 3 percent of Americans have weakened immune systems for a variety of reasons, from a history of cancer to taking certain medications, such as steroids.

The FDA’s decision to limit the category of immunocompromised individuals to receive the additional dose was awaited. Many scientists argue that the immunocompromised population is too diverse to consistently recommend additional shots of the coronavirus vaccine. Some, despite their conditions, can be protected by the standard vaccine dose. Others may be poorly shielded by the vaccines but may not benefit from additional vaccination.

Studies suggest that patients such as organ transplant recipients are in between – often showing a poor immune response to the standard vaccination schedule but benefiting from a third vaccination. A recent randomized, placebo-controlled study by Canadian researchers found that a third dose of the Moderna vaccine improved the immune response of the people in this group.

Categories
Health

F.D.A. Aiming to Velocity Vaccine Booster Shot for Immunocompromised Sufferers

F.D.A. Aiming to Speed Extra Vaccine Doses for Immunocompromised Patients

The Food and Drug Administration is accelerating efforts to approve additional doses of the coronavirus vaccines for Americans with compromised immune systems, a change that reflects growing concern within the Biden government about these at-risk patients as the contagious Delta variant rises nationwide.

The regulatory move would mean that people with an impaired immune response who need additional vaccination, such as certain cancer patients, could receive legal vaccination. It’s a safer alternative than having patients looking for syringes on their own, as many are doing now, several experts said.

“The data is clear that they did not get a good response initially” and require additional doses, said Dr. Anthony S. Fauci, White House senior medical advisor on the pandemic, in an interview Friday.

Compared to other Americans, “there are much, much more compelling reasons to do this sooner rather than later,” he said.

The benefits of vaccinating these patients can extend well beyond this group. Persistent infection with the coronavirus in immunocompromised people can lead to more communicable or virulent variants, according to the latest research. Protecting these patients can help prevent variants from occurring.

Officials from the Centers for Disease Control and Prevention and the FDA had been reviewing special programs to give immunocompromised patients additional vaccinations. Now, if scientific data from the CDC supports such a move, the FDA intends to possibly change the emergency approval of the vaccine, manufactured by Moderna, as early as next week, according to two people who are aware of the discussions.

The CDC could then recommend extra injections to certain patients with poor immune responses if their advisory committee suggests, officials said. The government’s change in strategy was first reported by the Washington Post.

The FDA is also considering changing the emergency clearances for the vaccines manufactured by Johnson & Johnson and Pfizer-BioNTech, according to those familiar with the discussions. Johnson & Johnson has not yet applied for full approval of its vaccine and a change in its approval is considered unlikely.

And if the FDA grants full approval to the Pfizer BioNTech vaccine soon as expected, a change to the emergency approval may be unnecessary. Doctors are then free to simply prescribe an additional injection for immunocompromised patients.

“If you tell me that full approval is expected by February, I would say that it is a long time for immunocompromised people,” said Dr. Dorry Segev, a transplant surgeon at Johns Hopkins University. “But the next month will bring us a lot of data.”

Dr. At the beginning of the week, Fauci made a distinction between booster shots for people who are fully vaccinated but may have declining immunity – for which the scientific justification is not yet clear – and extra vaccinations for people with weakened immune systems. Research shows that at least some of the latter group require additional doses.

The World Health Organization (WHO) on Wednesday condemned the move towards booster vaccinations for fully vaccinated people in rich countries, saying that poor countries urgently need the extra doses. But officials went out of their way to add that this criticism did not apply to additional doses for people with compromised immune systems who may not have been fully protected to begin with.

France has been offering additional doses of vaccine to certain people with weak immune responses since April, and Germany and Hungary have recently followed suit. In many European countries, however, the strategy is not limited to these patients, but also includes, for example, older adults or those who have received vaccines from AstraZeneca or Johnson & Johnson.

In the United States, at least 3 percent of the population is immunocompromised due to medical reasons such as some cancers, organ transplants, chronic liver disease, kidney failure and dialysis, or from commonly prescribed drugs such as rituxan, steroids, and methotrexate.

Updated

Aug. 6, 2021, 7:54 p.m. ET

With the rise of the Delta variant, some of these patients and their doctors have asked federal agencies to open a regulatory pathway for additional doses. Although CDC advisors had long appeared to have endorsed the idea, the FDA had not yet done so.

Older adults and people with certain conditions that suppress the immune system are routinely given extra doses of the influenza and hepatitis B vaccines. This experience provides a good justification for offering extra doses to some older adults and people whose immune responses are subdued, said Dr Balazs Halmos, oncologist at Montefiore Medical Center in the Bronx.

“It makes sense for me to be very proactive,” said Dr. Halmos. “I would like the FDA to take a swift position and possibly pursue these countries on their proactive approach.”

However, other experts are more prudent. Scientists are not yet sure which groups of immunocompromised people will benefit from an additional dose.

“I think you can justify both positions,” said Dr. Helen Boucher, an infectious disease doctor at Tufts Medical Center. “Germany is justified, but I also have the feeling that we are entitled to hold back because the information is far from perfect.”

Dr. Boucher says she has empathy for immunocompromised patients. But “the bottom line is we need more information,” she added.

Understand the state of vaccine mandates in the United States

This information has trickled in far too slowly for some Americans.

Deborah Rogow, 70, has multiple myeloma and is concerned about the spread of the contagious Delta variant. Ms. Rogow said it would have been ideal if a doctor would prescribe an additional dose if needed.

She is now alone, so Ms. Rogow plans to have a third dose of the Moderna vaccine at a pharmacy in Santa Barbara, California next week. The Moderna vaccine is still a long way from full approval, she noted, but she didn’t want a Pfizer BioNTech dose without more data on mixing the two vaccines.

“I would have definitely appreciated if I could have told my doctor that it was,” she said. “But it’s a little late.”

Extra doses may help some people with weak immune systems, but others may show little improvement and still others may not need extra doses at all. In a study of organ transplant recipients, only a third of patients who received a third dose showed any benefit.

“I wish we had a more rational process of identifying people within these categories who actually need it or not,” said Deepta Bhattacharya, an immunologist at the University of Arizona.

There are safety concerns about boosting immunity in patients whose responses are suppressed for a reason. One patient in the transplant study experienced mild rejection of her transplanted heart and recovered after receiving a third dose, said Dr. Segev, who led the research. People with autoimmune diseases can have flare-ups if their immunity is boosted.

“You walk this fine line between wanting to suppress the immune system and having the immune system activated in order to get a good vaccine response,” said Dr. Segev.

There is also not much long-term data on people who have received additional doses, he noted: “I don’t think there’s strong evidence that a third dose is still safe – there is encouraging evidence.”

In the meantime, he suggests that people with weak immune systems are safest to get an extra dose of vaccine if they participate in research studies where they can be closely monitored.

The coronavirus persists in some immunocompromised people for much longer than usual and, according to a study published in the New England Journal of Medicine on Thursday, has the potential to make major evolutionary leaps.

Some variants that are now floating around could have originated this way, researchers said, and leaving people with compromised immune systems unprotected could open the door to more dangerous variants.

Categories
Health

F.D.A. Aiming to Velocity Additional Vaccine Doses for Immunocompromised Sufferers

F.D.A. Aiming to Speed Extra Vaccine Doses for Immunocompromised Patients

The Food and Drug Administration is accelerating efforts to approve additional doses of the coronavirus vaccines for Americans with compromised immune systems, a change that reflects growing concern within the Biden government about these at-risk patients as the contagious Delta variant rises nationwide.

The regulatory move would mean that people with an impaired immune response who need additional vaccination, such as certain cancer patients, could receive legal vaccination. It’s a safer alternative than having patients looking for syringes on their own, as many are doing now, several experts said.

“The data is clear that they did not get a good response initially” and require additional doses, said Dr. Anthony S. Fauci, White House senior medical advisor on the pandemic, in an interview Friday.

Compared to other Americans, “there are much, much more compelling reasons to do this sooner rather than later,” he said.

The benefits of vaccinating these patients can extend well beyond this group. Persistent infection with the coronavirus in immunocompromised people can lead to more communicable or virulent variants, according to the latest research. Protecting these patients can help prevent variants from occurring.

Officials from the Centers for Disease Control and Prevention and the FDA had been reviewing special programs to give immunocompromised patients additional vaccinations. Now the FDA wants to change the emergency approvals of at least two of the vaccines if data from the CDC supports such a move, according to two people who are aware of the discussions.

The move, expected this month, was first reported by the Washington Post.

Full approval of the Pfizer BioNTech vaccine is expected in early September, maybe even earlier. “If you tell me that full approval is expected by February, I would say that it is a long time for immunocompromised people,” said Dr. Dorry Segev, a transplant surgeon at Johns Hopkins University. “But the next month will bring us a lot of data.”

Dr. At the beginning of the week, Fauci made a distinction between booster vaccinations for people who are fully vaccinated but may have declining immunity, for which the scientific justification is not yet clear, and extra vaccinations for people with weakened immune systems. Research shows that at least some of the latter group require additional doses.

The World Health Organization (WHO) on Thursday condemned the move towards booster vaccinations for fully vaccinated people in rich countries, saying that poor countries urgently need the extra doses. But officials went out of their way to add that this criticism did not apply to additional doses for people with compromised immune systems who may not have been fully protected to begin with.

France has been offering third doses to certain people with weak immune responses since April, and recently Germany and Hungary have followed suit. In many European countries, however, the strategy is not limited to these patients, but also includes, for example, older adults or those who have received vaccines from AstraZeneca or Johnson & Johnson.

In the United States, at least 3 percent of the population is immunocompromised due to medical reasons such as some cancers, organ transplants, chronic liver disease, kidney failure and dialysis, or from commonly prescribed drugs such as rituxan, steroids, and methotrexate.

With the rise of the Delta variant, some of these patients and their doctors have begged federal agencies to open a regulatory pathway for the third dose. Although CDC advisors had long appeared to have endorsed the idea, the FDA had not yet done so.

Updated

August 6th, 2021, 4:00 p.m. ET

Older adults and people with certain conditions that suppress the immune system are routinely given extra doses of the influenza and hepatitis B vaccines. This experience provides a good justification for offering extra doses to some older adults and people whose immune responses are subdued, said Dr Balazs Halmos, oncologist at Montefiore Medical Center in the Bronx.

“It makes sense for me to be very proactive,” said Dr. Halmos. “I would like the FDA to take a swift position and possibly pursue these countries on their proactive approach.”

However, other experts are more prudent. Scientists are not yet sure which groups of immunocompromised people will benefit from a third dose.

“I think you can justify both positions,” said Dr. Helen Boucher, an infectious disease doctor at Tufts Medical Center. “Germany is justified, but I also have the feeling that we are entitled to hold back because the information is far from perfect.”

Dr. Boucher says she has empathy for immunocompromised patients. But “the bottom line is we need more information,” she added.

This information has trickled in far too slowly for some Americans.

Deborah Rogow, 70, has multiple myeloma and is concerned about the spread of the contagious Delta variant. Ms. Rogow said it would have been ideal if a doctor would prescribe a third dose if necessary.

Understand the state of vaccine mandates in the United States

She is now alone, so Ms. Rogow plans to have a third dose of the Moderna vaccine at a pharmacy in Santa Barbara, California next week. The Moderna vaccine is still a long way from full approval, she noted, but she didn’t want a Pfizer BioNTech dose without more data on mixing the two vaccines.

“I would have definitely appreciated if I could have told my doctor that it was,” she said. “But it’s a little late.”

Extra doses may help some people with weak immune systems, but others may show little improvement even after a third dose, and still others may not need extra doses at all. In a study of organ transplant recipients, only a third of patients who received a third dose showed a benefit.

“I wish we had a more rational process of identifying people within these categories who actually need it or not,” said Deepta Bhattacharya, an immunologist at the University of Arizona.

There are safety concerns about boosting immunity in patients whose responses are suppressed for a reason. One patient in the transplant study refused her heart after receiving a third dose, said Dr. Segev, who led the research. People with autoimmune diseases can have flare-ups if their immunity is boosted.

“You walk this fine line between wanting to suppress the immune system and having the immune system activated in order to get a good vaccine response,” said Dr. Segev.

There isn’t a lot of long-term data on people who received a third dose either, he noted: “I don’t think there is strong evidence that a third dose is still safe – there is encouraging evidence.”

In the meantime, he suggests that the safest way for people with weak immune systems to get a third dose is to take part in research studies where they can be closely monitored.

The coronavirus persists in some immunocompromised people for much longer than usual and, according to a study published in the New England Journal of Medicine on Thursday, has the potential to make major evolutionary leaps.

Some variants that are now floating around could have originated this way, researchers said, and leaving people with compromised immune systems unprotected could open the door to more dangerous variants.