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FDA authorizes Covid antibody treatment as preventive after exposure

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“The unvaccinated or people with weak immune systems at high risk of severe disease can receive an injection if exposed to an infected person.

People at considerable risk of developing severe Covid-19, including millions of Americans with compromised immune systems, now have the option of receiving a preventive monoclonal antibody treatment if they have been or are at risk of being exposed to the coronavirus.

The Food and Drug Administration’s action on Friday brings hope to the estimated 3 percent of Americans who are immunocompromised, including those with autoimmune diseases, HIV patients, cancer patients and organ transplant recipients, who may still be vulnerable to Covid even after being fully vaccinated.

This is the first time an injectable coronavirus antibody treatment has been approved for use as a prevention of Covid after someone has been exposed to the virus.”

Read more, here.

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FDA decision on booster shots for immunocompromised expected soon

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“The nation’s top infectious disease doctor says he believes booster shots for the COVID-19 vaccine should be given “reasonably soon” to people with weakened immune systems.

“We need to look at them in a different light,” Dr. Anthony Fauci said on CNN’s ‘Fareed Zakaria GPS’ on Sunday. “We would certainly be boosting those people before we boost the general population that’s been vaccinated, and we should be doing that reasonably soon.”

The comments from the lead medical adviser to the White House on the pandemic are a change in messaging from about a month ago.”

Read more, here.

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Should You Recommend a COVID Booster to Patients?

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“Certain at-risk groups need to consider extra protection now.”

What’s the Current Booster Landscape?

“Several studies offer preliminary evidence on the benefits of boosters, especially for certain populations. A recent French study in JAMA showed that about 50% of 159 kidney transplant patients with low or no measurable antibodies after two doses of an mRNA vaccine mounted a response with a third shot, and with no serious side effects or rejection episodes. A study in the Annals of Internal Medicine also showed the benefits of a third dose in solid organ transplant patients. Pfizer data (that has not yet been peer reviewed) show antibody levels rise 11-fold in patients ages 65 to 75 after a booster.

Around the world, some countries and localities have gotten an early start on boosting. Boosters are being offered to patients over 60 years old in Israel. France is giving a booster dose to the severely immunocompromised 4 weeks after the second dose, and Hungary, Turkey, Thailand, Bahrain, and the United Arab Emirates are starting booster programs. The Mississippi Health Department is now recommending physicians consider boosters for the immunocompromised.”

Read more, here.

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Getting the COVID-19 Vaccine, What Kidney Patients Need to Know

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Most doctors agree that the benefits of the COVID-19 vaccine for people with kidney disease at any stage, including those on dialysis and those with a kidney transplant, are much greater than the risk of serious complications from the virus than from the vaccine.

Dialysis patients who contract COVID-19 are at extremely high risk of short-term mortality, possibly higher than 20 percent.

The National Kidney Foundation, American Society of Nephrology, and American Society of Transplantation all recommend that people with kidney disease or kidney transplant be vaccinated for COVID-19.

Vaccines are one of the most effective tools to protect your health and prevent disease. Vaccines work with your body’s natural defenses so your body will be ready to fight a virus if you are exposed (also called immunity).”

Read more, here.

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Immunocompromised to unvaccinated: You’re still a community

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3 Clark County women hope unvaccinated people stop and consider those who are at high risk of serious complications from COVID-19

“As people across the United States continue to flout the COVID-19 vaccine and cases of the delta variant surge, those living with compromised immune systems have a dire plea: consider the safety of others.

Jennifer Browning, Nicole Arneson and Laura Ellsworth are three friends living in Clark County who have all had kidney transplants. For them, life during the pandemic means strictly following the same COVID measures mandated for the general public before a vaccine ever became available.

“We don’t do the things that vaccinated people are doing and because we’ve been told by our medical providers that you need to continue to live as if you’ve been unvaccinated,” said Ellsworth.”

Watch the interview here.

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Call in the T-Cell Cavalry to Fight COVID in the Immunocompromised

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“Last year was one of collective confinement. The majority of us shuttered our doors to visitors, worked from home, and ventured out sparingly in hopes of evading the grasp of COVID-19. Now in 2021, thanks to vaccination rollout, those who have been vaccinated are hopefully on the path to normalcy. But not everyone is so fortunate. For some, 2021 will bring more isolation and loneliness than ever before, which is hard to imagine. I’m talking about immunocompromised adults and children. While much of the rest of the populace clinks glasses, hugs loved ones, and joins parties, immunocompromised individuals do not have the security of an effective vaccine, and for their health and safety will maintain their distance and watch the social revelry from the sidelines.”

Read more, here.

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If You’ve Done This, Your Risk of COVID After Vaccination Is 82 Times Higher

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“A study published July 23 in the Transplantation journal looked at COVID infections among transplant recipients. The researches analyzed data from more than 18,000 fully vaccinated people who had transplants for large organs from 17 transplant centers across the U.S. There were 151 breakthrough infections among the patients studied. According to the researchers, the risk of getting COVID after vaccination is 82 times higher for people who have had a transplant.

Out of the transplant breakthrough infections, 87 people were also hospitalized and 14 died. According to the study, this translates to a 485 times higher risk of breakthrough infection with associated hospitalization and death for transplant recipients. Per the CDC, most people who get breakthrough infections should not expect severe complications.

Study co-author Dorry Segev, MD, a transplant surgeon with Johns Hopkins University, told Science magazine that this is the first study to provide clinical evidence across multiple hospitals that transplant recipients are less protected by the vaccine.”

Read the full article, here.

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CDC Urges Vaccinated People To Mask Up Indoors In Places With High Virus Transmission

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“The Centers for Disease Control and Prevention revised its guidance on wearing masks Tuesday. In a reversal of its earlier position, the agency is now recommending that some fully vaccinated people wear masks indoors if they live in areas with significant or high spread.

Currently, much of the country falls into that category — with the exception of the Northeast and parts of the Upper Midwest. The CDC provides this link if you want to see the area of spread in the county where you live.

“This was not a decision that was taken lightly,” said Dr. Rochelle Walensky, the CDC’s director, acknowledging that people are “tired and frustrated.”

But Walensky pointed to new data showing that while vaccinated people still account for a small amount of risk, in rare cases they can get infected and spread the virus to others.”

Read more, here.

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Antibody Response After a Third Dose of the Vaccine in Kidney Transplant Recipients With Minimal Serologic Response to 2 Doses

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“Studies have reported low seroconversion rates (58% after the second dose) in solid organ transplant recipients who received a messenger RNA (mRNA) SARS-CoV-2 vaccine.1,2 Based on this evidence, the French National Authority for Health issued a recommendation in April 2021 to administer a third vaccine dose in immunosuppressed patients who did not respond after 2 doses. We examined the antibody responses of kidney transplant recipients who did not respond to 2 doses and received a third dose (100 μg) of the mRNA-1273 vaccine (Moderna).

Methods

All kidney transplant recipients followed up in the outpatient Kidney Transplantation Department of Strasbourg University Hospital between January 20, 2021, and June 3, 2021, with a negative history for COVID-19 and SARS-CoV-2 antispike IgG levels less than 50 arbitrary units (AU)/mL on the day of the first vaccine injection and 1 month after the second dose were included. All patients received a third vaccine dose between April 9, 2021, and May 12, 2021. The study protocol was approved by the local ethics committee and written informed consent was obtained.”

Learn more, here.

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CDC advisory committee voices support for immunocompromised people getting boosters

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During the last year and a half, immunocompromised people have been at extremely high risk for the virus. And for many, the COVID vaccine didn’t change that.

That’s why a group of independent Centers for Disease Control and Prevention experts at a Thursday meeting largely voiced support for allowing immunocompromised people to talk to their doctors about getting a third shot, a booster, that could increase their antibody response to vaccines.

Read more, here.

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