Covid-19 vaccine: Tens of millions of Americans might not have had an adequate response to shot

Tatelman had recently received her second dose of Pfizer’s Covid-19 vaccine and the end of the pandemic was finally in sight. Perhaps she could soon play with her grandchildren and return to her volunteer work helping foster children. Maybe in a few months, when her husband turned 75, they could go to a restaurant to celebrate.

When she left, she met her family doctor – who killed her very quickly.

To treat inflamed blood vessels in her lungs, Tatelman, 73, takes a drug that suppresses her immune system. Her doctor had recently read medical studies that suggested the vaccine might not work well in some people taking medications like yours.

He asked her to have a blood test to see if the vaccine had worked – if she had antibodies to the virus.

She took the test and had no detectable antibodies to Covid-19.

“It was a complete shock,” she said.

Tatelman was now full of questions for her doctor. Did their low antibody levels mean the vaccine wasn’t working? Should she have a third dose of the vaccine? Should she reduce the drugs that suppress her immune system so the vaccine can work better? Was there anything else she could try to make a Covid-19 vaccine work for her?

There is very little data to help Tatelman and her doctor answer these questions. Millions of other Americans are also taking immunosuppressants, which could weaken the effects of the Covid-19 vaccine, and they are entering new territory, for good reason fear that their vaccinations may not have worked.

When their vaccinations haven’t worked, they rely on the rest of the population to get vaccinated.

This should inspire people who haven’t been vaccinated to roll up their sleeves, said Dr. Francis Collins, director of the National Institutes of Health, told CNN on Thursday.

“Even if you think you don’t need this, consider this as a donation of your own goodwill to those who are more vulnerable,” said Collins. “That’s the best hope you have.”

Vaccines have never been tested in people with immunodeficiency

While there isn’t a clear number on how many Americans are on medication that could prove to be a challenge for the Covid-19 vaccine, it is a new one study can help with the assessment. In an article published last month, Dr. Beth Wallace, a rheumatologist and her team at the University of Michigan, ran a database of more than 3 million Americans to see how many immunosuppressants were taking.

Based on these data, Wallace estimates that about 6 million Americans are taking immunosuppressive drugs that could interfere with the vaccine.

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She said that was conservative as her database didn’t include people taking Medicare who were more likely to take such drugs. Their estimate also did not include people taking oral corticosteroids, which in high doses and over long periods of time could be a problem for the vaccine.

When pharmaceutical companies tested the Covid-19 vaccines in clinical trials last year, they specifically excluded people taking immunosuppressants.

That left these patients “stuck in a cucumber” without knowing whether the vaccines would work for them, said Dr. Kathryn Stephenson, Infectious Disease Specialist and Assistant Professor at Harvard Medical School.

After the vaccine was released to the public, researchers began to check how well it worked – or not – in immunocompromised people.

Some of the news was good.

A small study at the Icahn School of Medicine on Mount Sinai in New York City showed that patients taking certain drugs to treat ulcerative colitis and Crohn’s disease had “robust” antibody responses to the Pfizer and Moderna Covid-19 vaccine. The study was published on a preprint server.
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A study by researchers at the Johns Hopkins University School of Medicine showed that organ transplant patients fared nowhere near as well. In the study of more than 650 organ recipients – who take drugs to suppress their immune systems so they don’t reject their new organs – 46% had no antibody response after two doses of Pfizer or Moderna.
In another study, Washington University School of Medicine, looking at patients with conditions such as lupus, psoriasis, and inflammatory bowel disease, found that two types of medication they were taking – glucocorticoids and B-cell depleters – “severely” impaired the ability of the Pfizer, and Moderna -Vaccines to provoke an immune response.

“Nobody really expected the vaccine responses to look this bad,” said Stephenson, director of clinical trials at the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center, of the trials as a group.

She said every day immunocompromised patients flood her office with calls and emails asking what to do.

“It has become such a common question that we have perturbed patients so many times over the past week in three different meetings and conferences and seminars that we all discussed it and tried to strategize what to tell them,” said Stephenson.

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For the time being, she and her colleagues tell patients that it is not worth checking their antibodies after vaccination because it is difficult at this point to know exactly what level of antibodies would offer protection against Covid-19.

The US Food and Drug Administration Drug and the US Centers for Disease Control and Prevention also advise against checking for antibodies. Various medical societies such as American College of Rheumatology, the American Society for Transplantation, and the International Organization for the Study of Inflammatory Bowel Diseases, essentially saying the antibody tests won’t fully answer patients’ questions about whether their vaccinations have worked.
“For patients who do not have antibodies or who do not produce such a strong antibody response, we do not yet know whether they are protected,” said a statement by the Leukemia and Lymphoma Society. “There are other types of immunity that can provide protection. Immune cells known as T cells may play a role in our immune system’s ability to protect us from COVID-19.”
The CDC further advises against giving people with immunodeficiency an extra dose of the vaccine.

But some patients don’t listen.

Patients who receive additional doses themselves

Dr. Robert Montgomery is one of them.

Montgomery is the director of the NYU Langone Transplant Institute, where he himself receive A heart transplant in 2018.

After a test showed he had “virtually no response” to two doses of Pfizer’s Covid-19 vaccine, Montgomery said he was “deeply disappointed” and received a dose of Johnson & Johnson’s vaccine.

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He said getting a third dose was “uncharted territory” but he did it because he was exposed to patients with Covid-19 and he has seen immunocompromised transplant patients like himself often get very sick when dealing with the virus infect.

He says it worked: after he got the third dose of the vaccine, his antibodies rose.

Things weren’t going so well for Tatelman, the grandmother in Boston.

Like Montgomery, she received a dose of the vaccine from J&J to supplement her two doses of Pfizer.

A few days ago she learned that she still had no detectable antibodies against Covid-19 with this third dose.

“My doctor sent me a message that said, ‘I’m sure you are disappointed’ and I said, ” Disappointed ‘is nowhere near how I feel,” “Tatelman said. “It was incredibly depressing.”

Look to the future

The National Institutes of Health are looking to find out which approaches might work best when the vaccine fails in people with compromised immune systems.

“[We’re] We need to figure out what to do to adequately protect these people, “Dr. Anthony Fauci, director of the National Institute of Allergies and Infectious Diseases at the NIH, told CNN.

According to Dr. Daniel Rotrosen, director of the Department of Allergology, Immunology and Transplantation at NIAID, the researchers hope to begin recruiting about 200 vaccinated kidney transplant patients to participate in a study this summer.

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If tests show the Covid-19 vaccine isn’t working well, that study participant will be offered an extra dose of vaccine to see if it helps, Redrosen added.

Some doctors are skeptical that this is the case. They put more hope in giving immunocompromised patients regular doses of an antibody drug currently used to treat Covid-19.

Regeneron, a biotechnology company that makes a monoclonal Covid-19 antibody drug, is considering research proposals to prophylactically test its drugs on immunocompromised patients, according to a company spokeswoman.

“We agree that this group of patients could benefit from REGEN-COV,” wrote Alexandra Bowie in an email to CNN, referring to the company’s drug.

As these studies begin, Tatelman feels like she has never been vaccinated and has to rely on other people whose vaccines have worked.

She knows she shouldn’t hug her younger grandchildren who aren’t vaccinated. She has not resumed volunteering with foster children. Wednesday was her husband’s 75th birthday and they didn’t go to a restaurant to celebrate.

“Even close friends of mine don’t understand why I don’t go to a restaurant with them. They say, ‘Of course you can go to a restaurant’ and I say, ‘Absolutely, no, I can’t.” said. “Where am I safe? Where am i not sure? There are so many things that I just don’t know. ”

Correction: This story was made with revised numbers by Dr. Beth Wallace updated.

John Bonifield, Justin Lape, Michael Nedelman, and Lauren Mascaren contributed to this report.

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