EU authorities could decide “as a temporary measure” to use smaller doses of the vaccine to protect vulnerable people during the ongoing outbreak.
A smaller dose of the monkeypox vaccine appears to still be effective and can be used to stretch the current supply by five times, the European Medicines Agency said Friday, echoing a recommendation made earlier this month by the U.S. Food and Drug Administration.
The EU drug regulator said in a statement that injecting people with just one-fifth the regular dose of the smallpox vaccine made by Bavarian Nordic appeared to produce similar levels of antibodies against monkeypox as a full dose.
The approach calls for administering Bavarian Nordic’s vaccine with an injection just under the skin rather than into deeper tissue, a practice that may stimulate a better immune response. People still need to get two doses, about four weeks apart.
The EMA said national authorities could decide “as a temporary measure” to use smaller doses of the vaccine to protect vulnerable people during the ongoing monkeypox outbreak.
EU health commissioner Stella Kyriakides said the decision would allow the vaccination of five times as many people with the continent’s current supply.
“This ensures greater access to vaccination for citizens at risk and healthcare workers,” she said in a statement.
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Earlier this month, the U.S. FDA authorized a similar plan to extend the country’s monkeypox vaccine stocks. The technique has previously been used to stretch supplies of vaccines during other outbreaks, including yellow fever and polio.
The unusual recommendations from both regulators acknowledge the extremely limited global supplies of the Jynneos vaccine, originally developed against smallpox. Bavarian Nordic is the only company that makes it and it expects to have about 16 million doses available this year. On Thursday, the U.S. also announced a new agreement with a Michigan manufacturer to help speed production of 5.5 million vaccine vials recently ordered by the government.
The EMA authorized the vaccine in July based on experimental data that suggested it would work; the World Health Organization has estimated the shot is about 85% effective at preventing monkeypox.
Globally, there are more than 40,000 cases of monkeypox, of which about half are in Europe. Earlier this week, WHO chief Tedros Adhanom Ghebreyesus said there has been a 20% increase in cases reported in the last two weeks and that nearly all infections have been reported in men who are gay, bisexual or have sex with other men.
Tedros said WHO was in talks with vaccine manufacturers and countries to see if any might be willing to share doses. Africa has reported the highest number of suspected monkeypox deaths and although the disease has been endemic in parts of central and west Africa for decades, it has only a small supply of vaccines being used as part of a research study.
About 98% of monkeypox cases beyond Africa have been reported in men who are gay, bisexual or have sex with other men. WHO said there is no sign of sustained transmission beyond men who have sex with men, although a small number of women and children have also been sickened by the disease.
Monkeypox spreads when people have close, physical contact with an infected person’s lesions, their clothing or bedsheets. Most people recover without needing treatment, but the lesions can be extremely painful and more severe cases can result in complications including brain inflammation and death.
In the U.K., which at one point had the biggest outbreak outside Africa, officials said earlier this week they have seen signs the outbreak is slowing down.
CDC officials said between 26 million and 37 million adults haven’t had a single dose of any COVID vaccine.
U.S. adults who haven’t gotten any COVID-19 shots yet should consider a new option from Novavax — a more traditional kind of vaccine, health officials said Tuesday.
Regulators authorized the nation’s first so-called protein vaccine against COVID-19 last week, but the final hurdle was a recommendation from the Centers for Disease Control and Prevention.
“If you have been waiting for a COVID-19 vaccine built on a different technology than those previously available, now is the time to join the millions of Americans who have been vaccinated,” Dr. Rochelle Walensky, CDC’s director, said in a statement, endorsing an earlier decision from an influential advisory panel.
Most Americans have gotten at least their primary COVID-19 vaccinations by now, but CDC officials said between 26 million and 37 million adults haven’t had a single dose — the population that Novavax, for now, will be targeting.
“We really need to focus on that population,” said CDC adviser Dr. Oliver Brooks, past president of the National Medical Association. Hopefully, the vaccine “will change them over from being unvaccinated to vaccinated.”
While it’s unclear how many will be persuaded by a more conventional option, “I’m really positive about this vaccine,” agreed fellow adviser Dr. Pablo Sanchez of Ohio State University.
THE NOVAVAX DIFFERENCE
All of the vaccines used in the U.S. train the body to fight the coronavirus by recognizing its outer coating, the spike protein — and the first three options essentially turn people’s cells into a temporary vaccine factory. The Pfizer and Moderna vaccines deliver genetic instructions for the body to make copies of the spike protein. The lesser-used Johnson & Johnson option uses a cold virus to deliver those instructions.
In contrast, the Novavax vaccine injects copies of the spike protein that are grown in a lab and packaged into nanoparticles that to the immune system resemble a virus. Another difference: An ingredient called an adjuvant, that’s made from the bark of a South American tree, is added to help rev up that immune response.
Protein vaccines have been used for years to prevent other diseases including hepatitis B and shingles.
HOW WELL IT WORKS
Large studies in the U.S., Mexico and Britain found two doses of the Novavax vaccine were safe and about 90% effective at preventing symptomatic COVID-19. When the delta variant emerged last summer, Novavax reported a booster dose revved up virus-fighting antibodies that could tackle that mutant.
Typical vaccine reactions were mild, including arm pain and fatigue, but regulators did warn about the possibility of a rare risk, heart inflammation, that also has been seen with the Pfizer and Moderna vaccines, mostly in teen boys or young men.
But early on, manufacturing problems delayed the Novavax vaccine — meaning the shots were studied long before the omicron variant hit, so it’s not clear how well they hold up against the immune-evading mutant.
Still, Novavax points to lab testing that shows the first two shots do spur production of virus-fighting antibodies that are cross-protective against omicron, including the BA.5 subtype that’s currently the nation’s top threat. A booster dose further revved up cross-protective antibodies.
HOW TO USE NOVAVAX SHOTS
The CDC’s advisers unanimously endorsed the two-shot primary series. But several noted that it was important for regulators to clear a booster by the time, five or so months after their last dose, that Novavax recipients will need one.
Also, the two doses typically are given three weeks apart. But CDC officials said that like with other COVID-19 vaccines, it’s possible to wait up to eight weeks for the second dose — except for people at the highest risk, who need protection quickly.
WHAT HAPPENS NEXT
Walensky signed off on recommendations for adults to get the first two Novavax doses. In its first purchase, the U.S. government bought 3.2 million doses and vaccinations are expected to begin in the next few weeks.
The Novavax vaccine also is used in Europe, Canada, Australia, South Korea and other countries. Many allow booster doses, and European regulators recently cleared the shots to given as young as age 12.
The Maryland-based company likewise expects U.S. authorization of a booster dose and teen vaccinations to follow fairly soon.
And like other vaccine makers, Novavax is testing shots updated to better match the newest omicron subtypes — in anticipation of another round of boosters this fall and winter.
“We’ve taken the stance that we’re not going to ask employees to get vaccinated because of the sheer multiple who don’t want to get vaccinated,” said Mr. Lucanera, who is vaccinated. “If we demand for a lot of them to get vaccinated to come back to work, we are afraid they’re not going to come back.”
But as Covid cases have escalated, some of his unvaccinated workers have gotten sick. To cover their shifts, he has had to pay others overtime, which has been a drain on the company’s bottom line. Recently, he turned down a contract with a school district because he didn’t have enough officers to fulfill the request.
“It almost seems that whoever already doesn’t have it by this time has made up their minds,” Mr. Lucanera said. “If I put my foot down, will it hurt the company in terms of creating a bigger problem than we have?”
Still, for many unvaccinated workers, finding a new job is often not a desirable, or feasible, option.
Benjamin Rose, 28, who works at a global bank in the Chicago area, said his decision not to get the shot was “really just a cost-benefit analysis.” He contracted Covid-19 six months ago, he said, and a recent blood test showed he still had antibodies.
But because he is not vaccinated, his company requires that he work remotely even as it has begun to allow vaccinated employees back in the office. While he said he enjoyed the flexibility of remote work and was not opposed to vaccine mandates, he also did not want to feel like he was being coerced.
“I find it a little irksome how big corporations, the media and the government are all sort of this united front in pushing the vaccine so hard,” Mr. Rose said.
At the same time, he said, if his company instituted a vaccine mandate, he would likely comply.
“It’s not the hill I’m going to die on,” he said. “If it really became something that was going to strongly affect my career, I would probably just get it.”
The vaccines produced similar responses in all three groups of women, eliciting both antibody and T-cell responses against the coronavirus, the scientists found. Of particular note, experts said, was the fact that the shots produced high levels of neutralizing antibodies, which can prevent the virus from entering cells, in both pregnant and nonpregnant women.
“Clearly, the vaccines were working in these people,” said Akiko Iwasaki, an immunologist at Yale University who was not involved in the research. “These levels are expected to be quite protective.”
The researchers also found neutralizing antibodies in the breast milk of vaccinated mothers and in umbilical cord blood collected from infants at delivery. “Vaccination of pregnant people and lactating people actually leads to transfer of some immunity to their newborns and lactating infants,” said Dr. Ai-ris Y. Collier, a physician-scientist at Beth Israel who is the first author of the paper.
The results are “really encouraging,” Dr. Iwasaki said. “There is this added benefit of conferring protective antibodies to the newborn and the fetus, which is all the more reason to get vaccinated.”
The scientists also measured the women’s immune responses to two variants of concern: B.1.1.7, which was first identified in Britain, and B.1.351, which was first identified in South Africa. All three groups of women produced antibody and T-cell responses to both variants after vaccination, although their antibody responses were weaker against the variants, especially B.1.351, than against the original strain of the virus, according to the study.
“These women developed immune responses to the variants, although the asterisk is that the antibody responses were reduced several-fold,” said Dr. Dan Barouch, a study author and virologist at Beth Israel.(Dr. Barouch and his colleagues developed the Johnson & Johnson vaccine, which was not included in this study.)
“Overall, it’s good news,” he added. “And it increases the data that suggests that there is a substantial benefit for pregnant women to be vaccinated.”
For weeks, New Yorkers have witnessed the alarming rise of a homegrown variant of the coronavirus that has kept the number of cases in the city stubbornly high. City officials have repeatedly warned that the variant may be more contagious and may dodge the immune response.
On that second point, at least, they can now breathe easier: Both the Pfizer-BioNTech and Moderna vaccines will effectively prevent serious illness and death from the variant, two independent studies suggest.
Antibodies stimulated by those vaccines are only slightly less potent at controlling the variant than the original form of the virus, both studies found.
“We’re not seeing big differences,” said Michel Nussenzweig, an immunologist at Rockefeller University in New York and a member of the team that published one of the studies on Thursday.
possible explanation: Antibodies from vaccinated people are distributed across a broader range of parts of the virus, so no single mutation has a big impact on their effectiveness — making vaccines a better bet against variants than immunity from natural infection.
The variant first identified in New York, known to scientists as B.1.526, raced through the city after its initial discovery in November. It accounted for one in four diagnosed cases by November and nearly half of cases as of April 13. The variant that brought Britain to a standstill, B.1.1.7, is also circulating widely in New York. Together, the two add up to more than 70 percent of coronavirus cases in the city.
second study, Dr. Landau’s team found that the Pfizer and Moderna vaccines are only marginally less protective against the variant that devastated Britain and against forms of the variant discovered in New York that don’t contain the Eek mutation.
Several laboratory studies have shown that antibodies induced by the Pfizer and Moderna vaccines are slightly less powerful against a third variant, one identified in South Africa, which also contains Eek. Other vaccines fared worse. South Africa suspended use of the AstraZeneca vaccine after clinical trials showed that the vaccine did not prevent mild or moderate illness from the variant that was circulating there.
“It already started out as a lower level in terms of the immunity that it generated,” Dr. Nussenzweig said of the AstraZeneca vaccine. Referring to the Pfizer and Moderna shots, he said, “We’re so lucky in this country to have these vaccines compared to the rest of the world.”
Florian Krammer, an immunologist at the Icahn School of Medicine at Mount Sinai who was not involved in either of the new studies, said he was more concerned about other countries’ vaccine programs than about the variants themselves.
“I am less concerned about variants than I was two months ago,” he said, but added: “I’m worried about countries that don’t have enough vaccine and that don’t have that vaccine rollout. I’m not worried anymore about the U.S., honestly.”
Dr. Landau’s team also tested monoclonal antibodies used to treat Covid-19 against the variants. They found that the cocktail of monoclonal antibodies made by Regeneron worked as well against the variant discovered in New York as against the original virus.
The studies are reassuring, but they indicate that the Eek mutation is one to watch, said Jesse Bloom, an evolutionary biologist at the Fred Hutchinson Cancer Research Center in Seattle.
“This could certainly be a step toward the virus becoming somewhat more resistant to infection- and vaccine-mediated immunity,” Dr. Bloom said. “I don’t think it’s something that people need to immediately become alarmed about, but it definitely impresses us as important.”
Dr. Bloom led the analysis comparing vaccine-induced antibodies with those produced by natural infection. He found that the most powerful antibodies bind to multiple sites in a key part of the virus. Even if a mutation affects the binding in one site in this region, antibodies that target the remaining sites would still be protective.
Antibodies induced by the vaccine cover many more sites across this region than those from natural infection — and so are less likely to be affected by a mutation in any one site.
The study looked only at antibodies stimulated by the Moderna vaccine, but the results are likely to be the same for the Pfizer-BioNTech vaccine, he added.
“This could potentially be a good thing as the virus is creating mutations,” Dr. Bloom said.
An unvaccinated health care worker set off a Covid-19 outbreak at a nursing home in Kentucky where the vast majority of residents had been vaccinated, leading to dozens of infections, including 22 cases among residents and employees who were already fully vaccinated, a new study reported Wednesday.
Most of those who were infected with the coronavirus despite being vaccinated did not develop symptoms or require hospitalization, but one vaccinated individual, who was a resident of the nursing home, died, according to the study released by the Centers for Disease Control and Prevention.
Altogether, 26 facility residents were infected, including 18 who had been vaccinated, and 20 health care personnel were infected, including four who had been vaccinated. Two unvaccinated residents also died.
The report underscores the importance of vaccinating both nursing home residents and health care workers who go in and out of the sites, the authors said. While 90 percent of the 83 residents at the Kentucky nursing home had been vaccinated, only half of the 116 employees had been vaccinated when the outbreak was identified in March of this year.
identified 627 coronavirus infections in 78 skilled nursing facilities in the city in February, but only 22 were found in individuals who were already fully vaccinated. Two-thirds of the cases in the vaccinated individuals were asymptomatic, the report found, but two residents were hospitalized, and one died.
The authors of the Chicago study said their findings demonstrate that nursing homes should continue to follow recommended infection control practices, such as isolation and quarantine, use of personal protective equipment and doing routine testing, regardless of vaccination status.
They also emphasized the importance of “maintaining high vaccination coverage among residents and staff members” in order to “reduce opportunities for transmission within facilities and exposure among persons who might not have achieved protective immunity after vaccination.”
New York City health officials estimate that nearly a quarter of adult New Yorkers were infected with the coronavirus during the catastrophic wave of last spring, and that the toll was even higher among Black and Hispanic residents.
The estimates, based on antibody test results for more than 45,000 city residents last year, suggest that Black and Hispanic New Yorkers were twice as likely as white New Yorkers to have had antibodies to the coronavirus — evidence of prior infection.
Hispanic New Yorkers had the highest rate, with about 35 percent testing positive for antibodies, according to the study, whose authors include officials and researchers at the city Health Department and the National Institute for Occupational Safety and Health. Among Black New Yorkers, 33.5 percent had antibodies. Among Asian New Yorkers, the rate was about 20 percent. For white New Yorkers, the rate was 16 percent.
Antibody surveys of segments of the population have become a useful way to gauge what percentage of people were infected and what groups were most at risk, especially since there was limited testing for the virus during the first wave.
The new paper, which has been accepted by the Journal of Infectious Diseases, has substantial limitations: Of the 45,000 New Yorkers in the study, fewer than 3,500 were Black, a major underrepresentation. And the participants were recruited partly through advertisements online, which the study’s authors acknowledge may have attracted people who believed they had been exposed to Covid-19.
But the study adds to experts’ understanding of the disproportionate toll that the pandemic has taken on Black and Latino people.
Its findings also come amid a push to vaccinate more people in the United States. A recent survey conducted by the Kaiser Family Foundation found that the number of Americans, particularly Black adults, who want to get vaccinated has continued to increase. According to an analysis last month by The New York Times, Black people were still being inoculated at half the rate of white people. The disparities are especially alarming as Black and Latino people and Native Americans have been dying at twice the rate of white people.
In New York City, about 44 percent of white adults have received at least one dose of a Covid-19 vaccine, while 26 percent of Black adults and 31 percent of Latino adults have, according to city data.
Experts and community leaders across the country say that over all, the lower vaccination rates are linked to technological and linguistic barriers and disparities in access to vaccination sites. Other factors include social media misinformation and a hesitancy to be vaccinated. Hesitancy among African-Americans, experts say, can be tied to a longstanding mistrust of medical institutions that have long mistreated Black people.
have comparatively fewer white workers.
“These were the people who did not have the luxury of being able to work virtually,” she said.
Dr. Kitaw Demissie, who is dean of the School of Public Health at SUNY Downstate Medical Center in Brooklyn and was not involved in the study, noted that household crowding may have also contributed to differing infection rates. Some predominately Latino neighborhoods which were particularly hard hit in the first wave had high rates of household crowding.
More than 32,000 people in New York City have died from Covid-19 in total, according to a New York Times database.
Scott Cohen was on a ventilator struggling for his life with Covid-19 last April when his brothers pleaded with Plainview Hospital on Long Island to infuse him with the blood plasma of a recovered patient.
The experimental treatment was hard to get but was gaining attention at a time when doctors had little else. After an online petition drew 18,000 signatures, the hospital gave Mr. Cohen, a retired Nassau County medic, an infusion of the pale yellow stuff that some called “liquid gold.”
In those terrifying early months of the pandemic, the idea that antibody-rich plasma could save lives took on a life of its own before there was evidence that it worked. The Trump administration, buoyed by proponents at elite medical institutions, seized on plasma as a good-news story at a time when there weren’t many others. It awarded more than $800 million to entities involved in its collection and administration, and put Dr. Anthony S. Fauci’s face on billboards promoting the treatment.
A coalition of companies and nonprofit groups, including the Mayo Clinic, Red Cross and Microsoft, mobilized to urge donations from people who had recovered from Covid-19, enlisting celebrities like Samuel L. Jackson and Dwayne Johnson, the actor known as the Rock. Volunteers, some dressed in superhero capes, showed up to blood banks in droves.
took a long time to measure its effectiveness. Eventually, studies did emerge to suggest that under the right conditions, plasma might help. But enough evidence has now accumulated to show that the country’s broad, costly plasma campaign had little effect, especially in people whose disease was advanced enough to land them in the hospital.
N.I.H. recently halted an outpatient trial of plasma because of a lack of benefit.
Doctors have used the antibodies of recovered patients as treatments for more than a century, for diseases including diphtheria, the 1918 flu and Ebola.
So when patients began falling ill with the new coronavirus last year, doctors around the world turned to the old standby.
In the United States, two hospitals — Mount Sinai in New York City and Houston Methodist in Texas — administered the first plasma units to Covid-19 patients within hours of each other on March 28.
Dr. Nicole M. Bouvier, an infectious-disease doctor who helped set up Mount Sinai’s plasma program, said the hospital had tried the experimental treatment because blood transfusions carry a relatively low risk of harm. With a new virus spreading quickly, and no approved treatments, “nature is a much better manufacturer than we are,” she said.
As Mount Sinai prepared to infuse patients with plasma, Diana Berrent, a photographer, was recovering from Covid-19 at her home in Port Washington, N.Y. Friends began sending her Mount Sinai’s call for donors.
thousands of Orthodox Jewish people were getting tested for coronavirus antibodies and showing up to donate. Coordinating it all was exhausting.
“April,” Mr. Lebovits recalled with a laugh, “was like 20 decades.”
Two developments that month further accelerated plasma’s use. With the help of $66 million in federal funding, the F.D.A. tapped the Mayo Clinic to run an expanded access program for hospitals across the country. And the government agreed to cover the administrative costs of collecting plasma, signing deals with the American Red Cross and America’s Blood Centers.
news releases announcing those deals got none of the flashy media attention that the billion-dollar contracts for Covid-19 vaccines did when they arrived later in the summer. And the government did not disclose how much it would be investing.
American Red Cross and America’s Blood Centers since last April.
“The convalescent plasma program was intended to meet an urgent need for a potential therapy early in the pandemic,” a health department spokeswoman said in a statement. “When these contracts began, treatments weren’t available for hospitalized Covid-19 patients.”
As spring turned to summer, the Trump administration seized on plasma — as it had with the unproven drug hydroxychloroquine — as a promising solution. In July, the administration announced an $8 million advertising campaign “imploring Americans to donate their plasma and help save lives.” The blitz included promotional radio spots and billboards featuring Dr. Fauci and Dr. Hahn, the F.D.A. commissioner.
provided access to its advertising agency, which created the look and feel for the Fight Is In Us campaign, which included video testimonials from celebrities.
although he later corrected his remarks following criticism from the scientific community.
the Infectious Diseases Society of America recommended that plasma not be used in hospitalized patients outside of a clinical trial. (On Wednesday, the society restricted its advice further, saying plasma should not be used at all in hospitalized patients.) In January, a highly anticipated trial in Britain was halted early because there was not strong evidence of a benefit in hospitalized patients.
narrowed the authorization for plasma so that it applied only to people who were early in the course of their disease or who couldn’t make their own antibodies.
Dr. Marks, the F.D.A. regulator, said that in retrospect, scientists had been too slow to adapt to those recommendations. They had known from previous disease outbreaks that plasma treatment is likely to work best when given early, and when it contained high levels of antibodies, he said.
“Somehow we didn’t really take that as seriously as perhaps we should have,” he said. “If there was a lesson in this, it’s that history actually can teach you something.”
pandemic exceptionalism” — had drained valuable time and attention from discovering other treatments.
“Pandemic exceptionalism is something we learned from prior emergencies that leads to serious unintended consequences,” she said, referring to the ways countries leaned on inadequate studies during the Ebola outbreak. With plasma, she said, “the agency forgot lessons from past emergencies.”
While scant evidence shows that plasma will help curb the pandemic, a dedicated clutch of researchers at prominent medical institutions continue to focus on the narrow circumstances in which it might work.
Dr. Arturo Casadevall, an immunologist at Johns Hopkins University, said many of the trials had not succeeded because they tested plasma on very sick patients. “If they’re treated early, the results of the trials are all consistent,” he said.
found that giving plasma early to older people reduced the progression of Covid-19. And an analysis of the Mayo Clinic program found that patients who were given plasma with a high concentration of antibodies fared better than those who did not receive the treatment. Still, in March, the N.I.H. halted a trial of plasma in people who were not yet severely ill with Covid-19 because the agency said it was unlikely to help.
With most of the medical community acknowledging plasma’s limited benefit, even the Fight Is In Us has begun to shift its focus. For months, a “clinical research” page about convalescent plasma was dominated by favorable studies and news releases, omitting major articles concluding that plasma showed little benefit.
the website has been redesigned to more broadly promote not only plasma, but also testing, vaccines and other treatments like monoclonal antibodies, which are synthesized in a lab and thought to be a more potent version of plasma. Its clinical research page also includes more negative studies about plasma.
Nevertheless, the Fight Is In Us is still running Facebook ads, paid for by the federal government, telling Covid-19 survivors that “There’s a hero inside you” and “Keep up the fight.” The ads urge them to donate their plasma, even though most blood banks have stopped collecting it.
Two of plasma’s early boosters, Mr. Lebovits and Ms. Berrent, have also turned their attention to monoclonal antibodies. As he had done with plasma last spring, Mr. Lebovits helped increase acceptance of monoclonals in the Orthodox Jewish community, setting up an informational hotline, running ads in Orthodox newspapers, and creating rapid testing sites that doubled as infusion centers. Coordinating with federal officials, Mr. Lebovits has since shared his strategies with leaders in the Hispanic community in El Paso and San Diego.
And Ms. Berrent has been working with a division of the insurer UnitedHealth to match the right patients — people with underlying health conditions or who are over 65— to that treatment.
“I’m a believer in plasma for a lot of substantive reasons, but if word came back tomorrow that jelly beans worked better, we’d be promoting jelly beans,” she said. “We are here to save lives.”’
For more than a year, Dr. Andrew Wollowitz has mostly been cloistered inside his home in Mamaroneck, N.Y.
As chief of emergency medicine at Montefiore Medical Center in the Bronx, Dr. Wollowitz, 63, was eager to help treat patients when the coronavirus began raging through the city last spring. But a cancer treatment in 2019 had obliterated his immune cells, leaving him defenseless against the virus, so he instead arranged to manage his staff via Zoom.
A year later, people in Dr. Wollowitz’s life are returning to some semblance of normalcy. His wife, a dancer and choreographer, is preparing to travel for work at Austria’s National Ballet Company. His vaccinated friends are getting together, but he sees them only when the weather is nice enough to sit in his backyard. “I spend very little time in public areas,” he said.
Like his friends, Dr. Wollowitz was vaccinated in January. But he did not produce any antibodies in response — nor did he expect to. He is one of millions of Americans who are immunocompromised, whose bodies cannot learn to deploy immune fighters against the virus.
as high as 55 percent.
Most people who have lived with immune deficiencies for a long time are likely to be aware of their vulnerability. But others have no idea that medications may have put them at risk.
“They’ll be walking around outside thinking they’re protected — but maybe they’re not,” said Dr. Lee Greenberger, chief scientific officer of the Leukemia and Lymphoma Society, which funds research on blood cancers.
The only recourse for these patients — apart from sheltering in place until the virus has retreated — may be to receive regular infusions of monoclonal antibodies, which are mass-produced copies of antibodies obtained from people who have recovered from Covid-19. The Food and Drug Administration has authorized several monoclonal antibody treatments for Covid-19, but now some are also being tested to prevent infections.
Convalescent plasma or gamma globulin — antibodies distilled from the blood of healthy donors — may also help immunocompromised people, although a version of the latter that includes antibodies to the coronavirus is still months from availability.
compassionate use program. (Regeneron released trial results this week showing that the cocktail reduces symptomatic infections by 81 percent in people with normal immune systems.)
It’s unclear how many immunocompromised people don’t respond to coronavirus vaccines. But the list seems at least to include survivors of blood cancers, organ transplant recipients, and anyone who takes the widely used drug Rituxan, or the cancer drugs Gazyva or Imbruvica — all of which kill or block B cells, the immune cells that churn out antibodies — or Remicade, a popular drug for treating inflammatory bowel disease. It may also include some people over age 80 whose immune responses have faltered with age.
“We’re extremely concerned and interested in trying to see how we might be able to help those particular patients,” said Dr. Elad Sharon, an immunotherapy expert at the National Cancer Institute.
As the pandemic spread, doctors who specialize in treating blood cancers or who care for immunocompromised people expected at least some of their patients to encounter difficulties. Dr. Charlotte Cunningham-Rundles, an immunologist at Icahn School of Medicine at Mount Sinai in New York, has about 600 patients who are almost entirely dependent on getting regular doses of gamma globulin to stay safe from pathogens.
Even so, 44 of her patients became infected with the coronavirus; four died, and another four or five had long-term illnesses. (Chronic infections may offer opportunities for the virus to evolve into dangerous variants.)
registry to provide information and antibody tests to people with blood cancers. And several studies are assessing the response to coronavirus vaccines in people with cancer, autoimmune conditions like lupus or rheumatoid arthritis, or who take drugs that mute the immune response.
What You Need to Know About the Johnson & Johnson Vaccine Pause in the U.S.
On April 13, 2021, U.S. health agencies called for an immediate pause in the use of Johnson & Johnson’s single-dose Covid-19 vaccine after six recipients in the United States developed a rare disorder involving blood clots within one to three weeks of vaccination.
All 50 states, Washington, D.C. and Puerto Rico temporarily halted or recommended providers pause the use of the vaccine. The U.S. military, federally run vaccination sites and a host of private companies, including CVS, Walgreens, Rite Aid, Walmart and Publix, also paused the injections.
Fewer than one in a million Johnson & Johnson vaccinations are now under investigation. If there is indeed a risk of blood clots from the vaccine — which has yet to be determined — that risk is extremely low. The risk of getting Covid-19 in the United States is far higher.
The pause could complicate the nation’s vaccination efforts at a time when many states are confronting a surge in new cases and seeking to address vaccine hesitancy.
Johnson & Johnson has also decided to delay the rollout of its vaccine in Europe amid concerns over rare blood clots, dealing another blow to Europe’s inoculation push. South Africa, devastated by a more contagious virus variant that emerged there, suspended use of the vaccine as well. Australia announced it would not purchase any doses.
In one such study, British researchers followed nearly 7,000 people with Crohn’s disease or ulcerative colitis from 90 hospitals in the country. They found that less than half of patients who took Remicade mounted an immune response following coronavirus infection.
were protected after a single dose of the Pfizer vaccine and only 27 percent after a single dose of the AstraZeneca vaccine. (In Britain, the current practice is to delay second doses to stretch vaccine availability.)
Likewise, another study published last month indicated that fewer than 15 percent of patients with cancers of blood or the immune system, and fewer than 40 percent of those with solid tumors, produced antibodies after receiving a single dose of the Pfizer-BioNTech vaccine.
And a study published last month in the journal JAMA reported that only 17 percent of 436 transplant recipients who got one dose of the Pfizer-BioNTech or Moderna vaccine had detectable antibodies three weeks later.
Despite the low odds, immunocompromised people should still get the vaccines because they may produce some immune cells that are protective, even antibodies in a subset of patients.
“These patients should probably be prioritized for optimally timed two doses,” said Dr. Tariq Ahmad, a gastroenterologist at the Royal Devon and Exeter NHS Foundation Trust who was involved in the infliximab studies.
He suggested that clinicians routinely measure antibody responses in immunocompromised people even after two vaccine doses, so as to identify those who also may need monoclonal antibodies to prevent infection or a third dose of the vaccines.
Wendy Halperin, 54, was diagnosed at age 28 with a condition called common variable immunodeficiency. She was hospitalized with Covid-19 in January and remained there for 15 days. But the coronavirus induced unusual symptoms.
“I was having trouble walking,” she recalled. “I just lost control of my limbs, like I couldn’t walk down the street.”
Because she was treated for Covid-19 with convalescent plasma, Ms. Halperin has had to wait three months to be immunized and has made an appointment for April 26. But despite her condition, her body did manage to produce some antibodies to the initial infection.
“The take home message is that everybody should try and get the vaccine,” said Dr. Amit Verma, an oncologist at Montefiore Medical Center.
The gamble did not pay off in Dr. Wollowitz’s case. Without antibodies in his system to protect him, he is still working from home — a privilege he is grateful for. He was an avid mountain biker and advanced skier, both of which carry risk of injury, but with the coronavirus, he is playing it safe.
In anticipation of returning to his normal lifestyle, Dr. Wollowitz is tuning his bicycles. But he said he foresaw himself living this way till enough other people are vaccinated and the number of infections in the city drops.
“I’m not exactly sure what that date is,” he said. “I’m really waiting to get back out.”