Federal health officials have now confirmed 28 cases, including six in men, of a rare blood clotting disorder in adults who have received the Johnson & Johnson Covid-19 vaccine.
Dr. Tom Shimabukuro, the deputy director of the immunization safety office at the Centers for Disease Control and Prevention, presented the new cases on Wednesday at a meeting of a panel of advisers to the C.D.C.
The figure is an increase from the 15 confirmed cases, all of which were in women, that were reported at last month’s meeting.
Although officials have now identified a handful of cases in men, women — especially those between the ages of 30 and 49 — appear to remain at elevated risk. “The trend is that the reporting rates are higher in females compared to males in all age categories,” Dr. Shimabukuro said at the meeting.
lifted the suspension 10 days later and added a warning about the potential risks to the vaccine’s label, which notes that a connection between the vaccine and the condition is “plausible.”
Twenty-two of the confirmed cases so far have been in women, and six have been in men. All were in adults between the ages of 18 and 59 who received the vaccine before the national pause. (There was also one additional case recorded in a 25-year-old man who participated in the clinical trial.)
Three people have died and four remain hospitalized, including one who is in intensive care. No new deaths have been documented since last month’s meeting, Dr. Shimabukuro said.
The overall risk remains exceedingly low. More than 9 million doses of the Johnson & Johnson vaccine have now been administered in the United States.
There have been 12.4 cases per million doses among women between the ages of 30-39 and 9.4 cases per million doses among women between 40 and 49, the two demographic groups that appear to be at highest risk. Among older women and men of all ages, there were fewer than 3 cases per million doses.
Among the 28 confirmed cases, 12 people who developed the disorder had obesity, 7 had high blood pressure, 3 had diabetes, and 3 were taking estrogen, though it is not yet clear whether any of those factors might substantially increase the risk of the disorder.
Officials will continue to monitor for cases of the clotting disorder in people who have been vaccinated, Dr. Shimabukuro said.
There have been no confirmed cases of the clotting disorder following the Pfizer-BioNTech or Moderna vaccines, which employ a different technology, Dr. Shimabukuro said.
Up until just hours before the pause was recommended by American officials, regulators had planned for a revision to the F.D.A.’s emergency use authorization similar to the one formalized Friday, with warnings about the blood clots.
But top health officials decided in a meeting on April 12 that the government should call for a pause while federal authorities and the C.D.C.’s expert panel investigated a possible link between the clots and the vaccine. They feared a number of cases of the disorder had not been identified and wanted to allow more time for those who had just received the vaccine to reach the point at which the rare clotting typically appears.
“As we did this intensive scientific evaluation over recent days, I think we became more and more confident about the decision that was made today,” Dr. Janet Woodcock, the acting F.D.A. commissioner, said on Friday.
In the C.D.C. panel analysis, women between 30 and 39 appear to be at greatest risk, with 11.8 cases per million doses given. Among women 18 to 49, there have been seven cases per million doses. The condition, which the C.D.C. is calling thrombosis with thrombocytopenic syndrome, causes severe blood clots and also a tendency to bleed at the same time, because of abnormally low levels of platelets, a blood component involved in clotting.
The disorder is “rare but clinically serious,” Dr. Tom Shimabukuro, the deputy director of the C.D.C.’s immunization safety office, said at the meeting.
Additional potential cases, including some in men, are being reviewed. There was also a case in a 25-year-old man who participated in a clinical trial of the vaccine.
The patients’ symptoms closely resemble a rare syndrome that can be caused by heparin, a widely used blood thinner, Dr. Michael Streiff, a hematologist at Johns Hopkins University, told the panel. Heparin, typically used to treat blood clots, should not be given to these patients, he said.
South Africa will resume the use of the Johnson & Johnson vaccine to inoculate health care workers next week, offering some relief to the country that has suffered a series of blows to its vaccination efforts in recent months, according to South African authorities.
The country suspended an early-access Johnson & Johnson vaccination program last week after health officials in the United States put a pause on the vaccine amid concerns of rare blood clots that emerged in a handful of people who received it.
South Africa’s decision to move forward again was the second green light this week for Johnson & Johnson. On Tuesday, the European Union drug regulator also recommended resuming the rollout of the company’s vaccine.
Now, many eyes are on Washington, where a federal advisory panel is scheduled to meet Friday to discuss whether to lift the pause in the United States.
told reporters on Thursday.
Health experts welcomed the resumption of the vaccine campaign in South Africa, which has recorded more coronavirus cases than any other country on the continent and has suffered serious setbacks in its attempt to combat the virus in recent months.
In February, health officials scrapped plans to use the AstraZeneca vaccine after it proved ineffective against a variant of the virus now dominant in South Africa. The decision came a week after a million doses of the vaccine arrived in the country and amid a devastating second wave of virus cases.
Though the Johnson & Johnson vaccine has not yet been approved for general use in South Africa, it has been used as part of a research study offering early access to the vaccine to the country’s 1.2 million health care workers.
South African health officials are gearing up to extend vaccinations to the general public starting in May. In a first step to launching a national rollout, the country last week opened its vaccine registration to people over 60 years old, who will be among the first to be inoculated.
That plan depends on tens of millions of doses of the Pfizer-BioNTech vaccine, which requires two doses and will be used in major cities. The single-shot Johnson & Johnson vaccine, which is easier to store and better for hard-to-reach populations, will be used in the country’s rural areas.
In an early analysis of coronavirus vaccine safety data, researchers at the Centers for Disease Control and Prevention have found no evidence that the Pfizer-BioNTech or Moderna vaccines pose serious risks during pregnancy.
The findings are preliminary and cover just the first 11 weeks of the U.S. vaccination program. But the study, which included self-reported data on more than 35,000 people who received one of the vaccines during or shortly before pregnancy, is the largest yet on the safety of the coronavirus vaccines in pregnant people.
During the clinical trials of the vaccines, pregnant women were excluded. That left patients, doctors and experts unsure whether the shots were safe to administer during pregnancy.
“There’s a lot of anxiety about whether it’s safe and whether it would work and what to expect as far as side effects,” said Dr. Stephanie Gaw, a maternal-fetal medicine specialist at the University of California, San Francisco.
are more likely to become seriously ill, and more likely to die, than nonpregnant women with symptoms.
Because of those risks, the C.D.C. has recommended that coronavirus vaccines be made available to pregnant women, though it also suggests that they consult with their doctors when making a decision about vaccination.
The new study, which was published on Wednesday in The New England Journal of Medicine, is based largely on self-reported data from V-safe, the C.D.C.’s coronavirus vaccine safety monitoring system. Participants in the program use a smartphone app to complete regular surveys about their health, and any side effects they might be experiencing, after receiving a Covid-19 vaccine.
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 had also decided to delay the rollout of its vaccine in Europe amid concerns over rare blood clots, but it later decided to resume its campaign after the European Union’s drug regulator said a warning label should be added. South Africa, devastated by a more contagious virus variant that emerged there, suspended use of the vaccine, and Australia announced it would not purchase any doses.
Women who were pregnant were slightly more likely to report injection site pain than women who were not, but less likely to report the other side effects. They were also slightly more likely to report nausea or vomiting after the second dose.
Pregnant V-safe participants were also given an opportunity to enroll in a special registry that tracked pregnancy and infant outcomes.
By the end of February, 827 of those enrolled in the pregnancy registry had completed their pregnancies, 86 percent of which resulted in a live birth. Rates of miscarriage, prematurity, low birth weight and birth defects were consistent with those reported in pregnant women before the pandemic, the researchers report.
“This study is of critical importance to pregnant individuals,” Dr. Michal Elovitz, a maternal-fetal medicine specialist at the University of Pennsylvania said in an email. “It is very reassuring that there were no reported acute events in pregnant individuals” over the course of the study, she said.
But the report has several limitations and much more research is needed, experts said. Enrollment in the surveillance programs is voluntary and the data are self-reported.
In addition, because the study period encompassed just the first few months of the U.S. vaccination campaign, the vast majority of those enrolled in the pregnancy registry were health care workers. And there is not yet any data on pregnancy outcomes from people who were vaccinated during the first trimester of pregnancy.
“I think we can feel more confident about recommending the vaccine in pregnancy, and especially with pregnant people that are at risk of Covid,” Dr. Gaw said. “But we doneed to wait for more data for complete pregnancy outcomes from vaccines early in pregnancy.”
BRUSSELS — Johnson & Johnson said Tuesday that it would resume the rollout of its coronavirus vaccine in Europe after the European Union’s drug regulator said that a warning should be added to the product indicating a possible link to rare blood clots, but that the shot’s benefits outweigh the risks.
The company decided to delay distribution in the bloc’s 27 member states last week, after regulators in the United States suspended use of the vaccine there amid concerns about the potential side effect.
The E.U. drug regulator’s endorsement — even with the caveat — not only clears a path for Johnson & Johnson in Europe, but could presage how the United States will handle the vaccine in the days to come.
On Friday, an advisory panel to the Centers for Disease Control and Prevention is to meet for a second to time to decide whether to recommend lifting a “pause” put on the vaccine’s use in the United States, perhaps with a similar warning.
had the Johnson & Johnson vaccine.
But some health experts worry that the headline-grabbing pause, which began over a week ago, might discourage some people from getting vaccinated, even though the risks from Covid-19 are far greater than the risk from a clot.
“You’ve put a scarlet letter on the Johnson & Johnson vaccine,” said Dr. Paul A. Offit, a vaccine expert at Children’s Hospital of Philadelphia.
After clotting concerns associated with another vaccine, produced by AstraZeneca, were reported in Europe, Dr. Offit noted, some grew leery of it, overestimating the threat. For the Johnson & Johnson vaccine, the clot risk has been put at an estimated one in a million.
“If you take a theoretical million people who are infected with Covid, five thousand will die,” Dr. Offit said. “Therefore, the benefits of this vaccine clearly outweigh its risks.”
a statement, the agency stressed the importance of treating the potential side effect and issued guidelines to health care professionals on the lookout for the rare clotting disorder. It listed symptoms to be vigilant for, including shortness of breath, chest pain, leg swelling, persistent abdominal pain, severe and persistent headaches or blurred vision, and tiny blood spots under the skin.
The temporary suspension of the Johnson & Johnson rollout in the European Union had added to the bloc’s vaccine rollout woes, but it was not as big a blow as the AstraZeneca issues have been.
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 had also decided to delay the rollout of its vaccine in Europe amid concerns over rare blood clots, but it later decided to resume its campaign after the European Union’s drug regulator said a warning label should be added. South Africa, devastated by a more contagious virus variant that emerged there, suspended use of the vaccine, and Australia announced it would not purchase any doses.
Vaccination efforts have fallen behind in Europe partly because AstraZeneca, a British-Swedish pharmaceutical company that is a major component of the region’s inoculation efforts, was unable to deliver the number of doses expected in the first quarter of the year. Then its vaccine was suspended over the blood-clotting concerns.
Even though the authorities eventually declared that the benefits of the AstraZeneca vaccine outweighed risks, and advised E.U. members to use it, the damage had been done.
Pfizer-BioNTech vaccine, and was negotiating a new deal for future booster shots with the company for 2022 and 2023.
But while the impact for Europe may be cushioned, it could be a different story elsewhere. The Johnson & Johnson vaccine has been an important component of vaccination plans for countries around the world.
While it has not yet been rolled out at anything near the scale of AstraZeneca’s, some regions have pivoted to the shot amid AstraZeneca shortages. The African Union recently acquired 400 million doses.
The pause on Johnson & Johnson vaccinations in the United States, along with new restrictions on the use of AstraZeneca’s shot in Europe, rattled vaccination campaigns around the world relying on those vaccines. South Africa followed the United States in pausing Johnson & Johnson shots, though its health regulator in recent days recommended resuming its use.
U.S. health officials called for a pause in the vaccine’s use on April 13. Johnson & Johnson suspended its E.U. rollout immediately afterward, just as the first shipments of the shot were arriving in the region.
U.S. regulators and scientists are still studying the original reports of the clotting disorder and sifting through any new safety reports of possible cases of the clotting disorder. That effort has so far turned up little.
Dr. Rochelle P. Walensky, the C.D.C. director, said on Monday that health officials were investigating “a handful” of new, unconfirmed reports that emerged after the pause was recommended, to determine whether they might be cases of the rare blood clotting disorder.
“Right now, we are encouraged that it hasn’t been an overwhelming number of cases, but we are looking and seeing what has come in,” she said at a White House news conference.
Carl Zimmer contributed reporting from New Haven; Noah Weiland and Sharon LaFraniere from Washington; and Benjamin Mueller from London.
BRUSSELS—The European Union’s drug regulator on Tuesday said a warning should be added to the Johnson & Johnson Covid-19 vaccine indicating a possible link to rare and unusual blood clots, but stopped short of recommending it be pulled from use, saying its benefits outweigh its risks.
“The reported combination of blood clots and low blood platelets is very rare, and the overall benefits of Covid-19 Vaccine Janssen in preventing Covid-19 outweigh the risks of side effects,” the European Medicines Agency said in a statement, referring to the division of Johnson & Johnson that develops vaccines, Janssen. The rare clots were “very similar,” the agency added, to those associated with the AstraZeneca vaccine, for which the agency made a similar recommendation.
Johnson & Johnson decided to delay its rollout in the bloc’s 27 member states last week, after regulators in the United States called for a pause on the vaccine following concerns about the rare but serious side effect.
The EMA’s recommendation is not binding, but it is the first indication of what might happen next with the European rollout of the much-anticipated, single-shot vaccine that’s already been given to nearly eight million people in the United States. The agency said that regulators in individual E.U. member states should decide how to proceed taking into account their particular case load and vaccine availability.
damage had been done. Many Europeans have been refusing to take the vaccine, and several E.U. countries have limited its use to older people.
Pfizer-BioNTech vaccine, and was negotiating a new deal for future booster shots with the company for 2022 and 2023, signaling it was going to prioritize vaccines, like Pfizer’s and Moderna’s, that use the mRNA technology.
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.
But the Johnson & Johnson vaccine has been an important component of vaccination plans from the United States to South Africa.
U.S. health officials called for a pause in the vaccine’s use on April 13 to examine a rare blood-clotting disorder that emerged in a small number of recipients. Johnson & Johnson suspended its E.U. rollout immediately afterward. E.U. countries had just began receiving their first shipments of the vaccine, and all but Poland followed company guidance and have not begun administering it.
On Monday, federal health officials said they were investigating “a handful” of new, unconfirmed reports that have emerged since the nationwide pause of the Johnson & Johnson injections. Dr. Anthony S. Fauci, the United States’ leading infectious disease expert, said previously that he anticipated a decision about whether to resume administering the Johnson & Johnson vaccine this Friday, when an expert panel that is advising the Centers for Disease Control and Prevention is scheduled to meet.
Federal health officials are investigating “a handful” of new, unconfirmed reports that have emerged after Johnson & Johnson injections were paused nationwide, to determine whether they might be cases of a rare, serious blood clotting disorder that caused the pause, the director of the Centers for Disease Control and Prevention said Monday. It is unclear as yet whether the vaccine was responsible for the original few cases.
“Right now, we are encouraged that it hasn’t been an overwhelming number of cases but we are looking and seeing what has come in,” the director, Dr. Rochelle Walensky, said at a White House news conference on the pandemic.
Last week, federal health officials said they wanted vaccine recipients and medical providers to be aware of the original cases and to report any incidents of serious adverse reactions to the shots. Health officials called for the pause after six women ages 18 to 48 developed the blood clotting disorder within about one to three weeks after Johnson & Johnson injections. One died, and as of last week, a second remained hospitalized in critical condition.
On Wednesday, two more cases were added to the list: a seventh woman, and a man who participated in Johnson & Johnson’s clinical trial. Seven of the eight recipients had blood clots in the brain. The clotting disorder seemed to be combined with low levels of platelets, blood cells that typically prevent clotting. The cases were reported either to the C.D.C.’s database or directly to Johnson & Johnson.
that he seriously doubts the vaccine will be permanently pulled. But he said, “I do think that there will likely be some sort of warning or restriction or risk assessment.”
Experts are trying to determine whether the rare blood clotting disorder is in fact linked to the Johnson & Johnson vaccine. The investigation follows actions by European regulators who concluded that another vaccine — developed by AstraZeneca and based on a similar technology — may be linked to a rare clotting disorder.
Emergent BioSolutions, the company whose Baltimore manufacturing facility ruined up to 15 million doses of the Johnson & Johnson coronavirus vaccine, said Monday that it has temporarily shut down operations at the plant at the request of the Food and Drug Administration and acknowledged that the company must make improvements to “restore confidence” in its work.
The unusual acknowledgment came as regulators continue to inspect Emergent’s Bayview facility, as the Baltimore plant is known. The New York Times reported earlier this month that the F.D.A. was initiating a “for cause” audit of the Baltimore facility and that production of new batches of the Johnson & Johnson vaccine would be put on hold while the review was underway.
In Monday’s announcement, the company said that the F.D.A. inspection began a week ago and production stopped on Friday; the company also notified the Securities and Exchange Commission on Monday of the changes.
In a brief statement to reporters, Emergent also said it was quarantining existing vaccine substance produced at Bayview until after the inspection is over and it has had a chance to fix any problems that turn up in the review. The company’s stock has tumbled in recent weeks; it closed at $69.37 on Friday, down from $90.98 a month earlier.
It is unclear whether the vaccine was responsible for the clots.
Johnson & Johnson said in a statement on Monday that it is working with the F.D.A. and Emergent to address the findings of the inspection, and that it was “premature to speculate on any potential impact this could have on the timing of our vaccine deliveries.”
Emergent is a longtime government contractor that has spent much of the last two decades cornering a lucrative market in federal spending on biodefense. The Times reported last month that sales of its anthrax vaccines to the Strategic National Stockpile accounted for nearly half of the stockpile’s half-billion-dollar annual budget throughout most of the last decade, leaving the federal government with less money to buy supplies needed in a pandemic.
The company’s Bayview plant is one of two federally designated “Centers for Innovation in Advanced Development and Manufacturing” that were supposed to be at the ready in the event of a pandemic. The Times reported earlier this month that the Trump administration awarded a $628 million contract to the company, mostly to reserve space in the Baltimore facility, despite a history of problems.
accidentally mixed the ingredients of the two vaccines, ruining the doses and prompting the F.D.A. audit.
The Biden administration then stepped in and ordered Johnson & Johnson to take charge of manufacturing at the facility, and told Emergent to stop manufacturing the AstraZeneca vaccine to avoid future mix-ups.
“This inspection is ongoing,” the company said Monday. “While we await the F.D.A.’s full feedback, we are working with J.&J. and the F.D.A. on strengthening the supply chain for this vitally important vaccine.”
RIO DE JANEIRO — Taiwan has built thousands of homes for the poor in Paraguay, upgraded the country’s health care system, awarded hundreds of scholarships and even helped fund the futuristic Congress building in the capital, spending generously over decades to nurture their diplomatic ties.
But the alliance, which makes Paraguay one of only 15 nations to have full diplomatic relations with Taiwan, and the only one in South America, is facing an existential threat as Paraguay’s quest for vaccines becomes increasingly desperate.
With its health care system buckling as Covid-19 cases soar, Paraguayan officials across the political spectrum say the time has come to consider dumping Taiwan, which doesn’t export vaccines, in order to establish diplomatic ties with China, which does.
“This is really a life and death situation,” said Pepe Zhang, an associate director at the Atlantic Council who specializes in relations between Latin America and China. “In this very acute phase of the pandemic, less resourceful countries like Paraguay are asking where they’re going to get the vaccine.”
to rely predominantly on Chinese vaccines to blunt an epidemic that has left a brutal toll.
That has given Beijing considerable leverage in a region where it has a broad constellation of investments and projects. Suddenly, wresting Paraguay from Taiwan’s orbit — which would advance Beijing’s goal of politically isolating an island it regards as its territory — appears within reach.
Euclides Acevedo, Paraguay’s foreign minister, said recently that Beijing has made it clear it is interested in establishing ties with Paraguay. He has dangled that prospect of making the diplomatic switch as he has sought to pressure Taiwan and its ally, the United States, to get vaccines to Paraguay quickly.
late last month in an interview on the television network Telefuturo. “I think our strategic allies, including the United States and Taiwan, must respond.”
Beijing’s one-China principle forces countries to choose between having full diplomatic relations with Beijing or Taipei. Three countries in Latin America blindsided and angered the United States government in recent years by abruptly severing ties with Taiwan following secret negotiations with Beijing.
Panama, the Dominican Republic and El Salvador — came with promises of growing trade with Beijing and has made them early recipients of Chinese vaccines.
Mr. Acevedo said Paraguay should explore what it would gain by doing the same.
“President Xi Jinping has keen interest in partnering with us,” he said. “It’s a political debate that should draw input from all segments of the state and all of society.”
Yet, it’s not clear that Paraguay has taken formal steps toward exploring a flip.
Charles Andrew Tang, who heads the China-Paraguay Chamber of Commerce, said he advised officials at the health ministry earlier this year on the paperwork they would need to fill out to request purchasing Chinese vaccines.
Mr. Tang, who is seen in Paraguay as a key interlocutor with the Chinese government, said it is conceivable that Chinese vaccine manufacturers would sell vaccines to Paraguay even without formal diplomatic relations. But he said the onus was on officials in Paraguay to make the first move.
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.
“The virus can spread across borders, but mankind’s love also transcends borders,” he told reporters.
This week China’s main Covid-19 vaccine manufacturer, Sinovac, made a gesture that is certain to fuel speculation about Beijing’s plans in Paraguay. The South American soccer federation Conmebol, which is based in Paraguay, announced it was receiving a donation of 50,000 doses of CoronaVac, the Covid-19 vaccine produced by Beijing-based Sinovac.
“The leaders of this company have understood the enormous social and cultural value of soccer in South American countries,” the federation’s president, Alejandro Domínguez, said in a statement, calling the donation a “noble gesture.”
Despite all these signals, Taiwan’s position in Paraguay may be safer than it appears, said Lee McClenny, who served as the U.S. ambassador in Paraguay until last September. While cabinet members and businessmen have pressured President Mario Abdo Benítez to forge ties with China, the Chinese government didn’t show much interest in getting Paraguay to flip, he said.
“On the ground I didn’t see very effective efforts to make this happen,” Mr. McClenny said.
Besides, Mr. McClenny added, the Paraguayan president takes a special pride in the relationship with Taiwan, which was brokered in the 1950s by his late father, who served as the personal secretary to Alfredo Stroessner, the dictator who ran the country for 35 years. And Taiwanese aid has made a major impact in the landlocked, impoverished nation.
“It’s effective and benefits people’s lives in real ways,” Mr. McClenny said about Taiwan’s assistance.
The Biden administration has signaled its unease about the prospect that Paraguay could cut a deal with China. In a phone call with Mr. Abdo Benítez last month, Secretary of State Antony J. Blinken urged the Paraguay government to continue to “work with democratic and global partners, including Taiwan, to overcome this global pandemic,” according to a summary of the call provided by the State Department.
That message rankles opposition lawmakers, including the leftist Senator Esperanza Martínez, who served as health minister from 2008 to 2012. Ms. Martínez has long favored establishing relations with China, arguing that Paraguay stands to benefit in the long run by expanding trade. She said Washington’s exhortation was immoral.
“We’re being loyal to people who impose rules on us while we die,” she said. “Our allies are vaccinating people morning, afternoon and night while they block us from getting vaccines, saying we’ll turn into communists.”
Ernesto Londoño reported from Rio de Janeiro. Santi Carneri contributed reporting from Asunción, Amy Qin contributed reporting from Taipei, Taiwan and Sui-Lee Wee contributed reporting from Singapore.
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.”
