Johnson & Johnson’s COVID-19 vaccine will remain in limbo for a while longer after government health advisers declared Wednesday that they need more evidence to decide if a handful of unusual blood clots were linked to the shot — and if so, how big the risk really is. The reports are exceedingly rare — six cases out of more than 7 million U.S. inoculations with the one-dose vaccine. But the government recommended a pause in J&J vaccinations this week, not long after European regulators declared that such clots are a rare but possible risk with the AstraZeneca vaccine, a shot made in a similar way but not yet approved for use in the U.S. At an emergency meeting, advisers to the Centers for Disease Control and Prevention wrestled with the fact that the U.S. has enough alternative shots to vaccinate its population but other countries anxiously awaiting the one-and-done vaccine may not. “I continue to feel like we’re in a race against time and the variants, but we need to (move forward) in the safest possible way,” said CDC adviser Dr. Grace Lee of Stanford University, who was among those seeking to postpone a vote on the vaccine. Authorities have studied the clots for only a few days and have little information to judge the shot, agreed fellow adviser Dr. Beth Bell of the University of Washington. “I don’t want to send the message there is something fundamentally wrong with this vaccine,” Bell said. “It’s a very rare event. Nothing in life is risk-free. But I want to be able to understand and defend the decision I’ve made based on a reasonable amount of data.” These are not run-of-the-mill blood clots. They occurred in unusual places, in veins that drain blood from the brain, and in people with abnormally low levels of clot-forming platelets. The six cases raised an alarm bell because that number is at least three times more than experts would have expected to see even of more typical brain-drainage clots, said CDC’s Dr. Tom Shimabukuro. Also read: Australia won’t buy J&J coronavirus vaccine  “What we have here is a picture of clots forming in large vessels where we have low platelets,” Shimabukuro explained. “This usually doesn’t happen,” but it’s similar to European reports with the AstraZeneca vaccine. The good news: The government says there are no signs of similar clots after vaccination with the Pfizer and Moderna shots that are the mainstay of the COVID-19 fight in the U.S. The J&J cases now under investigation are all among women younger than 50. But the advisory panel stressed that there’s not enough information to tell if only certain groups would be at risk. In Europe, most but not all cases following AstraZeneca vaccinations have been among women under 60, leading different countries to use that vaccine in varying ways. Also, a 25-year-old man experienced a similar clot during U.S. testing of J&J’s vaccine, something the government scrutinized at the time but could not link to the shot. On Wednesday, the company also brought to the CDC’s attention a woman whose clot did not occur in the brain, sparking more questions about what other evidence to examine. Also read: Merck to help produce rival J&J’s COVID-19 vaccine The CDC expects its advisers to reconsider the evidence within two weeks. So far the clots have occurred between one and three weeks after people received the J&J vaccine, and officials cautioned that more reports could surface. The clot concerns could undermine public confidence in a vaccine many hoped would help some of the hardest-to-reach populations — in poor countries or in places like homeless shelters in the U.S. But the U.S. has intensive monitoring for COVID-19 vaccines, since side effects too rare to have occurred in studies of thousands of people sometimes pop up once shots are used in millions. Shimabukuro said spotting such a rare potential risk amid the nation’s huge vaccine rollout “is an example of a success story for vaccine safety.” Some vaccine specialists who were closely watching the deliberations expressed dismay that the public — here and abroad — will have to wait for more advice. “What they did was they punted,” said Dr. Paul Offit, a vaccine expert at the Children’s Hospital of Philadelphia. “I just don’t think waiting is going to give you a critical amount of information that is going to help you make a decision.” He noted that many European countries are dealing with the AstraZeneca uncertainty without stopping its use. Health officials recommended the J&J timeout in part to make sure doctors know how to recognize and treat the unusual condition. The CDC said Wednesday that four of the six women with the unusual clots were treated with a blood thinner named heparin — a treatment the government is warning doctors to avoid. The setback for J&J comes as the worldwide death toll from COVID-19 approaches 3 million, including more than 560,000 who perished in the U.S., which continues to report tens of thousands of new infections every day and an average of almost 1,000 deaths. So far, the J&J vaccine has been a minor player in U.S. vaccinations. More than 122 million Americans have received at least one vaccine dose, and nearly 23% are fully vaccinated. Moderna and Pfizer are on track to have delivered 300 million doses each by mid- to late July. Vaccinations are slower in Europe, where many countries have struggled for supply. J&J delayed some of its European deliveries amid the clot evaluation, but Poland said it would use the batch it already has in hand. European medical regulators plan to issue their own evaluation of the J&J clot issue next week When the clots were spotted after AstraZeneca vaccinations, scientists in Norway and Germany raised the possibility that some people are experiencing an abnormal immune response, forming antibodies that disable their platelets. That’s the theory as the U.S. now investigates the J&J reports.  

The European Union’s drug regulator will announce the conclusions of its investigation into the possible connection between AstraZeneca’s coronavirus vaccine and rare blood clots later Wednesday, including recommendations that could have far-reaching effects on the use of the shot that is key to global efforts to end the pandemic. Earlier this week, a senior official from the European Medicines Agency said there was a causal link between the AstraZeneca vaccine and the rare clots that have been seen in dozens of people worldwide, among the tens of millions who have received at least one dose of the shot. Also Read: Canada pauses AstraZeneca vaccine for under 55 Marco Cavaleri, head of health threats and vaccine strategy at the Amsterdam-based agency, said in comments to Rome’s Il Messaggero newspaper on Tuesday that “it is becoming more and more difficult to affirm that there isn’t a cause-and-effect relationship between AstraZeneca vaccines and the very rare cases of blood clots associated with a low level of platelets.” But Cavaleri acknowledged the agency hadn’t yet figured out how exactly the vaccine might be causing these rare side effects. The agency said its evaluation “has not yet reached a conclusion and the review is currently ongoing.” The EMA is particularly focused on two types of rare blood clots: one that appears in multiple blood vessels and another that occurs in a vein that drains blood from the brain. It is also evaluating reports of people who had low levels of blood platelets, which puts them at risk of severe bleeding. Also Read: UK regulator says AstraZeneca jab safe after 7 clot deaths The EMA, the World Health Organization and numerous other health authorities have said repeatedly that the AstraZeneca vaccine is safe and effective and that the protection it offers against COVID-19 outweighs the small risks of rare blood clots. As recently as last week, the EMA said “there is no evidence that would support restricting the use of this vaccine in any population” — a response to several countries doing just that — though an expert said more brain clots were being reported than would be expected. To date, most of the cases have been reported in younger women, who are more susceptible to developing such rare clots anyway, making understanding what is causing the clots potentially more difficult. “The problem is these clots are very unusual, and we don’t really know what the background rate of them is, so it’s very hard to know if the vaccine is contributing to this,” said Dr. Peter English, who formerly chaired the British Medical Association’s Public Health Medicine Committee. A full investigation would likely take months, but English said given the urgency of the continuing pandemic, regulators would likely make a quick decision. Also Read: What we know about AstraZeneca blood clot reports “It’s very likely we will see a suspension of the vaccine’s use in certain groups while they do the further investigations to give us clearer answers,” English said. In March, more than a dozen countries, mostly in Europe, suspended their use of AstraZeneca over the blood clot issue. Most restarted — some with age restrictions — after the EMA said countries should continue using the potentially life-saving vaccine. The suspensions were seen as particularly damaging for AstraZeneca because they came after repeated missteps in how the company reported data on the vaccine’s effectiveness and concerns over how well its shot worked in older people. That has led to frequently changing advice in some countries on who can take the vaccine, raising worries that AstraZeneca’s credibility could be permanently damaged, spurring more vaccine hesitancy and prolonging the pandemic. English said the back-and-forth over the AstraZeneca vaccine globally could have serious consequences. “We can’t afford not to use this vaccine if we are going to end the pandemic,” he said. That’s because the vaccine is cheaper and easier to store than many others, is critical to Europe’s immunization campaign and a pillar of the U.N.-backed program known as COVAX that aims to get vaccines to some of the world’s poorest countries. It has been endorsed for use in more than 50 countries, including by the 27-nation EU and WHO. U.S. authorities are still evaluating the vaccine. The governor of Italy’s northern Veneto region said any decision to change the guidance on AstraZeneca would cause major disruptions to immunizations — at a time when Europe is already struggling to ramp them up — and could create more confusion about the shot. “If they do like Germany, and allow Astra Zeneca only to people over 65, that would be absurd. Before it was only for people under 55. Put yourself in the place of citizens, it is hard to understand anything,” Luca Zaia told reporters on Wednesday. The latest suspension of AstraZeneca came in Spain’s Castilla y León region, where health chief Verónica Casado said Wednesday that “the principle of prudence” drove her to put a temporary hold on the vaccine that she still backed as being both effective and necessary. “If there are in fact individuals of a certain age group that could have a higher risk (of clotting) then we need to adjust its use,” Casado told Spanish public radio. “We are not questioning AstraZeneca. We need all the vaccines possible to reach the goal of 70% of the adult population.” French health authorities said they, too, were awaiting EMA’s conclusions and would follow the agency’s recommendations, especially for the 500,000 people who have received a first dose of AstraZeneca. Even officials in Asia said they were keen to hear the EMA’s decision. On Wednesday, South Korea said it would temporarily suspend the use of AstraZeneca’s vaccine in people 60 and younger. In that age group, the country is only currently vaccinating health workers and people in long-term care settings. The Korea Disease Control and Prevention Agency said it would also pause a vaccine rollout to school nurses and teachers that was to begin on Thursday, while awaiting the outcome of the EMA’s review. English, the former chair of the British drug regulator, said that even rare, serious side effects are seen with established vaccines and that policymakers often decide that bigger public health goals warrants their use, citing the polio vaccine as an example. For every million doses that are given of the oral polio vaccine, about one child is paralyzed from the live virus contained in the vaccine. On Tuesday, AstraZeneca and Oxford University, which developed the vaccine, paused a study of the shot in children while the U.K. regulator evaluates the link between the shot and rare blood clots in adults.

Authorities in Berlin and Munich are again suspending the use of AstraZeneca’s coronavirus vaccine for residents under age 60 due to new reports of unusual blood clots in people who recently received the shots, officials said Tuesday. The action was taken as a precaution ahead of a meeting later Tuesday of representatives from Germany’s 16 states and further recommendations expected from national medical regulators, said Berlin’s top health official, Dilek Kalayci. Also Read: Sweden is latest country to stop using AstraZeneca vaccine The decision came after the country’s medical regulator announced that it had received a total of 31 reports of rare blood clots in recent recipients of the AstraZeneca vaccine. Nine of the people died and all but two of the cases involved women aged 20 to 63, the Paul Ehrlich Institute said. Also Read: Major European nations suspend use of AstraZeneca vaccine Reports of an unusual form of blood clot in the head, known as sinus vein thrombosis, prompted several European countries to temporarily halt the use of the AstraZeneca vaccine earlier this month. After a review by medical experts, the European Medicines Agency concluded the benefits of the vaccine outweighed the risks. Also Read: Canada pauses AstraZeneca vaccine for under 55 At the same time, the agency recommended that warnings about possible rare side effects should be provided to patients and doctors. Most European Union countries, including Germany, resumed use of the vaccine. Earlier Tuesday, two state-owned hospitals in Berlin announced that they had stopped giving the AstraZeneca vaccine to female staff members under 55. The heads of five university hospitals in western Germany called for a temporary halt to the vaccine for all younger women, citing the blood clot risk. Kalayci, the Berlin state health minister, said the suspension of AstraZeneca vaccines for younger people was done as a precaution. “We have not had a case of serious side effects in Berlin yet,” she said, adding that all of those who had received the AstraZeneca shot already could rest assured that it provides good protection against the coronavirus. “Still, we need to treat it carefully and wait for the talks taking place at the federal level,” said Kalayci. The decision could affect appointments for tens of thousands of teachers and people with preexisting conditions who received invitations to get vaccinated in Germany’s capital in recent days. German news agency dpa quoted a spokesman for Munich, the country’s third-largest city, saying that the suspension of AstraZeneca vaccinations for people younger than 60 would last “until issue of possible vaccine complications for this group of persons has been resolved.” Some 2.7 million doses of the AstraZeneca vaccine have been administered across the whole of Germany so far. Some other European countries remain hesitant about giving the AstraZeneca shot to older people. In Madrid, residents ages 60 to 65 started receiving the vaccine Tuesday ahead of those between the ages of 66 and 79 because Spanish authorities have not yet reviewed new data provided by AstraZeneca about how well it works in the older age group. Spain is currently using the Pfizer/BioNTech and Moderna vaccines for people over 80 years old. Spanish health authorities have said that they are hoping to speed up the rollout of vaccines with the arrival of the jab developed by the pharmaceutical company Janssen, a subsidiary of Johnson & Johnson, which has also been approved for use in Europe and requires one shot only. Authorities in Berlin and Munich are again suspending the use of AstraZeneca’s coronavirus vaccine for residents under age 60 due to new reports of unusual blood clots in people who recently received the shots, officials said Tuesday. The action was taken as a precaution ahead of a meeting later Tuesday of representatives from Germany’s 16 states and further recommendations expected from national medical regulators, said Berlin’s top health official, Dilek Kalayci. The decision came after the country’s medical regulator announced that it had received a total of 31 reports of rare blood clots in recent recipients of the AstraZeneca vaccine. Nine of the people died and all but two of the cases involved women aged 20 to 63, the Paul Ehrlich Institute said. Reports of an unusual form of blood clot in the head, known as sinus vein thrombosis, prompted several European countries to temporarily halt the use of the AstraZeneca vaccine earlier this month. After a review by medical experts, the European Medicines Agency concluded the benefits of the vaccine outweighed the risks. At the same time, the agency recommended that warnings about possible rare side effects should be provided to patients and doctors. Most European Union countries, including Germany, resumed use of the vaccine. Earlier Tuesday, two state-owned hospitals in Berlin announced that they had stopped giving the AstraZeneca vaccine to female staff members under 55. The heads of five university hospitals in western Germany called for a temporary halt to the vaccine for all younger women, citing the blood clot risk. Kalayci, the Berlin state health minister, said the suspension of AstraZeneca vaccines for younger people was done as a precaution. “We have not had a case of serious side effects in Berlin yet,” she said, adding that all of those who had received the AstraZeneca shot already could rest assured that it provides good protection against the coronavirus. “Still, we need to treat it carefully and wait for the talks taking place at the federal level,” said Kalayci. The decision could affect appointments for tens of thousands of teachers and people with preexisting conditions who received invitations to get vaccinated in Germany’s capital in recent days. German news agency dpa quoted a spokesman for Munich, the country’s third-largest city, saying that the suspension of AstraZeneca vaccinations for people younger than 60 would last “until issue of possible vaccine complications for this group of persons has been resolved.” Some 2.7 million doses of the AstraZeneca vaccine have been administered across the whole of Germany so far. Some other European countries remain hesitant about giving the AstraZeneca shot to older people. In Madrid, residents ages 60 to 65 started receiving the vaccine Tuesday ahead of those between the ages of 66 and 79 because Spanish authorities have not yet reviewed new data provided by AstraZeneca about how well it works in the older age group. Spain is currently using the Pfizer/BioNTech and Moderna vaccines for people over 80 years old. Spanish health authorities have said that they are hoping to speed up the rollout of vaccines with the arrival of the jab developed by the pharmaceutical company Janssen, a subsidiary of Johnson & Johnson, which has also been approved for use in Europe and requires one shot only.