U.S. regulators on Thursday strictly limited who can receive Johnson & Johnson’s COVID-19 vaccine due to the ongoing risk of rare but serious blood clots. The Food and Drug Administration said the shot should only be given to adults who cannot receive a different vaccine or specifically request J&J’s vaccine. U.S. authorities for months have recommended that Americans get Pfizer or Moderna shots instead of J&J’s vaccine. FDA’s vaccine chief Dr. Peter Marks said the agency decided to restrict the vaccine after taking another look at the data on the risks of life-threatening blood clots and concluding that they are limited to J&J’s vaccine. Also read:Moderna seeks FDA authorization for 4th dose of COVID shot “If there’s an alternative that appears to be equally effective in preventing severe outcomes from COVID-19, we’d rather see people opting for that,” Marks said. “But we’ve been careful to say that-- compared to no vaccine-- this is still a better option.” The problem occurs in the first two weeks after vaccination, he added: “So if you had the vaccine six months ago you can sleep soundly tonight knowing this isn’t an issue.” The FDA authorized J&J’s shot in February last year for adults 18 and up. The vaccine was initially considered an important tool in fighting the pandemic because it required only one shot. But the single-dose option proved less effective than two doses of the Pfizer and Moderna vaccines. In December, the Centers for Disease Control and Prevention recommended Moderna and Pfizer shots over J&J’s because of its safety issues. As of mid-March, federal scientists had identified 60 cases of the side effect, including nine that were fatal. That amounts to 3.23 blood clot cases per 1 million J&J shots. The problem is more common in women under 50, where the death rate was roughly 1 per million shots, according to Marks. Marks said the FDA spent extra time analyzing the problem to be sure it wasn’t connected to a separate issue, such as women taking birth control medications that raise their risk of clotting. The J&J vaccine will carry a starker warning about potential “long-term and debilitating health consequences” of the side effect. Under the new FDA instructions, J&J’s vaccine could still be given to people who had a severe allergic reaction to one of the other vaccines and can’t receive an additional dose. J&J’s shot could also be an option for people who refuse to receive the mRNA vaccines from Pfizer and Moderna, and therefore would otherwise remain unvaccinated, the agency said. A J&J spokesman said in an emailed statement: “Data continue to support a favorable benefit-risk profile for the Johnson & Johnson COVID-19 vaccine in adults, when compared with no vaccine.” Also read: In reversal, FDA puts brakes on COVID shots for kids under 5 The clotting problems first came up last spring, with the J&J shot in the U.S. and with a similar vaccine made by AstraZeneca that is used in other countries. At that time, U.S. regulators decided the benefits of J&J’s one-and-done vaccine outweighed what was considered a very rare ri sk — as long as recipients were warned. COVID-19 causes deadly blood clots, too. But the vaccine-linked kind is different, believed to form because of a rogue immune reaction to the J&J and AstraZeneca vaccines because of how they’re made. Clots form in unusual places, such as veins that drain blood from the brain, and in patients who also develop abnormally low levels of the platelets that form clots. Symptoms of the unusual clots include severe headaches a week or two after the J&J vaccination — not right away — as well as abdominal pain and nausea. The New Brunswick, New Jersey-based company announced last month that it didn’t expect a profit from the vaccine this year and was suspending sales projections. The rollout of the company’s vaccine was hurt by a series of troubles, including manufacturing problems at a Baltimore factory that forced J&J to import millions of doses from overseas. Additionally, regulators added warnings about the blood clots and a rare neurological reaction called Guillain-Barré syndrome. Pfizer and Moderna have provided the vast majority of COVID-19 vaccines in the U.S. More than 200 million Americans have been fully vaccinated with the companies’ two-dose shots while less than 17 million Americans got the J&J shot.

Johnson & Johnson is peeling off a consumer health business that helped it become the world’s biggest health care products maker. The company said Friday that it will separate its segment that sells Band-Aids, Listerine and over-the-counter medicines like Tylenol from its pharmaceutical and medical device business. Company leaders told analysts that the split into two publicly traded companies will make each business more nimble in adapting to their respective markets. It also allows for a more precise allocation of capital. CEO Alex Gorsky said that while the company’s broad focus has worked in the past, the split addresses segments that “have evolved as fundamentally different businesses.” “We’ve seen a significant evolution in these markets, particularly on the consumer side,” Gorsky said, referring in part to a shift toward online shopping that accelerated during the COVID-19 pandemic. The segment selling prescription drugs and medical devices — J&J’s two largest businesses — will keep the Johnson & Johnson name. Its products include the cancer treatment Darzalex, a COVID-19 vaccine and medical devices for orthopedics and surgery. The new consumer health company has yet to be named. It will house brands including Neutrogena, Aveeno, and the iconic Band-Aids, which a company employee created more than 100 years ago. Pharmaceuticals and medical devices pulled in a combined $19.6 billion in revenue in the company’s recently completed third quarter, which turned out better than analysts expected. Consumer health brought in $3.7 billion. The consumer health business has more than 20 brands that each have over $150 million in annual sales, Gorsky noted. He added that the portfolio includes well-known names like Tylenol and children’s Tylenol that have reached all-time highs in market share. Also read: India approves Johnson & Johnson COVID-19 vaccine for emergency use An analyst asked company leaders on Friday why they were making the change now, when they have touted J&J’s diversity in the past as a way to help offset or balance a downturn in a particular segment. “I think we have consistently had the belief that our diversified portfolio is rooted in strategy,” Gorsky said. “However, it’s not anchored in strategy.” Johnson & Johnson, which was founded in 1886, said the split will occur in the next two years, if approved by the company’s board of directors. J&J is beginning its split as it also undergoes a leadership transition. The company said in August that Gorsky will step and be replaced in January by longtime company executive Joaquin Duato. READ: Mumbai imposes strict virus restrictions as infections surge The split also comes as J&J deals with criticism from some Democrats in Congress over another corporate move. J&J is facing thousands of lawsuits claiming that its talc-based baby powder, which it has stopped selling in the U.S. and Canada, caused ovarian cancer. U.S. Senators Dick Durbin of Illinois and Elizabeth Warren of Massachusetts, among others, recently sent a letter to the company asking for more information about a newly created subsidiary that filed for Chapter 11 bankruptcy protection. The senators in a Nov. 10 letter called the move a “corporate shell game” that would shield the company from liability in those cases. Company officials said that the split they announced Friday was “separate and distinct” from the baby powder situation. J&J’s announcement comes just days after General Electric said that it plans to split into three separate companies. It also follows similar moves by large pharmaceutical rivals Pfizer Inc., which spun off its consumer health product business in 2019, and Merck & Co. Shares of New Brunswick, New Jersey-based Johnson & Johnson rose less than 2% to $165.28 in late-morning trading while the Dow Jones Industrial Average climbed slightly. J&J shares had already climbed about almost 4% so far this year, while the Dow has jumped about 17%. J&J has been a component of the Dow Jones Industrial Average since 1997.

Johnson & Johnson asked the Food and Drug Administration on Tuesday to allow extra shots of its COVID-19 vaccine as the U.S. government moves toward expanding its booster campaign to millions more vaccinated Americans. J&J said it filed a request with the FDA to authorize boosters for people 18 and older who previously received the company's one-shot vaccine. While the company said it submitted data on several different booster intervals, ranging from two to six months, it did not formally recommend one to regulators. Last month, the FDA authorized booster shots of Pfizer’s vaccine for older Americans and other groups with heightened vulnerability to COVID-19. It’s part of a sweeping effort by the Biden administration to shore up protection amid the delta variant and potential waning vaccine immunity. Read:FDA adds warning about rare reaction to J&J COVID-19 vaccine Government advisers backed the extra Pfizer shots, but they also worried about creating confusion for tens of millions of other Americans who received the Moderna and J&J shots. U.S. officials don't recommend mixing and matching different vaccine brands. The FDA is convening its outside panel of advisers next week to review booster data from both J&J and Moderna. It’s the first step in a review process that also includes sign-off from the leadership of both the FDA and the Centers for Disease Control and Prevention. If both agencies give the go-ahead, Americans could begin getting J&J and Moderna boosters later this month. J&J previously released data suggesting its vaccine remains highly effective against COVID-19 at least five months after vaccination, demonstrating 81% effectiveness against hospitalizations in the U.S. But company research shows a booster dose at either two or six months revved up immunity even further. Data released last month showed giving a booster at two months provided 94% protection against moderate-to-severe COVID-19 infection. The company has not yet released clinical data on a six-month booster shot. FDA's advisers will review studies from the company and other researchers next Friday and vote on whether to recommend boosters. The timing of the J&J filing was unusual given that the FDA had already scheduled its meeting on the company's data. Companies normally submit their requests well in advance of meeting announcements. A J&J executive said the company has been working with FDA on the review. Read: To launch J&J Covid shot in India, Biological E begins talks with govt lab to test vaccine “Both J&J and FDA have a sense of urgency because it’s COVID and we want good data out there converted into action as soon as possible,” said Dr. Mathai Mammen, head of research for J&J's Janssen unit. The vaccine from the New Brunswick, New Jersey, company was considered an important tool in fighting the pandemic because it requires only one shot. But its rollout was hurt by a series of troubles, including manufacturing problems at a Baltimore factory that forced J&J to import millions of doses from overseas. Additionally, regulators have added warnings of several rare side effects to the shot, including a blood clot disorder and a neurological reaction called Guillain-Barré syndrome. In both cases, regulators decided the benefits of the shot still outweighed those uncommon risks. Rival drugmakers Pfizer and Moderna have provided the vast majority of U.S. COVID-19 vaccines. More than 170 million Americans have been fully vaccinated with the companies’ two-dose shots while less than 15 million Americans got the J&J shot.

It’s when a fully vaccinated person gets infected with the coronavirus. A small number of such cases are expected and health officials say they’re not a cause for alarm. COVID-19 vaccines work by teaching the body to recognize the virus. So if you’re exposed to it after vaccination, your immune system should be ready to spring into action and fight it. In studies, the two-dose COVID-19 vaccines by Pfizer and Moderna were around 95% effective at preventing illness, while the one-shot Johnson & Johnson shot was 72% effective, though direct comparisons are difficult. So while the vaccines are very good at protecting us from the virus, it’s still possible to get infected with mild or no symptoms, or even to get sick. Also read: Challenges remain despite Europe meeting 70 pct vaccine delivery goal If you do end up getting sick despite vaccination, experts say the shots are very good at reducing the severity of the illness — the main reason to get vaccinated. Most people with breakthrough infections experience mild illness, said Dr. William Moss, a vaccine expert at the Johns Hopkins Bloomberg School of Public Health. In the U.S., people who weren’t vaccinated make up nearly all hospitalizations and deaths from COVID-19. It’s difficult to determine why any particular breakthrough case happens. How much of the virus you’re exposed to could be a factor, Moss said. Our individual immune systems will also affect how well we respond to the shots. Some people, for example, have health conditions or take medications that could make their immune systems less responsive to the vaccines. People might also have been exposed to the virus before the shots took full effect. Though less likely, they may have received a dose that was improperly stored or administered, Moss said. Also read: Immunized but banned: EU says not all COVID vaccines equal The Centers for Disease Control and Prevention notes variants could be factors in some breakthrough cases, though evidence so far indicates the vaccines used in the U.S. are protective against them. Health officials are also watching for signs that breakthrough cases are rising, which could signal that protection from the vaccines is fading and boosters are needed.

Johnson & Johnson is asking for Supreme Court review of a $2 billion verdict in favor of women who claim they developed ovarian cancer from using the company’s talc products. The case features an array of high-profile attorneys, some in unusual alliances, including former independent counsel Kenneth Starr, who is representing the women who sued Johnson & Johnson. The nation’s largest business groups are backing the company, and a justice’s father also makes an appearance because of his long association with the trade group for cosmetics and personal care products. Read:Apple brings CEO Tim Cook to court in defense of app store The court could say as soon as Tuesday whether it will get involved. At the root, Johnson & Johnson argues that the company didn’t get a fair shake in a trial in state court in Missouri that resulted in an initial $4.7 billion verdict in favor of 22 women who used talc products and developed ovarian cancer. A state appeals court cut more than half the money out of the verdict and eliminated two of the plaintiffs, but otherwise upheld the outcome in a trial in which lawyers for both sides presented dueling expert testimony about whether the company’s talc products contain asbestos and asbestos-laced talc can cause ovarian cancer. The jury found for the women on both points, after which Judge Rex M. Burlison wrote that evidence at the trial showed “particularly reprehensible conduct on the part of Defendants.” The evidence, Burlison wrote, included that the company knew there was asbestos in products aimed at mothers and babies, knew of the potential harm and “misrepresented the safety of these products for decades.” Nine of the women have died from ovarian cancer, lawyers for the plaintiffs said Johnson & Johnson denies that its talc products cause cancer and it called the verdict in the Missouri trial “at odds with decades of independent scientific evaluations confirming Johnson’s Baby Powder is safe, is not contaminated by asbestos and does not cause cancer.” The company also is the maker of one of three COVID-19 vaccines approved for use in the United States. Health concerns about talcum powders have prompted thousands of U.S. lawsuits by women who claim asbestos in the powder caused their cancer. Talc is a mineral similar in structure to asbestos, which is known to cause cancer, and they are sometimes obtained from the same mines. The cosmetics industry in 1976 agreed to make sure its talc products do not contain detectable amounts of asbestos. Last year, a U.S. government-led analysis of 250,000 women found no strong evidence linking baby powder with ovarian cancer in the largest analysis to look at the question, though the study’s lead author called the results “very ambiguous.” Read:Asian shares mixed after retreat on Wall Street The findings were called “overall reassuring” in an editorial published with the study in January 2020 in the Journal of the American Medical Association. The study wasn’t definitive but more conclusive research probably isn’t feasible because a dwindling number of women use powder for personal hygiene, the editorial said. A few months later, the company announced it would stop selling its iconic talc-based Johnson’s Baby Powder in the U.S. and Canada, citing declining demand driven by what it called misinformation about health concerns. The disputed link between cancer and talc is not really a part of the high court case. Instead, the company said it should have not been forced to defend itself in one trial against claims by women from 12 states, differing backgrounds and with varying histories of using Johnson & Johnson products containing talc. The $1.6 billion in punitive damages is out of line and should be reduced, the company also argued in a brief that was written by Neal Katyal, a Washington lawyer who aligns with progressive causes and also represents corporate clients. Katyal, who was the acting top Supreme Court lawyer for a time in the Obama administration, declined an on-the-record interview. The U.S. Chamber of Commerce and trade associations for manufacturers, insurers and the pharmaceutical industry are among the business organizations backing Johnson & Johnson’s appeal. Tiger Joyce, president of the American Tort Reform Association, pointed to how long it took the trial judge to read the jury its instructions as an indication of how unfair the trial was to Johnson & Johnson. “When a defendant is facing a case where it takes over five hours for the judge to read the jury instructions to the jury, you just have to ask yourself what are we doing here,” said Joyce, whose group generally backs limits on liability lawsuits. Starr said in an interview with The Associated Press that none of Johnson & Johnson’s legal arguments is worth the court’s time. “As the jury found and as every judge to review this six-week trial record has concluded, Johnson & Johnson’s conduct over decades was reprehensible,” Starr said. In addition to Starr, other members of the women’s legal team are former Attorney General John Ashcroft and Washington lawyers David Frederick and Tom Goldstein, frequent advocates before the Supreme Court. Justice Brett Kavanaugh worked for Starr when he investigated the affair between President Bill Clinton and Monica Lewinsky, which led to Clinton’s impeachment. Read:Oprah and CNN: AT&T is merging media business with Discovery Another name that pops up in some documents in the case is E. Edward Kavanaugh, who was the longtime president of the Cosmetic, Toiletry and Fragrance Association and is the justice’s father. Kavanaugh’s group fought efforts to list talc as a carcinogen or attach warning labels to talc products. Kavanaugh is retired and the group now is called the Personal Care Products Council. Ethicists contacted by the AP said they haven’t seen anything that would warrant the justice having to step aside from the case. Already, one justice almost certainly won’t take part. Justice Samuel Alito reported last year that he owned $15,000 to $50,000 in Johnson & Johnson stock. Federal law prohibits judges from sitting on cases in which they have financial interest.

Dhaka, May 24 (UNB)--External Affairs Minister (EAM) S Jaishankar on Monday landed in New York, as part of his US visit, to meet with senior United States officials, and discuss Covid-related cooperation between the two countries, reports Hindustan Times. Ambassador of India to the UN TS Tirumurti received EAM Jaishankar on his first visit to New York after India entered the UN Security Council. "Privilege to receive External Affairs Minister @DrSJaishankar on his first visit to New York after #India entered the UN #SecurityCouncil on 1 January 2021," Ambassador Tirumurti tweeted. Jaishankar's US visit is slated to last till May 28, the External Affairs Ministry said last week. Read: India may firm up plans to export Bharat Biotech’s Covaxin The Foreign Minister is expected to meet UN Secretary-General Antonio Guterres in New York and later he will hold discussions with his counterpart Secretary of State Antony Blinken in Washington DC, the ministry said. He will also be meeting Cabinet members and Senior Officials of the Administration dealing with the bilateral relationship. "External Affairs Minister will have two interactions with business forums on economic and Covid-related cooperation between India and the US," said the ministry statement. According to Hindustan Times, India is engaged in talks with various US entities involved in Covid vaccines production and is looking forward to procuring and subsequently producing these vaccines. The issue of vaccine procurement is expected to be a key agenda item during Jaishankar's interaction with US leadership and other stakeholders. The US has already announced that it is going to distribute 80 million vaccines from its stockpile to countries in need. With India hit badly by the second Covid wave, efforts of New Delhi will focus on getting the maximum and also looking for tie-ups with vaccine developers to produce in India. US has a stockpile 60 million Astra Zeneca vaccine doses and also Pfizer, Moderna and Johnson & Johnson Covid-19 vaccines. Read: India virus death toll passes 300,000, 3rd highest in world US is playing a lead role in assisting India's fight against the Covid-19 virus. It has already provided large oxygen plants, concentrators, critical medicines like Remdesivir and also raw materials for vaccine manufacturer Serum Institute of India (SII), which is manufacturing Covishield. US is also backing India sponsored proposal on TRIPS waiver at the WTO. The TRIPS waiver aims to increase global vaccine production in order to take on the challenge of vaccinating the poorest of the poor and save lives. In October last year, India and South Africa, along with 57 members of WTO proposed a waiver from certain provisions of the TRIPS agreement for prevention, containment, and treatment of the coronavirus. EAM Jaishankar met his US counterpart Antony Blinken in early May in London during G7 Foreign Minister's meeting.

Several world leaders Thursday praised the U.S. call to remove patent protections on COVID-19 vaccines to help poor countries obtain shots. But the proposal faces a multitude of hurdles, including resistance from the pharmaceutical industry. Nor is it clear what effect such a step might have on the campaign to vanquish the outbreak. Activists and humanitarian institutions cheered after the U.S. reversed course Wednesday and called for a waiver of intellectual property protections on the vaccine. The decision ultimately is up to the 164-member World Trade Organization, and if just one country votes against a waiver, the proposal will fail. The Biden administration announcement made the U.S. the first country in the developed world with big vaccine manufacturing to publicly support the waiver idea floated by India and South Africa in October. On Thursday, French President Emmanuel Macron embraced it as well. “I completely favor this opening up of the intellectual property,” Macron said at a vaccine center. However, like many pharmaceutical companies, Macron insisted that a waiver would not solve the problem of access to vaccines. He said manufacturers in places like Africa are not now equipped to make COVID-19 vaccines, so donations of shots from wealthier countries should be given priority instead. Pfizer, Moderna, Johnson & Johnson and AstraZeneca — all companies with licensed COVID-19 vaccines — had no immediate comment, though Moderna has long said it will not pursue rivals for patent infringement during the pandemic. Also read: US tribe shares vaccine with relatives, neighbors in Canada U.S. Secretary of State Antony Blinken underscored the urgency of moving fast now. “On the current trajectory, if we don’t do more, if the entire world doesn’t do more, the world won’t be vaccinated until 2024,” he said in an interview with NBC while visiting Ukraine. India, as expected, welcomed the move. Australian Prime Minister Scott Morrison called the U.S. position “great news.” Italian Foreign Minister Luigi Di Maio wrote on Facebook that the U.S. announcement was “a very important signal” and that the world needs “free access” to vaccine patents. But Italian Premier Mario Draghi was more circumspect. Russian President Vladimir Putin said his country would support it. U.N. Secretary-General Antonio Guterres welcomed the U.S. decision too. But German Chancellor Angela Merkel’s office spoke out against it, saying: “The protection of intellectual property is a source of innovation and must remain so in the future.” Also read: US support behind vaccine patent waiver ‘monumental moment’ in Covid fight: WHO A Merkel spokeswoman, speaking on customary condition of anonymity, said Germany is focused instead on how to increase vaccine manufacturers’ production capacity. In Brazil, one of the deadliest COVID-19 hot spots in the world, Health Minister Marcelo Queiroga said he fears that the country does not have the means to produce vaccines and that the lifting of patent protections could interfere with Brazil’s efforts to buy doses from pharmaceutical companies. In closed-door talks at the WTO in recent months, Australia, Britain, Canada, the European Union, Japan, Norway, Singapore and the United States opposed the waiver idea, according to a Geneva-based trade official who was not authorized the discuss the matter and spoke on condition of anonymity. Some 80 countries, mostly developing ones, have supported the proposal, the official said. China and Russia — two other major COVID-19 vaccine makers — didn’t express a position but were open to further discussion, the official said. EU Commission President Ursula von der Leyen said the 27-nation bloc is ready to talk about the idea, but she remained noncommittal and emphasized that the EU has been exporting vaccines widely — while the U.S. has not. EU leaders said the bloc may discuss the matter at a summit that starts Friday. Also read: US backs waiving intellectual property rules on vaccines The pharmaceutical industry has argued that a waiver will do more harm than good in the long run. Easing patent protections would eat into their profits, potentially reducing the incentives that push companies to innovate and make the kind of tremendous leaps they did with the COVID-19 vaccines, which have been churned out at a blistering, unprecedented pace. The industry has contended, too, that production of the vaccines is complicated and can’t be ramped up simply by easing patent rights. Instead, it has said that reducing snarls in supply chains and shortages of ingredients is a more pressing issue. The industry has insisted that a faster solution would be for rich countries to share their vaccine stockpiles with poorer ones. “A waiver is the simple but the wrong answer to what is a complex problem,” said the International Federation of Pharmaceutical Manufacturers and Associations. “Waiving patents of COVID-19 vaccines will not increase production nor provide practical solutions needed to battle this global health crisis.” Intellectual property law expert Shyam Balganesh, a professor at Columbia University, said a waiver would only go so far because of bottlenecks in the manufacturing and distribution of vaccines. Also read: EU medicine regulator starts rolling review of Sinovac COVID-19 vaccine Backers of the waiver say that expanded production by the big pharmaceutical companies and donations from richer countries to poor ones won’t be enough, and that there are manufacturers standing by that could make the vaccines if given the blueprints. “A waiver of patents for #COVID19 vaccines & medicines could change the game for Africa, unlocking millions more vaccine doses & saving countless lives,” World Health Organization Africa chief Matshidiso Moeti tweeted. Just over 20 million vaccine doses have been administered across the African continent, which has 1.3 billion people. There is precedent: In 2003, WTO members agreed to waive patent rights and allow poorer countries to import generic treatments for the AIDS virus, malaria and tuberculosis. “We believe that when the history of this pandemic is written, history will remember the move by the U.S. government as doing the right thing at the right time,” Africa CDC Director John Nkengasong said.

The European Union’s drug regulatory agency said Tuesday that it found a “possible link” between Johnson & Johnson’s COVID-19 vaccine and extremely rare blood clots and that a warning should be added to the label. But experts at the agency reiterated that the vaccine’s benefits outweigh the risks. The European Medicines Agency made those determinations after a very small number of blood clot cases in people who had gotten the vaccine were reported in the United States. The agency said a warning about the blood clots should be added to labels for the Johnson & Johnson’s vaccine and that these rare blood disorders should be considered “very rare side effects of the vaccine.” The EMA, which oversees the use of pharmaceutical products in 27 countries with a combined population of about 448 million, also recommended a label change for the AstraZeneca COVID-19 vaccine after finding a link between it and rare blood clots. In both cases, the agency said the benefits of being immunized against COVID-19 still outweighed the very small risks of recipients developing the unusual clots. Last week, Johnson & Johnson halted its European roll-out of the vaccine after U.S. officials recommended a pause in the vaccine, when they detected six very rare blood clot cases among nearly 7 million people who had been vaccinated. European officials said they considered all currently available evidence from the U.S., which consisted of eight reports of serious cases of rare blood clots associated with low blood platelets, including one death. All of the cases occurred in people under age 60, but the EMA said that it hadn’t been able to identify any specific risk factors. Also read: Fauci says he expects J&J vaccine to resume later this week Last week, J&J halted its European rollout of its one-dose vaccine after the U.S. Food and Drug Administration recommended officials pause its use while the rare blood clot cases are examined. Officials identified six cases of the highly unusual blood clots among nearly 7 million people who were immunized with the shot in the U.S. Johnson & Johnson advised European governments to store their doses until the EU drug regulator issued guidance on their use; widespread use of the shot in Europe has not yet started. The delay was a further blow to vaccination efforts in the European Union, which have been plagued by supply shortages, logistical problems and concerns over unusual blood clots also in a small number of people who received the AstraZeneca COVID-19 vaccine. Experts worry the temporary halt on J&J’s shot could further shake vaccine confidence and complicate worldwide COVID-19 immunization efforts. Last week, South Africa suspended its use of the vaccine in the wake of the U.S. pause, and countries including Italy, Romania, the Netherlands, Denmark and Croatia put their J&J doses into storage. The blood clots linked to the J&J vaccine are occurring in unusual parts of the body, such as veins that drain blood from the brain. Those patients also have abnormally low levels of blood platelets, a condition normally linked to bleeding, not clotting. Aso read: J&J vaccine to remain in limbo while officials seek evidence In its statement, the EMA said the cases it reviewed of unusual blood clots in people who received the J&J shot “were very similar to the cases that occurred with the COVID-19 vaccine developed by AstraZeneca.” With the AstraZeneca vaccine, scientists in Norway and Germany have suggested that some people are experiencing an abnormal immune system response, forming antibodies that attack their own platelets. It’s not yet clear if there might be a similar mechanism with the Johnson & Johnson vaccine. But both the J&J and AstraZeneca vaccines, as well as a Russian COVID-19 vaccine and one from China, are made with the same technology. They train the immune system to recognize the spike protein that coats the coronavirus. To do that, they use a cold virus, called an adenovirus, to carry the spike gene into the body. “Suspicion is rising that these rare cases may be triggered by the adenovirus component of the AstraZeneca and J&J vaccines,” said Eleanor Riley, a professor of immunology and infectious diseases at the University of Edinburgh. She said that while more data was needed, “it remains the case that for the vast majority of adults in Europe and the USA, the risks associated with contracting COVID-19 far, far outweigh any risk of being vaccinated.” Aso read: Australia won’t buy J&J coronavirus vaccine On Monday, World Health Organization Director-General Tedros Adhanom Ghebreyesus said more than 5 million new cororavirus cases were confirmed worldwide last week, the highest-ever number in a single week. He noted that cases and hospitalizations among younger people were “increasing at an alarming rate.” The European Medicines Agency, which regulates drugs used in European Union member nations, said last month there was a “possible link” between the AstraZeneca vaccine and rare blood clots but said the benefits of vaccination far outweighed the risks of COVID-19. It noted the risk is less than the blood clot risk that healthy women face from birth control pills. The European Union ordered 200 million doses of the Johnson & Johnson for 2021 and EU officials had hoped the one-shot vaccine could be used both to boost the continent’s lagging vaccination rates and to protect hard-to-reach populations, like migrant workers and the homeless. Last month, the African Union announced it signed a deal to buy up to 400 million doses of the J&J vaccine. Johnson & Johnson also has a deal to supply up to 500 million doses to the U.N.-backed COVAX initiative that helps get vaccines to the world’s poor. Aso read: Company at heart of J&J vaccine woes has series of citations Any concerns about the J&J vaccine would be another unwelcome complication for COVAX and for the billions of people in developing countries depending on the program. COVAX recently was hit by supply issues after its biggest supplier, the Serum Institute of India, announced it would delay exports of the AstraZeneca vaccine for several months due to a surge of cases on the subcontinent.

The United States will likely move to resume Johnson & Johnson’s COVID-19 vaccine this coming week, possibly with restrictions or broader warnings after reports of some very rare blood clot cases, the government’s top infectious diseases expert said Sunday. Dr. Anthony Fauci, in a series of news show interviews, said he expects a decision when advisers to the Centers for Disease Control and Prevention meet Friday to discuss the pause in J&J’s single-dose vaccine. “I would be very surprised if we don’t have a resumption in some form by Friday,” he said. “I don’t really anticipate that they’re going to want it stretch it out a bit longer.” Aso read: J&J vaccine to remain in limbo while officials seek evidence Fauci, who is President Joe Biden’s chief medical adviser, said he believed that federal regulators could bring the shots back with restrictions based on age or gender or with a blanket warning, so that it is administered in a way “a little bit different than we were before the pause.” The J&J vaccine has been in limbo after the CDC and the Food and Drug Administration said last week they needed more evidence to decide if a handful of unusual blood clots were linked to the shot — and if so, how big the risk is. The reports are rare — six cases out of more than 7 million U.S. inoculations with J&J vaccine. The clots were found in six women between the ages of 18 and 48. One person died. Aso read: Australia won’t buy J&J coronavirus vaccine The acting FDA commissioner had said she expected the pause to last only a matter of days. Still, the decision last Tuesday triggered swift action in Europe and elsewhere. Fauci said he doubted very seriously that the U.S. would permanently halt use of the J&J vaccine. “I don’t think that’s going to happen,” he said. “The pause was to take a look, make sure we know all the information we can have within that timeframe, and also warn some of the physicians out there who might see people, particularly women, who have this particular adverse event, that they treat them properly.” Aso read: Company at heart of J&J vaccine woes has series of citations “I think it’ll likely say, ‘OK, we’re going to use it. But be careful under these certain circumstances.’” More than 6.8 million doses of the J&J vaccine have been given in the U.S., the vast majority with no or mild side effects. Authorities stressed they have found no sign of clot problems with the most widely used COVID-19 vaccines in the U.S. — from Moderna and Pfizer. Fauci appeared on NBC’s “Meet the Press,” CNN’s “State of the Union,” ABC’s “This Week” and CBS’ “Face the Nation.”

The Australian government has decided against buying the single-dose Johnson & Johnson coronavirus vaccine as a way to accelerate its immunization program. Health Minister Greg Hunt said Tuesday the Johnson & Johnson vaccine is similar to the AstraZeneca product, which Australia already contracted to buy. Also read: Merck to help produce rival J&J’s COVID-19 vaccine Australia had planned to rely on Australian-manufactured AstraZeneca with the goal of delivering at least one dose of vaccine to all eligible adults among a population of 26 million by October. But the government announced last week that the Pfizer vaccine is now the preferred option for people under 50 because of a potential health risk from AstraZeneca. Australia has doubled its Pfizer order to 40 million doses. Australia had acquired 3.7 doses of the Pfizer and AstraZeneca vaccines by Monday and had injected 1.2 million doses.