Most Americans should be given the Pfizer or Moderna vaccines instead of the Johnson & Johnson shot that can cause rare but serious blood clots, U.S. health officials said Thursday. The strange clotting problem has caused nine confirmed deaths after J&J vaccinations — while the Pfizer and Moderna vaccines don't come with that risk and also appear more effective, said advisers to the Centers for Disease Control and Prevention. The panel recommended the unusual move of giving preference to the Pfizer and Moderna vaccines, and late Thursday the CDC's director, Dr. Rochelle Walensky, accepted the panel's advice. Until now the U.S. has treated all three COVID-19 vaccines available to Americans as an equal choice, since large studies found they all offered strong protection and early supplies were limited. J&J's vaccine initially was welcomed as a single-dose option that could be especially important for hard-to-reach groups like homeless people who might not get the needed second dose of the Pfizer or Moderna options. Also read: Pfizer confirms COVID pill’s results, potency versus omicron But the CDC's advisers said during a meeting Thursday that it was time to recognize a lot has changed since vaccines began rolling out a year ago. More than 200 million Americans are considered fully vaccinated, including about 16 million who got the J&J shot. New data from unprecedented safety tracking of all those vaccinations persuaded the panel that while the blood clots linked to J&J's vaccine remain very rare, they're still occurring and not just in younger women as originally thought. In a unanimous vote, the advisers decided the safer Pfizer and Moderna vaccines are preferred. But they said the shot made by J&J's Janssen division still should be available if someone really wants it — or has a severe allergy to the other options. “I would not recommend the Janssen vaccine to my family members” but some patients may -- and should be able to -- choose that shot, said CDC adviser Dr. Beth Bell of the University of Washington. 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. Eventually U.S. regulators decided the benefits of J&J's one-and-done vaccine outweighed what was considered a very rare risk — as long as recipients were warned. European regulators likewise continued to recommend AstraZeneca's two-dose vaccine although, because early reports were mostly in younger women, some countries issued age restrictions. 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. It forms 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, dubbed “thrombosis with thrombocytopenia syndrome,” include severe headaches a week or two after the J&J vaccination — not right away — as well as abdominal pain and nausea. Also read: US expands Pfizer COVID boosters, opens extra dose to age 16 While it’s still very rare, the Food and Drug Administration told health care providers this week that more cases have occurred after J&J vaccinations since the spring. They occur most in women ages 30 to 49 -- about once for every 100,000 doses administered, the FDA said. Overall, the government has confirmed 54 clot cases— 37 in women and 17 in men, and nine deaths that included two men, the CDC's Dr. Isaac See said Thursday. He said two additional deaths are suspected. The CDC decides how vaccines should be used in the U.S., and its advisers called the continuing deaths troubling. In comparing the pros and cons of all the vaccines, the panelists agreed that side effects from the Pfizer and Moderna vaccines weren't as serious — and that supplies now are plentiful. Nor is J&J still considered a one-and-done vaccine, several advisers noted. The single-dose option didn't prove quite as protective as two doses of the Pfizer and Moderna vaccines. Plus, with extra-contagious virus mutants now spreading, booster doses now are recommended. For J&J recipients, a booster is recommended at least two months after vaccination. U.S. health officials had previously OK’d mixing vaccines for booster shots. Several countries, including Canada, already have policies that give preference to the Pfizer and Moderna vaccines. But J&J told the committee its vaccine still offers strong protection and is a critical option especially in parts of the world without plentiful vaccine supplies or for people who don't want a two-dose shot. While blood clots are rare, “unfortunately cases of COVID-19 are not,” J&J’s Dr. Penny Heaton said. The U.S. is fortunate in its vaccine availability and Thursday's action shouldn't discourage use of J&J's vaccine in places around the world where it's needed, said CDC adviser Dr. Matthew Daley of Kaiser Permanente Colorado. The FDA also warned this week that another dose of the J&J vaccine shouldn't be given to anyone who developed a clot following either a J&J or AstraZeneca shot. The committee also heard some of the first data on reported side effects of Pfizer vaccinations in younger children. Early last month, the CDC recommended a two-dose series for that age group, and more than 7 million doses have been given so far. But few problems have been reported. Of the 80 reported cases of serious side effects, about 10 involved a form of inflammation that has been seen in male teens and young adults.

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.”

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 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.

The company at the center of quality problems that led Johnson & Johnson to discard an unknown amount of its coronavirus vaccine has a string of citations from U.S. health officials for quality control problems. Emergent BioSolutons, a little-known company at the center of the vaccine supply chain, was a key to Johnson & Johnson’s plan to deliver 100 million doses of its vaccine to the U.S. by the end of May. But the company has been cited repeatedly by the Food and Drug Administration for problems such as poorly trained employees, cracked vials and mold around one of its facilities, according to records obtained by The Associated Press through the Freedom of Information Act. The records cover inspections at Emergent facilities since 2017. Johnson & Johnson said Wednesday that a batch of vaccine made by Emergent at its Baltimore factory, known as Bayview, can’t be used because it didn’t meet quality standards. It wasn’t clear exactly how many doses were involved or how the problem would affect future delivers of J&J’s vaccine. The company said in a statement it was still planning to deliver 100 million doses by the end of June and was “aiming to deliver those doses by the end of May.” J&J locked arms with Emergent in April 2020, enlisting the lesser-known company to manufacture the vaccine J&J was developing with federal funding. At the time, Emergent’s Bayview facility wasn’t scaled for making millions of doses of a potential COVID-19 vaccine, according to the FDA records that describe the plant as a contract testing laboratory that “did not manufacture products for distribution.” Upgrades in technology and personnel were required before Bayview could begin making what’s known as “drug substance” material for the vaccine, a two-month process during which the required biological cells are grown. Also read: EU regulator approves J&J’s one-shot COVID-19 vaccine The FDA inspected Emergent’s Bayview plant in April 2020, just as the agreement with J&J was being announced. The federal agency criticized the company for problems with its testing of a potential treatment for anthrax, according to the records obtained by the AP. The FDA’s lead investigator cited the company for failing to train employees “in the particular operations they perform as part of their function and current good manufacturing practices.” On the same day, Johnson & Johnson, in a separate news release, heralded its partnership with Emergent as a step toward the pharmaceutical giant’s goal of supplying more than 1 billion doses of the vaccine globally by the end of 2021. Other problems cited by the FDA during the April 2020 inspection included failures by the Bayview plant “to ensure that electronically held data generated during analytical testing” of material “was protected from deletion or manipulation.” The FDA’s lead investigator, Marcellinus Dordunoo, wrote that Emergent hadn’t investigated what he described as “data integrity concerns.” The inspection was the most recent in a series of critical reports from the FDA about Emergent, including one following a December 2017 inspection at a plant in Canton, Massachusetts, in which the FDA said the company hadn’t corrected “continued low level mold and yeast isolates” found in the facility. Nearly a year later, agency investigators questioned why Emergent had “an unwritten policy of not conducting routine compliance audits” at a separate plant in Baltimore, known as Camden, where an anthrax vaccine is filled into vials. Also read: Merck to help produce rival J&J’s COVID-19 vaccine Emergent’s revenues skyrocketed during the Trump administration, jumping from around $523 million in 2015 to more than $1.5 billion in 2020. The company has invested heavily in lobbying the federal government, according to disclosure records, which show the company spent $3.6 million on lobbying in 2020 alone. Emergent is one of about 10 companies that Johnson & Johnson is using to speed up manufacturing of its recently approved vaccine, the company said. The Bayview factory where the tainted vaccine ingredient was found had not yet been approved by the FDA, so no vaccine in circulation is affected. Emergent declined to comment. President Joe Biden has pledged to have enough vaccines for all U.S. adults by the end of May. The U.S. government has ordered enough two-dose shots from Pfizer and Moderna to vaccinate 200 million people to be delivered by late May, plus the 100 million single-dose shots from J&J. A federal official said Wednesday evening the administration’s goal can be met without additional J&J doses. A J&J spokesman said earlier Wednesday that the company met the end-of-March goal, and the Centers for Disease Control and Prevention’s online vaccine tracker showed J&J had provided about 6.8 million doses to the U.S. vaccine effort. J&J has been shipping finished vaccines from its factory in the Netherlands to the U.S. Also read: FDA says single-dose shot from J&J prevents severe COVID J&J said it was putting more of its manufacturing and quality experts inside Emergent’s factory to supervise production of the COVID-19 vaccine, a move meant to enable delivery of an additional 24 million vaccine doses through April. J&J said it still expects to deliver more than 1 billion vaccine doses globally by the end of the year. The J&J vaccine has been viewed as crucial for vaccination campaigns around the world, because only one shot is required and it can be shipped and stored at standard refrigeration temperatures, unlike some other vials that must be kept frozen. The company also has pledged to sell the vaccine without a profit, but only during the pandemic emergency. The problem with the vaccine batch was first reported by The New York Times. The FDA said it was aware of the situation but declined further comment.

The European Medicines Agency has authorized Johnson & Johnson’s one-dose coronavirus vaccine, giving the European Union’s 27 nations a fourth licensed vaccine to try to curb the pandemic amid a stalled vaccination drive in the bloc

U.S. President Joe Biden announced on Wednesday that his administration will order another 100 million doses of the Johnson & Johnson COVID-19 vaccine.

Drugmaker Merck & Co. will help produce rival Johnson & Johnson’s newly approved coronavirus vaccine in an effort to expand supply more quickly, a Biden administration official confirmed Tuesday.

Johnson & Johnson’s single-dose vaccine offers strong protection against severe COVID-19, according to an analysis released Wednesday by U.S. regulators that sets the stage for a final decision on a new and easier-to-use shot to help tame the pandemic.