Oregon health officials said Thursday that federal officials are investigating the death of a woman in her 50s who developed a rare blood clot and low platelets within two weeks of receiving the Johnson & Johnson vaccine against COVID-19. The Oregon Health Authority learned of the probe on Tuesday, two days after the U.S. Centers for Disease Control and Prevention began the investigation, the agency said. The woman, whose name was not released, received the dose before the CDC ordered a pause on the vaccine amid concerns it could cause dangerous clots. Also read: Fauci says he expects J&J vaccine to resume later this week The woman developed a “rare but serious blood clot in combination with very low platelets,” OHA said in a statement. Dr. Shimi Sharief, senior health advisor for the state’s health authority, said the woman’s symptoms were consistent with other cases — severe headache, abdominal pain, leg pain or shortness of breath . Health officials declined to release any further details, including the date the woman got the vaccine or where in Oregon she lived, citing patient privacy. The woman was hospitalized before her death and got the vaccine in early April, Sharief said. Until the investigation is complete, which health officials predict will take a week or more, it’s not certain that her death is related to the vaccine, the agency said. Federal and state agencies paused the J&J vaccine rollout on April 13 due to concerns about blood clots. “For most people that received the (J&J) vaccine, we are nearing the end of that time of where they need to be monitoring for symptoms,” Sharief said. The CDC warned that if people have symptoms within three weeks after receiving the vaccine they should contact their health care provider. Also read:J&J vaccine to remain in limbo while officials seek evidence Federal officials already were examining six reports of the unusual clots, including a death, out of more 8 million Americans given the one-dose vaccination so far. The CDC also told Texas health authorities Thursday that a woman in that state was hospitalized with possible blood clots associated with J&J vaccine recipients. A government advisory committee on vaccines is expected to meet Friday and could make a recommendation soon after on whether and how to resume use of the J&J vaccine. Sharief said whether Oregon resumes distribution of the J&J vaccine will be a “reflection” of the committee’s decision. “We have the utmost confidence that it would be a decision made with thorough investigation and consideration of the potential benefits and risks, in relation to each other, as we go through this pandemic,” Sharief 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.

Half of all adults in the U.S. have received at least one COVID-19 shot, the government announced Sunday, marking another milestone in the nation’s largest-ever vaccination campaign but leaving more work to do to convince skeptical Americans to roll up their sleeves. Almost 130 million people 18 or older have received at least one dose of a vaccine, or 50.4% of the total adult population, the Centers for Disease Control and Prevention reported. Almost 84 million adults, or about 32.5% of the population, have been fully vaccinated. Also Read: Vaccines to be made available at Alaska airports The U.S. cleared the 50% mark just a day after the reported global death toll from the coronavirus topped a staggering 3 million, according to totals compiled by Johns Hopkins University, though the actual number is believed to be significantly higher. The country’s vaccination rate, at 61.6 doses administered per 100 people, currently falls behind Israel, which leads among countries with at least 5 million people with a rate of 119.2. The U.S. also trails the United Arab Emirates, Chile and the United Kingdom, which is vaccinating at a rate of 62 doses per 100 people, according to Our World in Data, an online research site. The vaccine campaign offered hope in places like Nashville, Tennessee, where the Music City Center bustled Sunday with vaccine seekers. High demand for appointment-only shots at the convention center has leveled off enough that walk-ins will be welcome starting this week. Read South Africa scraps AstraZeneca vaccine, will give J&J jabs Amanda Grimsley, who received her second shot, said she’s ready to see her 96-year-old grandmother, who lives in Alabama and has been nervous about getting the vaccine after having a bad reaction to a flu shot. “It’s a little emotional. I haven’t been able to see my grandmother in a year and a half almost,” said Grimsley, 35. “And that’s the longest my entire family has ever gone without seeing her. And we’ll be seeing her in mid-May now.” The states with the highest vaccination rates have a history of voting Democratic and supporting President Joe Biden in the 2020 election: New Hampshire at the top, with 71.1%, followed by New Mexico, Connecticut, Massachusetts and Maine, CDC data show. Also Read: A rapid COVID-19 vaccine rollout backfired in some US states The demand has not been the same in many areas of Tennessee — particularly, rural ones. Tennessee sits in the bottom four states for rates of adults getting at least one shot, at 40.8%. It’s trailed only by Louisiana, Alabama and Mississippi — three other Southern states that lean Republican and voted for Donald Trump last fall. Vaccination rates do not always align with how states vote. But polling from The Associated Press-NORC Center for Public Affairs Research has shown trends that link political leanings and attitudes about the vaccines and other issues related to the pandemic, which has killed more than 566,000 people in the U.S. A poll conducted in late March found that 36% of Republicans said they will probably or definitely not get vaccinated, compared with 12% of Democrats. Similarly, a third of rural Americans said they were leaning against getting shots, while fewer than a fourth of people living in cities and suburbs shared that hesitancy. Read Ghana is first nation in world to receive COVAX vaccines Overall, willingness to get vaccinated has risen, polling shows. In January, 67% of adult Americans were willing to get vaccinated or had already received at least one shot. The figure has climbed to 75%, according to the latest AP-NORC poll. Nationwide, 24% of Black Americans and 22% of Hispanic Americans say they will probably or definitely not get vaccinated, down from 41% and 34% in January, respectively. Among white Americans, 26% now say they will not get vaccinated. In January, that number was 31%. Dr. Anthony Fauci, the nation’s top infectious disease expert, said the goal is to get community figures, from athletes to clergy, to encourage vaccinations, particularly as the seven-day national average of cases remains over 60,000 new infections per day. Read Coronavirus vaccines: How’s my country and the rest of the world doing? “What we are doing is we’re trying to get, by a community core, trusted messages that anyone would feel comfortable with listening to, whether you’re a Republican, a Democrat, an independent or whomever you are, that you’re comfortable,” Fauci said Sunday on ABC’s “This Week.” Fauci also indicated Sunday that the government will likely move to resume use of Johnson & Johnson’s COVID-19 vaccine this week, possibly with restrictions or broader warnings after reports of some very rare blood clot cases. In a series of news show interviews, Fauci said he expects a decision when advisers to the CDC meet Friday to discuss the pause in J&J’s single-dose vaccine. Read Japan begins COVID-19 vaccination drive amid supply worry “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.” Fauci, who is President Joe Biden’s chief medical adviser, said he believed federal regulators could bring the shots back with limits based on age or gender, or with a blanket warning, so the vaccine is administered in a way “a little bit different than we were before the pause.” The J&J vaccine was thrown into limbo after the CDC and the Food and Drug Administration said last week that 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 the J&J vaccine. The clots were found in women between the ages of 18 and 48. One person died. Read J&J vaccine to remain in limbo while officials seek evidence

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 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

South Africa will give the unapproved Johnson & Johnson vaccine to its front-line health workers beginning next week as a study to see what protection it provides from COVID-19, particularly against the variant dominant there, the health minister said Wednesday.