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Vaccine Hesitancy Leaves Doses to Expire in Some African Countries

With growing community transmission and high average mortality rates from the coronavirus in Malawi, there was widespread concern among the country’s health care advocates this week when the authorities announced that they would throw away 16,000 vaccine doses that had expired.

They were part of a total of 512,000 AstraZeneca vaccine doses that the landlocked southeast African nation had received from India, the African Union and Covax, the global initiative to procure and distribute vaccines. Health officials didn’t specify why the vaccines had expired, but said the doses went void on Tuesday “due to varying expiry dates of the received vaccine consignments.”

Health experts and campaigners warned that vaccine hesitancy, along with rumors that out-of-date jabs were being administered, might have contributed to the slow distribution of the vaccine doses and their eventual expiration.

In many African countries, vaccination campaigns have been hindered by factors like science skepticism, limited or no efforts to educate the public, inefficient distribution systems and concerns over the extremely rare but serious cases of blood clots being investigated among a small number of people who received the AstraZeneca and Johnson & Johnson vaccines. Those two vaccines, which require less stringent refrigeration, are crucial to efforts to immunize populations in poorer countries.

stopped plans to secure the AstraZeneca vaccine — a decision one official said was made to avoid duplicating the efforts of Covax, which will still supply AstraZeneca to African nations. But even though the decision was not linked to concerns over blood clotting, experts said it could still magnify misinformation about the vaccine. And the African Union is shifting its focus to the Johnson & Johnson vaccine, which could add to the problem. Its use has been paused in the United States.

In African countries, public confusion over whether to get inoculated, and if so when and where to do so, has contributed to the expiration of doses. Like Malawi, South Sudan saw 59,000 unused doses expire this month.

The problem is not unique to African countries. Tens of thousands of jabs have also been thrown away in countries like France and the United States. But African countries face far more serious supply shortages. According to a New York Times database, Africa has the slowest vaccination rate of any continent, with many countries yet to start mass vaccination campaigns.

Countries like Ghana, which was the first African nation to receive doses from Covax, is about to run out of its initial supplies with no sense of when the next batch may come.

“This inequality negatively affects the entire world,” said Dr. Ngozi Erondu, an infectious disease specialist and a senior health scholar at the O’Neill Institute at Georgetown University. If “entire regions and countries remain insufficiently vaccinated,” she said, “it will continue to ravage populations with persistent morbidity and leave the larger global health community always vulnerable to the virus.”

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C.D.C. Panel Keeps Pause on Use of J&J Vaccine, Weighing Risks

“Right now, we believe these events to be extremely rare, but we are also not yet certain we have heard about all possible cases, as this syndrome may not be easily recognized as one associated with the vaccine,” Dr. Rochelle P. Walensky, the C.D.C. director, said at a White House news conference on the pandemic on Wednesday.

During the panel discussion, experts noted that the “risk window” for the condition among vaccine recipients was still open and that new cases might emerge, because nearly 3.8 million people had received the shot within the last two weeks. In the six women, the severe clotting developed within about two weeks of the shot.

Other experts encouraged dissemination of health information on diagnosis and treatment of the condition so that awareness would spread among doctors, emergency rooms and people who had received the vaccine. A key point is that the blood-thinner heparin, a common treatment for clots, can harm these patients and should not be used.

Officials also noted that people with the condition needed to be treated as soon as possible because the clots were so serious. Some patients needed invasive procedures to remove large clots from blood vessels in their brains.

Several panel members reiterated that two other vaccines — from Moderna and Pfizer-BioNTech — are available, neither associated with the clotting problem, so continuing the pause would not stop most people in the United States from being vaccinated.

At the news conference, Jeffrey D. Zients, the White House’s pandemic coordinator, said that the pause would not generally interrupt the momentum of the country’s vaccination campaign.

“In the very short term, we do expect some impact on daily averages as sites and appointments transition from Johnson & Johnson to Moderna and Pfizer vaccines,” he said. “We have more than enough Pfizer and Moderna vaccine supply to continue or even accelerate the current pace of vaccinations.”

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Western Warnings Tarnish Vaccines the World Badly Needs

The solution in many European countries — to stop using seemingly riskier vaccines in younger people, who are at lower risk from Covid-19 — would be unworkable in Africa, where the median age in many countries is below 20.

And any further restrictions would compound the hurdles facing Covax, among them a paucity of funding for every part of inoculation programs beyond the touchdown of doses at airports.

Mali, in western Africa, has administered 7 percent of the AstraZeneca doses that Covax has delivered. Sudan, in eastern Africa, has given 8 percent of the doses it has received.

Skittishness over the AstraZeneca and Johnson & Johnson vaccines, analysts fear, could stoke demand for Russian- and Chinese-made shots about which far less is known. As it is, some global health officials have turned their attention to the Novavax vaccine, which is not yet authorized but makes up a third of Covax’s portfolio.

“Even at this stage of the pandemic, we have our fingers crossed that some vaccine will work to help vaccinate developing countries, instead of ramping up production of vaccines we know work,” said Zain Rizvi, an expert on medicines access at Public Citizen, an advocacy group.

In Kenya, where enthusiasm for vaccines is high in cities but perilously low in rural areas, “the story about blood clots from Europe could not have come at a worse time,” said Catherine Kyobutungi, the director of the African Population and Health Research Center there. “Even those who were perhaps on the fence, and leaning toward getting vaccinated, all of a sudden had second thoughts,” she said.

The American pause on Johnson & Johnson shots promised a second media furor.

“When the F.D.A. suspends, it makes headlines for days,” she said. “When it lifts the suspension, it doesn’t make as many headlines.”

Mady Camara contributed reporting from Dakar, Senegal.

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Several States Pausing Use of Johnson & Johnson Vaccine After CDC, FDA Advisory

“Usually, an anticoagulant drug called heparin is used to treat blood clots. In this setting, administration of heparin may be dangerous, and alternative treatments need to be given,” the statement said.

Like many states, New York had already prepared for a significant drop in its supply of the Johnson & Johnson vaccine after federal officials said that supplies would be limited because of a production issue at a Baltimore manufacturing plant. On Friday, Gov. Andrew M. Cuomo said that New York expected to receive 34,900 Johnson & Johnson shots, a decrease of 88 percent from the previous week.

Dr. Zucker, New York’s health commissioner, said that the state would honor appointments made at state-run mass vaccination sites for the Johnson & Johnson vaccine by giving people the Pfizer-BioNTech vaccine instead. That vaccine requires two doses, and it was not immediately clear how the state would handle the additional strain on its supply.

New Jersey health officials said the state would work with its vaccination sites to help people get appointments for the Pfizer or Moderna vaccine instead. Mayor Bill de Blasio of New York City said that the city would do the same, rescheduling appointments at city-run vaccine sites.

“Every site has been told this morning to stop giving the J&J shots,” he said at a news conference.

The city’s health commissioner, Dr. Dave Chokshi, said that around 234,000 residents have received the Johnson & Johnson vaccine and none had reported any blood clots so far. The city had been relying on the vaccine to inoculate hard-to-reach New Yorkers, including people who are homebound.

Both Mr. Cuomo and Mr. de Blasio received the Johnson & Johnson vaccine at separate appearances last month, which they framed as an effort to boost confidence in that vaccine’s efficacy rate and to address vaccine hesitancy.

Regulators in Europe and elsewhere are concerned about a similar issue with another coronavirus vaccine, developed by AstraZeneca and Oxford University researchers. That vaccine has not been authorized for emergency use in the United States.

Rebecca Robbins contributed reporting.

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Worry Over 2 Covid Vaccines Deals Fresh Blow to Europe’s Inoculation Push

BRUSSELS — First it was AstraZeneca. Now Johnson & Johnson.

Last week, British regulators and the European Union’s medical agency said they had established a possible link between AstraZeneca’s Covid-19 vaccine and very rare, though sometimes fatal, blood clots.

On Tuesday, Johnson & Johnson said it would pause the rollout of its vaccine in Europe and the United States over similar concerns, further compounding the continent’s one-step-forward-two-steps-back efforts to quickly get people immunized against the coronavirus.

European officials had been confident that they had secured enough alternative vaccine doses to take up the slack of the AstraZeneca problems and achieve their goal of fully inoculating 70 percent of the European Union’s adult population — about 255 million people — by the end of the summer.

On Tuesday, European officials did not immediately say whether they believed the milestone would also survive the Johnson & Johnson suspension. But the European commissioner for health, Stella Kyriakides, wrote on Twitter that “Today’s developments with the J&J vaccine in the US are under close monitoring” by the bloc’s medicines regulator.

months of short supplies and logistical problems.

There is mounting evidence that the concerns are eroding Europeans’ willingness to get the AstraZeneca vaccine in particular, and threatening to elevate already high levels of vaccine hesitancy generally.

YouGov poll published last month, 61 percent of the French, 55 percent of Germans and 52 percent of Spaniards consider the AstraZeneca vaccine “unsafe.” That is in stark contrast to the findings of a similar poll from February, when more people in those countries, with the exception of France, believed that the shot was more safe than unsafe.

Regulators have asked vaccine recipients and doctors to be on the lookout for certain symptoms, including severe and persistent headaches and tiny blood spots under the skin. Doctors’ groups have circulated guidance about how to treat the disorder.

In Poland, where the vaccination campaign relies to a large extent on AstraZeneca and where its use has not been restricted, a recent poll showed that given a choice, fewer than 5 percent of Poles would choose the AstraZeneca shot.

Almost everywhere across the European Union, it seems, many are eager for alternatives, as the new types of vaccines that include the Moderna and Pfizer, which utilize science known as “mRNA,” have not been associated with similar side effects.

Data from the 27 E.U. member states by the European Center for Disease Prevention and Control shows that over all, 80 percent of vaccine doses distributed to the bloc have already been administered. That share drops to 65 percent for AstraZeneca, however, suggesting that many of its doses are sitting unused.

Yet it is hard to predict how serious a blow the latest twist in the AstraZeneca saga — and the new Johnson & Johnson concerns — will be to E.U. vaccination efforts, as officials in Brussels have made big if belated efforts to turbocharge the second-quarter supply of doses.

The European Union is poised to receive at least 300 million doses of various vaccines, three times what it got in the first quarter. Two hundred million are slated to come from Pfizer/BioNTech. Moderna is expected to deliver 35 million doses. Another 55 million doses are due of the Johnson & Johnson jab, and 70 million from AstraZeneca.

In the rosiest scenario, the European Union could get up to 360 million doses by June.

On Thursday, after Spain’s government changed the age threshold for the AstraZeneca shot, two-thirds of people called up for vaccination in Madrid did not show up, Antonio Zapatero, the regional health minister, told a news conference on Friday.

He attributed the no-show by 18,200 people to “confusion” generated by Spain’s central government, which said on Wednesday that the AstraZeneca vaccine should be given only to people over 60. Before this change, Mr. Zapatero said, the rate of abstention was 2 percent.

In Belgium, where the use of the AstraZeneca vaccine has also been limited, the authorities said they did not expect major delays in the overall rollout, but they are still concerned about the confusion that the rare blood clotting issue is causing.

Yves Van Laethem, a top epidemiologist who is the country’s Covid task force spokesman, said he expected a two-week delay that would mostly affect younger age groups in late summer. He said the E.U. regulator guidance had only partly helped in clarifying the situation.

The European Medicines Agency’s opinion “wasn’t very clear, and it is also part of the problem,” Dr. Van Laethem said in an interview. “When you say, ‘We don’t apply limitations, but we just say there are serious side effects,’ there is part science and part diplomacy in that.”

He said the limited effect that the new AstraZeneca issues would have on Belgian’s rollout was in large part because the country had ordered big shares of other vaccines.

Although all E.U. countries have been offered a chunk of each vaccine approved in the bloc so far — AstraZeneca, Johnson & Johnson, Moderna and Pfizer — many opted to forgo parts of their share of more expensive or cumbersome vaccines like Pfizer and Moderna early on, instead favoring the AstraZeneca jab.

“In Britain or Eastern Europe, a big part of the campaigns are based on AstraZeneca,” Dr. Van Laethem said.

Wealthier bloc members like Denmark, France, Germany and the Netherlands can better compensate for the loss of confidence in AstraZeneca, because they acquired extra doses of other vaccines — especially Pfizer — through a secondary market after poorer E.U. nations gave theirs up.

Those countries — including Bulgaria, Croatia, Latvia and Slovakia — are likely to be less able to quickly offer alternatives.

Dr. Van Laethem, the Belgian immunologist, said that the national and European authorities needed to better communicate the costs and benefits of taking the AstraZeneca dose versus and the other authorized vaccines.

Experts worry that even limited concerns over one vaccine’s unlikely side effects can affect people’s overall willingness to be immunized.

“The main thing is to make people understand that the problem is the virus,” he said. “We have to vaccinate people — the risk linked to the virus is higher than those rare side effects.”

Raphael Minder contributed reporting from Madrid and Constant Méheut from Paris.

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How Worried Should You Be About the J&J Vaccine and Blood Clots?

On Tuesday morning, U.S. federal health regulators recommended a pause in the use of Johnson & Johnson’s Covid-19 vaccine while they investigated six reports of blood clots in women ages 18 to 48. One has died, and a second is hospitalized in critical condition.

As of Monday, 6.8 million people in the United States had received the vaccine without any other serious adverse reactions reported.

Experts have yet to determine to what extent, if any, the vaccine is responsible for the clots. But the investigation follows actions by European regulators who concluded that a vaccine made by AstraZeneca may also be the cause of a similar, extremely rare clotting disorder.

U.S. and European public health experts have emphasized that for most people, the benefits of the Covid vaccines far outweigh the risks.

recommends that people who have received the Johnson & Johnson vaccine within the past three weeks should contact their doctors if they experience severe headaches, abdominal pain, leg pain or shortness of breath. People should not be concerned about mild headaches and flu-like symptoms in the first few days after vaccination. Those are common, harmless side effects brought on by the immune system’s production of a defense against the coronavirus.

During clinical trials and after vaccines go into wide use, experts keep track of any medical problems experienced by people who receive them. If an unusually large cluster of cases turns up, regulators may decide to pause a trial or stop the use of a vaccine to investigate further.

Pauses are common, and typically the investigations reveal that the medical problems were a matter of coincidence. If the investigation reveals that a vaccine does pose a risk, regulators may write new guidance about who should or should not receive it.

regulators have said, roughly one in 1,000 people are affected by a blood clot in a vein every year.

But the clotting disorder of concern in the vaccine recipients is much rarer and different from typical blood clots. In addition to clotting in the brain — called cerebral venous sinus thrombosis, or CVST for short — the patients all had a notably low level of platelets, which left them prone to abnormal bleeding.

said the company was aware of an extremely rare disorder involving people with blood clots in combination with low platelets in a small number of individuals who have received our COVID-19 vaccine. “In addition, we have been reviewing these cases with European health authorities,” the company said in its statement. “We have made the decision to proactively delay the rollout of our vaccine in Europe.”

At the news conference on Tuesday, Dr. Marks of the F.D.A. said the cases were “very, very similar.”

a number of possible symptoms, including swelling in the leg, persistent abdominal pain, severe and persistent headaches or blurred vision, and tiny blood spots under the skin beyond the area where the injection was given.

But that set of symptoms was so vague that almost immediately, British emergency rooms experienced a surge in patients who were worried that they fit the description.

Nonetheless, German researchers say that such symptoms in vaccine recipients must be followed up. Blood tests can detect the antibodies.

Doctors in Germany and Norway have treated patients with blood-thinning drugs to try to stop the growth of the clots, and with intravenous immune globulin, which can help eliminate the misguided antibodies that are causing the problem.

AstraZeneca vaccines. One recipient, a physician in Florida, died from a brain hemorrhage when his platelet levels could not be restored, and others have been hospitalized. U.S. health officials have said that the cases are being investigated, but they have not reported the findings of those reviews and have yet to indicate that there is any link to the vaccines.

Benjamin Mueller contributed reporting.

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Johnson & Johnson Vaccine Deliveries To Dip in U.S.

Federal officials have said they still expect enough supply from the two other authorized vaccine manufacturers to be able to fulfill President Biden’s promise of having enough doses for all adults in the country by the end of May.

Nonetheless, states were counting on the Johnson & Johnson vaccine to fill important gaps in vaccination campaigns. Easier to store and transport — the vaccine can be kept at normal refrigeration temperatures for three months — states had begun using it in transformative ways, on homeless populations, migrant workers and college students.

Federal administrators divide vaccine doses nationwide based on each state’s adult population. That means that California will bear the brunt of the reduction: After receiving 572,700 doses of the Johnson & Johnson vaccine this week, it will get only 67,600 next week, according to Centers for Disease Control and Prevention data.

In Texas, the allocation will drop to 46,300 from 392,100. Florida, which received 313,200 shots this week, will get 37,000 next week. Guam, which received 16,900 doses this week, will receive none next week.

In Michigan, Gov. Gretchen Whitmer said Friday that she had urged President Biden to surge Covid-19 vaccines into her state, where a worst-in-the-nation outbreak has filled hospitals and forced some schools to close. “At this point that’s not being deployed, but I am not giving up,” Ms. Whitmer said, describing a Thursday evening call with the president. “Today it’s Michigan and the Midwest. Tomorrow it could be another section of our country.”

Ms. Whitmer, a Democrat whom the president considered as a potential running mate, took pains to praise aspects of Mr. Biden’s coronavirus response at a Friday news conference. But Ms. Whitmer said a rapid influx of shots, particularly the Johnson & Johnson vaccine, was essential to tamping down case numbers even as she resisted additional restrictions on gatherings and businesses.

Jeff Zients, the White House Covid coordinator, said at a news briefing on Friday that the administration does not plan to shift additional vaccine doses to hard-hit states like Michigan, which is slated to get another 17,500 Johnson & Johnson doses next week, an 88 percent drop compared to the nearly 148,000 doses it received this week, according to C.D.C. data.

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U.S. Bet on Covid Vaccine Manufacturer Even as Problems Mounted

Because of the pandemic, most of the auditors drew their conclusions from documents and video tours, during which Emergent workers controlled the camera angles, one former company official said.

Johnson & Johnson’s auditors said monitoring reports for bacteria or other contaminants were filed four to six months late. AstraZeneca’s said that Emergent repeatedly loosened monitoring criteria so it appeared to meet them, resorting to measures like “historical averages.” But even then it failed the tests, the report said.

In another audit, BARDA officials documented similar concerns, classifying some of them, including the risks of microbiological contamination, as “critical.” That designation is reserved for the most serious problems that pose an immediate and significant risk.

Emergent’s own internal audit in July also said the flow of workers and materials through the plant was not adequately controlled “to prevent mix-ups or contamination.”

The reports echoed quality-control shortcomings documented in an April inspection by the F.D.A., reported earlier by The Associated Press, that concluded the facility was “not ready for commercial operations.”

Multiple audits underscore how poorly the company was prepared for the huge workload it accepted.

The Covid-19 projects required significantly more testing to ensure materials remained stable, but Emergent had just one employee coordinating it all, the BARDA audit found. Emergent acknowledged at the time that its testing system was “not ideal” and pledged to train at least one more Emergent worker and hire a third. BARDA did not respond to requests for comment on its audit or any of the others, beyond saying that it had “worked with Emergent to resolve the issues” raised during the F.D.A. inspection.

Another internal investigation in August found that Emergent approved four raw materials used to produce AstraZeneca’s vaccine without first fully testing them. That type of shortcut, called a conditional release of material, occurred on average twice a week in October, internal logs show. The measure was deemed necessary because the company was working with shortened production times, testing backlogs and the needs of Operation Warp Speed, the Trump administration’s crash vaccine development program. And while a manager “knowingly deviated” from standards, the report said, the batches of vaccine would be not released without quality and safety tests.

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