View Source

Baltimore Vaccine Plant’s Troubles Ripple Across Africa, Europe and Canada

WASHINGTON — Quality-control problems at a Baltimore plant manufacturing Covid-19 vaccines have led health officials on three continents to pause the distribution of millions of Johnson & Johnson doses, as the troubles of a politically connected U.S. contractor ripple across the world.

Doses made at the plant owned by Emergent BioSolutions have not been cleared by the Food and Drug Administration for use in the United States, and the Biden administration has repeatedly assured Americans that none of the Johnson & Johnson shots administered domestically were made there.

But millions of doses have been shipped abroad, including to Canada, the European Union and South Africa. Regulators in various countries are now working to ensure that those doses are safe after the disclosure in March that workers at the Baltimore plant accidentally contaminated a batch of Johnson & Johnson’s vaccine with the harmless virus used to manufacture AstraZeneca’s. Both vaccines were produced at the same site. The mistake forced Emergent to throw out up to 15 million Johnson & Johnson doses after tests showed that the batch failed to meet purity requirements.

E.U. officials, as well as those in Canada and South Africa, said there was no evidence that any of the doses they had received were tainted. But the problems identified in Baltimore have slowed their vaccination efforts while they perform additional quality assessments as a precaution.

said they would “not allow the release of any product until we feel confident that it meets our expectations for quality.” The plant is still finishing batches of vaccine that were already in process.

previously acknowledged that it had allowed doses of AstraZeneca’s Covid-19 vaccine made at the same Emergent plant to be sent to Canada and Mexico but said it had not attested to their quality, instead leaving that assessment to the company and authorities in both countries. Unlike the Johnson & Johnson vaccine, the AstraZeneca vaccine is not approved for use in the United States.

The Times reported last month that Emergent had discarded five lots of AstraZeneca vaccine — each the equivalent of two million to three million doses — between October and January because of contamination or suspected contamination at the same Bayview plant in Baltimore.

The European Union’s drug regulator, the European Medicines Agency, said in a statement to The Times that one batch of vaccine manufactured at the Emergent facility “is being used” after “a thorough testing of the batch and a review of the controls in place at the manufacturing site.” There is no indication of any problems with those doses.

That batch was distributed for use in the European Union only after meeting “the rigorous quality standards of our company and the European Medicines Agency,” Johnson & Johnson said in a statement.

Two more batches, amounting to about 2.5 million doses, are on hold as regulators in Europe and the United States investigate the cause of the contamination at the Emergent plant and ensure that problems have been fixed, the E.M.A. said.

“When the investigations conclude, E.M.A. may decide on actions to prevent future contamination of batches,” the statement said.

Batches of vaccine made at Emergent are not released for bottling until they have passed required safety tests, including one designed to identify “adventitious agents” such as a virus used in the manufacture of another product. People familiar with Emergent’s processes said the tests were much the same whether the vaccine was destined for domestic or foreign use.

one of the lowest vaccination rates of any country, and the Johnson & Johnson vaccine is particularly important to the nation’s plans. Many developing countries are relying on AstraZeneca’s vaccine, but South Africa stopped using it in February after a trial indicated that it was less effective against the dominant coronavirus variant then circulating in the country.

Under its contract with Johnson & Johnson, Emergent manufactured the active ingredient for the vaccine in bulk, and the substance was then sent to other facilities for final processing and packaging. One of the sites performing these final manufacturing stages is a plant run by the South African company Aspen Pharmacare. Johnson & Johnson announced in March that the site would support the company’s pledge to provide vaccine to countries throughout Africa.

The Canadian regulatory authority, Health Canada, said in a statement that officials were working with Johnson & Johnson and the F.D.A. to perform further assessments of vaccine manufactured at the Emergent facility and that the doses “will only be released for distribution once Health Canada is satisfied that they meet the Department’s high standards for quality, safety and efficacy.”

The newly disclosed delays underscore the global impact of the problems at the Baltimore factory operated by Emergent, a government contractor known for its aggressive lobbying and political connections.

As The Times previously reported, the federal government last year banked on Emergent to be the main domestic manufacturer for both the Johnson & Johnson and AstraZeneca vaccines even as evidence of serious quality problems mounted.

announced “significant revenue growth and corresponding profitability” for the first quarter of this year and projected record revenues for 2021, driven largely by the company’s Covid-19 vaccine manufacturing deals.

Emergent built a profitable business largely by cornering the market for biodefense products, a Times investigation found. Throughout most of the last decade, sales of the company’s anthrax vaccines accounted for nearly half of the annual budget of the nation’s emergency medical reserve, the Strategic National Stockpile, leaving the federal government with less money to buy supplies needed in a pandemic.

Emergent has repeatedly touted its influence in Washington in presentations to investors. Six of its 10 board members have previously served in government, and since 2010, the company has spent an average of $3 million a year on lobbying — far outspending similarly sized biotech firms, and roughly matching the outlays of some larger pharmaceutical companies.

Matina Stevis-Gridneff contributed reporting from Brussels and Ian Austen from Ottawa.

View Source

Denmark decides not to use Johnson & Johnson’s vaccine over rare blood clots.

Denmark will not use the Johnson & Johnson vaccine, the Danish Health Authority announced on Monday, saying in a statement that the country could make adequate progress using other vaccines and did not need to run the risk of a rare, dangerous blood clotting condition that may be linked to the Johnson & Johnson vaccine.

The country has halted administering the AstraZeneca vaccine for similar reasons, after two people died of blood clots after being given that vaccine.

Denmark had been planning to use the Johnson & Johnson single-dose vaccine before reports emerged about a possible link to the clotting condition, which seems to mainly affect younger women. Dropping the vaccine from its plans will set back the country’s timetable for vaccinating adults under 40 by about a month, Danish officials said.

The United States temporarily suspended using the Johnson & Johnson vaccine, but the Food and Drug Administration announced on Friday that it would be made available again, with a warning about the possible clotting risk added to its label.

endorsed use of the Johnson & Johnson vaccine with an added warning.

The Danish Health Authority, however, said it had independently investigated the vaccine and decided against using it.

“Taking the present situation in Denmark into account, what we are currently losing in our effort to prevent severe illness from Covid-19 cannot outweigh the risk of causing possible side effects in the form of severe blood clots in those we vaccinate,” the authority said in a statement.

“One should also bear in mind that, going forward, we will first and foremost be vaccinating younger and healthy people,” Helene Probst, the deputy director general of the authority, said in the statement.

Christina Anderson contributed reporting.

View Source

Russian Attempts to Expand Sputnik Vaccine Sets Off Discord in Europe

BRATISLAVA, Slovakia — When Slovakia’s prime minister welcomed a military aircraft carrying 200,000 doses of the Sputnik V vaccine from Russia in March, he posed proudly for photographs on the tarmac in front of crates stuffed with what he expected to be his country’s medical salvation.

Slovakia at the time had the world’s highest per-capita death rate from Covid-19, and the arrival of the Russian vaccine offered a rare glimmer of hope. For Russia it offered big benefits, too: a small but symbolically important new market for its product in the European Union, which has so far declined to register the vaccine and urged member states to hold off on orders until approval is granted.

But the effort by the Slovakian leader, Igor Matovic, soon blew up in his face, costing him his job and almost toppling the whole government — just three months after it adopted a new security strategy rooted in unequivocal support for NATO and wariness of Russia.

The strongly pro-Western Slovak government, torn between its commitment to abide by European rules and desperation for a way out of the health crisis, spasmed in crisis for weeks.

Sputnik V, the world’s first registered vaccine, is the medical breakthrough proclaimed last summer by President Vladimir V. Putin of Russia, but it has already proved itself to be remarkably effective in spreading disarray and division in Europe.

In France, President Emmanuel Macron talked to Mr. Putin recently about possible deliveries of Sputnik, which Mr. Macron’s own foreign minister derided as a “propaganda tool.” The Austrian chancellor, Sebastian Kurz, furious that European regulators have been slow in approving Sputnik, has clashed with Germany’s leader, Angela Merkel, over the bloc’s vaccination program, which so far involves only Western vaccines.

But Slovakia provides the most concrete example of how Russia’s vaccine diplomacy has had side effects that can be highly toxic.

The decision by Mr. Matovic, then the Slovakian prime minister, to order two million doses of Sputnik V set the country at odds with the European Union and brought one of Eastern Europe’s most stoutly pro-Western governments to the brink of collapse as junior partners in a fractious governing coalition, outraged by the import of Sputnik, defected.

said in a tweet in February that Mr. Putin offered Sputnik V to the world as a “weapon to divide and rule.” And Poland said it was considering buying Chinese vaccines, despite similar concerns about it, but would definitely not order Sputnik V.

A recent survey by the Globsec research group found that, among those willing to be vaccinated, only 1 percent of Poles and Romanians and 2 percent of Lithuanians would choose Sputnik over American and European brands. Even in Hungary, the lone European Union member to start inoculating its citizens with Russia’s product, only 4 percent want Sputnik V.

But in Slovakia, around 15 percent of those willing to be vaccinated expressed a preference for the Russian vaccine, offering Moscow an opportunity to break out of the quarantine imposed by deep suspicion elsewhere.

That Russia targeted Slovakia as a place to widen Sputnik’s narrow beachhead in Europe was evident long before Mr. Matovic decided to order the vaccine.

video on Facebook in January saying that he was ready to help broker a deal with Moscow for the delivery of Sputnik.

His pitch appealed to the generally Russia-friendly sentiments of many ordinary Slovaks, particularly those of an anti-establishment bent.

Martin Smatana, a former Health Ministry official in Bratislava, said he had been amazed by how many of his friends want the Russian vaccine and say, “Screw the system, use Sputnik.”

a report this past week, the European Union’s foreign service said that Russia’s drive to promote Sputnik abroad was aimed at “sowing distrust” in Europe’s medicines regulator and stoking divisions.

In response, the Russian state investment agency spearheading Sputnik’s export drive lamented that the vaccine, which it hails as a “vaccine for all mankind,” has fallen victim to “unfortunate daily information attacks.” On Friday, after Brazil raised concerns about Sputnik, complaining of inadequate data, the vaccine’s developer in Moscow, the Gamaleya Institute, issued an angry statement complaining that “unethical forces continuously attack the Sputnik V vaccine for competitive and political reasons.”

The testy arguments in Slovakia over the vaccine reached a peak in April when the country’s drug regulatory agency claimed that Mr. Matovic had fallen for a Russian bait-and-switch. It said the vaccine doses sent to Slovakia at a cost of around $2 million differed from the Sputnik V reviewed favorably in a peer-reviewed February article in The Lancet, a respected British medical journal.

The Slovak claim, denounced by Moscow as “sabotage,” cast doubt on Sputnik’s main selling point: a proven efficacy rate of over 90 percent against Covid-19. The Lancet gave the vaccine 91.6 percent efficacy in February, and Russian scientists have since claimed a “real world” rate 97.6 percent.

But the main issue with Sputnik has never been whether it works — most experts believe it does — but Russia’s repeated failure to follow procedure and provide all the data needed by foreign regulators to assess safety. Slovakia’s regulator made its damning statement not because it had discovered any specific problems with Sputnik but “due to the lack of data from the manufacturer, inconsistencies in dosage forms and inability to compare the batches used in different studies and countries.”

The 200,000 doses that Russia delivered in March were still all unused at a pharmaceutical company in eastern Slovakia as of last week. But Mr. Matovic said Russia had already returned the money paid by Slovakia.

Pavol Babos, a political analyst in Bratislava, said Mr. Matovic was “never pro-Russian” but “very naïve.” Desperate for a way to slow the pandemic and lift his own slumping ratings, the prime minister, Mr. Babos added, “fell into a trap set by Russian propaganda.”

But Mr. Matovic scoffed at accusations that Moscow had played him to promote its own geopolitical agenda. The Russians, he said, “wanted to help, but instead of thanking them we said, ‘You are stupid, and you are cheating people around the world.’”

Most at fault, Mr. Matovic said, was the State Institute for Drug Control, which asserted that the Sputnik V batches Russia sent to Slovakia did “not have the same characteristics and properties” as the version V reviewed by The Lancet. This, he said, “was an extremely incorrect political statement.”

Zuzana Batova, the institute’s director, who has received death threats from aggressive Sputnik fans, declined to be interviewed, saying she did not want to pour oil on the fire.

The head of the Biomedical Research Center, which carried out a series of 14 tests in Slovakia on the Russian vaccine, said she had no concerns over whether Sputnik V works but was troubled by Russia’s lack of transparency.

While the potential side effects of the AstraZeneca and Johnson & Johnson vaccines have been documented in detail publicly, the center’s chief, Silvia Pastorekova, said, “We know nothing about Sputnik’s side effects.”

The Russian vaccine, she said, passed all of her team’s tests but failed to win approval from the state regulator because more than three-quarters of the documents required to meet European norms had either not been submitted or were incomplete.

“We are part of the European family and we should accept the rules of the family,” Ms. Pastorekova said.

Monika Pronczuk contributed reporting from Brussels, and Kristina Hamarova from Bratislava.

View Source

The E.U. May Reopen to Vaccinated American Tourists. Here’s What to Know.

BRUSSELS — A yearlong ban on all but the most essential travel from the United States to the European Union may be lifted soon, just in time for summer vacation.

In an interview with The New York Times on Sunday, Ursula von der Leyen, president of the European Commission, said she would put forward a policy proposal for the union’s 27 member states to accept visitors who have received E.U.-approved vaccines, paving the way for a reopening of travel.

“The Americans, as far as I can see, use European Medicines Agency-approved vaccines,” Ms. von der Leyen said. “This will enable free movement and the travel to the European Union.”

But many questions remain. Here is what to know.

While Ms. von der Leyen’s comments signaled a major shift from the current policy, the details of exactly how and when the restart of travel would begin are still being worked out.

European Commission issued recommendations on the measures last month, in an attempt to standardize the documentation needed by travelers within the E.U. So far, travelers have been asked to provide various documents including medical certificates, test results, and declarations ahead of travel, making it hard to move around within the bloc.

The proposed certificate would provide digital proof that a person has been vaccinated against the coronavirus, has received a negative test result, or has recovered from the virus.

The initiative came after a push by tourism-dependent members of the European Union to salvage the summer travel season.

Matina Stevis-Gridneff reported from Brussels and Megan Specia from London.

View Source

E.U. Sues AstraZeneca Over Missing Vaccine Doses

The European Union has sued AstraZeneca over what the bloc has described as delays in shipping hundreds of millions of doses of coronavirus vaccines, a sharp escalation of a longstanding dispute between the bloc and the maker of one of the world’s most important vaccines.

AstraZeneca has said that it would be able to deliver only a third of the 300 million doses that European officials had been expecting by the end of June. As a result, European officials said on Monday that they believed AstraZeneca had broken its contract, and that they were seeking speedier deliveries than the company said it could muster.

The two sides’ relationship had grown acrimonious in January when AstraZeneca slashed its expected deliveries for the first quarter of the year, setting back the bloc’s vaccination campaign by weeks as cases picked up across the continent and political leaders faced scorching criticism for inadequate planning.

For AstraZeneca, whose cheap and easy-to-store shot is being used by 135 countries, the lawsuit could create further difficulties in a bruising stretch. No company had been as instrumental in the race to vaccinate poorer countries around the world, but AstraZeneca has been buffeted in recent weeks by the discovery of an exceedingly rare, though serious, side effect that has prompted restrictions on its use in parts of Europe.

voted to recommend lifting a pause on the Johnson & Johnson Covid vaccine and adding a label about an exceedingly uncommon but potentially dangerous blood clotting disorder.

  • Federal health officials are expected to formally recommend that states lift the pause.
  • Administration of the vaccine ground to a halt recently after reports emerged of a rare blood clotting disorder in six women who had received the vaccine.
  • The overall risk of developing the disorder is extremely low. Women between 30 and 39 appear to be at greatest risk, with 11.8 cases per million doses given. There have been seven cases per million doses among women between 18 and 49.
  • Nearly eight million doses of the vaccine have now been administered. Among men and women who are 50 or over, there has been less than one case per million doses.
  • Johnson & Johnson had also decided to delay the rollout of its vaccine in Europe amid similar concerns, but it later decided to resume its campaign after the European Union’s drug regulator said a warning label should be added. South Africa, devastated by a more contagious virus variant that emerged there, also suspended use of the vaccine but later moved forward with it.
  • That could make it more difficult for European officials to demand faster shipments. But Belgian courts, like many in continental Europe, consider not only the wording of a contract, but also its genesis, which could work to the advantage of the European Union.

    “A European judge looks at the good faith or lack of it that the parties brought into the contract, at the way in which the contract was negotiated, the general atmosphere,” said Professor Van Calster. “I think that the commission probably hopes that the judge will be able to determine that AstraZeneca, in particular, has failed to supply a number of vaccines which they could have reasonably supplied to the European Union.”

    He said that the court could rule that AstraZeneca must surrender a certain number of doses, but that the outcome was uncertain.

    AstraZeneca said on Monday that it “regrets the European Commission’s decision to take legal action over the supply of Covid-19 vaccines,” describing the lawsuit as “without merit.”

    It said that it would deliver almost 50 million doses to the bloc by the end of April, and that it had “fully complied with the advance purchase agreement with the European Commission and will strongly defend itself in court.”

    Stefan de Keersmaecker, a spokesman on health issues for the European Commission, said that the bloc had begun legal action because it believed the purchase agreement had been breached.

    negotiating a contract with Pfizer for 1.8 billion doses over the next two years.

    Ursula von der Leyen, the president of the European Commission, told The New York Times on Sunday that AstraZeneca had squandered the bloc’s trust.

    “The noncommunication of AstraZeneca of the problems made it like pulling a chewing gum, because you never knew what was going on,” she said. Ms. von der Leyen added that the delivery shortfalls were too steep to ignore.

    “At the moment, the company has a delay in delivering 200 million doses of vaccine by the end of the second quarter,” she said. “The number speaks for itself.”

    AstraZeneca’s vaccine is being widely used across Europe, though some countries have curbed its use in younger people because of the risk of very rare blood clots. The European Medicines Agency, the bloc’s drug regulator, said this month that the shot’s benefits still outweighed its risks, but that it should carry a warning.

    The vaccine is not yet authorized for use in the United States. American officials have given a few million doses that were manufactured there to Canada and Mexico.

    View Source

    Vaccinated American Tourists May Soon Travel to Europe

    BRUSSELS — American tourists who have been fully vaccinated against Covid-19 will be able to visit the European Union over the summer, the head of the bloc’s executive body said in an interview with The New York Times on Sunday, more than a year after shutting down nonessential travel from most countries to limit the spread of the coronavirus.

    The fast pace of vaccination in the United States, and advanced talks between authorities there and the European Union over how to make vaccine certificates acceptable as proof of immunity for visitors, will enable the European Commission, the executive branch of the European Union, to recommend a switch in policy that could see trans-Atlantic leisure travel restored.

    “The Americans, as far as I can see, use European Medicines Agency-approved vaccines,” Ursula von der Leyen, president of the European Commission, said Sunday in an interview with The Times in Brussels. “This will enable free movement and the travel to the European Union.

    “Because one thing is clear: All 27 member states will accept, unconditionally, all those who are vaccinated with vaccines that are approved by E.M.A.,” she added. The agency, the bloc’s drugs regulator, has approved all three vaccines being used in the United States, namely the Moderna, Pfizer/BioNTech and Johnson & Johnson shots.

    short list of countries with very low caseloads of the virus, including Australia, New Zealand and South Korea.

    Some E.U. countries have made small exceptions to permit visitors from outside the bloc. Greece, for example, said last week that it would open its borders to travelers from the United States starting Monday, provided they show proof of vaccination or a negative coronavirus test.

    The visitors from the handful of countries that are officially permitted to visit the European Union under existing rules would normally still have to comply with various sets of requirements implemented on a country-by-country basis, including having a negative coronavirus test and following quarantine rules.

    undesirable in Europe a year ago, when the pandemic was raging in the United States, to being in the front of the line of global travelers free to resume leisure trips.

    But the return of leisure travel to Europe on a bigger scale will also highlight the deepening inequality between the vaccinated and the unvaccinated, both within countries and, particularly, on a global level. With India in the throes of the worst rise in coronavirus infections in the world, and with the past week’s global case total the highest since the pandemic began, that contrast could become even more jarring.

    View Source

    J. & J. to Resume E.U. Vaccine Rollout, With Warning of Rare Side Effect

    BRUSSELS — Johnson & Johnson said Tuesday that it would resume the rollout of its coronavirus vaccine in Europe after the European Union’s drug regulator said that a warning should be added to the product indicating a possible link to rare blood clots, but that the shot’s benefits outweigh the risks.

    The company decided to delay distribution in the bloc’s 27 member states last week, after regulators in the United States suspended use of the vaccine there amid concerns about the potential side effect.

    The E.U. drug regulator’s endorsement — even with the caveat — not only clears a path for Johnson & Johnson in Europe, but could presage how the United States will handle the vaccine in the days to come.

    On Friday, an advisory panel to the Centers for Disease Control and Prevention is to meet for a second to time to decide whether to recommend lifting a “pause” put on the vaccine’s use in the United States, perhaps with a similar warning.

    had the Johnson & Johnson vaccine.

    But some health experts worry that the headline-grabbing pause, which began over a week ago, might discourage some people from getting vaccinated, even though the risks from Covid-19 are far greater than the risk from a clot.

    “You’ve put a scarlet letter on the Johnson & Johnson vaccine,” said Dr. Paul A. Offit, a vaccine expert at Children’s Hospital of Philadelphia.

    After clotting concerns associated with another vaccine, produced by AstraZeneca, were reported in Europe, Dr. Offit noted, some grew leery of it, overestimating the threat. For the Johnson & Johnson vaccine, the clot risk has been put at an estimated one in a million.

    “If you take a theoretical million people who are infected with Covid, five thousand will die,” Dr. Offit said. “Therefore, the benefits of this vaccine clearly outweigh its risks.”

    a statement, the agency stressed the importance of treating the potential side effect and issued guidelines to health care professionals on the lookout for the rare clotting disorder. It listed symptoms to be vigilant for, including shortness of breath, chest pain, leg swelling, persistent abdominal pain, severe and persistent headaches or blurred vision, and tiny blood spots under the skin.

    The temporary suspension of the Johnson & Johnson rollout in the European Union had added to the bloc’s vaccine rollout woes, but it was not as big a blow as the AstraZeneca issues have been.

    Vaccination efforts have fallen behind in Europe partly because AstraZeneca, a British-Swedish pharmaceutical company that is a major component of the region’s inoculation efforts, was unable to deliver the number of doses expected in the first quarter of the year. Then its vaccine was suspended over the blood-clotting concerns.

    Even though the authorities eventually declared that the benefits of the AstraZeneca vaccine outweighed risks, and advised E.U. members to use it, the damage had been done.

    Pfizer-BioNTech vaccine, and was negotiating a new deal for future booster shots with the company for 2022 and 2023.

    But while the impact for Europe may be cushioned, it could be a different story elsewhere. The Johnson & Johnson vaccine has been an important component of vaccination plans for countries around the world.

    While it has not yet been rolled out at anything near the scale of AstraZeneca’s, some regions have pivoted to the shot amid AstraZeneca shortages. The African Union recently acquired 400 million doses.

    The pause on Johnson & Johnson vaccinations in the United States, along with new restrictions on the use of AstraZeneca’s shot in Europe, rattled vaccination campaigns around the world relying on those vaccines. South Africa followed the United States in pausing Johnson & Johnson shots, though its health regulator in recent days recommended resuming its use.

    U.S. health officials called for a pause in the vaccine’s use on April 13. Johnson & Johnson suspended its E.U. rollout immediately afterward, just as the first shipments of the shot were arriving in the region.

    U.S. regulators and scientists are still studying the original reports of the clotting disorder and sifting through any new safety reports of possible cases of the clotting disorder. That effort has so far turned up little.

    Dr. Rochelle P. Walensky, the C.D.C. director, said on Monday that health officials were investigating “a handful” of new, unconfirmed reports that emerged after the pause was recommended, to determine whether they might be cases of the rare blood clotting disorder.

    “Right now, we are encouraged that it hasn’t been an overwhelming number of cases, but we are looking and seeing what has come in,” she said at a White House news conference.

    Carl Zimmer contributed reporting from New Haven; Noah Weiland and Sharon LaFraniere from Washington; and Benjamin Mueller from London.

    View Source

    E.U. Regulator Says J.&J. Shot Should Carry Rare Clot Risk Label

    BRUSSELS—The European Union’s drug regulator on Tuesday said a warning should be added to the Johnson & Johnson Covid-19 vaccine indicating a possible link to rare and unusual blood clots, but stopped short of recommending it be pulled from use, saying its benefits outweigh its risks.

    “The reported combination of blood clots and low blood platelets is very rare, and the overall benefits of Covid-19 Vaccine Janssen in preventing Covid-19 outweigh the risks of side effects,” the European Medicines Agency said in a statement, referring to the division of Johnson & Johnson that develops vaccines, Janssen. The rare clots were “very similar,” the agency added, to those associated with the AstraZeneca vaccine, for which the agency made a similar recommendation.

    Johnson & Johnson decided to delay its rollout in the bloc’s 27 member states last week, after regulators in the United States called for a pause on the vaccine following concerns about the rare but serious side effect.

    The EMA’s recommendation is not binding, but it is the first indication of what might happen next with the European rollout of the much-anticipated, single-shot vaccine that’s already been given to nearly eight million people in the United States. The agency said that regulators in individual E.U. member states should decide how to proceed taking into account their particular case load and vaccine availability.

    damage had been done. Many Europeans have been refusing to take the vaccine, and several E.U. countries have limited its use to older people.

    Pfizer-BioNTech vaccine, and was negotiating a new deal for future booster shots with the company for 2022 and 2023, signaling it was going to prioritize vaccines, like Pfizer’s and Moderna’s, that use the mRNA technology.

    But the Johnson & Johnson vaccine has been an important component of vaccination plans from the United States to South Africa.

    U.S. health officials called for a pause in the vaccine’s use on April 13 to examine a rare blood-clotting disorder that emerged in a small number of recipients. Johnson & Johnson suspended its E.U. rollout immediately afterward. E.U. countries had just began receiving their first shipments of the vaccine, and all but Poland followed company guidance and have not begun administering it.

    On Monday, federal health officials said they were investigating “a handful” of new, unconfirmed reports that have emerged since the nationwide pause of the Johnson & Johnson injections. Dr. Anthony S. Fauci, the United States’ leading infectious disease expert, said previously that he anticipated a decision about whether to resume administering the Johnson & Johnson vaccine this Friday, when an expert panel that is advising the Centers for Disease Control and Prevention is scheduled to meet.

    View Source

    Changing Strategy, the E.U. Bets Big on Pfizer to Battle Covid

    BRUSSELS — Bruised by major disruptions in supplies of the AstraZeneca and Johnson & Johnson vaccines, the European Union Wednesday announced it was putting trust and money into the Pfizer-BioNTech shot to salvage its vaccination rollout and secure doses for the future.

    The pivot away from AstraZeneca, once a pillar of the E.U. inoculation program, comes after months of discord over delayed shipments and as the company battles worries over rare potential side effects of its shots.

    In announcing the change in strategy, Ursula von der Leyen, president of the European Commission, said Pfizer had agreed to an early shipment of doses that she said should likely allow the bloc to reach its goal of inoculating 70 percent of adults by the end of the summer.

    That goal was in jeopardy after AstraZeneca failed to deliver on expected doses in the first quarter of the year, then suffered fresh setbacks over potential side effects related to blood clots. The European vaccine campaign was dealt a further blow Tuesday when Johnson & Johnson said it would delay its own rollout in Europe because of similar concerns and after regulators paused its use in the United States.

    supply disruptions from AstraZeneca in late January, and then with the emergence of the potential rare blood disorder that has battered the public’s confidence in vaccines and led to appointment cancellations.

    “As we can see with the announcement by Johnson & Johnson yesterday, there are still many factors that can disrupt the planned delivery schedules of vaccines,” Ms. von der Leyen said Wednesday.

    Ms. von der Leyen said the Pfizer doses under negotiation for the next two years would include potential booster shots to extend the immunity of people who have already been inoculated, as well as possible new shots or boosters targeting emerging variants that might prove resilient against existing vaccines.

    The AstraZeneca and Johnson & Johnson vaccines performed well in clinical trials and the possible dangerous side effects have been rare. But trials of the Pfizer and Moderna shots shows that they were even more effective in preventing infection, and similar side effects have not emerged. Another mRNA vaccine, from CureVac, is in clinical trials.

    On Wednesday, the European Medicines Agency, the bloc’s top drug regulator, said it was expediting its investigation of “very rare cases of unusual blood clots” in recipients of the Johnson & Johnson vaccine, and expected to issue a recommendation next week. While the evaluation is ongoing, the agency reiterated its view that the benefits of the vaccine outweigh the risks.

    In a setback for AstraZeneca, Denmark on Wednesday became the first country to permanently stop the administration of the company’s vaccine, saying the potential side effects were significant enough to do so given that it had the pandemic under control and could rely on the Pfizer and Moderna inoculations.

    With the fresh commitment by Pfizer to bring forward the delivery of 50 million doses originally slated for the end of the year, the company expects to deliver 250 million doses in total to the bloc by the end of June.

    Ms. von der Leyen said more than 100 million people in the European Union had already received at least one vaccine dose, and 27 million had received both. The additional Pfizer vaccines, together with 35 million doses expected from Moderna over the next three months, and a more limited use of AstraZeneca doses already in the pipeline, should likely be enough to get the bloc to the coveted milestone of reaching 255 million people by September, E.U. officials said.

    In stark contrast to the criticism of AstraZeneca’s handling of its E.U. dealings, Ms. von der Leyen praised Pfizer effusively, highlighting how important the company’s ability to respond quickly to help the European Union has been.

    “I want to thank BioNTech/Pfizer; it has proven to be a reliable partner,” Ms. von der Leyen said. “It has delivered on its commitments, and it is responsive to our needs.”

    Addressing another sore point, Ms. von der Leyen said that the future Pfizer doses would be produced in the European Union.

    Ample exports from the factories within the bloc to the rest of the world have enabled countries like Mexico and Canada to launch their vaccination campaigns, but those exports have also been identified as one reason there weren’t enough vaccines to go around in Europe.

    The United States and Britain, by contrast, held tight to the vaccines made in their countries, helping speed along their inoculation efforts.

    Monika Pronczukcontributed reporting.

    View Source