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European regulators decline to restrict use of Johnson & Johnson vaccine, call blood clots very rare

Mexican President Andres Manuel Lopez Obrador was inoculated with the first dose of the Astra Zeneca vaccine Tuesday.
Mexican President Andres Manuel Lopez Obrador was inoculated with the first dose of the Astra Zeneca vaccine Tuesday.PEDRO PARDO/AFP via Getty Images

WASHINGTON — European regulators said Tuesday that Johnson & Johnson’s coronavirus vaccine may be tied to very rare blood clots, but they placed no restrictions on its use in the European Union.

The decision, by the European Medicines Agency, was based on the same US data that led American regulators to pause use of the vaccine. That hold remains in place as US authorities make an independent evaluation. New guidance is expected as early as Friday.

The European regulators said that blood clots should be added to the packaging of the vaccine as a possible rare side effect, but they took no further action. The benefits of the vaccine outweigh the risks, they said.

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“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 agency said, using the official name for the vaccine made by Johnson & Johnson.

Six cases of blood clots have been reported in the United States as having possible ties to the vaccine. The European regulators said they had evaluated eight US cases, without explaining the discrepancy. — WASHINGTON POST

Two-thirds of unvaccinated Americans in poll signal they won’t get a shot

WASHINGTON — Most Americans who haven’t received a coronavirus vaccination say they’re unlikely to get the shot, according to an Axios-Ipsos poll released Monday, indicating the US mass immunization campaign could soon reach its peak.

Of the unvaccinated adults, two in three told pollsters they were either “not likely at all” or “not very likely” to get a vaccine. That proportion has remained level for more than month. Meanwhile, just 14 percent of unvaccinated Americans said they were likely to get the vaccine.

In total, 44 percent of respondents said they hadn’t received a vaccine, while 56 percent reported receiving at least one shot.

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If the figures don’t significantly change, immunizations could top out at around 70 percent of the adult population.

Early in the pandemic, health experts said herd immunity would require at least 70 percent of the population to develop resistance to the virus, but that target has become less clear as new, more transmissible coronavirus variants have emerged and cases have become more widespread. — WASHINGTON POST

Mexico’s president gets AstraZeneca shot in effort to calm the fears

MEXICO CITY — President Andrés Manuel López Obrador received a shot of the AstraZeneca coronavirus vaccine on Tuesday at his daily news conference, in an effort to calm worries about possible complications from the product.

“This helps a lot, it protects all of us,” the president said, after a nurse injected it into his upper arm as he sat in a chair at the National Palace, in front of reporters. “I call on all the elderly to get their vaccine. There’s no risk, for starters, and the vaccine doesn’t hurt.”

López Obrador, 67, had promised he wouldn’t get the shot until it was his age group’s turn under Mexico’s multistage vaccine plan. He raised eyebrows a few weeks ago by saying he might delay further, since he still had antibodies from a bout of COVID-19 that briefly sidelined him in January.

He changed his mind after some countries limited or suspended the use of AstraZeneca due to reports of blood clots developing in a tiny percentage of those receiving the vaccine. Mexico, like many other countries, had bet heavily on the product, but supplies have been delayed. The government is also administering the Pfizer BioNTech vaccine as well as Chinese and Russian vaccines.

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Mexico has administered about 14 million vaccine doses. Nearly 4 million people, or 3 percent of the population, have been fully vaccinated. The country has been pummeled by the virus, suffering more than 300,000 deaths, according to government estimates. — WASHINGTON POST

Congressional panel to probe company that ruined vaccine doses

WASHINGTON — A congressional panel has opened an investigation into Emergent BioSolutions, whose Baltimore factory ruined millions of doses of the Johnson & Johnson vaccine, focusing on whether it was improperly awarded a $628 million federal contract to manufacture vaccines.

The inquiry will look into whether a Trump administration official steered the work to the company despite questions about its qualifications, according to a statement released late Monday. The investigation was announced by Representatives Carolyn B. Maloney, a New York Democrat who heads the House Committee on Oversight and Reform, and James E. Clyburn, a Democrat from South Carolina who heads a subcommittee on the pandemic response.

Clyburn requested that Emergent’s two top executives testify at a May 19 hearing and provide a wide array of records.

The Emergent Baltimore facility is one of two federally designated Centers for Innovation in Advanced Development and Manufacturing that were supposed to be at the ready in case of a pandemic. The company secured a $628 million contract to manufacture the Johnson & Johnson and AstraZeneca vaccines in June.

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The lawmakers said that Dr. Robert Kadlec, assistant health secretary for preparedness and response under the former president, Donald Trump, and previously a consultant for Emergent, “appears to have pushed for this award despite indications that Emergent did not have the ability to reliably fulfill the contract.”

Kadlec could not immediately be reached for comment. In a recent interview, he said he knew Emergent was a risky choice but that federal officials had turned to it because few companies based in the United States were able to make the type of vaccines developed by Johnson & Johnson and AstraZeneca.

The congressional inquiry is the latest in a series of problems for Emergent, a longtime federal contractor that has a reputation for aggressive lobbying. This month, the Food and Drug Administration began an audit of its factory in Baltimore after workers contaminated a batch of Johnson & Johnson’s vaccine with an ingredient for AstraZeneca’s vaccine, another product manufactured at the plant.

Emergent said Monday that it had suspended operations at the plant and acknowledged it needed to make improvements to “restore confidence” in its work. It also said it was quarantining the vaccine substance already produced at the plant until after the inspection ends and the company has had a chance to fix any problems.

Biden administration officials have said AstraZeneca’s vaccine will no longer be made at the plant, and Johnson & Johnson has vowed to exert stronger control over Emergent, its subcontractor. The FDA has not certified the facility to distribute any vaccine; all Johnson & Johnson doses that have been administered were manufactured overseas. AstraZeneca’s vaccine is not yet authorized in the United States. — NEW YORK TIMES

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