Tag: vaccine injury

US calls for pause in Johnson & Johnson vaccinations over blood clot concerns

The FDA and Centers for Disease Control and Prevention announced Tuesday that they are calling for an immediate pause on the use of the single-dose Johnson & Johnson vaccine after discovering six cases in the United States of a rare and severe type of blood clot that developed about two weeks after the vaccine was administered in these patients.

“Safety is a top priority for the federal government,” acting FDA Commissioner Dr. Janet Woodcock told reporters in a virtual news briefing, adding that while the blood clots were “extremely rare” the government was acting “out of an abundance of caution.”

“We are committed to patient safety,” Woodcock said, but she encouraged Americans to continue to get vaccinated with the Pfizer and Moderna vaccines.

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246 vaccinated residents diagnosed with COVID; 3 dead, Michigan reports

As many as 246 Michigan residents considered fully vaccinated against COVID-19 were later diagnosed with the virus, and three have died, state officials confirmed Monday.

The cases were reported between Jan. 1 and March 31, and the 246 had a positive test 14 or more days after the last dose in the vaccine series, said Lynn Sutfin, a spokeswoman for the Michigan Department of Health and Human Services, in an email.

“Some of these individuals may ultimately be excluded from this list due to continuing to test positive from a recent infection prior to being fully vaccinated,” she said.

“These cases are undergoing further review to determine if they meet other CDC criteria for determination of potential breakthrough, including the absence of a positive antigen or PCR test less than 45 days prior to the post-vaccination positive test. In general, these persons have been more likely to be asymptomatic or mildly symptomatic compared with vaccinated persons.”

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Oxford halts trial of AstraZeneca COVID vaccine in children and teenagers over blood-clotting issue

The University of Oxford has paused administering doses of the COVID-19 vaccine it developed with AstraZeneca PLC AZN, -0.63%AZN, +0.15% in a small U.K. study aimed at evaluating its safety and effectiveness in children and teenagers, to wait for further information on rare blood-clotting issues that have been found in a small group of adults that received it, the Wall Street Journal reported Tuesday. The trial was started in mid-February and involves more than 200 young people aged 6 to 17 years old, the paper said. It cited an Oxford spokesman as saying that the trial had not found any safety issues, but that broader concerns and a review of the vaccine by regulators in the U.K. and European Unions were behind the move. The European Medicines Agency said earlier it expects to update the public on its investigation of the blood-clotting issue later this week.

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Clear link between AstraZeneca vaccine and rare blood clots in brain, EMA official tells paper

There is a link between AstraZeneca’s COVID-19 vaccine and very rare blood clots in the brain but the possible causes are still unknown, a senior official for the European Medicines Agency (EMA) said in an interview published on Tuesday.

However, the EMA later said in a statement that its review of the vaccine was ongoing and it expected to announce its findings on Wednesday or Thursday. An AstraZeneca spokesman declined to comment on the matter.

“In my opinion, we can now say it, it is clear that there is an association (of the brain blood clots) with the vaccine. However, we still do not know what causes this reaction,” Marco Cavaleri, chair of the vaccine evaulation team at the EMA, told Italian daily Il Messagero.

Cavaleri provided no evidence to support his comment.

The EMA has repeatedly said the benefits of the AstraZeneca shot outweigh the risks as it investigates 44 reports of an extremely rare brain clotting ailment known as cerebral venous sinus thrombosis (CVST) out of 9.2 million people in the European Economic Area who have received the vaccine.

The World Health Organization has also backed the vaccine.

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Facebook ‘corrects’ woman’s complaint vaccine ‘is killing me,’ then she dies

Facebook, which routinely adds its editorial comments to posts with which it disagrees, recently “fact-checked” a woman’s complaint about her reaction to a coronavirus vaccine.

Desiree Penrod, 25, said on Facebook after getting vaccinated in early March: “The vaccine is killing me today. My arm hurts, beyond exhausted, headache, stomach cramps and earaches.”

Penrod also posted: “Multiple people told me that I looked pale today. Yesterday, I was fine but today it’s taking its toll on me.”

Facebook, citing the World Health Organization, added a disclaimer to a post by Penrose, “COVID-19 vaccines go through many tests for safety and effectiveness before they’re approved.”

A week later, Penrod died. Her obituary said she “passed away unexpectedly.”

Facebook’s editorial comment citing the WHO provided a link to the international organization, whose investigation into the origin of COVID-19 has been criticized because of China’s control of it.

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