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Pfizer bivalent COVID shots link to stroke: U.S. health authorities

14 January 2023 07:38 pm - 6     - {{hitsCtrl.values.hits}}

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A safety monitoring system flagged that U.S. drugmaker Pfizer Inc (PFE.N) and German partner BioNTech's updated COVID-19 shot could be linked to a type of brain stroke in older adults, according to preliminary data analyzed by U.S. health authorities.

The U.S. Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) said on Friday that a CDC vaccine database had uncovered a possible safety issue in which people 65 and older were more likely to have an ischemic stroke 21 days after receiving the Pfizer/BioNTech bivalent shot, compared with days 22-44.

An ischemic stroke, also known as brain ischemia, is caused by blockages in arteries that carry blood to the brain.

The FDA and CDC said that other large studies, the CDC's Vaccine Adverse Event Reporting System, other countries' databases and Pfizer-BioNTech's databases had not flagged this safety issue, adding that it requires more investigation.

"Although the totality of the data currently suggests that it is very unlikely that the signal in VSD (Vaccine Safety Datalink) represents a true clinical risk, we believe it is important to share this information with the public," the health authorities said.

Pfizer and BioNTech said in a statement that they have been made aware of limited reports of ischemic strokes in people 65 and older following vaccination with their updated shot.

"Neither Pfizer and BioNTech nor the CDC or FDA have observed similar findings across numerous other monitoring systems in the U.S. and globally and there is no evidence to conclude that ischemic stroke is associated with the use of the companies' COVID-19 vaccines," the companies added.

This safety concern has not been identified with Moderna's (MRNA.O) bivalent shot and both the CDC and FDA continue to recommend that everyone aged 6 months and older stay up-to-date with their COVID-19 vaccination. (Reuters)


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  Comments - 6

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  • Kariyawasam Saturday, 14 January 2023 08:31 PM

    Doctors have NO SCIENCE . So the governments have no one to depend on except the pharmaceutical companies, thus whatever the pharmaceutical companies make the governments would authorise them to be delivered to people. For us Sri Lankans the only solution to COVID is to trust our 2000 year old indigenous medicines , remember before the European military invasion of Sri Lanka , who looked after our health when we had great civilisations.

    Dinesh Sunday, 15 January 2023 05:20 AM

    Ask any doctor in Sri Lanka or in any other country , if the vaccines are safe, they will immediately assume an expert personality and would say in a authoritative voice “ Vaccines Are Safe “ “ Why you are doubting , they are safe “ And if we press them any more they would respond with “ I am a doctor, if you can’t believe me then whom you can trust “ “ Listen I studied medicine for five years and you are asking the same question again “. Now the American CDC has come up with the truth so our “learned” doctors would start to change their “ expert “ opinion accordingly. What a bullshit !!

    c Sunday, 15 January 2023 05:47 AM

    those who panicked over covid a disease made up and forced people to take vaccines should be given death sentence and in the future will have to face judgement day for real

    Adwani Sunday, 15 January 2023 07:08 AM

    Whatever it is, even before, the cold and flu were prevalent and no such issues were considered as harzadous to health. Our (Pakkawa Hungry) Modayo brought this poor Island to this stage, with commissions and bribes, imposing false lockdowns and stealing public funds.

    Ganesh Sunday, 15 January 2023 10:35 AM

    No Vaccine is safe, at the same time no one is safe from any Virus, with or without a vaccine.

    Seqi Monday, 16 January 2023 12:54 PM

    The more the booster shots the more likely to catch the disease as vaccination lowers the bodies ability to produce natural immunity. The RNA Pfizer and Moderna vaccines are still as yet untested. Pfizer is under investigation for knowingly pushing untested and unsafe drugs......


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