'Possible link' between J&J COVID-19 shot and blood clots found, European regulator says

These reports of cerebral venous sinus, thrombosis and thrombosis. Agrippina are similar to reports of thrombin attic events with thrombosis Dapena seen in europe after vaccination with the astrazeneca vaccine. In the european cases, both men and women presented with the blood clots, though they were more frequent in women, the astrazeneca Don johnson johnson vaccines both use an adenovirus factor. These vaccines are different from the Pfizer and Moderna vaccines, which are MRNA based vaccines and to be very clear these types of reactions. Blood clots in combination with low platelets are not being seen with the authorized vaccines from Pfizer and Moderna. I know the information we have presented may be very concerning to americans, especially those who have already received the johnson and johnson vaccine. For people who have received the vaccine more than a month ago, the risk of a blood clot is exceptionally low. For people receive the vaccine meaning recently, meaning within the last few weeks they should be aware of their symptoms and immediately seek medical assistance with any symptoms of concern. But also I want to reiterate to this group. Even in this group, these events are extremely rare symptoms of a cerebral venous sinus, thrombosis or other associated severe blood clot. Might include a severe headache, abdominal pain, leg pain, or shortness of breath, all leading to an emergency department visits. Importantly, we have two other vaccines that are authorized for use in this country. Again, we are not seeing these events with the other two vaccines with Pfizer and Moderna. Jointly CDC and FDA were able to identify these rare events and act quickly to alert health care providers and the public. This demonstrates that the safety systems we have in place are working. We will continue to monitor vaccinations and adverse events across this country. This pause will allow us to accelerate reporting of possible adverse events from healthcare providers across the country and all of you. Yeah.

Video above: CDC says J&J pause shows safety system is workingExperts at the agency that regulates drugs for the European Union said Tuesday that they found a "possible link" between the Johnson & Johnson COVID-19 vaccine and very rare blood clots after a small number of cases were reported in the United States, but they confirmed the vaccine's benefits still outweighed the very small risks of recipients developing the unusual clots.The European Medicines Agency said a warning about the rare blood clots should be added to labels for Johnson & Johnson's COVID-19 vaccine. The agency said these rare blood disorders should be considered as "very rare side effects of the vaccine."Last week, Johnson & Johnson halted its European roll-out of the vaccine after U.S. officials recommended a pause in the vaccine, when they detected six very rare blood clot cases among nearly 7 million people who had been vaccinated.European officials said they considered all currently available evidence from the U.S., which consisted of eight reports of serious cases of rare blood clots associated with low blood platelets, including one death.Last week, J&J halted its European rollout of its one-dose vaccine after the U.S. Food and Drug Administration recommended officials pause its use while the rare blood clot cases are examined. Officials identified six cases of the highly unusual blood clots among nearly 7 million people who were immunized with the shot in the U.S.Johnson & Johnson advised European governments to store their doses until the EU drug regulator issued guidance on their use; widespread use of the shot in Europe has not yet started.The delay was a further blow to vaccination efforts in the European Union, which have been plagued by supply shortages, logistical problems and concerns over unusual blood clots also in a small number of people who received the AstraZeneca COVID-19 vaccine. Experts worry the temporary halt on J&J's shot could further shake vaccine confidence and complicate worldwide COVID-19 immunization efforts.Last week, South Africa suspended its use of the vaccine in the wake of the U.S. pause, and countries including Italy, Romania, the Netherlands, Denmark and Croatia put their J&J doses into storage.The blood clots linked to the J&J vaccine are occurring in unusual parts of the body, such as veins that drain blood from the brain. Those patients also have abnormally low levels of blood platelets, a condition normally linked to bleeding, not clotting.With the AstraZeneca vaccine, scientists in Norway and Germany have suggested that some people are experiencing an abnormal immune system response, forming antibodies that attack their own platelets.It's not yet clear if there might be a similar mechanism with the Johnson & Johnson vaccine. But both the J&J and AstraZeneca vaccines, as well as a Russian COVID-19 vaccine and one from China, are made with the same technology. They train the immune system to recognize the spike protein that coats the coronavirus. To do that, they use a cold virus, called an adenovirus, to carry the spike gene into the body."Suspicion is rising that these rare cases may be triggered by the adenovirus component of the AstraZeneca and J&J vaccines," said Eleanor Riley, a professor of immunology and infectious diseases at the University of Edinburgh. She said that while more data was needed, "it remains the case that for the vast majority of adults in Europe and the USA, the risks associated with contracting COVID-19 far, far outweigh any risk of being vaccinated."On Monday, World Health Organization Director-General Tedros Adhanom Ghebreyesus said more than 5 million new cororavirus cases were confirmed worldwide last week, the highest-ever number in a single week. He noted that cases and hospitalizations among younger people were “increasing at an alarming rate.”The European Medicines Agency, which regulates drugs used in European Union member nations, said last month there was a “possible link” between the AstraZeneca vaccine and rare blood clots but said the benefits of vaccination far outweighed the risks of COVID-19. It noted the risk is less than the blood clot risk that healthy women face from birth control pills.The European Union ordered 200 million doses of the Johnson & Johnson for 2021 and EU officials had hoped the one-shot vaccine could be used both to boost the continent's lagging vaccination rates and to protect hard-to-reach populations, like migrant workers and the homeless.Last month, the African Union announced it signed a deal to buy up to 400 million doses of the J&J vaccine. Johnson & Johnson also has a deal to supply up to 500 million doses to the U.N.-backed COVAX initiative that helps get vaccines to the world’s poor.Any concerns about the J&J vaccine would be another unwelcome complication for COVAX and for the billions of people in developing countries depending on the program. COVAX recently was hit by supply issues after its biggest supplier, the Serum Institute of India, announced it would delay exports of the AstraZeneca vaccine for several months due to a surge of cases on the subcontinent.

LONDON —

Video above: CDC says J&J pause shows safety system is working

Experts at the agency that regulates drugs for the European Union said Tuesday that they found a "possible link" between the Johnson & Johnson COVID-19 vaccine and very rare blood clots after a small number of cases were reported in the United States, but they confirmed the vaccine's benefits still outweighed the very small risks of recipients developing the unusual clots.

The European Medicines Agency said a warning about the rare blood clots should be added to labels for Johnson & Johnson's COVID-19 vaccine. The agency said these rare blood disorders should be considered as "very rare side effects of the vaccine."

Last week, Johnson & Johnson halted its European roll-out of the vaccine after U.S. officials recommended a pause in the vaccine, when they detected six very rare blood clot cases among nearly 7 million people who had been vaccinated.

European officials said they considered all currently available evidence from the U.S., which consisted of eight reports of serious cases of rare blood clots associated with low blood platelets, including one death.

Last week, J&J halted its European rollout of its one-dose vaccine after the U.S. Food and Drug Administration recommended officials pause its use while the rare blood clot cases are examined. Officials identified six cases of the highly unusual blood clots among nearly 7 million people who were immunized with the shot in the U.S.

Johnson & Johnson advised European governments to store their doses until the EU drug regulator issued guidance on their use; widespread use of the shot in Europe has not yet started.

The delay was a further blow to vaccination efforts in the European Union, which have been plagued by supply shortages, logistical problems and concerns over unusual blood clots also in a small number of people who received the AstraZeneca COVID-19 vaccine. Experts worry the temporary halt on J&J's shot could further shake vaccine confidence and complicate worldwide COVID-19 immunization efforts.

Last week, South Africa suspended its use of the vaccine in the wake of the U.S. pause, and countries including Italy, Romania, the Netherlands, Denmark and Croatia put their J&J doses into storage.

The blood clots linked to the J&J vaccine are occurring in unusual parts of the body, such as veins that drain blood from the brain. Those patients also have abnormally low levels of blood platelets, a condition normally linked to bleeding, not clotting.

With the AstraZeneca vaccine, scientists in Norway and Germany have suggested that some people are experiencing an abnormal immune system response, forming antibodies that attack their own platelets.

It's not yet clear if there might be a similar mechanism with the Johnson & Johnson vaccine. But both the J&J and AstraZeneca vaccines, as well as a Russian COVID-19 vaccine and one from China, are made with the same technology. They train the immune system to recognize the spike protein that coats the coronavirus. To do that, they use a cold virus, called an adenovirus, to carry the spike gene into the body.

"Suspicion is rising that these rare cases may be triggered by the adenovirus component of the AstraZeneca and J&J vaccines," said Eleanor Riley, a professor of immunology and infectious diseases at the University of Edinburgh. She said that while more data was needed, "it remains the case that for the vast majority of adults in Europe and the USA, the risks associated with contracting COVID-19 far, far outweigh any risk of being vaccinated."

On Monday, World Health Organization Director-General Tedros Adhanom Ghebreyesus said more than 5 million new cororavirus cases were confirmed worldwide last week, the highest-ever number in a single week. He noted that cases and hospitalizations among younger people were “increasing at an alarming rate.”

The European Medicines Agency, which regulates drugs used in European Union member nations, said last month there was a “possible link” between the AstraZeneca vaccine and rare blood clots but said the benefits of vaccination far outweighed the risks of COVID-19. It noted the risk is less than the blood clot risk that healthy women face from birth control pills.

The European Union ordered 200 million doses of the Johnson & Johnson for 2021 and EU officials had hoped the one-shot vaccine could be used both to boost the continent's lagging vaccination rates and to protect hard-to-reach populations, like migrant workers and the homeless.

Last month, the African Union announced it signed a deal to buy up to 400 million doses of the J&J vaccine. Johnson & Johnson also has a deal to supply up to 500 million doses to the U.N.-backed COVAX initiative that helps get vaccines to the world’s poor.

Any concerns about the J&J vaccine would be another unwelcome complication for COVAX and for the billions of people in developing countries depending on the program. COVAX recently was hit by supply issues after its biggest supplier, the Serum Institute of India, announced it would delay exports of the AstraZeneca vaccine for several months due to a surge of cases on the subcontinent.

'Possible link' between J&J COVID-19 shot and blood clots found, European regulator says

TRACKING THE COVID-19 VACCINE

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