EU Finds J&J Blood Clot Link But Still Safe

[Lonnie]

EU regulator finds possible blood clot link with J&J vaccine, but says benefits outweigh risks

Published Tue, Apr 20 202110:14 AM EDTUpdated 3 Hours Ago

 

Key Points

• The J&J shot was initially greenlit in the European Union on March 11.
• The EMA researched all available evidence, it said, including eight reports from the U.S. of serious cases of unusual blood clots — one of which had a fatal outcome.
• More than 7 million people had received the vaccine in the United States as of April 7, it said.

 

• LONDON — The European Medicines Agency said Tuesday the Johnson & Johnson Covid-19 vaccine has possible links to rare blood clot incidents, but reiterated that its benefits still outweighed the risks.

 

″(The) EMA’s safety committee (PRAC) concluded that a warning about unusual blood clots with low blood platelets should be added to the product information for COVID-19 Vaccine Janssen,” the agency said in a press release.

“Healthcare professionals and people who will receive the vaccine should be aware of the possibility of very rare cases of blood clots combined with low levels of blood platelets occurring within three weeks of vaccination.”

The EMA researched all available evidence, it said, including eight reports from the U.S. of serious cases of unusual blood clots — one of which had a fatal outcome. More than 7 million people had received the vaccine in the United States as of April 7, it said.

The U.S. Food and Drug Administration earlier this month advised states to suspend the use of J&J’s shot “out of an abundance of caution.” As a result, the pharmaceutical firm decided to delay the rollout of its vaccine in Europe while regulators assessed any risks. On Tuesday, the company confirmed that it would resume shipments to the bloc after the EMA’s review.

The EMA already said last week that while reviewing the latest details, it was still of the view that the benefits of the vaccine outweighed the risks.

 

The J&J shot, which only requires one does, was initially greenlit in the European Union on March 11. It now remains to be seen how the different countries will interpret the latest guidance from the EMA. France has already indicated it will only use the vaccine on people aged above 55.

“COVID-19 is associated with a risk of hospitalisation and death. 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 EMA said on Tuesday, using the name of J&J’s Belgian unit.

This is not the first issue with blood clots and a Covid-19 vaccine.

More than a dozen European countries suspended the use of the AstraZeneca shot in March after some people who received the shot reported unusual incidents with blood clots, 18 of which were fatal.

The EMA reviewed the cases and also said the vaccine was safe and should be used in the fight against the coronavirus.

Nonetheless, a few days later, the EMA also said there was a “possible link to very rare cases of unusual blood clots with low blood platelets” and this should therefore be listed as “very rare side effects” for the AstraZeneca vaccine.

Some countries adjusted the rollout of this vaccine, deciding to administer it only to people above 60 years of age, and Denmark went further by completely stopping its use.

So far, there have been more than 103 million doses administered in the EU, according to data from the European Centre for Disease Prevention and Control.

[Bob]

What remains puzzling to me is the failure of almost all articles on the subject to discuss the background rate of blood clots in the general population.  In every article I've read, the background blood clot rate (the number of blood clot issues expected to be experienced by any population) far exceeds the rate experienced by the vaccinated population.  If one believes those numbers, then one could conclude that there is far less likelihood that one would experience a clotting issue if one was vaccinated than not vaccinated!

To simplify my comments, so far the US has experienced 8 serious blood clotting issues within the population of 7 million people who have been vaccinated with the questioned vaccine. According to the medical literature, the lowest number of blood clot issues expected (US history) would be 1 to 3 cases per year of 1000 people within the general population.  Using the lowest number there (1 serious blood clot issue per year within a general population of 1000 people),  then one would expect 7000 cases for a general population of 7 million people.  One-sixth of that (or two month's worth) would be 583 serious blood clotting issues that would be expected.  Sure sounds to me like a much worse number than the 8 cases reported. 

[Lonnie]

1 hour ago, Bob said:

Sure sounds to me like a much worse number than the 8 cases reported

Excellent point Bob...are you suggesting J&J reduces the chance of blood clots?

[spoon]

From my reading, the blod clot due to vaccine are not similar to the typical blod clot that happened in general population which is usually deep vein thrombosis. Blood clot due to the vaccine are the rare kind CVST (brain) and in other location such as stomach, and arteries. Another observation is the low level of platlets. U can google about this, and it seems to link the cause to antibody reaction that clump blood platlets together and caused the clot. Anyway the article below mentioned that the occurance of this type of reaction to antibody is 1 in 250000. Another point about the clot seen due to the vaccine is that it seems to be targetting those who are younger and healthy, mainly women below 50.

https://www.bbc.com/news/health-56674796.amp

[unicorn]

It's not as well known to the general public, but birth control pills carry a 1 in 10,000 risk of blood clots in non-smoking women, and in smoking women it's much higher. I wonder if the women who got the clots (and they've all been women) were smokers. It hasn't been discussed. Smoking alone carries a huge risk of blood clotting. Of course, the risk for the illness is much higher than the risk of clotting from the vaccine, but if the risk is only for smoking women, maybe smoking women can be steered to the other vaccines, unless they really don't want the 2nd shot that the other two manufacturers' vaccines recommend.