It is unclear when our country will start administering the Johnson & Johnson vaccine, following the positive ruling of the EMA this afternoon. The producer says deliveries to Europe will resume, and Belgium expects 62,400 new vaccines next week. The European Medicines Agency believes that the benefits of vaccination clearly outweigh the potential side effects. It allows coagulation and low platelet counts to be included in the packaging as a possible “very rare” side effect.
ANP, Bilga, Reuters, Special Reports
The advice came out this afternoon after the EMA had to conduct a Janssen vaccine safety check. The J&J vaccine has not yet been given in Europe, but in the United States, eight severe cases of blood clots following vaccination have been reported, each with a low platelet count. One person died. In the United States, the vaccine has already been given to more than 7 million people.
There are no specific risk factors
The data analyzed by the EMA shows that all people affected by side effects are under the age of 60. In most cases it concerns women. The clots occurred within three weeks after vaccination, but the EMA was not able to identify specific risk factors. An immune response could be a possible explanation.
As far as the EMA is concerned, the benefits of the vaccine remain crucial. “Covid-19 carries with it the risk of hospitalization and death. The reported combination of blood clots and low platelets is extremely rare and the overall benefits of the Corona Janssen vaccine outweigh the risks of side effects.”
The analysis was performed by PRAC, the EMA Risk Assessment Committee. It found that clot formation usually occurs in unusual locations such as blood vessels in the brain (cerebral venous thrombosis, CVT) or abdomen (visceral venous thrombosis, SVT), or in arteries, with low platelet counts or bleeding. “The cases studied are very similar to those that occurred with the AstraZeneca Covid-19 vaccine,” says the EMA. Reports of such side effects have also been received from individuals vaccinated with the Pfizer or Moderna vaccine, but to a much lesser extent.
Do not alter your vaccination strategy.
With that in mind, the EMA does not recommend that European member states change their vaccination strategy. They can now really start giving the vaccine to anyone 18 years of age or older. However, EMA has a combination of thrombosis and low platelet count listed on the package leaflet as a “very rare” potential side effect.
It also recommends that healthcare professionals and vaccines remain alert to potential side effects for up to three weeks after administration. For symptoms such as shortness of breath, chest pain, swelling of the legs, persistent abdominal pain, neurological symptoms such as severe and persistent headache or blurred vision, and small spots of blood under the skin near where the vaccine was given, seek urgent medical attention.
Deliveries have resumed
Belgium received its first 36,000 vaccines from Johnson & Johnson last week, and they are already in vaccination centers, where they are currently “in quarantine”. It is not clear when they will be used effectively. The vaccination task force will meet tomorrow, the Supreme Health Council on Thursday, and there will be a European meeting of health ministers on Friday.
With 36,000 vaccines, it is possible to vaccinate so many people as only one dose is required. It will be used as a priority for home vaccination, so for people who are unable to go to the vaccination center on their own.
Last week, the same company asked countries to stop vaccinations temporarily, and also announced that it would temporarily stop providing new vaccines. The company announced this afternoon that the latest decision has been canceled and deliveries will resume. Belgium expects another 62,400 new doses next week.
It is also possible that a new decision will be made on AstraZeneca
J&J also indicates that product information for the vaccine will be adjusted upon the request of the EMA. There will be a warning about very rare side effects. The company reiterates that it “remains committed to providing 200 million doses” to the European Union, Norway and Iceland.
“The safety and well-being of the people who use our products is our top priority,” says Belgian director Paul Stoveles, in charge of the company’s scientific activities. He says he appreciates a “careful evaluation” by the EMA’s Security Committee. He emphasizes that being aware of symptoms that may indicate rare side effects will help correct the diagnosis and treatment.
Vaccine scientist Pierre Van Damme is also expecting new advice from EMA on Thursday or Friday about the vaccine from AstraZeneca, which is currently only given to people over the age of 56 in Belgium, he said tonight in Het Journal op Eén. “The EMA provides a slightly more detailed analysis of risks and benefits by age group for the AstraZeneca vaccine. We will be able to immediately include this in our policy advice, so that we can come up with a complete vaccination plan.”
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