The European Medicines Agency (EMA) said Friday that it has started a study of blood clots in people who have been given the Covid-19 vaccine from Johnson & Johnson. So far, four such cases have been reported in the US.
According to the EMA, four serious cases of blood clots with low platelet counts have been reported to date after vaccination with this preparation. One occurred in clinical trials and three after vaccination. One of them was fatal.
- What is the risk of blood clots after vaccination? Dr. Grzesiowski explains
This vaccine is currently only used in the US. It was authorized in the EU on March 11, 2021, but vaccination with it has not yet started in any EU country. This is due in April.
The EMA said it is currently unclear whether there is a cause and effect relationship between the Johnson & Johnson vaccine and blood clots. The agency is investigating these cases.
This is the fourth vaccine that has been approved in the EU, after the preparations of Pfizer / BioNTech, Moderna and AstraZeneca.
In order to increase the production of the vaccine and meet the demand for it, the Johnson & Johnson concern has concluded contracts in recent months with laboratories in Europe, which will participate in the final production process. These are: Sanofi in France, Catalent in Italy and IDT Biologika in Germany.
Thanks to the signing of these agreements, the vaccine production and distribution process will be simplified. Currently, the active substance of the preparation produced in Leiden in the Netherlands must be sent to the USA, where it is bottled and packaged, but there it is subject to American law that restricts its export.
The EU placed an order for 200 million doses of this vaccine, with an option for an additional 200 million doses. In mid-March, the President of the European Commission, Ursula von der Leyen, announced that EU countries should receive in the second quarter of this year. approximately 55 million doses of the preparation.
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The American company, for its part, did not disclose the exact schedule of vaccine deliveries to the EU.
Developed by Janssen Pharmaceutica, the pharmaceutical part of Johnson & Johnson, the formulation is a single-dose vector vaccine. To maintain its properties, it should be stored for up to two years at minus 20 degrees Celsius, of which at least three months can be stored at 2-8 degrees C.
The vaccine, administered by intramuscular injection, is based on the replication-defective adenovirus Ad26, which serves as a carrier of the genetic material by which the body begins to produce the spike protein (spike protein, S protein) of the SARS-CoV-2 coronavirus. The vaccinated person’s body then starts to develop immunity to the virus protein.
EMA on Wednesday at a press conference reported very rare cases of blood clots in combination with low platelet levels within 14 days of vaccination with AstraZeneca.
She also emphasized that these are very rare cases and that AstraZeneki’s benefits in preventing Covid-19 outweigh the risks of side effects.
From Brussels, Łukasz Osiński (PAP)
Read also:
- EMA on AstraZeneca: These symptoms mean that the vaccine is not working properly
- What’s next with AstraZeneca? Can it be restricted or withdrawn?
- Expert: There is a link between AstraZeneca and blood clots
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