LONDON (AP) – The European Union’s drug regulation agency said on Tuesday it had found a ‘possible link’ between Johnson & Johnson’s COVID-19 vaccine and extremely rare blood clots, and recommended that a warning be given on the label. be added. But experts from the agency have reiterated that the benefits of the vaccine outweigh the risks.
The European Medicines Agency has made its decision after investigating a small number of blood clots in people vaccinated in the US. According to him, these problems should be considered as a very rare side effect of the vaccine. ‘
J&J immediately announced that it would review its label as requested and resume transporting vaccines to the EU, Norway and Iceland. A statement said: “The safety and well-being of the people who use our products is our top priority.”
Following the EMA’s decision, Stella Kyriakides, Commissioner for Health and Food Safety, tweeted that vaccinations save lives and added: “I call on the Member States to follow the opinion of our experts.”
The Dutch Minister of Health, Hugo de Jonge, said that the Netherlands will start immunizing with the J&J vaccine on Wednesday.
In March, the EMA, which oversees the use of pharmaceuticals in 27 countries across the continent, with a combined population of about 448 million, also recommended a label change for the AstraZeneca vaccine after a link between it and rare blood clots were found.
In both cases, the agency said the benefits of the COVID-19 vaccine outweigh the very small risks of developing unusual blood clots.
“There is innumerable human suffering behind all these cases (coronavirus),” said Emer Cooke, the EMA’s executive director, noting that 3 million people worldwide died in the outbreak. “These vaccines play an extremely important role in combating this pandemic. ”
Last week, J&J stopped the European explosion of the vaccine after US officials recommended a break due to six cases of a very rare type of blood clot among nearly 7 million Americans vaccinated with the formula.
European officials have said they are considering all available evidence from the US, which ultimately consists of eight cases, including one death. Everything occurred in people under 60, but the EMA said it could not identify any specific risk factors.
According to the EMA’s Cooke, no unusual blood clotting cases have been reported in connection with the J & J vaccine in Europe and that the agency will need further investigations from the company as the vaccine is rolled out.
Last week, Johnson and Johnson advised European governments to save their doses until the EU drug regulator provides guidance on their use. The widespread use of the shot in Europe has not yet begun.
The delay was a further blow to the vaccination efforts in the EU, which are plagued by supply shortages, logistical problems and the constant concern about blood clots.
Last week, South Africa suspended the use of the J&J vaccine in the wake of the US interruption, and countries such as Italy, Romania, the Netherlands, Denmark and Croatia saved their doses. But other countries, including Poland, France and Hungary, have said they are continuing with their J&J vaccination plans.
The blood clots linked to the J&J vaccine are found in unusual parts of the body, such as veins that drain blood from the brain. These patients also have abnormally low platelets, a condition commonly associated with bleeding, not clotting.
In its statement, the EMA said that the cases it investigated in recipients of the J&J shot were very similar to those seen in people who received the AstraZeneca vaccine.
With the AstraZeneca vaccine, scientists in Norway and Germany have suggested that some people experience an abnormal immune system reaction in which they form antibodies that attack their own platelets.
It is not yet clear if there could be a similar mechanism with the Johnson & Johnson vaccine. But both the J&J and AstraZeneca vaccines, as well as a Russian and from China, are manufactured using the same technology.
They all train the immune system to recognize the vein protein that covers the coronavirus. To do this, they use a cold virus, called an adenovirus, to carry the spike gene into the body.
“The suspicion is growing that these rare cases may be caused 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.
The EMA said last month that the risk of rare blood clots associated with the AstraZeneca vaccine is lower than the blood clot risk that healthy women face as a result of birth control pills.
The EU has ordered 200 million doses of the vaccine for 2021. EU officials hoped the one-shot vaccine could be used to boost the continent’s vaccination rates and also protect hard-to-reach groups such as migrant workers and the homeless.
Johnson & Johnson also has an agreement to deliver 500 million doses to the UN-backed COVAX program, which seeks to get vaccines for billions of the world’s poor.
Any concerns about the J&J vaccine could be another unwelcome complication for COVAX. COVAX’s largest supplier, the Serum Institute of India, recently announced that shipping of the AstraZeneca vaccine will be delayed by several months due to an increase in cases in India.
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Mike Corder in The Hague, The Netherlands; Linda A. Johnson in Trenton, New Jersey, Lauran Neergaard in Washington; and Raf Casert in Brussels contributed to this report.