LONDON (AP) – The European Union’s drug regulatory 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 it be added. a warning on the label. But agency experts reiterated that the benefits of the vaccine outweigh the risks.
The European Medicines Agency made its decision after examining a small number of cases of clots in people vaccinated in the US. He said these problems should be considered “very rare side effects of the vaccine”.
J&J immediately announced that it would review its label as requested and resume vaccine shipments to the EU, Norway and Iceland. In a statement, it said, “The safety and well-being of the people who use our products is our number one priority.”
Following the EMA decision, EU Commissioner for Health and Food Safety Stella Kyriakides tweeted that vaccines save lives and added: “I urge Member States to follow the opinion of the our experts “.
Dutch Health Minister Hugo de Jonge said the Netherlands would start vaccinating itself with the J&J vaccine on Wednesday.
In March, the EMA, which oversees the use of pharmaceuticals in 27 countries on the continent, with a combined population of about 448 million, also recommended a label change for the AstraZeneca vaccine after finding a link between this and rare blood clots.
In both cases, the agency said the benefits of COVID-19 vaccination outweigh the small risks of developing unusual clots.
“There is incalculable human suffering behind all these cases (coronavirus),” said Emer Cooke, executive director of the EMA, noting that 3 million people worldwide have died in the outbreak. “These vaccines play an immensely important role in the fight against this pandemic.”
Last week, J&J stopped the European launch of the vaccine after US officials recommended a pause in its use due to six cases of a very rare type of blood clot among nearly 7 million vaccinated Americans with the formula.
European officials said they took into account all available evidence from the U.S., which ultimately consisted of eight cases, including one death. It all happened in people under 60, but the EMA said it had not been able to identify any specific risk factors.
Cooke, of the EMA, said there had been no reports of unusual blood clots related to the J&J vaccine in Europe and that the agency will require additional studies of the company as its vaccine is rolled out.
Last week, Johnson & Johnson advised European governments to store their doses until the EU drug regulator issued guidelines on their use. Widespread use of the shot in Europe has not yet begun.
The delay meant once again for vaccination efforts in the EU, which have been affected by shortages of supply, logistical problems and persistent concerns about clots.
Last week, South Africa suspended the use of the J&J vaccine following a break in the United States and countries such as Italy, Romania, the Netherlands, Denmark and Croatia stored their doses. But other countries, including Poland, France and Hungary, said they would go ahead with their J&J vaccination plans.
Blood clots related to the J&J vaccine occur in unusual parts of the body, such as veins that drain blood from the brain. These patients also have abnormally low levels of blood platelets, a condition usually associated with bleeding and not clotting.
In its statement, the EMA said the cases it reviewed in recipients of the J&J trait were very similar to those seen in people who had obtained the AstraZeneca vaccine.
With the AstraZeneca vaccine, scientists in Norway and Germany have suggested that some people experience an abnormal immune system response in which they form antibodies that attack their own platelets.
It is not yet clear if a similar mechanism may exist with the Johnson & Johnson vaccine. But both the J&J and AstraZeneca vaccines, as well as one from Russia and China, are made with the same technology.
They all train the immune system to recognize the spike protein that coats the coronavirus. To do this, they use a cold virus, called an adenovirus, to carry the ear gene to the body.
“The suspicion arises 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.
The EMA said last month that the risk of rare clots associated with the AstraZeneca vaccine is lower than the risk of blood clots in healthy women due to birth control pills.
The EU ordered 200 million doses of the J & 2021 vaccine by 2021. EU officials hoped the single vaccine could be used to increase the continent’s backward vaccination rates and also to protect hard-to-reach groups, such as now migrant workers and homeless people.
Johnson & Johnson also has an agreement to supply up to 500 million doses to the UN-backed COVAX program, which seeks to get vaccines to billions of the world’s poor.
Any concerns about the J&J vaccine would be another unwanted complication for COVAX. COVAX’s largest supplier, the Serum Institute of India, recently announced that it would delay shipments of the AstraZeneca vaccine for several months due to a wave of 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.