LONDON (AP) – The European Union’s Drug Enforcement Agency said on Tuesday it had found a “possible link” between Johnson & Johnson’s COVID-19 vaccine and extremely rare blood clots and recommended adding a warning on the label. But the agency’s experts reiterated that the benefits of the vaccine outweigh the risks.
The European Medicines Agency has made its decision after examining a small number of cases of clots in people vaccinated in the United States. 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 shipments of vaccines to the EU, Norway and Iceland. In a statement, it said: “The safety and well-being of people who use our products is our number one priority.”
Following the EMA’s decision, EU Health and Safety Commissioner Stella Kyriakides wrote on Twitter that vaccinations save lives and added: “I urge Member States to follow the opinion of our experts.”
Dutch Health Minister Hugo de Jonge said the Netherlands would begin immunization with the J&J vaccine on Wednesday.
In March, the EMA, which monitors the use of pharmaceuticals in 27 countries on the continent with a combined population of about 448 million, also recommended a change to the label for the AstraZeneca vaccine after finding a link between it and rare blood clots.
In both cases, the agency stated that the benefits of immunization against COVID-19 outweigh the very small risks of developing unusual clots.
“There is unspeakable human suffering behind all these cases (coronavirus),” said Emer Cooke, EMA’s executive director, noting that 3 million people worldwide have died in the outbreak. These vaccines play an extremely important role in combating this pandemic.
Last week, J&J stopped the European launch of the vaccine after US officials recommended a break in its use due to six very rare cases of blood clot in nearly 7 million Americans vaccinated with the formula.
European officials said they had considered all available evidence in the United States, which eventually consisted of eight cases, including one death. All occurred in people under 60, but the EMA said it was unable to identify specific risk factors.
Cooke of the EMA said that no unusual cases of blood clots related to the J&J vaccine have been reported in Europe and that the agency will request further studies from the company as its vaccine is launched.
Last week, Johnson & Johnson advised European governments to keep their doses until the EU drug regulator issued instructions on their use. The widespread use of photography in Europe has not yet begun.
The delay was another blow to EU vaccination efforts, which were affected by a shortage of supplies, logistical problems and persistent clot concerns.
Last week, South Africa suspended the use of the J&J vaccine following the US break, and countries such as Italy, Romania, the Netherlands, Denmark and Croatia have submitted their doses. But other countries, including Poland, France and Hungary, have said they will go ahead with their J&J immunization 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 platelets in their blood, a condition normally associated with bleeding, not clotting.
In its statement, the EMA stated that the cases it analyzed in the 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 response in which they form antibodies that attack their own platelets.
It is not yet clear if there may be a mechanism similar to the Johnson & Johnson vaccine. But both the J&J and AstraZeneca vaccines, as well as the Russian and Chinese ones, are made with the same technology.
They all train the immune system to recognize the spike protein that covers the coronavirus. To do this, they use a cold virus, called an adenovirus, to carry the spike gene into the body.
“There is a suspicion that these rare cases can 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 faced by healthy women on birth control pills.
The EU has ordered 200 million doses of J&V vaccine by 2021. EU officials hoped the single vaccine could be used to increase the continent’s delayed vaccination rates and also to protect hard-to-reach groups, such as migrant workers and homeless people.
Johnson & Johnson also has an agreement to provide up to 500 million doses to the UN-backed COVAX program, which seeks to bring 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, Serum Institute of India, recently announced that it will delay shipments AstraZeneca vaccine for several months due to a wave of cases in India.
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Mike Corder The Hague, The Netherlands; Linda A. Johnson in Trenton, New Jersey, Lauran Neergaard in Washington; and Raf Casert of Brussels contributed to this report.