The Atlanta Journal-Constitution
Agency: J&J shots linked to clots; odds favor use
Regulator suggests adding warning label, company promptly says it will do so.
The European Union’s drug regulatory agency said Tuesday it found a “possible link” between Johnson & Johnson’s COVID-19 vaccine and extremely rare blood clots and recommended a warning be added to the label. But experts at the agency reiterated the vaccine’s benefits outweigh the risks.
What happened
The European Medicines Agency made its determination after examining a small number of clot cases in people vaccinated in the U.S. It said these problems should be considered “very rare side effects of the vaccine.”
J&J immediately announced it will revise 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’S decision, EU Health and Food Safety Commissioner Stella Kyriakides tweeted 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 start immunizing with the J&J vaccine Wednesday.
In March, the EMA, which oversees the use of pharmaceutical products in 27 countries across the continent with a combined population of about 448 million, likewise recommended a label change for Astrazeneca’s vaccine after finding a link between it and rare blood clots.
In both cases, the agency said
the benefits of being immunized against COVID-19 outweigh the very small risks of developing the unusual clots.
“There is untold human suffering behind all of these (coronavirus) cases,” said Emer Cooke, the EMA’S executive director. “These vaccines play an immensely important role in combating this pandemic.”
How it happened
Last week, J&J halted its European rollout of the vaccine after U.S. officials recommended a pause in its use because of six cases of a very rare type of blood clot among nearly 7 million Americans vaccinated with the formula.
European officials said they considered all available evidence from the U.S., which ultimately consisted of eight cases, including one death. All occurred in people under 60, but the EMA said that it hadn’t been able to identify any specific risk factors.
The EMA’S Cooke said that no
unusual blood clot cases connected to the J&J vaccine had been reported in Europe and that the agency will require further studies from 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 guidance on their use. Widespread use of the shot in Europe has not yet started.
Why it matters
The delay was a further blow to vaccination efforts in the EU, which have been plagued by supply shortages, logistical problems and the concerns over clots.
Last week, South Africa suspended J&J vaccines in the wake of the U.S. pause, and countries including Italy, Romania, the Netherlands, Denmark and Croatia put their doses into storage. But other countries, including Poland, France and Hungary, said they would move forward with their J&J immunization plans.