ITV News Science Editor Tom Clarke explains what the Johnson & Johnson delay means for us in the UK
Johnson & Johnson (J&J) has said it is delaying the rollout of its coronavirus vaccine in Europe amid a US probe into rare blood clots.
“We have been reviewing these cases with European health authorities,” the pharmaceutical company said. “We have made the decision to proactively delay the rollout of our vaccine in Europe.” Hundreds of thousands of doses of the vaccine were due to be shipped to Europe in the coming weeks. Asked earlier on Tuesday about a possible halt to the rollout of J&J vaccines in Germany, a Health Ministry spokesman said there were no immediate plans to change the schedule. “I don’t currently have the date from which Johnson & Johnson will be administered,” the spokesman, Hanno Kautz, told reporters in Berlin.
“But in principle, we naturally always take such warnings in an international context seriously and investigate them.”
Listen to the ITV News coronavirus podcast
The European Medicines Agency, the EU’s medicines regulator, said it had already started reviewing the J&J vaccine in order to assess reports of blood clots in people who received the shot. In a joint statement released on Tuesday, the Centres for Disease Control (CDC) and Prevention and the Food and Drug Administration said they were investigating clots in six women in the days after vaccination, in combination with reduced platelet counts.
CDC's Advisory Committee on Immunisation Practices will meet on Wednesday to discuss the reports. “Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution,” Dr Anne Schuchat, Principal Deputy Director of the CDC and Dr Peter Marks, director of the FDA’s Centre for Biologics Evaluation and Research said.
More than 6.8 million doses of the Johnson & Johnson vaccine have been administered in the US. US federal distribution channels, like mass vaccination sites, will halt their J&J vaccine rollout, while states and other providers are expected to follow. The other two approved vaccines, from Moderna and Pfizer, have not been impacted by the pause.The CDC and FDA have recommended that those who have had the J&J vaccine and are experiencing severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after receiving the jab contact their healthcare provider.
They added that they want to educate vaccine providers and health professionals about the “unique treatment” required for the type of clot that has been reported.
The J&J vaccine received emergency use authorisation from the FDA in late February. It was hoped that its single-dose and relatively simple storage requirements would speed up the country's rollout.
However, the jab currently only makes up a small portion of doses administered in the US as J&J has experienced production delays and manufacturing errors at the Baltimore plant of a contractor.
Just last week, the pharmaceutical company took over the facility with the hopes of ramping up production and meeting its target of offering around 100 million doses by the end of May.
News of the recommended pause hit US stock markets immediately, with Dow futures falling almost 200 points just over two hours before the opening bell. Shares of J&J dropped almost 3%.
Up until now, concern about blood clots has involved the Oxford/AstraZeneca vaccine, which has not yet been approved in the US. Last week, European regulators said they found a possible link between the Oxford/AstraZeneca jab and a very rare type of blood clot that occurs together with low blood platelets, and seems to occur more in younger people.
However, it added that the vaccine is still highly effective and the benefits of receiving it outweigh the risks.
Following this announcement, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) announced that under-30s in the UK will be offered Pfizer or Moderna vaccines rather than the Oxford/AstraZeneca vaccine.