Johnson & Johnson says it is delaying the launch of its coronavirus vaccine in Europe in the middle of a US probe into rare blood clots.
The company announced the decision Tuesday after U.S. regulators said they recommended a “pause” in the administration of the single-shot shot to investigate reports of potentially dangerous blood clots.
“We have reviewed these cases with European health authorities,” the company said. “We have decided to proactively delay the launch of our vaccine in Europe.”
Hundreds of thousands of doses of the vaccine would be transported to Europe in the coming weeks.
Asked on Tuesday about a possible halt to the rollout of Johnson & Johnson (J&J) vaccines in Germany, a spokesman for the Ministry of Health said there were no immediate plans to change the schedule.
“I do not currently have the date from which Johnson & Johnson will be administered,” spokesman Hanno Kautz told reporters in Berlin. “But in principle, of course, we always take such warnings seriously in an international context and examine them.”
The European Medicines Agency, the EU’s equivalent to the US Food and Drug Administration (FDA), said it had already begun reviewing the J&J vaccine to assess reports of blood clots in people who received the shot.
“These reports point to a ‘safety signal’, but it is not clear at this time whether there is a causal link between vaccination” with the Johnson & Johnson shot, it said. Experts “investigated these cases and will determine whether regulatory action may be necessary,” it added.
In a joint statement on Tuesday, the US Centers for Disease Control and Prevention (CDC) and the FDA said they were examining blood clots in six women that occurred in the days after vaccination. Blood clots were observed along with reduced platelets – making the usual treatment for blood clots, the blood-thinning heparin, potentially “dangerous”.
One American patient died of blood clot complications after receiving the J&J vaccine while another is in critical condition, a senior researcher for the FDA said on Tuesday.
In total, six people between 18 and 48 developed a rare form of cerebral blood clotting with low platelets between six and 13 days after receiving the shot.
“One case was fatal, and one patient is in critical condition,” said Dr. Peter Marks.
More than 6.8 million doses of the J&J vaccine have been administered in the United States, most of them without any or mild side effects.
US federal distribution channels, including mass vaccination sites, will pause the use of the J&J shot, and states and other vendors are expected to follow. The other two approved vaccines, from Moderna and Pfizer, are not affected by the break.
The CDC’s advisory committee on immunization methods will meet on Wednesday to discuss the cases and the FDA has also launched an investigation into the cause of blood clots and low platelet counts.
“Until that process is complete, we recommend a pause in the use of this vaccine of an abundance of caution,” says Dr. Anne Schuchat, head of the CDC and Dr. Marks, head of the FDA’s center for biological evaluation and research, said in a joint statement.
They recommend that people who received the J&J vaccine who experience severe headache, abdominal pain, leg pain or shortness of breath within three weeks of receiving the shot contact their healthcare provider.
Officials say they also want to educate vaccine providers and healthcare professionals about the “unique treatment” required for this type of blood clot.
J&J and AstraZeneca manufactured with the same technology
The J&J vaccine was approved for emergency use by the FDA at the end of February with great fanfare, with the hope that its single dose and relatively simple storage requirements would speed up vaccinations across the country. Still, the shot is only a small fraction of the doses administered in the United States as J&J has been plagued by production delays and manufacturing failures at a contractor’s plant in Baltimore.
Last week, the pharmaceutical manufacturer took over the plant to increase production in hopes of fulfilling its commitment to the US government to provide about 100 million doses by the end of May.
So far, concerns about the unusual blood clots have focused on the AstraZeneca vaccine, which has not yet been licensed in the United States. Last week, European regulators said they found a possible link between the shots and a very rare type of blood clot that occurs with low blood platelets, one that seems to occur more in younger people.
The European Medicines Agency emphasized that the benefits of receiving the vaccine outweigh the risks for most people. But several countries have introduced limits on who can get the vaccine; The UK recommended that people under 30 be offered options.
But the J&J and AstraZeneca vaccines are made with the same technology. Leading Covid-19 vaccines train the body to recognize the nail protein that covers the outer surface of the coronavirus. But the J&J and AstraZeneca vaccines use a cold virus, called adenovirus, to carry the nail gene into the body. J&J uses a human adenovirus to create its vaccine, while AstraZeneca uses a chimpanzee version.
The announcement hit the US stock markets immediately, with Dow futures falling nearly 200 points just over two hours before opening time. The shares in Johnson & Johnson fell almost 3 percent.
( Jowharwith AP)