Johnson & Johnson shares pushed to a three-week high Tuesday, with the company restarting shipments of its COVID-19 vaccine to Europe after the European Union’s drug agency said its benefits outweigh the potential risk of a “rare” side effect of blood clots.
The agency said a warning should be added to product information about the Janssen-branded vaccine but also said the overall benefit-risk remains positive.
Shares of Johnson & Johnson rose as much as 3.1% to trade above $167 each, marking their first time above that price since March 29. The shares had added about 11% over the past year.
The drug maker said it will resume shipments of the vaccine in the European Union, Norway and Iceland, and that it will provide updated guidance from the medicines agency and healthcare professionals to national healthcare authorities.
“We appreciate the rigorous review of the [Pharmacovigilance Risk Assessment Committee] and share the goal of raising awareness of the signs and symptoms of this very rare event to ensure the correct diagnosis and appropriate treatment,” said Paul Stoffels, J&J’s chief scientific officer, in a Tuesday statement.
The blood-clot cases occurred in people less than 60 years of age and most were in women. The clotting took place within three weeks of receiving the vaccine.
European regulators are investigating whether Johnson & Johnson’s COVID-19 vaccine caused unusual blood clotting after four cases were reported in vaccine recipients, including one fatality.
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee disclosed Friday that they are reviewing the vaccine after three people who received J&J’s vaccine in the US and another who was involved in a clinical trial developed blood clots. It’s currently not clear if the vaccine caused these clots.
J&J said that it was working closely with experts and regulators to assess data coming in, but that so far, they have found a small number of very rare side effects.
The investigation comes as European states prepare to add the vaccine to their roster of COVID-19 shots. J&J’s vaccine was recommended for authorization by the EMA on March 11, but has not yet been distributed.
The agency stated Wednesday that blood clots can be a “very rare” side effect of AstraZeneca’s shot in people with low blood platelet levels. Approximately 169 cases of blood clots in the brain and 53 cases of blood clots in the spleen had been reported as of April 4, according to the EMA.
Issues have been popping up as J&J’s shot has rolled out in the US.
One of the factories that produces both drug companies’ vaccines is in hot water after it was reported by the New York Times that 15 million doses of Johnson & Johnson’s vaccine had been cross-contaminated with AstraZeneca’s vaccine at a U.S. factory run by Emergent BioSolutions. None of those shots were distributed to the public.
Officials in Colorado and North Carolina stopped giving out J&J’s vaccine this week after two dozen people experienced minor adverse reactions like nausea and dizziness.
J&J’s stock traded down about 1% on Friday morning.
Denmark, Norway, and Iceland suspended their roll out of AstraZeneca and the University of Oxford’s COVID-19 vaccine as a “precautionary” step Thursday, citing concerns about blood clots in people who had received the shot.
One person in Denmark who was immunized with the vaccine died from a blood clot, the Danish Health Authority said in a statement Thursday. At this point, it’s not known whether there is a link between the vaccine and blood clots, it said.
AstraZeneca vaccine and blood clots: the stats so far
There have been a total of four reported cases in Europe of people getting vaccinated with a specific batch of AstraZeneca’s shot and then developing blood clots afterwards, according to the EMA. The batch of 1 million doses had been sent to 17 EU countries, including Denmark.
At least five countries – Austria, Estonia, Lithuania, Luxembourg, and Latvia – have suspended the use of this particular batch. Norway, Denmark, and Iceland suspended the vaccine completely.
The EMA said Wednesday that one person in Europe had been diagnosed with multiple blood clots in vessels 10 days after vaccination. It was unclear whether this was the Danish case, although by that time Austrian authorities had already reported a death.
Insider contacted the Danish health authority for clarification, and a spokesperson said that they were “not at liberty to inform on the data that we receive from other authorities, national or international.”
Another person in Europe was hospitalized with a blood clot in the lung after being vaccinated, who was “now recovering,” the EMA said.
The time-frame between getting the vaccine and developing the clot for this person was not documented.
There were two other reports of blood clots, the EMA said. No further details were provided such as age, or whether they had medical conditions that made their blood more likely to clot.
No more blood clots than in general population
The EMA said in a press release that overall, as of Thursday, there had been 30 cases amongst more than 5 million who had been vaccinated with AstraZeneca’s shot overall. There was no indication that the vaccine caused blood clots, and this wasn’t a known side effect, they said.
Professor Jon Gibbons, director of the Institute of Cardiovascular and Metabolic Research at the University of Reading, said in a statement that blood clots in the general population were relatively common, and affected an average of between one and two people per 1,000 – a higher proportion than 30 in 5 million.
“Therefore if there is any association between the vaccine and clotting, the risk is likely to be very low indeed,” he said.
Dr. Phil Bryan, the Medicines and Healthcare Products Regulatory Agency (MHRA) safety lead, said in a statement that the number of reports of blood clots received so far in the UK – where more than 11 million doses of AstraZeneca’s vaccine have been given – were not greater than what would have occurred usually in a population that size.
The UK did not receive the batch from which the four most recent reports of clots arose.
Denmark’s approach ‘super’ cautious
Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine, said in a statement that the Danish approach was “super” cautious.
“Since we know with great certainty that the vaccine prevents COVID-19, and we are almost totally uncertain that the vaccine can have caused this problem, the risk and benefit balance is still very much in favour of the vaccine in my view,” he said.
Evans said that it was difficult to distinguish between coincidence and the vaccine’s side effects.
“This is especially true when we know that COVID-19 disease is very strongly associated with blood clotting and there have been hundreds if not many thousands of deaths caused by blood clotting as a result of COVID-19 disease,” he said.
Professor Anthony Harnden, Deputy Chair of the Joint Committee on Vaccination and Immunisation – the organization that advises the UK’s vaccine strategy – said in a statement that the public should have “confidence” that AstraZeneca’s vaccine was “safe and highly effective at preventing severe disease, including the prevention of blood clots caused by COVID-19.”