Johnson & Johnson jumps as vaccine shipments to Europe set to resume after regulator says benefits outweigh blood clot risks

johnson and johnson vaccine
A nurse loads a syringe with a dose of Johnson & Johnson’s COVID-19 vaccine in Athens, Ohio.

  • Johnson & Johnson shares climbed Wednesday after a European regulator found an overall benefit of the drug maker’s COVID-19 vaccine.
  • The European Medicines Agency did find a possible link between the vaccine and the ‘rare’ side effect of blood clots.
  • J&J said it will resume shipment of its Janssen vaccine to the European Union.
  • See more stories on Insider’s business page.

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 European Medicines Agency said Tuesday it found a possible link between the company’s vaccine and “very rare” cases of “unusual blood clots with low blood platelets.”

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.

The US recently paused the rollout of the Johnson and Johson vaccine on reports of the blood-clot cases.

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European regulators are watching J&J’s vaccine for unusual blood clots

Vaccine
Registered Nurse Robert Orallo administers the Pfizer Covid-19 vaccine at the Blood Bank of Alaska in Anchorage on March 19, 2021.

  • European regulators are investigating whether Johnson & Johnson’s vaccine could cause blood clots.
  • The investigation was opened after four cases were reported, including one fatality.
  • J&J’s vaccine was authorized for European distribution last month, but hasn’t been given out yet.
  • See more stories on Insider’s business page.

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.

Approximately 4.9 million doses of J&J’s vaccine have been administered in the US, according to the CDC.

It’s not the first time the link between vaccines and blood clots has been investigated

The EMA has been closely watching reports of blood clots linked to another vaccine: AstraZeneca’s two-dose immunization.

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.

Cases of blood clots have also reported in patients who had received Moderna and Pfizer’s vaccines, a J&J spokesperson said in a statement.

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.

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There’s no evidence yet that AstraZeneca’s vaccine causes blood clots, and experts say any risks are outweighed by the shot’s benefits

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A vaccinator administers an injection of AstraZeneca/Oxford Covid-19 vaccine to a patient at a vaccination centre in Chester, northwest England, on February 15, 2021.

  • Denmark and Norway suspended the use of AstraZeneca’s COVID-19 shot Thursday as a “precautionary measure”.
  • The Danish Health authorities cited concerns about blood clots in people that had received the shot.
  • Data suggests that the risk of clots is no greater than in the population at large.
  • See more stories on Insider’s business page.

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.

This follows Austrian authorities saying Sunday that a 49-year-old woman had died as a result of severe coagulation disorders after taking the shot.

The Danish Health authorities said officials “have to react” to reports of possible serious side effects, although there was “good evidence” that the vaccine was both safe and effective.

The European Medicines Agency (EMA) OK’d the shot on January 29, having looked extensively at all its safety and efficacy data, but individual countries can ultimately decide whether they give it to their citizens.

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.”

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