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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US officials may need 2 weeks or more to determine if Johnson & Johnson’s vaccine causes rare blood clots

Pharmacist Madeline Acquilano fills a syringe with the Johnson & Johnson Covid-19 Vaccine before inoculating members of the public at Hartford Hospital in Hartford, Connecticut, on March 3, 2021. - Some 7,400 vials of the Johnson & Johnson Covid-19 single shot vaccine were delivered and an initial offering of the vaccine was given to ten members of the public. (Photo by Joseph Prezioso / AFP) (Photo by JOSEPH PREZIOSO/AFP via Getty Images)
A pharmacist at the Hartford Hospital in Hartford, Connecticut, fills a syringe with the Johnson & Johnson COVID-19 vaccine.

  • US agencies may need two weeks or more to know if Johnson & Johnson’s shot causes rare blood clots.
  • The CDC is shuffling to collect more data, two senior White House health officials told Politico.
  • But medical experts worry that pausing the shot for much longer could increase vaccine hesitancy.
  • See more stories on Insider’s business page.

US federal agencies may need two weeks or more to know whether Johnson & Johnson’s coronavirus vaccine is linked to rare blood clots, two senior White House health officials told Politico on Saturday.

US regulators recommended a pause in the distribution of J&J’s shot last Tuesday due to six reports of clotting among women who’d recently received the vaccine.

The particular blood clot in question, central venous sinus thrombosis (CVST), forms in the brain – so it can lead to headaches or stroke. In an average year, the condition occurs in about five people out of every million.

The Centers for Disease Control and Prevention’s vaccine advisory panel is scheduled to convene Friday to discuss whether to lift the vaccine pause. But two health officials told Politico that the CDC still might not have enough data by then to determine if J&J’s vaccine indeed causes rare clots.

US regulators may ultimately consider placing age- or gender-based restrictions on the shot, which has been authorized for people ages 18 and older. Alternatively, regulators could simply deliver stronger warnings about possible blood clots in unusual cases.

Many political leaders and medical experts worry that if regulators take too long to evaluate the potential blood clot link, an increasing share of Americans will lose trust in J&J’s vaccine.

“The longer the pause is, the longer it’s going to take for us to convince people that this particular vaccine is safe again,” Arkansas Gov. Asa Hutchinson told Politico.

Peter Gulick, an associate professor of medicine at Michigan State University, said the J&J pause could delay the prospect of herd immunity – the threshold beyond which the virus won’t be able to pass easily from person to person.

“The fear is that, hearing all this, the anti-vaxxers and even the ones on the fence are falling off the fence now into the arena of ‘I don’t think I want to get any vaccine until things are known a little more,'” Gulick told Insider. “We may have taken two steps backwards as far as our wanting to get herd immunity.”

Searching for blood clots in a ‘muddied water’ of data

johnson and johnson covid vaccine
Johnson & Johnson’s coronavirus vaccine is delivered as a single shot, while both Pfizer’s and Moderna’s require two jabs.

The CDC’s vaccine advisory panel has already met once to review the rare blood clot cases. At a meeting last Wednesday, the panel recommended continuing the pause on J&J’s vaccine until more data could be gathered.

“It’s important from the perspective of the public: When we say rare, what does that mean?” Dr. Beth Bell, a professor of global health at the University of Washington, said during the meeting. “I want to be able to feel comfortable with my family members and myself getting this vaccine.”

US regulators are now encouraging doctors to report any post-vaccination CVST cases over the last few weeks. Regulators are also working with Johnson & Johnson to find out more about the six reported cases – in particular, whether the women had underlying health problems or were taking any medications that could have predisposed them to clotting.

So far, regulators have noticed a few patterns: The women were between the ages of 18 and 48. They also had a rare combination of CVST and low levels of platelets – colorless blood cells that help clots form.

Before the vaccines were authorized, this combination was primarily seen in association with the blood-thinning drug heparin. In rare cases, people taking the medication develop antibodies that bind to a specific platelet, which can make them more susceptible to clots.

“This observation of the low platelet count is part of the mystery and something that has to be worked through to see if that’s connected or not,” Namandjé Bumpus, director of the pharmacology and molecular sciences department at Johns Hopkins Medicine, told Insider.

But medical experts stressed the need for more data before associating the clots with any particular group yet.

“Everything is just like a big muddied water and then you just try to clear things out as much as you can to try to evaluate what is going on,” Gulick said.

Vaccinations may slow for the homeless, prisoners, or rural Americans

Michigan vaccine
Yvonne Gibbs, 72, receives Moderna’s COVID-19 vaccine, at the TCF Center in Detroit.

Shortly after US regulators announced a pause in J&J’s vaccine, White House COVID-19 coordinator Jeff Zients said the recommendation wouldn’t affect the pace of the US vaccine rollout.

“We have more than enough supply of Pfizer and Moderna vaccines to continue the current pace of about 3 million shots per day,” Zients said at a Tuesday press briefing.

Indeed, many health departments, pharmacies, and vaccine clinics that planned on administering Johnson & Johnson were able to quickly procure other shots so people didn’t lose their appointments.

But some vaccination sites – particularly those in rural areas – were forced to shut down temporarily. A state-run mass vaccination site in Aurora, Illinois, was canceled earlier this week, terminating appointments of 1,000 people. Around the same time, a Johnson & Johnson clinic in Jefferson County, Illinois, put vaccinations on hold.

The J&J pause has also slowed the pace of vaccinations for homeless people, prisoners, and those unable to leave their homes due to illness or old age. J&J’s vaccine is the only single-dose shot authorized in the US, so it’s the easiest to administer. It’s also easier to store than the Pfizer or Moderna vaccines (it can be kept in standard refrigerators rather than freezers).

On top of that, people may gravitate toward J&J’s vaccine if they’re afraid of needles or have difficulty taking time off work to get vaccinated.

“We’re actually seeing that some people opt for the Johnson and Johnson shot just because of their circumstances – it’s one dose, it’s available, and so on,” Johan Bester, director of bioethics at the University of Nevada, Las Vegas School of Medicine, told Insider.

Without the J&J option, medical experts said, US health officials may have a harder time convincing more Americans to get vaccinated – even as new, more contagious variants drive up cases across the country.

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Johnson & Johnson had a very bad week – but fears of negative reactions and blood clots are likely overblown

johnson & johnson vaccine
Nurse Elizabeth Johnson administers a COVID-19 vaccine to Melissa Mendez in Reading, Pennsylvania.

Johnson & Johnson’s coronavirus vaccine rollout hit several unfortunate snags this week – some far worse than others.

The New York Times reported on Tuesday that 62 million of the company’s vaccine doses must be checked for contamination, following an error at a Maryland manufacturing plant that already ruined 15 million doses. The plant’s workers accidentally mixed up some vaccine ingredients last month.

Then a vaccination site in Colorado, three sites in North Carolina, and one in Georgia all temporarily stopped administering Johnson & Johnson’s shot after about 45 people in total experienced minor adverse reactions involving nausea, dizziness, fainting, or lightheadedness.

To top it off, European regulators announced Friday that they are investigating Johnson & Johnson’s shot for links to unusual blood clotting after four blood-clot cases, including one death, were reported among vaccine recipients.

The timing of these developments was unfortunate, experts said, but there’s no reason to doubt the shot’s safety yet.

“You don’t want to be fueling unnecessary worries about the safety of vaccines when you’re still seeing an enormous outbreak and death rates all over the world from COVID,” Art Caplan, a bioethicist at New York University, told Insider.

He added that the side effects observed at the US vaccination sites were “absolutely trivial.”

Although symptoms like nausea and fainting aren’t common responses to coronavirus vaccines, they aren’t abnormal, either.

“When you see these clusters [of side effects], they usually are worked out and have no relation to the vaccine,” Arnold Monto, an epidemiologist at the University of Michigan’s School of Public Health, told Insider. Monto chairs the Food and Drug Administration’s Vaccine Advisory Committee, which voted to recommend the Pfizer, Moderna, and Johnson & Johnson shots.

People could get dizzy or nauseous for many reasons

johnson & johnson vaccine line
Kristine Ko, right, waits in line for her vaccine at the Cal State LA walk-up mass vaccine site in Los Angeles on April 8.

Most of the negative reactions to Johnson & Johnson’s shot occurred within 15 minutes after a person got vaccinated, public-health officials in Colorado, Georgia, and North Carolina reported. In total between the three states, seven people were taken to hospitals for observation. As of Friday, all but one had been released and everyone was expected to fully recover.

Officials haven’t yet pinpointed why these clusters of adverse reactions were identified in such a short time frame. But they’ve emphasized that there’s no reason to be concerned about the shot itself.

In a news release, Georgia’s public health commissioner, Kathleen Toomey, said the state was looking into “what may have caused the reactions, including the conditions at the fairgrounds such as heat and the ability to keep the site cool.”

Caplan said it’s also possible that the people who felt dizzy or nauseous were elderly or had underlying health conditions that may have predisposed them to adverse reactions. And once one site reports a cluster of patient reactions, that makes others more likely to look for them and take swift action.

Whatever the reason, Monto said, the fact that adverse reactions are being reported and investigated shows that local officials are working hard to minimize harm.

“Any pause in vaccination shows that the system is working because we’re not trying to sweep anything under the rug,” he said.

In a statement, Johnson & Johnson told Insider that it takes all adverse reactions seriously. The company said it would “carefully assess the events” and share any findings with the FDA.

“There is no greater priority than the safety and well-being of the people we serve,” the statement said.

The link between J&J’s shot and blood clots remains tenuous

johnson & johnson vaccine
A vial of Johnson & Johnson’s shot.

Just four blood-clot cases have been identified among people who’ve gotten Johnson & Johnson’s shot so far. In one of those cases, a participant in the company’s clinical trial died of a clotting disorder.

The other three blood-clot cases occurred during J&J’s US rollout, which has administered nearly 5.4 million doses of its vaccine. That’s fewer than one clot case per 1 million shots.

Experts aren’t convinced there’s a cause-and-effect relationship at all, though.

“It isn’t really clear how many people get blood clots anyway,” Caplan said. ‘That makes it hard to know whether it’s connected to vaccination.”

The European Union’s health regulator, the European Medicines Agency (EMA), announced its investigation after receiving information about the blood-clot cases from the FDA, Bloomberg reported. The EU authorized Johnson & Johnson’s vaccine in March and is scheduled to roll out the shot later this month.

The agency said it wasn’t sure what relationship, if any, existed between the vaccine and blood clots.

Earlier this week, the EMA announced that potentially fatal blood clots might be a rare side effect of AstraZeneca’s vaccine, which has been authorized in more than 110 countries but not yet in the US. Both that shot and Johnson & Johnson’s are viral-vector vaccines, which introduce a coronavirus gene into the body using a genetically engineered common-cold virus. Scientists don’t know whether the platform itself could be linked to clotting.

Still, any risk of clots should be weighed against the risk of getting COVID-19, Caplan said.

“If I live in Brazil and I’m still seeing 3,000 deaths a day, and somebody said to me, ‘We’re going to pull AstraZeneca vaccine out of here because we found somebody who died of a blood clot that might be related to the vaccine,’ I’d say, ‘You better recalculate your risk-benefit ratio,'” he said.

The bigger problem is a lack of supply

For now, the most pressing issue with Johnson & Johnson’s vaccine isn’t any safety concern – it’s the lack of consistent supply.

Johnson & Johnson promised to ship 24 million doses in US this month, but it’s unclear if the company will meet that goal, given the recent manufacturing issues, which occurred at a plant run by Emergent Biosolutions, a US government contractor.

Quality-control managers must first test 62 million doses to see if they can be salvaged, and the FDA must also certify that the Maryland plant can release more doses to the public.

Jeff Zients, the White House COVID-19 response coordinator, said at a Friday briefing that Johnson & Johnson “expects a relatively low level of weekly dose delivery” until the FDA signs off on the plant.

The total number of Johnson & Johnson shots allocated to states and other jurisdictions is expected to drop around 85% next week, to around 1.5 million doses. But that decrease follows an unprecedented surge of roughly 11 million doses last week.

Johnson & Johnson has said it’s still on track to provide close to 100 million doses by the end of May.

Allison DeAngelis contributed reporting.

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7 people died in the UK from blood clots after getting AstraZeneca’s COVID-19 vaccine

AstraZeneca vaccine
A vial of the Oxford University/AstraZeneca COVID-19 vaccine.

  • Seven people have died from blood clots after the AstraZeneca COVID-19 vaccine, UK regulators said.
  • A total of 30 blood clots possibly linked to the vaccine have been reported in the UK.
  • The UK’s drug regulator maintains the benefits of the shots outweigh the risks.
  • See more stories on Insider’s business page.

Seven people have died from blood clots after receiving AstraZeneca’s COVID-19 vaccine, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) said Saturday, according to multiple reports.

The agency on Thursday reported 25 new cases of rare blood clots possibly linked to the vaccine, bringing the total number of cases to 30, but did not indicate how many, if any, people had died. MHRA has not received clotting reports following the BioNTech and Pfizer vaccine, it said in its Thursday report.

It’s still unclear if the AstraZeneca vaccine is causing the blood clots, or if it’s just a coincidence.

MHRA maintains the shots are safe. Seven deaths out of more than 18 million AstraZeneca doses delivered by March 24 still means that adverse outcome possibly related to the shot is extremely rare.

“The benefits … in preventing Covid-19 infection and its complications continue to outweigh any risks and the public should continue to get their vaccine when invited to do so,” Dr. June Raine, the chief executive of the MHRA, told the BBC.

Many countries have resumed use of AstraZeneca’s vaccine

In March, more than a dozen countries, mostly in Europe, temporarily suspended the AstraZeneca vaccine‘s rollout due to concerns about its possible link to the rare blood clots, Insider’s Barnaby Lane reported.

Many resumed or partially resumed its use after the European Medicines Agency and the World Health Organization emphasized its safety.

“The benefits of the AstraZeneca vaccine in preventing COVID-19, with its associated risk of hospitalization and death, outweigh the risks of side effects,” the European Medicines Agency said in a press briefing March 31, echoing what the regulator said in the weeks prior.

As Insider’s Dr. Catherine Schuster-Bruce previously reported, the EMA said an expert panel including hematologists, neurologists, and epidemiologists could not identify any specific risk factors including age, gender, or previous medical disorder that raised some people’s risk of “these very rare events.”

While there are some theories as to why a vaccine could lead to blood clots, none have been proven in this case, EMA said.

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Investigations into possible rare, serious vaccine side effects are not worrying – they’re reassuring

fauci vaccine
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, prepares to receive his first dose of a COVID-19 vaccine at the National Institutes of Health on December 22, 2020 in Bethesda, Maryland.

  • The European regulator this week declared the AstraZeneca-Oxford University vaccine safe.
  • But it will keep investigating reports of rare clots after vaccination, particularly among younger women.
  • These investigations into side effects shouldn’t worry us – they’re a sign monitoring is working.
  • See more stories on Insider’s business page.

All effective medicines have side effects. We put up with them because, overall, the medicines make us feel better, or prevent something far worse.

The same principle applies to COVID-19 vaccines.

The benefits of AstraZeneca’s shot in preventing COVID-19 – which has killed 2.6 million people worldwide – outweighs the risk of any side effects, the European medicines regulator said Thursday. Its statement followed a thorough investigation into reports of rare and serious blood clots in vaccinated people.

The European Medicines Agency (EMA) said it found no increased risk of blood clots overall with AstraZeneca’s vaccine. But it couldn’t rule out a link between the vaccine and very rare, serious blood clots in the brain, or a clotting disorder called disseminated intravascular coagulation (DIC), particularly in women under 55 years old.

The EMA still recommended that people in this demographic take the shot because the risk of these blood disorders was “extremely small.”

Despite the recommendation, France announced Friday that it would not give people under 55 AstraZeneca’s vaccine.

Ian Douglas, professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine, told Insider that the EMA’s announcement was not worrying, but “reassuring.”

It not only showed that potential side effects were being monitored closely, but that regulators were being upfront with the public, he said.

“For these reports to happen, there needs to be a suspicion of a link. But everytime we hear it, it won’t mean that it has been caused by the vaccine necessarily,” he said.

“It would be worse if all this was being done in secret, and something got out.”

Lots we still don’t know about the rare blood clots

There are lots of details that we don’t yet know about the 25 reported cases of serious clots: 18 in the brain, seven elsewhere in the body, related with DIC.

It’s possible that these people were at increased risk of blood clots anyway. For example, they may have had underlying illnesses linked to clots, including COVID-19, or an inherited blood disorder. Smoking, the combined oral contraceptive pill, and hormone replacement therapy are all common reasons a woman under 55 may have an increased blood-clot risk.

The EMA also said that a greater number of women under 55 may have been immunized with AstraZeneca’s vaccine, due to targeted vaccine campaigns in different EU countries.

The EMA has updated the AstraZeneca vaccine’s leaflet for patients and healthcare professionals to include signs and symptoms of clotting, so people know when to seek help. A severe or worsening headache or blurred vision after immunization requires prompt medical attention, for example, whereas a mild headache doesn’t.

Regulators may well establish more potential links between serious illness and other COVID-19 vaccines over the next few months, and issue more guidance. This shouldn’t cause alarm: it’s simply a sign that the monitoring system works.

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Blood clots are not a typical vaccine side effect, despite questions raised by AstraZeneca’s COVID-19 vaccine

AstraZeneca Vaccine Bottles COVID 19 coronavirus.JPG
AstraZeneca’s COVID-19 vaccine.

  • There’s no evidence that COVID-19 vaccines, or any others, cause blood clots.
  • It’s likely a coincidence that some AstraZeneca vaccine recipients have gotten blood clots.
  • Some countries have stopped using the AstraZeneca vaccine anyway.
  • See more stories on Insider’s business page.

Several European countries have paused their use of the AstraZeneca COVID-19 vaccine due to a few reports of blood clots in those who got the shot.

However, health experts and officials have said there’s no evidence that the vaccine causes clots. It’s more likely coincidental that some vaccine recipients experienced bleeding abnormalities around the time they received their vaccine.

In fact, AstraZeneca reviewed its vaccination records and found there were fewer events of reported blood clots in the vaccinated population than in the general population.

“No vaccines have been shown to cause blood clots,” Daniel Salmon, director of the Institute for Vaccine Safety at Johns Hopkins University, told Insider. He added that he would not be worried about experiencing them as a vaccine side effect, even if he were a person at high risk of blood clots.

Some of the risk factors for blood clots – serious injury or surgery, confinement to bed, pregnancy, and obesity, according to the National Blood Clot Alliance – overlap with the eligibility criteria for COVID-19 vaccines. In many countries, shots are being given first to bedridden residents of long-term care facilities and people with preexisting conditions.

Some countries have stopped using the vaccine, despite WHO recommendations

At least 16 countries have suspended use of the AstraZeneca vaccine since two vaccine recipients – a 60-year-old woman in Denmark and a 49-year-old woman in Austria – died of blood clots or bleeding abnormalities after getting their shots.

The World Health Organization said Friday that countries should continue using the vaccine unless a causal link between the jabs and the clots is proven. Such a link has not been found.

“People die every day. There will be people who are immunized who die of other causes,” said Mariangela Simao, WHO’s assistant director-general, according to the Washington Post.

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