Scientists exploring possible link between Johnson & Johnson, AstraZeneca vaccine blood clot issues

Doctors, scientists and public health experts are turning to Europe for clues, where a similar vaccine made by AstraZeneca — not yet authorized in the U.S. — also has been linked to a number of rare blood clots.

“It’s hard to say if it’s the same problem,” said Dr. Richard Kuhn, Ph.D., a virology expert at Purdue University, “but it does seem the vaccine triggers an antibody response that activates platelets, leading to clots.”

While many experts have hesitated to say for sure if there is a link, Schaffner said there’s a growing consensus in the scientific community after none of these rare clots have been linked to the Pfizer or Moderna vaccines, which use mRNA, a different technology.

“I think we shouldn’t be coy about that any longer,” Schaffner said, adding that it may be time to “accept the fact that these are vaccine-induced but very rare events.”

But experts cautioned that even if there is a link, current evidence suggests the risk of developing a blood clot after getting the Johnson & Johnson vaccine is exceedingly low — lower, in fact, than being struck by lightning.

Responding to a report on one of the six clot cases published in the New England Journal of Medicine, Johnson & Johnson penned a response Friday, insisting a clear link has not yet been established.

“At this time, evidence is insufficient to establish a causal relationship between these events and the [Johnson & Johnson] vaccine,” Janssen scientists said, adding that the vectors used in their vaccine and AstraZeneca’s are “substantially different” and that those differences could lead to “quite different biological effects.” The researchers added that “more evidence is needed” to further clarify the cause of this clotting, combined with low platelet count in those receiving the COVID-19 vaccine.

Next week, the Centers for Disease Control and Prevention’s independent advisory committee will review all evidence and make a recommendation about whether to resume using J&J vaccines.

Different theories

Still with more questions than answers, scientists are exploring different theories about why this type of shot — called a viral vector vaccine — might cause rare clotting problems.

Vaccines work by prompting our immune systems to develop antibodies against a virus, and a prevailing theory is that viral vector vaccines somehow trigger an abnormal immune response, leading to the blood clots.

Scientists in Germany identified a specific antibody in many people who developed clots after receiving the AstraZeneca vaccine — and U.S. researchers subsequently identified the same antibody in individuals who developed similar clots after getting a J&J vaccine. In these subjects, the body’s immune system has formed antibodies that attach to platelets, the specialized blood cells that join together to form clots.

“It’s not the vaccine that’s causing it — it’s the body’s immune response to the vaccine,” said Dr. Alex Spyropoulos, a blood clot specialist and professor at the Feinstein Institutes for Medical Research.

Experts say the condition, cerebral venous sinus thrombosis, or CVST, is exceedingly rare.

The Food and Drug Administration and CDC said that in the six women who experienced a clot, the problem manifested six to 13 days after receiving the shot, a time frame that tracks with an immune response, Spyropoulos said.

It’s still not clear why a vaccine would trigger this cascade of events, but researchers said it mimics another well-documented reaction to heparin, a common blood thinner. For this reason, the CDC and FDA have warned against using heparin to treat anyone recently vaccinated with the Johnson & Johnson vaccine.

Existing evidence from the United States and Europe hints that women may be at greater risk – perhaps in part because women are already more likely than men to develop CVST, based on previous data.

“We have to be careful about the assumptions we make,” Spryopoulos cautioned, “especially given how infrequent these events have been.”

It’s possible similar cases will develop in men, but if the CDC advisory panel concludes that the risk is higher in women, the FDA could move toward a black box warning — a label for drugs and medical devices with potentially serious side effects – on the Johnson & Johnson vaccine for certain women.

Though the abrupt halt to an already authorized vaccine may instill concerns and foment hesitancy around the vaccine, experts said it’s a good sign drugs are being properly vetted for safety.

“I really want to stress to the public that they need to remain confident in our concepts and the times regarding vaccines in general,” said Dr. Jason Goldman, an internal medicine doctor representing the American College of Physicians on the expert panel said, adding that members of the general public should “not to let this sour your decision on getting vaccinated in general.”

“We do have confidence in the process,” Goldman added. “And we will make the right decision regarding public safety.”

Amanda Benarroch, M.D., a psychiatry resident at Mayo Clinic in Rochester, Minnesota, is a contributor to the ABC News Medical Unit. ABC News’ Sasha Pezenik and Sony Salzman contributed to this report.

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Death of NSW woman who suffered blood clotting ‘likely’ linked to AstraZeneca coronavirus vaccine

The TGA says the death of the 48-year-old who developed blood clots after receiving the AstraZeneca shot “is likely to be linked to vaccination”.

The fatal blood clotting suffered by a woman in NSW is “likely” linked to the AstraZeneca COVID-19 vaccine she received, Australia’s medical regulator has announced. 

The revelation came in a statement late on Friday night from the Therapeutic Goods Administration (TGA).

The TGA’s Vaccine Safety Investigation Group (VSIG) met on Friday and concluded the blood clotting in the 48-year-old woman’s arteries and veins, as well as her low platelet count, was “likely to be linked to vaccination”.

She was vaccinated with the AstraZeneca shot on 8 April and admitted to hospital four days later, where she died.

The review of the woman’s death was complicated by her underlying medical conditions, including diabetes, and “some atypical features”, the TGA’s statement said.

It said “anti-PFA antibodies” – which activate platelets, and have been found in almost all other internationally reported blood clot cases – were also absent. 

“Despite the atypical clinical features and the negative antibody test, in the absence of an alternative cause for the clinical syndrome, [VSIG] believed that a causative link to vaccination should be assumed at this time,” the statement said. 

This is the third report of a case of the rare blood clotting disorder linked to the AstraZeneca vaccine in Australia and the first death. The other two cases are being treated in hospital and have been recovering well.

Last Thursday, adults in Australians under the age of 50 were warned off receiving the AstraZeneca shot, with Pfizer becoming the preferred vaccine for that demographic. 

The TGA said the woman who died was vaccinated before authorities made the decision later that day, it said in its Friday statement.

Laboratory tests from the woman are still pending and an autopsy will be conducted next week. 

“Given this is an atypical presentation, should the test results and autopsy provide an alternative causation, VSIG would review their decision,” the TGA said.

TGA chief John Skerritt said this week that blood clotting associated with the AstraZeneca vaccine was so rare that “your chances of winning the lotto are much higher”, with the regulator’s Friday statement saying the three cases in Australia so far equated to a frequency of one in 295,000.

Earlier on Friday, Chief Medical Officer Paul Kelly urged people to continue to get vaccinated, saying the benefits far outweighed any harm.

He said he had read one unpublished overseas study that suggested COVID-19 brought a risk of blood clotting itself.

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Queensland to recalibrate Pfizer COVID-19 vaccine rollout across the state as Torres Strait pauses AstraZeneca program

The COVID-19 vaccination rollout in the Torres Strait Islands has been paused by the local health service, as it works through the implications of changed advice for administering the AstraZeneca vaccine to people under 50.

Queensland Premier Annastacia Palaszczuk said today the rollout would continue in the Torres Strait, located close to COVID-19-stricken Papua New Guinea, as authorities worked to recalibrate the rollout, which would include setting up more Pfizer hubs across the state.

Late on Thursday night, Australian health authorities advised that the Pfizer vaccine should be given to Australians aged under 50, amid concerns of rare blood clots potentially linked to the AstraZeneca vaccination. 

Queensland Chief Health Officer Jeannette Young has encouraged people over 50 to continue coming forward to receive the AstraZeneca vaccine.

“It is important that older people who are not at that increased risk of having those adverse events from the AstraZeneca vaccine continue to come forward and get vaccinated,” Dr Young said.

“We don’t know when we might have an outbreak of COVID-19 — we need to be prepared, so people must come forward and get vaccinated.

Pfizer vaccine hubs will be set up in every Queensland Health hospital and health service across the state, in light of the new storage requirements by the Therapeutic Goods Administration (TGA).

“Originally we were only going to put them in the larger ones, but now we’ll be rolling them out across the whole state — so there will be Pfizer vaccine available across the whole state,” Dr Young said.

She said authorities had recently revised storage advice for Pfizer doses and it could now be stored for two weeks in a normal freezer, rather than a freezer at -70 degrees Celsius, and for five days in a normal fridge.

Premier Annastacia Palaszczuk said the vaccine rollout was “business as usual”.

“We accept the health advice about the continued rollout of AstraZeneca,” she said.

That includes vaccinating people in the Torres Strait Islands, near Papua New Guinea, which is grappling with a major outbreak.

“The continuation of the rollout of the vaccine program in the Torres Strait is absolutely critical,” Ms Palaszczuk said.

“That has been happening because of the high rates in Papua New Guinea … We will absolutely be monitoring the rollout up there, but the rollout will continue in the Torres Strait Islands.”

Tony Brown, executive director of medical services for the Torres and Cape Hospital and Health Services (TCHHS), said the changed recommendations had significant implications for the region, where most of the population was under 50 years old.

Torres Shire Council Mayor Vonda Malone said about 800 of the area’s residents had been vaccinated so far, and the news had caused concern among that group.

“The news certainly rocked confidence around the safety of the vaccine,” she said.

“I’ve been informed by Torres and Cape Hospital and Health Services that this will put a direct pause on the continuation and rollout of the vaccine as far as it continuing throughout the Torres Strait — at this stage, we’re not sure when that will occur.

“With the vaccine, it is something that we have to have to ensure we have that protection because of the close proximity of the Torres Strait with the looming cases in PNG.”

She said: “we’ve just got to ensure that it’s safe and our communities are understanding the possible effects from the vaccine”.

“I was awaiting the rollout for Thursday Island, which wasn’t due until later this month, but at the same time those up in the top western communities were the first to get the vaccine,” she said.

“I believe the Torres and Cape HHS team will be going back to the top western communities as of next week to just continue the monitoring of the first rollout of vaccines, so there will be some follow-up in that respect.

“I’ve called for Torres and Cape [Health Service] to really get some advice out and some reassurance for those who’ve already received the vaccine for how they can best make those assessments and work with their doctors to make sure their health and wellbeing is intact.”

Ms Palaszczuk also said the Commonwealth had agreed to publish more regular data about how many doses were being sent to the states.

“That’s actually going to be quite transparent now, so we’ll have that information coming to us on a much more regular basis, which is great news,” she said.

Authorities said Queensland had now administered vaccines to everyone in the 1a category — including healthcare workers treating COVID-19 patients and quarantine hotel workers — and has moved onto the 1b category, which includes other health workers and frontline workers such as paramedics, police officers and correctional services staff.

Queensland had no locally acquired COVID-19 cases overnight, though one new case was detected in a returned traveller in hotel quarantine.

The state has 63 active cases, with 9,700 tests were carried out on Thursday. 

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Victoria pauses AstraZeneca COVID-19 vaccine rollout for those under 50

The Victorian government is extending its pause on the rollout of the AstraZeneca vaccine to people under 50, amid concerns about potential blood clotting.

Victoria is also asking the federal government to send shipments of the AstraZeneca vaccine to GPs only for the next two weeks, so that more older people can get the jab.

Victoria’s Acting Premier, James Merlino, said the pause would allow for new training for staff to discuss the risks of the vaccine.

He also said it would allow for indemnity issues to be resolved, after reports some doctors were reluctant to offer the AstraZeneca vaccine to under 50s because of legal concerns.

“The implications of the advice we received from ATAGI (the Australian Technical Advisory Group on Immunisation) last week are quite significant and require a recalibration or reset of the Commonwealth’s vaccination program roll-out,” he said.

Mr Merlino said there was information about the AstraZeneca vaccine that needed to be translated into languages other than English, to provide all communities with information about the risks.

“Those things all need to happen so that people can truly make an informed decision as per the ATAGI advice from last week,” he said.

ATAGI, which advises the federal government on immunisation issues, said the advice was based on assessment of the risks and benefits of the vaccine.

The expert panel said the AstraZeneca coronavirus vaccine may be used in adults aged under 50 years where the benefits were likely to outweigh the risks for that individual.

The federal government last week said the Pfizer vaccine would become the preferred vaccine for people under 50.

The advice from ATAGI led to healthcare workers being turned away from vaccination centres in Melbourne last week.

The Victorian health department said health services should continue offering the AstraZeneca vaccine to people over 50, or people who have received their first dose of the vaccine without issues.

Mr Merlino said he had asked the federal government to divert shipments of the AstraZeneca vaccine that were to be sent to state vaccination centres, to community doctors who could then vaccinate more people aged over 70.

“We’ve got enough AstraZeneca to deliver what we need to deliver, GPs are calling out for more,” he said.

“We are ready, willing and able to do more, it’s of course always contingent on supply but this is a common sense way.”

A leading epidemiologist has said delays in the COVID-19 vaccination program in Australia will push back the re-opening of international borders for at least another year or two.
Mary-Louise McLaws, from the University of New South Wales, said at the current rate of vaccination, it would take a couple of years for a majority of Australians to be covered.
She said the vaccine timeline would improve if the Pfizer vaccines could be secured and delivered by September — but that seemed unlikely.

“We may be able to fully vaccinate everybody who wants to be vaccinated — and I have estimated that at 85 per cent of the population — we might be able to open up our borders by May or June next year,” she told ABC Radio Melbourne.

Professor McLaws, who is also a member of the World Health Organization’s advisory panel on COVID-19, said Australia should reconsider the vaccine rollout schedule.

She said we should be vaccinating frontline workers and younger people with the Pfizer vaccine in order to “ringfence” the elderly.

“For those 50 and over, AstraZeneca does give a good level of protection,” she said.

“Once our young have their Pfizer, the elderly are even more protected.

“Really, we need the Pfizer to start with the young ones because they are the ones that place the older people at risk.”

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Australia refuses to buy J&J vaccine due to AstraZeneca similarities, as both firms are scrutinized over blood clots — RT World News

Australia has declined to purchase a vaccine made by Johnson & Johnson, because its mechanism is similar to the one used in AstraZeneca’s jab. Both vaccines are currently being investigated for links to blood clots.

The Johnson & Johnson (J&J) vaccine is “an adenovirus vaccine, the same type of vaccine as the AstraZeneca vaccine,” a spokesperson for Australian Health Minister Greg Hunt said in a statement.

The spokesperson said the government “does not intend to purchase any further adenovirus vaccines at this time.” Hunt himself later confirmed to reporters that the government’s vaccine advisory body will not be recommending the purchase of J&J shots.

Australia’s national broadcaster ABC reported that J&J filed an application for “provisional registration” with the country’s drug regulator, the Therapeutic Goods Administration (TGA). Apart from the AstraZeneca/Oxford vaccine, only the Pfizer/BioNTech vaccine is currently approved for use in Australia.

The news came as TGA reported the country’s second case of rare blood clots believed to be linked to the AstraZeneca shot. The first case involved a 45-year-old man from Melbourne who was vaccinated last month. Around 700,000 doses of the vaccine in question had been administered in Australia as of Tuesday, according to local media.

Also on
Ireland’s vaccine advisory body recommends halting use of AstraZeneca’s Covid-19 vaccine in under-60s over blood clot risk

A British-Swedish company, AstraZeneca came under scrutiny in several countries around the world when some people began suffering from blood clots after being immunized. Earlier, the European Medicines Agency (EMA), EU’s top drug regulator, concluded that the “unusual” blood clots are a “very rare” side effect of AstraZeneca’s vaccine, which is now officially known as Vaxzevria.

The EMA also argued that the benefits of getting the AstraZeneca vaccine still “outweigh” the possible risks from it.

On Friday, the EMA launched an inquiry into the J&J vaccine as well, following reports that four people who received it had suffered from blood clots, and one of them died. In a statement to the media, J&J said that “no clear causal relationship” had been established between the dangerous condition and the shot.

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Another rare blood clot case in Australia is ‘likely’ linked to the AstraZeneca vaccine

The Vaccine Safety Investigation Group, which advises the Therapeutic Goods Administration, announced the “likely” link between the blood clots and the vaccine on Tuesday morning.

An Australian woman in her 40s is believed to have developed blood clots after receiving the AstraZeneca vaccine. 

The Vaccine Safety Investigation Group, which advises the Therapeutic Goods Administration, announced the “likely” link between the blood clots and the vaccine on Tuesday morning. 

It is the second Australian report of a case of rare blood clots after a 44-year-old Melbourne man developed the condition following his AstraZeneca vaccination last month.

The case occurred in a woman in her 40s who was vaccinated in Western Australia,” a statement read. 

“The person remains in hospital receiving treatment and is in a stable condition.”

Expert advisers to the TGA have concluded the latest incident is similar to blood clotting cases seen in Europe and the United Kingdom.

There have been about 700,000 doses of AstraZeneca vaccines administered in Australia, so the two cases equate to a frequency of one in every 350,000 people.

The United Kingdom has found the overall risk of these rare blood clots was approximately one in 250,000 people who received the vaccine.

People who have received the AstraZeneca vaccine have been asked to look out for symptoms including severe or persistent headaches, blurred vision, shortness of breath, chest pain, leg swelling or abdominal pain.

Symptoms also include unusual skin bruising and pinpoint round spots beyond the site of injection.

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Acting Chief Medical Officer addresses AstraZeneca vaccine concerns

Acting Chief Medical Officer Michael Kidd says a rare blood-clotting disorder in a Melbourne man who received the AstraZeneca vaccine is under investigation by the Therapeutic Goods Administration.

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Victoria’s Acting Premier James Merlino explains fortnight freeze on AstraZeneca rollout for those under 50

Mr Merlino says the Commonwealth must provide translated materials and more clarity on indemnity issues before Victoria can resume vaccinating people under 50 with the AstraZeneca jab.

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Coronavirus: Canberrans under 50 still able to get AstraZeneca vaccine | The Canberra Times

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Canberrans under 50 will still be able to receive the AstraZeneca vaccine, but would need to fill out a consent form before they’re administered the dose, the territory’s Health Minister has said. Rachel Stephen-Smith said consent forms had been updated in the wake of new advice from Australia’s vaccine advisory group surrounding the AstraZeneca jab. The group recommended last Thursday the AstraZeneca vaccine be limited to those over 50, due to a potential risk of a rare blood-clotting condition developing. Those under 50 have been recommended they receive the Pfizer vaccine instead, with the move significantly hampering Australia’s vaccine rollout. Ms Stephen-Smith said despite the advice, those under 50 eligible to get the vaccine as part of phase 1b could still get the AstraZeneca if Pfizer was not as readily available. READ MORE: “It’s important to note [the recommendation] is not a complete ban on under 50s getting the AstraZeneca,” Ms Stephen-Smith told ABC Radio Canberra on Monday. “It’s a question of having a conversation with your GP if you have an underlying health condition, and if you can’t get access to the Pfizer vaccine, whether the benefit [of getting AstraZeneca] outweighs the risk.” It comes as the federal government abandoned its target to have vaccinated all eligible Australians by the end of the year. Prime Minister Scott Morrison said issues with the vaccine rollout had meant the 2021 target was not possible. “While we would like to see these doses completed before the end of the year, it is not possible to set such targets given the many uncertainties involved,” Mr Morrison wrote on Facebook. Australia-based company CSL was in the process of ramping up production of a locally made AstraZeneca vaccine, but the new advice has meant more doses of Pfizer will be required. The Pfizer vaccine is only available from overseas. Ms Stephen-Smith said despite the delay in the vaccine rollout, the federal government were being realistic about the situation. “There’s a lot of uncertainty at the moment, and it’s important for people to remember that the approach Australia has taken is to be very cautious around the vaccine program in terms of health advice,” she said. “The primary goal is to maintain community confidence in the vaccine, and that was why we acted on the TGAS’s and [vaccine advisory group’s] advice in relation to the AstraZeneca vaccine.” Following the new advice handed down on Thursday night in relation to the AstraZeneca vaccine, Canberrans who had been invited to schedule a vaccine appointment had been urged to wait until Monday to call up and make a time. Health officials scrambled on Friday to reschedule those set to get the AstraZeneca vaccine to get a Pfizer one instead. However, Ms Stephen-Smith said those set to get the vaccine were able to book an appointment. So far, more than 1 million doses of the vaccine have been administered to Australians as part of phases 1a and 1b or the rollout. Our journalists work hard to provide local, up-to-date news to the community. This is how you can continue to access our trusted content:


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Coronavirus latest: Australia abandons vaccination schedule over AstraZeneca chaos

Japan’s total confirmed Covid-19 cases topped 500,000 at the weekend, official data showed. Infections have spread rapidly, with cases increasing from 400,000 in early February. Vaccines remain widely unavailable in the country, which is now grappling with the emergence of more contagious variants.

On May 19, for the first time since the pandemic struck, the world-famous Shakespeare’s Globe theatre on London’s South Bank, hopes to open its doors to audiences. A Midsummer Night’s Dream kicks off a summer season of live drama and the eerie stillness that currently hangs over this beautiful replica Elizabethan playhouse will be broken by the sound of audience members. 

Marchers took to the streets in Bucharest to protest against restrictive measures to fight the spread of Covid-19, as Romania recorded more than 4,000 new cases and 139 deaths on Saturday. About 1,000 people converged on Victory Square and University Square, opposing curfews and business closures

Thailand on Sunday reported 967 new coronavirus cases, a single-day record, as the south-east Asian country deals with a third wave of infections. The new cases took Thailand’s total number of infections to 32,625, with deaths remaining at 97, according to the kingdom’s department of disease control.

A laboratory technician uses a pipette at the Valneva laboratories in Vienna
A laboratory technician uses a pipette at the Valneva laboratories in Vienna © Akos Stiller/Bloomberg

Valneva, the French Covid-19 vaccine maker backed by the UK government, has filed for a US initial public offering seeking to take advantage of investor appetite for biotechnology during the pandemic. The Paris-listed company, with a market cap of more than €1bn, filed to raise $100m in American Depositary Shares.

London-listed Novacyt shares tumbled nearly 40 per cent to 421.4p before the weekend after it issued a warning on revenues when the UK Department of Health and Social Care did not extend its supply contract for Covid-19 tests. Novacyt said it has taken legal advice, adding “it has strong grounds to assert its contractual rights”.

Vaccitech, the start-up that owns the technology behind the AstraZeneca vaccine, has warned that concerns about the rare blood clotting side-effect could hit royalties and affect the reputation of products in its pipeline. The Oxford university spinout on Friday published its prospectus for an initial public offering of at least $100m on Nasdaq. 

China’s Center for Disease Control is thinking about mixing vaccines and varying the sequence of doses to boost efficacy. Gao Fu, the agency’s head, said health authorities were “considering how to solve the problem that the efficacy of existing vaccines is not high”, according to local media.

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