Roy Butler inquest hears Janssen 'had no idea' of reported number of fatalities after covid jab
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Senior doctors in charge of safety for Janssen had “no idea” how many people were reported to have died following the administration of its covid vaccine.
The medics were giving evidence at the inquest into the death of Waterford soccer player Roy Butler, aged 23, who died of a brain bleed five days after receiving the Johnson & Johnson covid vaccine on August 12, 2021.
Louis Humberto Anaya-Velarde, the medical safety officer for Janssen’s covid-19 vaccine agreed under cross examination from Ciara Davin, BL, barrister for Mr Butler’s family, that Mr Butler’s death was a concern for the company. But he said that in his medical opinion, Mr Butler’s death was not linked to the vaccine.
Janssen “came to the conclusion there was insufficient evidence” to link spontaneous haemorrhage to the vaccine, he said.
The European Medicines Agency (EMA) agreed there was insufficient evidence to link these cerebral haemorrhages, or brain bleeds, to the vaccine, he said.
Some 400 cases were reported internationally of people suffering haemorrhagic conditions — similar to Mr Butler’s brain bleed — after receiving the Johnson & Johnson vaccine, but the number of deaths among this global cohort was not provided.
Some 59 people had suffered similar brain bleeds after receiving the vaccine within 10 days.
Two of these — both women living in the US — died.
A 45-year-old woman died in hospital from a brain bleed after suffering from an acute headache and another woman had a stroke the day she received the vaccine.
Ms Davin said considering Mr Butler complained of feeling unwell from the time he got the vaccine, with headaches, grogginess, sweats and pain before his condition worsened and he suffered a catastrophic blain bleed, surely “2 + 2 = 4” and he suffered a rare side effect to the vaccine and died.
However, Dr Anaya-Velarde disagreed.
“A single case is not enough usually to establish causal relationship,” he said.
Dr Anaya-Velarde told Cork Coroner’s Court that two to six safety officers had worked on the covid vaccine, with a pool of up to 30 scientists working on it. Dr Anaya-Velarde said that this was within the prescribed safety regulations.
Ms Davin remarked that only two safety officers were effectively overseeing the vaccine’s safety despite more than 660m doses of it being distributed worldwide (660,062,540 up to February 20224), although not all distributed doses were administered to patients.
Some 281,500 doses were distributed in Ireland up to the end of February with 241,743 primary doses administered in that time frame.
“How many people died because of the Johnson & Johnson vaccine?” Ms Davin asked.
Dr Anaya-Velarde replied: “I can’t give a figure."
The Johnson & Johnson vaccine was an adenovirus vaccine — a different type of vaccine from the more commonly administered MRNA covid vaccines.
The Johnson & Johnson vaccine was given an emergency licence “in the interests of public health” for use during the covid pandemic, meaning it did not have to undergo as rigorous testing as usual prior to coming to market.
But research and clinical trials had been completed to their end point, Dr Anaya-Velarde said. And the company committed to providing longer follow up on patients.
Approximately 40,000 patients were in the clinical trials and half of these — some 20,000 actually received the vaccine.
However, concerns about blood clotting was raised early on in the vaccine’s use.
The Centre for Disease Control and Prevention (CDC) in the US advised using the MRNA vaccine instead of the adeno vaccine due to concerns over some blood clotting disorders, the court heard.
And the HSE had recommended MRNA vaccines over the Johnson&Johnson vaccine primarily due to the risk of clotting disorders, Ms Davin said.
The company has now withdrawn it “for commercial reasons” from the European market and it is no longer administered in the US market either.
Logesvaran Yogendran, Vice President Global Safety Strategy and Risk Management with Janssen, said that he had “no idea” how many deaths had been reported as a result of the vaccine.
The company only became aware of Mr Butler’s death through social media reports.
Mr Butler, an avid footballer, who had played with Waterford FC, was described in Cork Coroner’s Court as fit and healthy before he received one shot of the Johnson & Johnson covid vaccine on August 12, 2021. He repeatedly told friends and family that he felt “shook” and unwell after getting the vaccine. Four days later he suffered a catastrophic brain bleed and he died the following day, August 17, 2021.
“He was perfect, he got this injection, then he wasn’t perfect,”his mother Angela Butler told the court on Tuesday.
Roy’s brother, Aaron Butler said that his only sibling "had it all" before his death.
"He was the total package — looks, funny and was healthy.
“I still believe Roy went downhill after the vaccine.
“I just want truth of what happened.”
The inquest in front of Coroner Philip Comyn in Cork Coroner’s Court continues on Thursday.