An inquest into the death of a young man who died five days after receiving a Covid-19 vaccine has heard evidence from two senior safety officers at Johnson & Johnson who have been unable to provide a figure as to how many people have died worldwide as a result of receiving its jab.
Cork City Coroner's Court heard that Roy Butler, of O'Reilly Road in Waterford, died on 17 August 2021, five days after he got the Janssen jab.
Medics at Cork University Hospital (CUH) told the inquest yesterday that Roy, 23, suffered a "catastrophic intercranial bleed" having complained of feeling groggy and unwell prior to going into convulsions at his home.
He was taken by ambulance to Waterford University Hospital on 16 August 2021 and then onwards to CUH where he died the following day.
His parents, Angela and Martin, and his brother Aaron, yesterday said in evidence that Roy was rarely sick.
A talented footballer he played for Villa United in Waterford and trained several times a week. His father, Martin, said that Roy was "captain of every team he played for".
Angela said that she was left with "precious memories" of Roy who was born seven years after his older brother Aaron.
All three family members said they just want the truth as to what happened to a much loved son and brother.
On day two of the inquest, the court heard evidence from Johnson & Johnson company director and vaccine safety officer Dr Luis Humberto Anaya-Velarde.
The inquest also briefly heard evidence from Dr Logesvaran Yogendran, Vice President of Global Strategy and Risk Management at the company.
Dr Anaya-Velarde offered his condolences to the Butler family at the tragic loss of their son. He indicated that he was a director at Johnson & Johnson. However, he was unable to say how many other people hold that title.
He said that the company had carried out a study to see if there was any link between its vaccine and intercranial bleeds.
He said that having evaluated reported cases there was "insufficient evidence" to make a link between intercranial brain bleeds and its vaccine.
Ciara Davin, BL for the Butler family, asked Dr Anaya-Velarde if he was concerned about the evidence which was before the court yesterday.
She said that this involved the deterioration and subsequent death of a young and healthy man just days after he received the Johnson & Johnson vaccine. Dr Anaya-Velarde accepted that the case had caused concern.
However, he insisted that there was no link between the death of Roy Butler and the vaccine he received from the pharmaceutical company.
He also stated that a single case does not provide sufficient evidence to confirm an association.
"A single case may be tragic, it may be compelling - we take every case seriously, particularly this case where a healthy man of a young age dies, but from a scientific point of view, a single case is not sufficient for proof."
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Both Dr Anaya-Velarde and Dr Yogendran were asked if they could provide information as to how many people have lost their lives worldwide as a result of getting the Johnson & Johnson vaccine. Both men stated that they did not have the relevant data.
Dr Yogendran said in evidence that deaths had to be reported by an identified person with medical qualifications. The dead person also needed to be identified to the company. This led Ms Davin to suggest that the number could be even higher than recorded by the pharma company.
Dr Anaya-Velarde said that they had received 60 reports of cases of intercranial bleeds worldwide relating to persons who had received their vaccine. Roy Butler was one of the impacted people included in this number.
Dr Anaya-Velarde said that a review of its data found that two people between the age of 18 and 50 had died globally after having a spontaneous intercranial haemorrhage like the one experienced by Mr Butler, within a week of having the vaccine.
He indicated that as of the end of February of this year 281,500 Johnson & Johnson one jab doses were distributed in Ireland with 241,743 administered. Dr Anaya-Velarde could not be drawn on how many vaccines had been wasted in this or other countries.
Dr Anaya-Veldarde said that they first heard of the passing of Mr Butler’s death on social media. He described the symptoms Roy Butler described to friends in the days after he got the vaccine as examples of "reactogenicity" - which he stated involved the symptoms which persons generally experience after having a vaccine.
These include headaches, possible jaw pain and a feeling of unwellness. He said such reactions were "very common" post vaccine.
He accepted that he could not rule out the possibility that the intercranial haemorrhage was caused by the vaccine. However, he stressed that in his medical opinion the receiving of the vaccine and the death of Mr Butler "were not related".
Ms Davin, representing the family, said that it was very clearly a case of "two plus two is four" and that the death of the young and healthy man was caused by the vaccine.
Dr Anaya-Velarde added that their study on intercranial haemorrhage and the vaccine was submitted to the European Medicines Agency which agreed with their finding that there was "insufficient evidence" to establish a causal link between the vaccine and such adverse medical events.
The inquest will continue tomorrow with evidence from Assistant State Pathologist Dr Margaret Bolster, who carried out a post-mortem examination on the deceased.
