Number of people that died from Janssen vaccine is unknown - inquest hears

Janssen executives in the witness box at Roy Butler inquest

Medical safety personnel with responsibility for the Janssen covid vaccine were unable to say how many people died from the vaccine, an inquest heard today.

Two doctors - one a Director at the pharmaceutical company - gave evidence at the inquest into the death of footballer Roy Butler (23) from Waterford, who died on August 17 2021, five days after receiving the Janssen covid vaccine.

The inquest heard that the vaccine manufacturer became aware of Roy Butler’s death via social media.

It was revealed that Janssen had a group of ‘between two and six people’ working on the safety monitoring aspect of the vaccine, which was administered to 660 million people worldwide.

Safety experts from the pharmaceutical company admitted that it was ‘impossible to know’ how many people died worldwide after receiving the vaccine because the safety data collected is based on a voluntary reporting system according to industry standards.

Dr Luis Humberto Anaya Velarde, Medical Safety Director over Johnson and Johnson’s Janssen vaccine, gave evidence of the clinical trial process for the company’s covid 19 vaccine and associated adverse effects that emerged after the vaccine had been released for public use.

Counsel for the Butler family Ciara Davin BL asked Dr Anaya if he knew how many people in total had died from the Janssen vaccine worldwide.

Dr Anaya said he did not know.

“I cannot give you that answer. It is impossible to know,” he said.

Ms Davin put the same question to Dr Logesvaran Yogendran, Janssen’s Vice-President of Medical Safety Strategy.

Dr Yogendran said he did not know the figure.

“The number of fatal outcomes in totality is not something we would be looking for,” Dr Yogendran said.

“Is that not something you are interested in?” Ms Davin asked.

“We review all the data that is there, the information is not available as a totality,” Dr Yogendran said.

The inquest heard that the vaccine was released under conditional marketing approval by the EMA in line with a ‘pandemic’ situation, Dr Anaya said.

“It is done for public health reasons,” Dr Anaya told Cork City Coroner Philip Comyn.

Dr Anaya explained that the Janssen covid vaccine met all the requirements under conditional marketing use by the EMA.

However, Dr Anaya admitted that the pharmaceutical company had no long-term safety data.

“The research for clinical trials had been completed, we omitted to provide a longer follow up on these patients,” Dr Anaya said.

Roy Butler suffered a catastrophic brain hemorrhage four days after he received the Janssen shot at a pharmacy on August 12 2021.

On the second day of the inquest in Cork, Dr Anaya gave details of a safety report completed by Janssen that found a total of two women had died in similar circumstances to Roy Butler. The information was supplied in answer to the Coroner’s request for specific safety data from the pharmaceutical company.

Both women died in the US - one suffered a massive stroke on the day she received the vaccine and the second, a 45 year old woman, died in hospital from a brain bleed after attending with symptoms of a severe headache.

The inquest heard these cases resulted from rigidly defined and specific search methodologies applied by Janssen, including the criteria of “valid cases only.”

Valid cases, according to the safety report supplied by Janssen to the Coroner, means only cases with ‘a defined patient, drug, event and reporter’ are included. However, the entire safety surveillance system is based on voluntary reports, the inquest heard.

The first report supplied to the Coroner was based on an age range 18 years old to fifty years with no background medical conditions, within seven days of receiving the Janssen shot.

However, a second report supplied to the Coroner with slightly expanded search criteria revealed a figure of 60 people that died in similar circumstances to Roy Butler. This figure included Roy himself. In this search, the age range of under 50 was removed and the time frame expanded from seven to ten days post vaccine.

The company conducted another study over a period of less than two years that resulted in 400 reports of intracerebral hemorrhage, the inquest heard.

Under questioning from Counsel for the family, Ms Davin BL, Dr Anaya confirmed that many cases of deaths post vaccine are not included in safety reports ‘because they are not relevant.’

“Not relevant according to you?” Ms Davin asked.

“No, they are not relevant under the clinical detail,” Dr Anaya said. Assessments conducted under specific clinical detail are standard practice, the inquest heard.

“You heard about the case of Roy Butler on social media, it wasn’t reported to you, so do you accept that there must be other cases?” Ms Davin said.

“It is a voluntary basis surveillance system, that is the industry standard,” Dr Anaya said.

The fatality figures included on published safety reports are researched and compiled by medically qualified personnel who are either direct employees of Johnson and Johnson or contracted to the company, the inquest heard.

A total of 241, 743 doses of the Janssen vaccine were administered here in Ireland, out of 281,500 distributed.

Dr Anaya said there was no evidence to lead the vaccine safety team to conclude that the catastrophic brain bleed that Roy suffered was triggered by the vaccine.

Ms Davin asked if he agreed there was a temporal proximity between the vaccine and Roy’s death.

“Yes that is not disputed,” Dr Anaya said.

Ms Davin asked if he agreed that Roy died as a result of a brain hemorrhage.

“Yes he did,” the doctor replied.

Ms Davin pointed out that the post-mortem could find no clear cause for the brain hemorrhage.

“Isn’t that highly unusual?” she asked.  

“Yes,” the doctor replied.

Ms Davin pointed out that the inquest had heard evidence that there had been complaints of intracerebral hemorrhage, blood and vascular disorders following administration of the Janssen vaccine.

“On the facts of this case isn't it probable that Roy suffered maybe a rare or extremely rare reaction to the vaccine?” Ms Davin asked.

The witness said that a single case is not sufficient evidence, that there needs to be an evaluation.

“One person, like Roy Butler, isn’t that possible?” Ms Davin said.

“Yes,” Dr Anaya replied.

“Yes. Thank you,” Ms Davin said.

“You just need to look at the facts, the temporal proximity… what Roy himself told us, that needs to be taken seriously by your company,” Ms Davin said.

Roy Butler’s parents Angela and Martin, and his brother Aaron, told the inquest yesterday that they want the truth of what happened to Roy.

The inquest continues tomorrow with autopsy evidence to be heard from Assistant State Pathologist Dr Margaret Bolster.

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