‘Slow’ UK response to AstraZeneca side-effects alarms experts

Nine days after having her first shot of the Oxford/AstraZeneca Covid-19 vaccine in mid-March, Julia began to have a headache. Though it persisted for several days, she put the pain down to a migraine.

Then on March 29, her husband Peter, a retired doctor, came home and found her in a coma. Doctors at Harrogate and District Hospital determined she had a “catastrophic brain injury” resulting from cerebral venous sinus thrombosis (CVST) and a very low platelet count — the rare blood condition linked to the AstraZeneca jab. Two days later Julia was dead at the age of 59.

“We were coming to the end of Covid, the prospect of having had the vaccination, of seeing our grandchildren, looking forward to a life together, and that’s what we should have had, a life together,” said Peter, whose surname has been withheld to protect his privacy.

He blames himself for not having picked up the on the signs of a brain haemorrhage earlier but also the government for not being sufficiently open with the public about the emerging evidence of potentially fatal reactions to the AstraZeneca vaccine.

By the time Julia started suffering headaches, the UK Medicines and Healthcare products Regulatory Agency (MHRA) was well into an investigation of a link between the AstraZeneca jab and the rare blood disorder that killed her.

Haematologists across the UK, where the jab is the mainstay of the vaccination programme, had been alerted to the risks. But it would take another couple of weeks for the health authorities to abruptly change their guidance, advising that adults under 30 should be offered an alternative to the AstraZeneca jab.

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The possible link was first recognised by doctors in Norway early in March and subsequently by peers in Germany and the Netherlands. By March 15 eight European countries had suspended their AstraZeneca inoculation programmes. Three days later the MHRA put out a statement downplaying suggestions that the AstraZeneca jab had caused the blood clotting disorder.

“This has been reported in less than one in a million people vaccinated so far in the UK, and can also occur naturally,” the regulator said then. “A causal association with the vaccine has not been established.”

Most European countries have since resumed using the vaccine but have put in place much stricter guidance, limiting its use to the over-55s, over-60s or in some cases people over 65. Denmark this week became the first country in Europe to end the use of the vaccine.

Chart of ICU admissions prevented per blood clot caused, by age and exposure risk showing that the potential benefits of the AstraZeneca vaccine outweigh the harm in all but one scenario - under 30s in a low exposure environment. Based on research carried out by the Winton Centre for Risk and Evidence Communication

The UK decision to change the guidance for under-30s only was driven by the science that showed they were the only age group where the risks from the vaccine might exceed the chances of developing serious Covid-19.

The cumulative number of reports received by MHRA of blood clots with low platelet counts in recipients of the AstraZeneca jab rose from five by March 14 to 30 by March 21 and 79 by March 31, including 19 deaths. The latest figures to April 5, released on Thursday evening, show the number of clotting cases at 100 with 22 deaths, out of 20.6m people who have had the AstraZeneca jab.

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The MHRA refused a request by the Financial Times to provide a timeline of when the adverse reactions occurred, rather than when they were reported, on grounds of patient confidentiality. “We cannot release details related to individual reports (such as individual reaction dates), as these risk identification (or misidentification) of individuals,” it said.

Because the MHRA is generally held in very high regard in UK medical circles — and praised for its speed in reviewing new Covid-19 therapies and vaccines for clinical trials and emergency use in the pandemic — experts have been unwilling publicly to criticise its response to AstraZeneca side-effects.

But several scientists have told the FT that the regulator was too slow both to pick up on the reports of the adverse reaction and communicate its findings to the medical profession, the public and the media.

Prof Stephan Lewandowsky, a psychologist at the University of Bristol studying the rollout of Covid-19 vaccines, said other European countries had taken a far more cautious attitude to immunisation than the UK throughout the pandemic. This had led to greater vigilance in the search for side-effects and faster communication of risks to the public.

“The MHRA was slow in responding to the emergence of a specific constellation of symptoms associated with the AstraZeneca vaccine and slow to communicate what they were finding — and I am not the only one who thinks so,” he said.

Gillies O’Bryan-Tear of the UK Faculty of Pharmaceutical Medicine agreed the regulator might have acted a bit sooner. “I am a great fan of the MHRA. Their response [to vaccine side-effects] has been measured but, yes, a bit late. Deciding how and when to communicate this sort of information is very tricky indeed.”

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The days before the abrupt change in guidance became an information vacuum. The MHRA had issued its regular weekly bulletin on adverse reactions to vaccines on April 1 — the day before the four-day UK Easter holiday in which it reported 30 more cases of the blood disorder but provided no further analysis.

The new guidance was issued on April 7 after a the MHRA held a joint news conference with the Joint Committee on Vaccination and Immunisation. Haematologists and other experts associated with the two government bodies had been discouraged from speaking to the media ahead of the decision.

“In a crisis you want the best experts out there and speaking to journalists, not to be silenced,” said Fiona Fox, chief executive of London’s Science Media Centre. “I don’t object to the MHRA taking more time to assess the evidence but I really worry about them leaving a vacuum that could be filled with misinformation.”

Peter believes that his wife, who was once an AstraZeneca drug rep, could have been saved through specialist treatment if the MHRA and government had been quicker to alert the public to possible side-effects.

“There was an opportunity, a three day window, when something could have been done,” said Peter. But despite his personal tragedy, he said people should still have the AstraZeneca jab, as long as they have as much information as possible about the risks and benefits.


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