Canada has second case of rare blood clots after AstraZeneca vaccine

The Telegraph

Revealed: Why Britain’s regulator missed the link between the AstraZeneca jab and rare blood clots

Early in March, some four weeks after the first AstraZeneca vaccine was administered in Europe, little signals – like flares – started to go off all over the continent. First in Austria, on March 7, and days later in Denmark, Norway and Iceland, European healthcare regulators began to report small numbers of blood clots and deaths among people who had received the vaccination. Then on 15 March, Germany announced seven cases and three deaths and, like others, suspended use of the vaccine. The AstraZeneca jab was associated with a “striking accumulation of a special form of very rare cerebral vein thrombosis in connection with a deficiency of blood platelets and bleeding,” said the Paul-Ehrlich Institut, Germany’s renowned medicines regulator. But in Britain, where the AstraZeneca rollout had started a full month earlier and 11 million doses had already been administered, there was nothing. On March 11, the UK’s newly sovereign Medicines and Healthcare products Regulatory Agency (MHRA) put out a statement saying it could see no evidence of a problem. “We continually monitor the safety of vaccines to ensure that the benefits outweigh any potential risks,” said Dr Phil Bryan, the MHRA’s Vaccines Safety Lead. “Reports of blood clots received so far are not greater than the number that would have occurred naturally in the vaccinated population. “The safety of the public will always come first.” But the MHRA was, it appears, wrong. An investigation by The Telegraph has established that signals had been firing unnoticed in the UK’s Yellow Card database for at least a month, perhaps longer. In January, a patient suffered a brain clot following their first dose of the AstraZeneca jab, The Telegraph has confirmed. Then in early February, two similar cases followed, including a death and a life-changing CVST clot in a young adult. All had low platelets and all were reported into the Yellow Card system. On Friday, the MHRA told The Telegraph: “We are aware of thromboembolic events that occurred in January, however, our first report was received in the week commencing 8 February…. we cannot disclose information about individual cases to protect patient and reporter confidentiality.” There remains no doubt the benefit of taking the AstraZeneca jab outweighs the risk now associated with the vaccine. This is the judgment not just of the MHRA but also the European Medicines Agency (EMA) and the World Health Organization (WHO). The risk of developing cerebral venous sinus thrombosis (CVST) in combination with a low platelet count or thrombocytopenia after getting the vaccine is vanishingly small, and estimated to occur in just 1-in-100,000 cases, perhaps less. This, says Sir David Spiegelhalter, Britain’s foremost expert in risk, is about the same chance of dying from a general anaesthetic, or of correctly guessing the last five digits of a stranger’s mobile phone number. With Covid itself, the risk of CVST alone is estimated to be eight to 10 times higher, according to an analysis of US data published last week. Nonetheless, the MHRA faces serious questions as to why it did not detect the signals sooner. The issue is not that it has been left looking flatfooted or even that earlier detection would necessarily have altered its advice, but that the delay left it unable to shape international policy and confidence in what remains a vital vaccine in the fight against Covid 19 for the world. Prof Stephan Lewandowsky, a psychologist at the University of Bristol studying the rollout of Covid-19 vaccines, told the Financial Times on Friday: “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.” So why was the MHRA slower than others to spot the early signals? The Telegraph’s investigation suggests the issue relates to the algorithms it had in place to interrogate the UK data and its limited access to early emerging data from Europe. Observers say this should be seen in the context of the “operational and logistical challenges” the regulator faced in the run-up to the UK formally leaving the EMA on December 31, and the MHRA formally becoming a sovereign regulator for the first time on January 1. The key to fast-moving pharmacovigilance is to efficiently sift the wheat from the chaff. When a new drug launches thousands of adverse reactions start pouring into regulatory reporting systems from both patients and clinicians. From January 4 to March 14, a total of 532 “blood system events”, including 20 deaths, came through the UK’s Yellow Card system relating to the AstraZeneca jab, according to an analysis of published MHRA data by Dr Hamid Merchant, a pharmaceutical scientist at the University of…