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Covid-19: European countries suspend use of Oxford-AstraZeneca vaccine after reports of blood clots

BMJ 2021; 372 doi: https://doi.org/10.1136/bmj.n699 (Published 11 March 2021) Cite this as: BMJ 2021;372:n699

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Re: Covid-19: European countries suspend use of Oxford-AstraZeneca vaccine after reports of blood clots

Dear Editor

“The EMA’s safety committee is reviewing the issue but said that there was currently no indication that vaccination has caused these conditions, which are not listed as side effects.”

This statement displays a similar lack of urgency to that issued in September 2010 by EMA in respect of the Pandemrix vaccine and the possibility that it was causing narcolepsy in some recipient children.

“The Committee concluded that the available evidence was insufficient to determine whether there is any link between Pandemrix and reports of narcolepsy……”(1)

There can be few individuals who are unaware of the eventual outcome in that situation. A significant number of claimants alleging causation between their narcolepsy / cataplexy with the Pandemrix vaccine were left with life long disabling conditions and have since received compensation in the courts. The UK Vaccine Damage Payment Unit also issued awards being satisfied on the balance of probability, that the vaccine caused narcolepsy.

The fact that the clotting problems reported in association with the Oxford Astra Zeneca vaccine are not listed as side effects does not rule out a possible association and is of little reassurance.

Narcolepsy and cataplexy were not initially listed in the side effects in the Summary of Product characteristics for Pandemrix, something the MHRA should be mindful of when responding to concerns re the possible connection between clotting problems and the Oxford Astra Zeneca vaccine today.

The absence of clotting disorders from the list of recognised side effects in association with the Oxford Astra Zeneca covid vaccine no more evidences the safety of that vaccine today than the absence of narcolepsy from the Pandemrix side effects did back in 2010.

The latest ADR reports published by the MHRA state that 11.5m doses of the Pfizer vaccine and 9.7m doses of the Oxford Astra Zeneca vaccine have been given in the UK between 9th December 2020 and 28th February 2021.

Fourteen cases of deep vein thrombosis have been reported with the Oxford Astra Zeneca vaccine and only eight with the Pfizer brand.

Overall in the category of “vascular disorders” the Oxford vaccine has 1635 reports and 3 fatalities with the Pfizer brand having only 1119 reports and 1 fatality. (2)
Evidently one is more likely to suffer a disorder of this kind with the Oxford vaccine than the Pfizer one.

Mr Philip Bryan vaccine safety lead for the MHRA is quoted as having said that the reports received in respect of clotting problems so far were “not greater than the number that would have occurred naturally in the vaccinated population.”

This dismissive statement resembles that published by the MHRA in February 2011 when they said that four reports of narcolepsy following administration of Pandemrix vaccine in the UK (received after the reports from Finland came to light) were “no more than they expected to see by coincidence after vaccination” (3)

In September 2010, EMA had previously reported on worryingly high numbers of cases of narcolepsy in Pandemrix recipients in several other countries.

“As per 17 September 2010, there are 81 reports from healthcare professionals suggestive of narcolepsy, all collected through spontaneous reporting systems. Of these, 34 reports come from Sweden, 30 from Finland, 10 from France, 6 from Norway and 1 from Portugal. In addition, there are a further 13 consumer reports from Sweden and 2 from Norway” (4)

In as much as the ADR systems employed in Sweden, Norway, Finland, Portugal and France were superior to that used in the UK in the early detection of the scale of the problem with narcolepsy in association with Pandemrix, it might be prudent this time around, for the MHRA, in light of the reports from Norway, Iceland, Austria, Lithuania, Luxembourg, Italy, and Latvia to instigate an immediate investigation to rule out possible under reporting of the clotting problem in the UK?

(1) 23 September 2010 EMA/CHMP/588294/2010 Press Office
European Medicines Agency updates on the review of Pandemrix and reports of narcolepsy

(2) https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-...

(3) MHRA Public Assessment Report, post pandemic safety review February 2011

(4) 23 September 2010 EMA/CHMP/588294/2010 Press Office
European Medicines Agency updates on the review of Pandemrix and reports of narcolepsy

Competing interests: No competing interests

15 March 2021
Wendy E Stephen
Retired nurse
Stonehaven, Scotland