Both the European Medicines Agency (EMA) safety committee and the WHO advisory committee on vaccine safety were due to meet on 16 March to discuss reports of blood clots in patients who have received the Oxford/AstraZeneca vaccine.
Several EU countries have paused vaccinations with the Oxford/AstraZeneca jab in recent days, despite a statement from the EMA that ‘benefits of the AstraZeneca vaccine in preventing COVID-19, with its associated risk of hospitalisation and death, outweigh the risks of side effects’.
AstraZeneca has said that ‘careful review of all available safety data of more than 17m people vaccinated in the EU and UK’ with its vaccine ‘has shown no evidence of an increased risk of pulmonary embolism, deep vein thrombosis (DVT) or thrombocytopenia, in any defined age group, gender, batch or in any particular country’.
Both the BMA and RCGP have spoken out in support of the vaccine – and NHS England medical director for primary care Dr Nikki Kanani said on Twitter that it was ‘safe and effective’. The RCGP has said patients have continued to accept invitations to vaccination clinics – although at least one GP reported ‘cancellations and gaps’ in clinics ‘due to the unproven reports’.
— Dr Nikita Kanani (@NikkiKF) March 15, 2021
A statement from AstraZeneca said: ‘So far across the EU and UK, there have been 15 events of DVT and 22 events of pulmonary embolism reported among those given the vaccine, based on the number of cases the company has received as of 8 March. This is much lower than would be expected to occur naturally in a general population of this size and is similar across other licensed COVID-19 vaccines.
‘The monthly safety report will be made public on the European Medicines Agency website in the following week, in line with exceptional transparency measures for COVID-19.’
It added that clinical trials for the vaccine found that thrombotic events ‘were lower in the vaccinated group’.
COVID-19 vaccine campaign
BMA public health medicine committee co-chair Dr Penelope Toff said: ‘The vaccination programme here in the UK has been incredibly successful – with over 11m doses of the Oxford/AstraZeneca vaccinations given and almost 25m COVID-19 vaccines in total – and is greatly contributing to protecting the health of the public and ensuring that life returns to normal as soon as possible.
‘It’s important to note the views of our own regulator, the Medicines and Healthcare products Regulatory Agency, the WHO and the EMA, who are still advocating that the Oxford/AstraZeneca vaccine is safe for use.
‘Given the enormous lifesaving benefits of the vaccine we should be continuing to encourage people to get both first and second doses of the AstraZeneca and Pfizer jab. It is vital to retain perspective and acknowledge the dreadful death toll from this virus as well as the lives that have and will continue to be saved as a result of the vaccination programme.’
RCGP chair Professor Martin Marshall said: ‘Over 24m in the UK have now been vaccinated, many of whom have successfully received the AstraZeneca vaccine with no side effects. Where patients have reported side effects such as flu-like symptoms and muscle aches, these have been minor and transient.
‘The public should be reassured that whilst these new vaccines were developed and approved at speed, no corners were cut and patient safety has been, and remains, paramount.
‘The MHRA has been unable to confirm that the reports of blood clots were caused by the vaccine and is advising people to get their vaccine when asked to do so.
‘The message we are hearing back from our GP members is that patients are following this advice, and GPs and our teams are continuing with the vaccination effort to ensure that as many people as possible are protected, as quickly as possible.’