Major Regulators Urge People To Keep Taking AstraZeneca Jab After Finding No Proven Link To Blood Clots
The MHRA urged people to take the jab when offered an appointment
The UK and EU medical regulators said the benefits of the Oxford-AstraZeneca Covid-19 vaccine "far outweigh the risks" and concluded there was no evidence to suggest the jab could cause blood clots.
The statements came after several European countries halted the use of the this version of the jab while they investigated whether there was a link with the small number of people who had developed issues after receiving it.
The European Medicines Agency said this was the wrong course of action and the jab was “safe and effective” and taking outweighed any potential risks.
The UK regulator the Medicines and Healthcare products Regulatory Agency (MHRA) said it had conducted its own review in the safety of the jab after five men aged between 19 to 59 had developed a "very rare and specific" type of blood clot some time after receiving their vaccine, but said the evidence "does not suggest" they were related. One of the men is known to have died.
Dr June Raine, chief executive of the MHRA, said the condition can "occur naturally" in people who have not been vaccinated and those suffering from the virus.
"Given the extremely rare rate of occurrence of these... events among the 11 million people vaccinated, and as a link to the vaccine is unproven, the benefits of the vaccine in preventing COVID-19, with its associated risk of hospitalisation and death, continue to outweigh the risks of potential side effects", she said.
"You should therefore continue to get your jab when it is your turn."
She added: "We continually monitor safety during use of all a vaccines to protect the public, and to ensure the benefits continue to outweigh the risks."But the leading medic did urge people to take the "precautionary measure" of seeking medical advice if they had a headache which persisted for more than four days after their vaccine, or developed bruising beyond where they received their jab.
Meanwhile, Professor Sir Munir Pirmohamed, chair of the Commission on Human Medicines, said after a "rigorous analysis" that the evidence "does not suggest that blood clots are caused by Covid-19 Vaccine AstraZeneca".
"We have been closely reviewing all reports of blood clots in the vein...following vaccination," he added.
"There is no evidence either that VTE is occurring more often in people who have received the vaccine than in people who have not, for either vaccine."
At a later press conference in Brussels to reveal the results of a safety check of the vaccine, Emer Cooke from the EMA said: “The committee has come to a clear scientific conclusion; this is a safe and effective vaccine, its benefits in protecting people from Covid-19 with the associated risks of death and hospitalisation outweighed the possible risks.
“The committee also concluded that the vaccine is not associated with an increase in the overall risk of thromboembolic events or blood clots.”
She added: “Now, during the investigation and review we began to see a small number of cases of rare and unusual but very serious clotting disorders, and this then triggered a more focused review.
“Based on the evidence available, and after days of in-depth analysis of lab results, clinical reports, autopsy reports and other information from the clinical trials, we still cannot rule out definitively a link between these cases and the vaccine.
“What the committee has therefore recommended is to raise awareness of these possible risks by making sure that they're included in the product information, drawing attention to these possible rare conditions, and providing information to healthcare professionals and vaccinated people will help to spot and mitigate any possible side effects.
“We're also launching additional investigations to understand more about these rare cases, and we're conducting targeted observational studies.”
Cooke said 7 million people in the EU and 11 million in the UK have had the AstraZeneca vaccine, and while all side effects need to be monitored, she added: “I want to reiterate that our scientific position is that this vaccine is a safe and effective option to protect citizens against Covid-19.”
The review comes after Health Secretary Matt Hancock revealed the UK was facing vaccine supply issues due to a delay in a delivery of four million doses arriving from India, while a further batch of 1.7 million needed to be retested.
In a statement to the Commons he played down the issues with the batch that needs further testing, saying it “shows the rigour of our safety checks”.