European regulator to conduct review into safety of Oxford jab
THE EUROPEAN Medicines Agency is conducting a full scientific review of the AstraZeneca Covid-19 jab but has said it currently “remains convinced” that the “benefits of this vaccine outweigh the risk”.
The regulator, which approved the jab for Europe, is due to offer a further update tomorrow after several European countries halted its use due to reports of some people suffering blood clots following vaccination.
Emer Cooke, the EMA’s executive director, told a press briefing yesterday there was no current indication that the Oxford/AstraZeneca’s coronavirus vaccine was the cause of the “very rare” reported blood clots.
“I want to stress at present there is no indication that vaccination has caused these conditions,” she said.
“They have not come up in the clinical trials and they are not listed as known side events with this vaccine.
“In clinical trials both vaccinated people and people who received the placebo have shown some very small number of blood clot developments.
“The number of thromboembolic events overall in vaccinated people seems not to be higher than that seen in the general population.”
Some countries have suspended use of a particular batch of the jab due to concerns, but Ms Cooke said the small number of reports from Europe involved several batches and “therefore it is unlikely to be something related to a specific batch”.
However, she said this would form part of the EMA’s ongoing investigation.
Some 30 cases of blood clots had been reported to the EMA by March 10 among almost five million people vaccinated, but additional cases had been reported over the weekend, Ms Cooke said.
She said there would be an increase in the reporting of such cases due to the publicity surrounding the current reports.
The EMA is looking at the incidence of blood clots and some reports of abnormally low levels of blood platelets among some people who have had the jab.
Ms Cooke said: “We have pulled together an ad hoc meeting again today to help us evaluate these cases with all the surrounding information that the member states will have. The experts will then carry on their assessment and again will meet on Thursday to come to a conclusion on the full information that has been gathered, and to advise us as to whether there are any further actions that need to be taken. We will inform the public of the outcome immediately after this meeting.”
Peter Openshaw, professor of experimental medicine at Imperial College London, said the decision to pause rollout of the Oxford/AstraZeneca jab could be a “disaster” for Covid-19 vaccine uptake in Europe.
Asked what he would say to those in the UK who are booked to receive the vaccine, he told BBC Radio 4’s Today programme: “I really wouldn’t be worried at the present time.”
It is unlikely to be something related to a specific batch. Emer Cooke, executive director of the European Medicines Agency.