UK regulator sees ‘no reason’ to discontinue Oxford vaccine - as Germany, France and Italy suspend use
The UK’s medicines regulator has said there is “no reason to discontinue” the use of the Oxford/AstraZeneca Covid-19 vaccine, despite several countries suspending its use.
Prime Minister Boris Johnson has assured that the jab is safe and stressed that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is one of the “toughest and most experienced” in the world.
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The comments come as Germany, France and Italy became the latest countries to suspend the rollout of the vaccine following reports of blood clots among some people who have had the jab.
Professor Andrew Pollard, head of the Oxford University vaccine group, said that while it was right that regulators investigate reports of such side effects, data from millions of people was “very reassuring” that there was no link between blood clots and the vaccine.
The German government said it was suspending its use of the vaccine as a “precaution” and on the advice of its national vaccine regulator.
According to the European Centre for Disease Prevention and Control, Germany has received slightly more than three million doses of the AstraZeneca vaccine and only used 1.35 million doses so far.
French president Emmanuel Macron said France was also suspending use of the vaccine as a precaution and Italy’s medicines regulator has also announced a temporary ban.
This follows the Netherlands, the Republic of Ireland, Denmark, Norway, Bulgaria, Iceland and Thailand, which have all temporarily suspended their use of the jab.
Last week, the World Health Organisation (WHO), the European Medicines Agency (EMA) and the MHRA said there was no evidence of a link between the jab and an increased risk of blood clots.
Professor Sir David Spiegelhalter, a statistician from the University of Cambridge, said the decision to pause the AstraZeneca vaccine rollout in some countries, including Denmark, Norway and Ireland, could be doing “more harm than good”.
He told the World At One: “I’ve looked at the AstraZeneca reports and they’ve said that 17 million jabs across the EU and the UK (had been administered) and they’ve had about 15 cases of deep vein thrombosis and 22 cases of pulmonary embolism reported.
“Doing some sums, deep vein thrombosis happens to one in 1,000 people per year of all ages.
“So, out of those 17 million jabs, we would expect at least 17,000 of those people to get a deep vein thrombosis some time in the year.
“So that means that there will have been – and you can pretty well guarantee it – 350 people who have had an AstraZeneca jab then had a deep vein thrombosis in the week following that.”
Is the vaccine safe?
Prof Pollard said that “safety is clearly absolutely paramount” but that about 3,000 cases of blood clots occur every month in the UK from other causes.
He added that more than 11 million doses have now been given in the UK, and the MHRA has said “very clearly that they’re not seeing any increase in the number of cases of blood clots” over what they would see normally.
“I think at this moment we’ve got the most data from the UK, which looks very reassuring, but of course it’s absolutely right that there’s careful monitoring of safety and this gets looked into,” he said.
AstraZeneca also said its own review had found 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.
In clinical trials for the jab, the number of clotting incidents was small and “lower in the vaccinated group” than in those who were unvaccinated, it added.
“To overcome the pandemic, it is important that people get vaccinated when invited to do so,” the firm said in a statement.
While on a visit to Coventry on Monday (15 March), Mr Johnson was asked for his views on the news that Ireland and the Netherlands had paused the rollout of the jab.
Asked directly if he could tell the public that the AstraZeneca vaccine was safe, he said: “Yes, I can. In the MHRA we have one of the toughest and most experienced regulators in the world.
“They see no reason at all to discontinue the vaccination programme… for either of the vaccines that we’re currently using.
“They believe that they are highly effective in driving down not just hospitalisation but also serious disease and mortality.
“We continue to be very confident about the programme and it’s great to see it being rolled out at such speed across the UK.”