A decision by Denmark to temporarily halt use of the Oxford/AstraZeneca vaccine is a “precautionary measure” and people should continue to get their jab, the UK regulator has said.
Danish authorities have paused vaccine rollout after a small number of blood clots and one death were reported, though they have said there is no confirmed link to the vaccine.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) said evidence had not confirmed the vaccine caused the problems, and said people should still go and get their Covid-19 vaccine when asked to do so.
Dr Phil Bryan, MHRA vaccines safety lead, said: “Vaccine safety is of paramount importance and we continually monitor the safety of vaccines to ensure that the benefits outweigh any potential risks.
“It has not been confirmed that the report of a blood clot, in Denmark, was caused by the Covid-19 vaccine (from) AstraZeneca.
“The Danish authorities’ action to temporarily suspend use of the vaccine is precautionary whilst they investigate.
“Blood clots can occur naturally and are not uncommon. More than 11 million doses of the Covid-19 Vaccine AstraZeneca vaccine have now been administered across the UK.
“Reports of blood clots received so far are not greater than the number that would have occurred naturally in the vaccinated population.”
Dr Bryan said the safety of the public always comes first and the issue is being kept under close review “but available evidence does not confirm that the vaccine is the cause”.
Professor Anthony Harnden, deputy chairman of the Joint Committee on Vaccination and Immunisation, said: “Vaccine safety is critically important. Our UK regulator, the MHRA, review all reports of adverse events for both vaccines as they are reported.
“The public should have confidence that both vaccines used in the UK vaccination programme are safe and highly effective at preventing severe disease, including the prevention of blood clots caused by Covid.”
Asked about the report from Denmark, Prime Minister Boris Johnson’s spokesperson said: “We’ve been clear that it’s both safe and effective… and when people are asked to come forward and take it, they should do so in confidence.”
It comes as Public Health England (PHE) said four more cases of the P1 Covid-19 variant first identified in Manaus, Brazil, had been found in the UK.
Three in South Gloucestershire are all close or household contacts of the two existing P1 cases in the area, while one case in Bradford, West Yorkshire, involves a person who tested positive in late February after travelling back from Brazil via Paris.
Contact tracing teams have followed up close contacts of this individual and advised them to isolate and get a test.
The latest cases bring the total number of P1 variant cases in the UK to 10 – seven in England and three in Scotland, all of which have links to travel or to a previously confirmed case that has travelled to Brazil, PHE said.
Earlier this week, the European Medicine Agency said Austria had suspended the use of a batch of the AstraZeneca vaccine after a person was diagnosed with blood clots and died 10 days after vaccination.
Another was admitted to hospital with pulmonary embolism (blockage in arteries in the lungs) after being vaccinated.
As of March 9, there have been two other reports of cases linked to clots for the batch, the agency said.
It added: “There is currently no indication that vaccination has caused these conditions, which are not listed as side-effects with this vaccine.”
Norway, Estonia, Latvia, Lithuania and Luxembourg are also reported to have suspended the use of the same batch over the concerns.
In a statement, AstraZeneca said patient safety was its “highest priority” and regulators have “clear and stringent efficacy and safety standards” for the approval of any new medicine.
“The safety of the vaccine has been extensively studied in phase three clinical trials and peer-reviewed data confirms the vaccine has been generally well tolerated,” it said.
Meanwhile, the European Medicines Agency has authorised Johnson & Johnson’s one-dose coronavirus vaccine for use. The MHRA is considering its use for the UK.