Officials defend shot after EMA, MHRA rulings

British Prime Minister Boris Johnson poses for a photo with a vial of the AstraZeneca / Oxford University Covid-19 candidate vaccine.

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The UK government and health experts in the country have rushed to defend the coronavirus vaccine developed by AstraZeneca and the University of Oxford after concerns about a possible link with blood clots.

On Wednesday, the UK’s health and vaccine regulators changed guidelines on who should get the shot. They now recommend that anyone under the age of 30 get an alternative vaccine because they fear it could lead to a serious blood clot in rare cases.

Following a safety review of the AstraZeneca vaccine, fueled by concerns about reports of rare blood clotting disorders in a small number of vaccinated individuals, both the UK and European drug regulators (the MHRA and EMA respectively) emphasized that the benefits of the injection continued to be outweighed the risks.

However, despite concerns that the vaccine’s reputation could be further harmed, experts have rushed to defend it – and one Twitter user noted that officials appeared to have gone into “harm reduction” mode.

On Thursday, the British health secretary stressed that the risk of a blood clot after receiving the AstraZeneca Covid vaccination is about the same as on a long-haul flight. He said the safety measures surrounding the vaccine were robust and allowed regulators to “track down this extremely rare event.”

About the chance of getting a blood clot, Matt Hancock told BBC Breakfast “The safety system we have around this vaccine is so sensitive that it can accommodate events of four in a million – I’ve been told this is about the same risk as taking a long-haul flight.”

Meanwhile, British Prime Minister Boris Johnson, who has himself received a first shot of the vaccine, said that ‘the best thing people should do is look at what the MHRA says, our independent regulator – that’s why we have them, that’s why they’re independent.

“Their advice to people is to keep going out, get your shot, get your second shot,” he added on Thursday.

It comes amid growing concern that Wednesday’s announcement could lead to vaccine hesitation in Britain, where the immunization program has gone well so far, with more than 31.7 million adults taking a first dose to date. have received a vaccine. The UK has been working on a vaccine through priority groups, with the under 50 (with no underlying health problems) next in line for an injection.

England’s Deputy Chief Medical Officer Jonathan Van-Tam also tried to downplay the concerns on Wednesday, saying reports of blood clots were “disappearingly rare.” He also noted that “changes in vaccine preferences are business as usual and this is a course correction.”

“If you’re sailing across the Atlantic with a huge liner, it’s not really reasonable that you don’t have to make at least one course correction on that voyage,” he said at a news conference, adding that the vaccines were kept. under “very careful assessment.”

Hesitation about vaccinations ‘clearly a concern’

Andrew Freedman, infectious disease reader at Cardiff University School of Medicine, was one of the experts who said the UK’s move to restrict the use of the AstraZeneca vaccine was wise.

“It sounds like a wise decision based on the evidence we have so far for a likely causal link between the AZ vaccine and these very rare thrombotic side effects that have been noted,” he told CNBC on Thursday. However, he noted that hesitation about vaccines was now “clearly a concern.”

“It will be important to continue to emphasize the message that vaccination saves lives and has already saved thousands of lives in the UK,” he added.

Meanwhile, Andrew Pollard, a professor of pediatric infection and immunity at the University of Oxford who co-developed the shot with AstraZeneca, said on Wednesday in a statement that “safety has been our priority during the development of the vaccine … and we are reassured. to ensure that safety surveillance remains under the close scrutiny of regulatory and public health authorities while the vaccine is rolled out around the world. “

I doubt

Countries in mainland Europe will likely have a harder time convincing their citizens that the AstraZeneca vaccine is safe, given the many doubts and disputes over the shot and supplies to date.

After a second review of the shot, the European Medicines Agency also ruled on Wednesday that the vaccine was safe, but said it found a “possible link” between the shot and very rare cases of blood clots. However, the EMA did not impose age restrictions on recipients.

The agency’s executive director, Emer Cooke, tried to reassure the public, noting that researchers were still trying to find out what caused a small number of rare but serious blood clots, including cerebral venous sinus thrombosis (CVST).

The issue, “clearly demonstrates one of the challenges of large-scale vaccination campaigns when millions of people are given these vaccines. Very rare events may occur that were not identified during the clinical trials,” she said.

EU leaders met on Wednesday evening but could not agree on a coordinated strategy regarding the AstraZeneca vaccine.

To date, four European countries have stopped using the AstraZeneca vaccine altogether, including Denmark and the Netherlands, while a large number of others, including Germany, France and Spain, have imposed age restrictions on the injection.

Most of the cases of blood clots identified by regulators occurred in women under 60 within two weeks of the injection. However, officials are still investigating specific risk factors that may have contributed to the phenomenon.

Unusual blood clotting with low platelets will be added as a “very rare” side effect to the vaccine’s product information, the EMA added.