Officials defend shot after EMA, MHRA decisions

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

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The British government and the country’s health experts were quick to defend the coronavirus vaccine developed by AstraZeneca and the University of Oxford following concerns about a possible connection with blood clots.

On Wednesday, health and vaccine regulators in the UK released a change in orientation about who should receive the injection. They now recommend that anyone under the age of 30 receive an alternative vaccine amid concerns that it may, in rare circumstances, lead to a serious blood clot.

Following a safety review of the AstraZeneca vaccine, prompted by concerns about reports of rare blood clotting disorders in a small number of vaccinated individuals, drug regulators in the UK and Europe (MHRA and EMA, respectively) emphasized that the benefits of the vaccine still outweighed the risks.

However, amid concerns that the vaccine’s reputation could be further damaged, experts rushed to defend it – and a Twitter user commented that employees appeared to have gone into “damage limitation” mode.

On Thursday, the UK health secretary emphasized that the risk of a blood clot after receiving the AstraZeneca Covid vaccination is almost the same as on a long-haul flight. He said the safety measures around the vaccine are robust and allow regulators to “detect this extremely rare event”.

On the chances of developing a blood clot, Matt Hancock told the BBC Breakfast: “The security system that we have around this vaccine is so sensitive that it can detect events that are four in a million – I am told that this is about the equivalent risk of taking a long-haul flight.”

Meanwhile, UK Prime Minister Boris Johnson, who received the first injection 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 are independent.

“The advice they give people is to keep going, get your jab, get your second jab,” he added on Thursday.

This is amid growing concerns that Wednesday’s announcement could lead to vaccine hesitation in Britain, where the immunization program has been going well so far, with more than 31.7 million adults having received the first vaccine. dose of a vaccine so far. The UK has been working with priority groups for a vaccine, with those under 50 (without underlying health conditions) next in line for a vaccine.

England’s deputy chief medical officer, Jonathan Van-Tam, also sought to minimize concerns on Wednesday, saying reports of blood clots were “rare”. He also noted that “changes in preference for vaccines are business as usual and this is a course correction.”

“If you are sailing a large ocean liner across the Atlantic, then it is not really reasonable that you do not need to make at least one course correction while traveling,” he said at a news conference, adding that the vaccines were kept under “much review. careful “.

Vaccination hesitation ‘clearly a concern’

Andrew Freedman, a reader of infectious diseases at the Cardiff University School of Medicine, was among the experts saying the UK move to restrict the use of the AstraZeneca vaccine was sensible.

“It seems like a sensible decision based on the evidence we have so far of a likely causal link between the AZ vaccine and those very rare thrombotic side effects that have been observed,” he told CNBC on Thursday. However, he noted that the vaccine’s hesitation was now “clearly a concern”.

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

Meanwhile, Andrew Pollard, professor of pediatric infection and immunity at the University of Oxford, who developed the vaccine together with AstraZeneca, said in a statement on Wednesday that “safety has been our priority during the development of the vaccine … and we’re confident to see if safety monitoring continues to be under the scrutiny of regulators and public health officials as the vaccine is launched around the world. “

EU uncertainty

Continental European countries are likely to have a harder time convincing their citizens that the AstraZeneca vaccine is safe, given the countless doubts and disputes over the injection and supplies so far.

After a second analysis of the injection, the European Medicines Agency also decided on Wednesday that the vaccine was safe, but said it found a “possible link” between the injection and very rare cases of blood clots. The EMA did not impose any age restrictions on recipients, however.

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

The question, “clearly demonstrates one of the challenges posed by large-scale vaccination campaigns, when millions of people receive these vaccines, very rare events can occur that have not been identified during clinical trials,” she said.

EU leaders met on Wednesday night, but were unable to agree on a coordinated strategy in relation to the AstraZeneca vaccine.

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

The majority of blood clotting cases identified by regulators occurred in women under the age of 60 within two weeks after the injection. The authorities are still investigating the specific risk factors that may have contributed to the phenomenon.

The unusual blood clotting with low platelets will be added as a “very rare” side effect to vaccine product information, EMA added.