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Officials defend shots after EMA, MHRA decisions



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

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

On Wednesday, British health and vaccine regulators issued a change to the guidelines on who should receive the shot. They now recommend that anyone under the age of 30 should receive an alternative vaccine, worrying that in rare circumstances it could lead to a serious blood clot.

Following a safety review of the AstraZeneca vaccine, triggered by concerns about reports of rare blood clots in a small number of vaccinated individuals, both UK and European drug regulators (MHRA and EMA respectively) stressed that the benefits of jab still outweigh the risks.

However, experts have rushed to defend it in concern that the vaccine̵

7;s reputation could be damaged – and a Twitter user commented that officials had apparently gone into “harm reduction” mode.

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

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

Meanwhile, British Prime Minister Boris Johnson, who himself has gotten a first shot at the vaccine, said that “the best thing people need to do is look at what the MHRA is saying, our independent regulator – that’s why we have them, it is why they are independent.

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

There is growing concern that Wednesday’s announcement could lead to vaccine delay in the UK, where the vaccination program has so far been successful, with over 31.7 million adults having received a first dose of a vaccine so far. The UK has been working through priority groups for a vaccine, with under 50s (without underlying health conditions) next in line for a shot.

England deputy director Jonathan Van-Tam also tried to downplay concerns on Wednesday, saying the reports of blood clots were “vanishingly rare.” He also noted that “changes in vaccine preference are business as usual and this is a course correction.”

“If you are sailing a massive liner across the Atlantic, it is not really fair that you will not have to make at least one course correction during this voyage,” he said during a press conference, adding that the vaccines were kept under “very careful review. “

Vaccine hesitation “clearly a problem”

Andrew Freedman, a lecturer in infectious diseases at Cardiff University School of Medicine, was among the experts who said the UK’s move to curb the use of the AstraZeneca vaccine made sense.

“It sounds like a sensible decision based on the evidence we have so far had a probable causal link between the AZ vaccine and these very rare thrombotic side effects that have been noticed,” he told CNBC on Thursday. He noted, however, that vaccination doubts were now “clearly a problem.”

“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, professor of pediatric infection and immunity at the University of Oxford, who developed the shot with AstraZeneca on Wednesday, said in a statement that “safety has been our priority during the development of the vaccine … and we are reassured to see “Safety monitoring will continue under the close supervision of regulators and public health authorities as the vaccine is rolled out worldwide.”

I am unsure

Countries on the European mainland are likely to have a harder time convincing their citizens that the AstraZeneca vaccine is safe given the many doubts and disputes that have been shot and delivered to date.

After another review of the shot, the European Medicines Agency also decided on Wednesday that the vaccine was safe, but said it found a “possible link” between jab and very rare cases of blood clots. However, the EMA placed no age restrictions on recipients.

The agency’s CEO Emer Cooke looked to reassure the public, noting that researchers are still trying to find out what has caused a small number of rare but serious blood 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. There may be very rare events that were not identified during the clinical trials,” she said.

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

So far, four European countries have stopped using the AstraZeneca vaccine altogether, including Denmark and the Netherlands, while a fleet of others, including Germany, France and Spain, have put age restrictions on the shot.

Most cases of blood clots identified by the regulators occurred in women under the age of 60 within two weeks of the shot. Officials are still investigating specific risk factors that could have contributed to the phenomenon.

Unusual platelet clots will be added as a “very rare” side effect to the vaccine’s product information, the EMA added.


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