Rabu, 07 April 2021

Britain to offer under 30s an alternative to AstraZenca vaccine over blood clot concerns - Sydney Morning Herald

London: Young people in Britain will be offered an alternative to the AstraZeneca vaccine over fears about a potential link to blood clots, in a decision that Australian authorities will consider whether to follow.

The Medicines and Healthcare Regulatory Agency announced the plan on Wednesday (Thursday AEST) following weeks of debate over whether a rare but deadly blood condition is linked to the jab.

While the drug regulator stopped short of banning the vaccine for certain age groups, it said the risk of developing life-threatening blood clots was higher in younger people and it made sense to offer those aged 18 to 29 a different vaccine if possible.

The agency still has not determined a clear link between the jab and 79 cases of rare clotting but did say the evidence of causality was getting stronger.

“The balance of benefits and risks if very favourable for older people but it is more finely balanced for the younger people,” said MHRA chief executive June Raine.

In a separate decision, the European Medicines Agency said it would list the blood clots as a “very rare” side effect of the AstraZeneca vaccine but decided it was safe for all ages to use.

Australian Health Department secretary Brendan Murphy told reporters on Wednesday that the issue was under review by the Therapeutics Goods Administration.

Britain’s deputy chief medical officer Professor Jonathan Van-Tam described the decision to not offer under 30s the AstraZeneca vaccine a “course correction” which would not slow down the country’s barnstorming vaccination rollout.


“This is a massive beast that we are driving along at enormous pace with enormous success,” he said.

“If you sail a massive liner across the Atlantic then it’s not really reasonable that you aren’t going to have to make at least one course correction during that voyage.”

There have been 79 cases of rare blood clots with low platelets in the UK out of 20 million doses. Nineteen of those 79 people died – three of whom were aged under 30.

The cases occurred in 51 women and 28 men aged from 18 to 79.

“From these reports, the risk of these type of rare blood clot is about four people in a million who received the vaccine,” Raine said. “This is extremely rare.”

Younger people are much less likely to die from COVID-19 so the balance of risks versus benefits from a vaccine was different to older people, Raine said.

The MHRA produced a graphic that examined the rate of intensive care admissions prevented by having the AstraZeneca jab versus the risk of serious side-effects from the product. The graphic was on the basis of low community transmission.

The graphic examined the rate of intensive care admissions prevented by having the AstraZeneca jab versus the risk of serious side-effects.

The graphic examined the rate of intensive care admissions prevented by having the AstraZeneca jab versus the risk of serious side-effects.Credit:MHRA

For those aged 20 to 29, the rate of ICU admissions prevented from having the vaccine was 0.8 for every 100,000 people. But the risk from serious side effects from the vaccine was 1.1 in 100,000.

The benefits were much higher for older groups.

“With the proven effectiveness against the disease that is still a huge risk to our population, the balance of benefits and known risks of the vaccine is still very favourable for the vast majority of people,” Raine said.

Young people who have already had one dose of the AstraZeneca jab have been told to get their second despite Wednesday’s decision.

Other under 30s will be offered jabs by Pfizer, Moderna or potentially Johnson and Johnson.

A medical worker prepares to administer a dose of the AstraZeneca vaccine.

A medical worker prepares to administer a dose of the AstraZeneca vaccine.Credit:AP

Several countries have already imposed limits on who can receive the vaccine, and any restrictions are closely watched since the vaccine, which is cheaper and easier to store than many others, is critical to global immunisation campaigns and is a pillar of the United Nations-backed program known as COVAX that aims to get vaccines to some of the world’s poorest countries.

The European Medicine Agency’s investigation focused on unusual types of blood clots that are occurring along with low blood platelets. One rare clot type appears in multiple blood vessels and the other in veins that drain blood from the brain.

Sabine Straus, the chair of the EMA’s safety committee, said the best data is coming from Germany where there is one report of the rare clots for every 100,000 doses given, although she noted far fewer reports in the UK. Still, that’s less than the clot risk that healthy women face from birth control pills, noted another expert, Peter Arlett.

The agency said most of the cases reported have occurred in women under 60 within two weeks of vaccination but based on the currently available evidence it was not able to identify specific risk factors.

With AP

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2021-04-07 18:45:06Z

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