Oxford jab 'is safe' despite clot concerns

People under 30 will be offered alternative in the UK after 'rare side effect' is detected

People under the age of 30 in the United Kingdom will be offered an alternative to the Oxford/AstraZeneca COVID-19 vaccine due to a rare blood clot risk, in what the government's vaccination advisory body describes as a "course correction" in its clinical advice.

The European Medicines Agency, or EMA, also updated its advice for the Oxford/AstraZeneca vaccine on Wednesday, saying that the clots should be listed as a "rare side effect".

In news briefings on Wednesday afternoon, both the UK joint committee on vaccines and immunization, or JCVI, and the EMA confirmed their existing advice that the jab is safe and "the vaccine benefits outweigh any risks".

JCVI chairman Wei Shen said the clinical advice to swap vaccines for younger age groups was "really out of the utmost caution" rather than "any serious safety concerns".

He said people who have already had a first dose of the Oxford jab should still take a second dose when offered one.

A review by the EMA's safety committee concluded that "unusual blood clots with low blood platelets should be listed as very rare side-effects" of the vaccine.

A Reuters report said the EMA findings are expected to have an "immediate impact on inoculation plans" for the EU rollout and "will require a coordinated response".

Sky News reported that health ministers from the 27 EU member states would meet to discuss the regulators' findings on the Oxford/AstraZeneca jab after the Wednesday news briefings.

A trial of the Oxford/AstraZeneca vaccine in children is being paused in the UK while regulators investigate more into a potential association between the vaccine and the rare form of clot.

The UK's Medicines and Healthcare products Regulatory Agency, which is also known as the MHRA, is continuing an investigation after UK drug safety experts said there could be a causal link between the jab and rare blood clotting events, including cerebral venous sinus thrombosis, also called CVST, agencies reported.

It follows confusion on Tuesday after a senior official for the EMA said in an interview that there was a link between the vaccine and the clots, though the EMA quickly denied that it had established a "causal connection".

Without providing evidence to support his comment, Marco Cavaleri, chair of the vaccine evaluation team at the EMA, told Italian daily newspaper Il Messagero: "In my opinion, we can now say it, it is clear that there is an association (of the brain blood clots) with the vaccine. However, we still do not know what causes this reaction."

Studies by AstraZeneca of its vaccine found no higher risk of clots, while the EMA has repeatedly said the benefits of the jab outweigh the risks of hospitalization due to COVID-19, and the World Health Organization has endorsed it.

Some countries, including Germany, France, and the Netherlands have already paused use of the vaccine in younger people while investigations continue.

Quoted in The Guardian on Tuesday, Saad Shakir, director of the drug safety research unit at Southampton University, said evidence of links between the vaccine and the clots "is consistent with causality".

But Shakir said the AstraZeneca vaccine was safe and effective: "It has protected millions of people from COVID-19 and will continue to do so around the world," he said, adding that vaccination programs must continue, "with risk mitigation for women under 55".

The Times noted that organizers of the UK study of immune responses in children had reported no safety concerns but would pause the trial until the regulator had assessed the risk.

The MHRA said on Wednesday the Oxford/AstraZeneca jab has been given to more than 20 million UK adults with 79 rare blood clotting cases reported, and 19 deaths, according to British media.

Responding to concerns around the vaccine on Tuesday, Britain's Prime Minister Boris Johnson urged the public to get their vaccine when offered as the regulator's current advice is to keep giving the jab.

"The best thing people should do is look at what the MHRA say, our independent regulator－that's why we have them, that's why they are independent," said Johnson.

The Times reported that government ministers are concerned that announcements from Europe "could dissuade younger people from coming forward "to get the jab.

Speaking on BBC Radio 4's Today program on Wednesday, Jeremy Hunt, chair of the health select committee, said: "There may or may not be a causal link, but even then it's the balance of risk.

"What we know is that the risk of COVID killing you is much higher for older people, and it looks like the risk of this type of blood clot is also lower for older people so that risk profile may change depending on age."

Ian Douglas, a professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine, told Sky News on Wednesday that the benefits from the AstraZeneca vaccine are "very large" despite one in 600,000 people getting blood clots after receiving it.

Meanwhile, the UK has begun the rollout of its third COVID-19 vaccine, the Moderna jab, in Wales.

Vaccines minister Nadhim Zahawi said the jabs will be deployed across all of the UK "around the third week of April", with "more volume" expected by May. He said the UK will have enough jabs to offer all adults their first dose by July.

Zahawi told BBC's Breakfast program that more Pfizer and Oxford/AstraZeneca doses will also arrive and the Janssen vaccine is "coming through as well".