KEEP CALM AND CARRY ON JABBING
Under-30s to be given alternative to Oxford vaccine over clotting fears ++ But as risks are so tiny, the call from politicians, experts and even Europe is...
watchdogs, scientists and politicians all urged Britain to keep faith with the astraZeneca vaccine last night.
Despite under-30s now being offered an alternative jab, they insisted the Oxford version’s benefits far outweighed any potential risks from very rare blood clots.
boris Johnson led the concerted effort to reassure the public, saying the vaccine was ‘safe, effective and had saved thousands of lives’.
And the head of the MHRA, the uK’s drugs regulator, said that any danger was ‘extremely small’.
The statements came after the MHRA found a ‘reasonably plausible’ link between the AstraZeneca vaccine and rare blood clots.
It said evidence of a connection was getting firmer with 79 reported cases following use of the jab, with 19 deaths.
June Raine, who heads the MHRA, said however the chances of this ‘rare
suspected side-effect’ were extremely low and the benefits of the jab outweighed the risks ‘for the vast majority’ of people.
The agency did not impose restrictions itself, but the Joint Committee on Vaccination and Immunisation (JCVI) said that out of utmost caution, it now recommended that under-30s should be offered an alternative. The guidance applies to younger people only because their risk from Covid is very low.
The committee insisted other adults should continue to come forward as normal for first or second doses.
The Scottish Government said it is now considering whether there will be any ‘implications for the timescales’ of its vaccination programme, but that it remains ‘on track’ to deliver first doses to all adults by the end of July.
It came as the first doses of the Moderna vaccine were given in Scotland yesterday after the arrival of supplies from an order of one million doses.
The MHRA findings raised fears of a public loss of confidence in a vaccine that has been the cornerstone of Britain’s highly successful rollout.
Scotland’s deputy chief medical officer Nicola Steedman said: ‘Following the statements by the MHRA and the JCVI, we want to stress the evidence shows that, overall, the benefits of the Oxford/ AstraZeneca vaccine outweigh the risks and it continues to be a safe and effective vaccine.
‘However, the Scottish Government will follow the JCVI recommendation to offer alternative vaccines to adults under 30 without underlying health conditions.
‘We continue to urge anyone offered a vaccination to take up their appointment. Everyone who has received their first dose of the AstraZeneca vaccine should receive their second dose as this gives greater and longer lasting protection against the virus.’ Professor Wei
‘Already saved thousands of lives’
Shen Lim, coronavirus chairman for the vaccines committee said: ‘The Covid-19 vaccines have already saved thousands of lives and the benefit for the majority of the population is clear – if you are offered a vaccine, you should take it.’
The Prime Minister said: ‘As the regulators have said, this vaccine is safe, effective and has already saved thousands of lives – and the vast majority of people should continue to take it when offered. We will follow today’s updated advice, which should allow people of all ages to continue to have full confidence in vaccines, helping us save lives and cautiously return towards normality.’
The Oxford jab was also firmly backed yesterday by the EU’s medical regulator. Emer Cooke, executive director of the European Medicines Agency, said clots were very rare and the risk of death from Covid was ‘much greater’.
The NHS is now likely to offer those under 30 the Pfizer or Moderna vaccine as an alternative.
Ministers and officials insisted that the ‘change of course’ would not affect the UK Government’s target to vaccinate all 53million adults by July 31.
Mr Johnson said: ‘We’ll get on with rolling out the vaccine programme.
‘I don’t think anything I’ve seen leads me to suppose that we will have to change the road map or deviate from the road map in any way.’
Vaccines Minister Nadhim Zahawi said: ‘We will follow the advice and are confident in meeting our programme targets.
‘We keep going on the most successful vaccination programme in history.’
Professor Jonathan Van-Tam, England’s deputy chief medical officer, told a briefing: ‘Vaccines continue to be the way out for the UK, they continue to be the way we can get our lives back to normal and our economy opened up again in the shortest time possible.’
The new guidelines followed a review by the MHRA and the Commission on Human Medicines. They examined a potential link between the Oxford/AstraZeneca jab and what is known as cerebral venous sinus thrombosis (CVST), where potentially fatal clots form in the veins that drain the brain.
This has been combined with what is known as thrombocytopenia, where a patient also has abnormally low levels of platelets – cell fragments in the blood that form clots and stop or prevent bleeding.
There have been around four cases and one death for every one million vaccines given.
Dr Raine said that although a link between the vaccine and the clots was unproven, it was ‘reasonably plausible’. She said, however, that the blood clots were ‘extremely rare’. She added: ‘Based on the current evidence, the benefits of the Covid-19 vaccine AstraZeneca against Covid-19 and its associated risks – hospitalisation and death – continues to outweigh the risks for the vast majority of people.
‘Our review has reinforced that the risk of this rare suspected side effect remains extremely small.
‘The evidence is firming up and our review has concluded that while it’s a strong possibility, more work is needed to establish beyond all doubt that the vaccine has caused these side effects.’
The MHRA received 79 UK reports of blood clotting alongside low levels of platelets following the use of the jab up to and including March 31.
Of these, 44 were of CVST with thrombocytopenia and 35 were of thrombosis in other major veins with thrombocytopenia. All occurred after a first dose of the AZ jab.
The cases were in 51 women and 28 men, aged from 18 to 79 years. Nineteen of the 79 died, of whom 13 were women.
However, officials note that more women have been vaccinated than men and there is no apparent different in risk between them. Eleven of those who died were under the age of 50 and three under 30. The MHRA concluded the risk level is very favourable for older people but ‘more finely balanced’ for younger groups. Linda Bauld, Professor of Public Health at the University of Edinburgh said: ‘The risk is that you have four people out of one million who may develop one of
these rare blood clots. But if one million mid-life aged people catch covid, 1,000 of them could die. These are vanishingly tiny risks, but medicines regulators have to be ultra cautious.
‘My message to everybody would be to take up your appointment.’
James Chalmers, Professor of Respiratory Research at Dundee University said: ‘The vaccine regulators have done exactly what they should do, which is take the most cautious approach possible. The vast majority of the public don’t need to be concerned about this.’
Professor Van-Tam used a nautical analogy to describe the ‘course correction’. He said: ‘This is a massive beast that we are driving along at enormous pace with enormous success, this vaccine programme.
‘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.
‘The idea of withholding a vaccine where a potential harm, for example in the 40-49 group, is 0.5 harms per 100,000 people versus 51.5 intensive care admissions averted, and that’s not taking into account hospitalisations, long Covid and spreading to others, then the notion that you would clip the vaccine at that point is pretty absurd really.
‘So it is very much an independent decision but it has been taken in an extremely rational way.’
The World Health Organisation said a causal link between the vaccine and blood clots is ‘plausible’ but ‘not confirmed’.
Sabine Straus, safety committee chairman at the European Medicines Agency, said: ‘This vaccine has proven to be highly effective, it prevents severe disease and hospitalisation and it is saving lives. Vaccination is extremely important in helping us in the fight against Covid-19 and we need to use the vaccines we have to protect us from the devastating effects.’
Professor Anthony Harnden, deputy chairman of the JCVI, said the risk/benefit ratio changed with age, adding: ‘We on JCVI have decided that risk-benefit ratio doesn’t really stack up when it comes to the very well under-30s.
‘We felt, having weighed up all the data, that the benefits outweighed the risks in anybody over the age of 30. But under the age of 30 it was not clear the benefits did outweigh the risks and therefore we decided… as a precautionary approach we would advise an alternative vaccine for that particular age group.
‘We just thought there was enough doubt in our minds that the benefits did not completely outweigh the risks of the vaccine in the very young, well age group.’
More than 20million doses of the AstraZeneca vaccine have now been given in the UK, saving an estimated 6,000 lives.
Latest Department of Health data shows that 31.5 million people in the UK have had their first jab, and 5.4 million of these have now also received their second dose.
‘Precautionary approach’
IN the history of vaccinations, the quickest ever developed was for mumps. From Petri dish to people’s arms, it took four years – an incredible scientific feat.
Still, compared to the Oxford/AstraZeneca Covid-19 jab’s evolution, that’s positively slothful. That serum was in clinics and pop-up centres in less than a year – a low-cost, life-saving gift to the world.
Given that, it was understandable any troubling side effects would attract intense attention, especially as it is central to Britain’s plans for beating the virus – and reopening society and the economy.
So it was encouraging that the drugs regulator MHRA yesterday said that fatal blood clots, possibly linked to the jab, were ‘extremely rare’.
However, the watchdog exercised utmost caution and recommended that under-30s should be given an alternative to the AstraZeneca vaccine.
True, this is a setback. But only the most malicious could paint it as a disaster.
Keeping perspective – and avoiding panic – are vital. The benefits of receiving the vaccine remain overwhelming for the vast majority of adults. The risk of death from Covid, let alone serious illness, is far greater than the one-in-a-million chance of suffering a life-threatening clot.
Of course, 100 per cent safety is impossible to guarantee. On every medicine bottle label there is a frightening list of potential side effects. But the greatest danger is if large numbers of Britons, egged on by the pernicious ‘anti-vaxx’ brigade, suddenly shun the jabs.
In the UK, the spectacular vaccine blitz is saving thousands of lives. In Europe, where leaders’ smears have torpedoed take-up, there is a third Covid wave and countless needless deaths.
Our political leaders and their scientists must focus on reassuring waverers that AstraZeneca is safe and effective.
Plans for vaccine passports, which are illogical, fraught with complications and would seize a great many of our hard-won liberties, should be put squarely on ice.
The economy, which protects jobs, pays for public services and generates prosperity, is fizzing with optimism. But it can only ignite once lockdown is lifted. First, Britain must conquer Covid. Millions have already played their part by accepting jabs when offered them. To regain our normal lives, they must continue to do so.