No Evidence AstraZeneca Vaccine Causes Blood Clots, Says UK Regulator

There is no proven link between the AstraZeneca vaccine and rare blood clotting, the Medicines and Healthcare products Regulatory Agency (MHRA) has said.

Following a “rigorous scientific review” of all the available data, the regulator said the available evidence does not suggest that blood clots in veins are caused by the jab and it has urged people to take it when invited to do so.

It follows a detailed review of cases as well as data from hospital admissions and GP records. Experts from the government’s independent advisory group, the Commission on Human Medicines, also reviewed the data.

It comes after more than a dozen countries, including France, Germany, Italy and Spain suspended its use.

Dr June Raine, MHRA chief executive, said: “Our thorough and careful review, alongside the critical assessment of leading, independent scientists, shows that there is no evidence that that blood clots in veins is occurring more than would be expected in the absence of vaccination, for either vaccine.”

The regulator said it has received five reports of a rare blood clot after five men aged between 19 and 59 received the Oxford/AstraZeneca vaccine.

The clot – cerebral venous sinus thrombosis (CVST) – prevents blood from draining out of the brain.

One of these cases was fatal, experts from the regulator told a press briefing.

“We have received a very small number of reports of an extremely rare form of blood clot in the cerebral veins (sinus vein thrombosis, or CSVT) occurring together with lowered platelets soon after vaccination,” said Dr Raine. “This type of blood clot can occur naturally in people who have not been vaccinated, as well as in those suffering from Covid-19.”

A further, detailed review into the five cases is ongoing. This has been reported in less than 1 in a million people vaccinated so far in the UK, and can also occur naturally – a causal association with the vaccine has not been established.

Phil Bryan, MHRA vaccine safety lead, said: “We take every single report of a suspected side effect seriously.

“We have received five reports of what is a very unique, specific form of blood clot … and this is similar to some of the cases that have been reported in Europe in the past week or so.

“What we don’t know is whether these cases have been caused by the vaccine.

“We are working closely with our experts and haematologists to try to gather more information to determine this.”

He added that these clots do happen very rarely naturally.

Bryan added: “Where we are now is that no proven causal association with what is still an extremely rare medical event has been proven for the AZ vaccine.

“But we do know that these are highly effective vaccines. We still have a huge burden of Covid disease in the population.

“So, right now, the balance of benefits and known risks of the vaccine are favourable.”

Professor Sir Munir Pirmohamed, chair of the Commission on Human Medicines, said: “Having reviewed all the data that was available to us, as well as reports, what we concluded was that there was no increased risk of peripheral venous thromboembolism based on all the data that’s available to us at the moment.

“We will still recommend that the vaccine is taken when you’re offered the vaccine.”

The World Health Organisation has also stated that the benefits of the vaccine “far outweigh the risks”. 

Dr Hans Kluge, WHO regional director for Europe, said it was “routine to signal adverse events” but reiterated that people should “have confidence” in the protection given by vaccines.

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‘No Doubt’ There Will Be Further Wave Of Covid-19, Warns Statistics Chief

The UK’s national statistician said he has “no doubt” that there will be a further wave of Covid-19 infections in the autumn.

Professor Sir Ian Diamond, head of the Office for National Statistics (ONS), also said there is a lot of regional variation in terms of how many people have antibodies.

His comments come after England’s chief medical officer Professor Chris Whitty said there were still risks to reopening society and the UK will experience another surge of cases at some point, potentially in late summer or through the autumn and winter.

Sir Ian said people need to understand how the data is moving forward and look at the impact of the “wonderful” vaccine rollout.

“But having said that, we need also to recognise that this is a virus that isn’t going to go away,” he told The Andrew Marr Show on BBC One.

“And I have no doubt that in the autumn there will be a further wave of infections.”

Asked if it is too early to know how much of the fall in infections across the UK is down to the vaccine rollout, he said there are a number of moving parts such as vaccines and restrictions.

Sir Ian told the programme: “I mean I would say though that this has been an incredibly impressive vaccine rollout, and we’ve been looking at antibodies in the population, and we’ve been scaling up our survey in order to be able to take many more blood tests so that we can look at the impact.

“And what we’re seeing is quite remarkable increases in the level of antibodies in the over-80s, and increasingly in the over-70s. So I’m very, very confident that the vaccine rollout is really starting to provide some real protection.

“At the other side we see very relatively high levels amongst young people which just shows how much of young people have been affected by the virus.

“I’d finally just say on this that there is a lot of regional variation, so we find 30% of London have antibodies whereas only 16% in the South West, so we need to recognise that as well.”

During the week, Prof Whitty said he would “strongly advise” against any move to shorten the timetable for easing lockdown restrictions.

Speaking to the Commons Science and Technology Committee, Prof Whitty said the measures pencilled in for May 17, when indoor mixing of up to six people could be allowed, involved “significant risks”.

Modelling considered by the Scientific Advisory Group for Emergencies (Sage) has suggested that even under the most optimistic set of assumptions, at least a further 30,000 Covid-19 deaths could occur.

Prof Whitty said: “What we are going to see is, as things are opening up, what all the modelling suggests is that at some point we will get a surge in virus.

“We hope it doesn’t happen soon, it might for example happen later in the summer if we open up gradually or because of the seasonal effect it might happen over the next autumn and winter.

“All the modelling suggests there is going to be a further surge and that will find the people who either have not been vaccinated or where the vaccine has not worked.

“Some of them will end up in hospital and sadly some of them will go on to die.”

Elsewhere, charities have written an open letter to encourage people with underlying health conditions to come forward for a coronavirus vaccine.

Cancer Research UK, Mencap and the Terrence Higgins Trust are among 18 signatories to the letter aimed at people in vaccine cohort six.

The group includes carers as well as people with a range of underlying health conditions that put them at greater risk from coronavirus.

They include chronic respiratory, heart, kidney and liver disease and neurological conditions, immunosuppression, asplenia, diabetes, morbid obesity and severe mental illness.

People with sickle cell disease, lupus and those on a GP learning disability register, as well as people who have vascular disease or have had a stroke are also included in group six.

More than 23.6 million people have received their first dose of a coronavirus vaccine in the UK, according to the latest government figures.

There were a further 5,534 lab-confirmed cases of Covid-19 in the last 24 hour period, while 121 deaths were recorded in the UK of people who tested positive for coronavirus in the last 28 days.

Meanwhile, the NHS is to text millions of vulnerable people with underlying health conditions asking them to take the vaccine.

People with conditions such as diabetes and certain forms of cancer will receive a link to reserve an appointment for a jab at a vaccination centre or pharmacy across England.

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Ending Lockdown Too Fast Risks New Covid Variants Emerging, Top Scientist Warns

ASSOCIATED PRESS

A security guard holds a sign at Blackburn Cathedral, which is being used as a mass vaccination center during the coronavirus outbreak in Blackburn. 

Ending Covid lockdown restrictions too swiftly could run the risk of new vaccine-resistant variants taking hold, top expert Sarah Gilbert has said. 

Speaking to MPs on Wednesday, Oxford University’s professor of vaccinology also warned relaxing restrictions too quickly could boost transmission of the virus. 

It comes after Boris Johnson this week revealed his roadmap out of lockdown, with a pledge to end all social distancing by June 21. 

Gilbert has urged caution, however, telling the Commons’ science and technology committee: “To make sure that we have the lowest chance possible of new variants arising we need to prevent the virus from transmitting between people and we’re now doing that very effectively with the vaccines.”

She added: “We cannot allow only the vaccines to do all the work of protecting the population, while at the current time in the UK we still have relatively high levels of transmission.

“And there is a danger that if measures are lifted too quickly that transmission could increase, and that puts us at a greater risk of selection of new variants that are not so well effectively neutralised by the virus.

“It wouldn’t be all or nothing but it could be a significant change, and we want to minimise the chances of that happening as much as we possibly can.”

Anthony Harnden, deputy chair of the Joint Committee on Vaccination and Immunisation (JCVI) agreed “it’s really, really important that we don’t rush this”. 

He said: “I refer back to my original answer about vaccination not being the only way out pandemic.

PA

Prime minister Boris Johnson leaves 10 Downing Street

“We must go slowly, and the reason is because we want to keep transmission down and we want to keep infection rates down. And if we don’t, we will lose all the benefits of those vaccines that we’ve acquired and in the last few months because we will get the environment for new variant strains to emerge and have ‘vaccine escape’. So it’s really, really important that we don’t rush this.”

Schools are scheduled to reopen on March 8, followed by relaxations of some social distancing measures later in the month. 

Non-essential shops, pubs, restaurants, hairdressers and gyms will reopen no earlier than April 12 in the prime minister’s phased plan.

Johnson is under pressure from backbench Tory MPs in the Covid Recovery Group, who have been demanding the government speeds up the plan. 

The PM has argued, however, that England is taking a “cautious but irreversible” path out of lockdown. 

Scientists are still examining new data about how effective the vaccines are in reducing transmission and hospitalisations. 

Philip Dormitzer, vice president and chief scientific officer of viral vaccines at Pfizer, said the company believes its vaccine will protect against the variants seen to date.

He told the committee: “From real world effectiveness data, both UK and in Israel where the UK variant is common, we’re starting to get our first direct evidence, and we are seeing protection against the UK variant that is equivalent to the protection we saw in controlled trials before that variant was circulating.

“For other variants at this point we have to rely more on laboratory data, and the laboratory data thus far, I would say are quite reassuring.

“We do see with the South African variant some reduction in the level of neutralisation.

“So yes these mutations can reduce the level of neutralisation, but they do not reduce the level of neutralisation anywhere near as low as neutralisation that was observed at the time that people were protected in the trial.

“So we think it is likely that the vaccine will protect against the variants that we have seen to date, but the way to be sure is of course the real world data because laboratory measures of immunity cannot be translated directly to known protection –  that requires actually observing protection in the field.”

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These Celebs Are Urging You To Get The Coronavirus Vaccine

Romesh Ranganathan, Beverley Knight and Denise Lewis want you to have the coronavirus vaccine.

The celebs appear in a new star-studded advert urging people from ethnic minority communities to take up the vaccine when they’re invited. The ad has been organised by actor and writer Adil Ray, best known for BBC One comedy Citizen Khan.

Research shows hesitancy in getting the vaccine is “disproportionately high” among Black, Asian, and minority ethnic groups. Data also suggests people from Black and south Asian backgrounds are more likely to die from Covid-19 than white people.

The ad – which features the likes of Meera Syal, Moeen Ali and David Olusoga, too – will air at 9.56pm on Thursday evening.

It’ll be screened across several networks, including ITV, Channel 4, and Channel 5, as well as multiple Sky TV channels. The makers expect it to reach an audience of around 10 million people.

“We are in unprecedented times and the fact remains that this pandemic disproportionately affects people from ethnic minority communities,” said Ray.

“It’s heartening to see the major broadcasters come together in an equally unprecedented television broadcast at this crucial time, an indication of how serious this situation is. We must all engage and encourage one another to do the right thing. The message is simple: take the vaccine, save lives.”

Medics have highlighted how structural inequalities within Britain’s healthcare system and racist historical medical practices have caused widespread distrust among minority groups, who have suffered poorer health outcomes throughout their lives.

Ivo Vlaev, professor of Behavioural Science at Warwick Business School and a member of the NHS Covid Behaviour Change Unit, said “fake news” is largely to blame for vaccine hesitancy. “Fake news and conspiracy theories about the Covid-19 vaccine seem to spread almost as fast as the virus itself,” he said.

“They range from the utterly outlandish, such as the vaccine containing a microchip allowing Bill Gates to track peoples movements, to claims it contains pork, which could cause even more harm among BAME group.”

Prof Vlaev said in addition to this, the government is “battling concerns around safety and critics arguing regulators approved the Pfizer vaccine too quickly”.

A key consideration when tackling vaccine take-up is where positive messages come from, he added.

“We know we trust messages more when the person delivering them is like us or we perceive them to be a figure of authority,” he said. “Therefore faith groups and charities that have the trust of the community have an important role to play. Trusted celebrities can also be more persuasive.”

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EU Accused Of ‘Almost Trumpian Act’ After Backtracking On Vaccine Block

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Cats And Dogs May Need A Covid Vaccine Of Their Own, Say Experts

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Had A Covid Vaccine? You Could Still Spread The Virus, Warns Van-Tam

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Halve 12-Week Gap Between Covid Vaccine Doses, Doctors Urge Government

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UK To Face Delays In Delivery Of Pfizer Vaccine

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The UK Is Cut Off From Much Of Europe – What You Need To Know About Freight And Travel Bans

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