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Covid: UK may approve one-dose Johnson & Johnson vaccine suspended by US FDA over blood clot fears

Covid vaccine blood clot fears have struck a second jab as the US today stopped using the Johnson & Johnson shot which the UK may approve within days.

The Food and Drug Administration (FDA) has called for use of the jab to be suspended after six young women developed blood clots after receiving it.

British vaccine regulators are expected to green-light the pioneering one-shot vaccine this week and to start receiving deliveries in the summer.

The UK has ordered 30million doses of the jab, which would be enough to immunise more than half of the adult population. 

However, they are not expected to be available until the second half of 2021, by which time most adults will have been vaccinated with a different jab and many of Johnson & Johnson’s will likely be surplus.

Around seven million people in the US have already been given the vaccine. It is one of three being used there, with 98million people given Pfizer’s and 85m given Moderna’s.

The six women who developed clots – representing a rate of around one in a million – were aged between 18 and 48; one of them died and another is in hospital, the New York Times reports. 

The condition in question, known as cerebral sinus venous thrombosis (CSVT), is the development of a blood clot in a vein that carries blood away from the brain. It is extremely rare but seems to be happening slightly more often in young people who have been vaccinated – although not in older people.

On Twitter the FDA said: ‘ We are recommending a pause in the use of this vaccine out of an abundance of caution… Right now, these adverse events appear to be extremely rare.’ 

The news makes Johnson & Johnson’s vaccine – made by a Belgian subsidiary called Janssen – the second to become embroiled in a blood clot scare.

Countries in Europe, including the UK, have stopped giving the AstraZeneca vaccine to young people because of concerns it might increase the likelihood of a rare type of brain blood clot that can trigger strokes. 

The news makes Johnson & Johnson’s vaccine – made by a Belgian subsidiary called Janssen – the second to become embroiled in a blood clot scare after European countries stopped using the AstraZeneca jab for the same reason

The FDA can’t force doctors to stop using the vaccine without stripping it of official approval, which it hasn’t done, so the decisions will be made by individual states.

Its decision will not affect the UK’s vaccine rollout for now because the Johnson & Johnson jab has not yet been approved by regulators or put into use. 

The MHRA, Britain’s drug regulator, is expected to issue a decision this week on whether the vaccine should be used.

If it gives the green light, the UK Government can buy 30million doses of the jab, which would be enough to vaccinate the same number of people. Unlike other vaccines, only one dose is needed to protect people from Covid.

EUROPE REGULATOR INVESTIGATING J&J JAB CLOT CASES

The European Medicines Agency last week launched a review of four blood clot cases in people who had received the Johnson & Johnson Covid vaccine.

Four serious cases of rare blood clots with low platelet counts were detected in people vaccinated with the jab in Europe. One of the people died, sparking a review from the European Medicines Authority (EMA).  

In the US, four clinics had already paused J&J vaccinations by Friday after eight people suffered ‘adverse reactions’.

Officials did not specify what types of reactions the eight people had to the shot, but said they were ‘consistent with common reactions in adults being vaccinated with any vaccine,’ and cited the number of cases as the trigger for the pause.  

Professor Peter Openshaw, a member of the Covid-19 clinical information network, told BBC Radio 4’s Today programme last week: ‘We still don’t know whether they are directly related and caused by the vaccine but it seems possible that they could be. 

‘It wouldn’t be surprising to find the J&J, the Janssen vaccine, also causes rare blood clots because it’s based on an adenovirus technology which is not that far away from the technology being used in the AstraZeneca vaccine.’

Asked if he was concerned it could undermine public confidence in coronavirus jabs, Professor Openshaw said: ‘These are extraordinarily rare events and there is no medicine that is going to be completely free of side effects but this is on the scale of the risk of adverse outcome you would expect if you get into a car and drive 250 miles, and many of us wouldn’t blink before taking that risk.’ 

Clinical trials suggest the vaccine offers 100 per cent protection from severe Covid leading to hospitalisation or death, and around 66 per cent protection from mild infection. 

Although officials are still likely to approve the vaccine because the risk of a blood clot is so tiny and not proven to be caused by the jab, it is possible that the UK could complete its vaccine rollout without Johnson & Johnson’s vaccine.

Using only Pfizer and Moderna’s vaccines for new patients from this point onwards would allow the country to vaccinate around 48million adults out of a total 52m.

Around 20million have already been given the Oxford/AstraZeneca jab, and the combined 57m doses of Pfizer and Moderna will be enough to immunise around 28.5m people, although some will be lost to wastage.

It is likely that the UK will get through the majority of these supplies, which are already being used, by the time J&J’s vaccine even starts to become available.

The company told MailOnline in February: ‘If approved by the MHRA, we expect to begin delivering the UK allocation in the second half of this year.’

In addition, the first batches of 30million ordered doses of the Novavax vaccine, being made at home in England, are expected to come on-stream even sooner.

That jab is likely to be put to the MHRA for approval this month and could start to be used soon after, its developers suggested in March.  

When all the Moderna and Pfizer doses are used up – and even if no more AstraZeneca vaccine is given to new patients – there will likely only be around four million people who haven’t had their first jab with one of those three. 

These four million could easily be mopped up with AstraZeneca’s vaccine, although this is no longer recommended for under-30s, or with Novavax.

The Government is sticking to its target of offering vaccine first doses to all adults in the UK by the end of July.

Announcing its decision on Twitter, the FDA – which has the same role as the MHRA in the UK – said: ‘Today FDA and CDC issued a statement regarding the Johnson & Johnson Covid-19 vaccine. 

‘We are recommending a pause in the use of this vaccine out of an abundance of caution.

This graphic shows how different Covid vaccines being used around the world compare. The UK is already using AstraZeneca, Pfizer and Moderna vaccines, and has ordered Johnson & Johnson's

 This graphic shows how different Covid vaccines being used around the world compare. The UK is already using AstraZeneca, Pfizer and Moderna vaccines, and has ordered Johnson & Johnson’s

HEALTH CHIEF FAUCI SAYS US MAY NOT USE ASTRAZENECA JAB

Dr Anthony Fauci today claimed the US may never need to use AstraZeneca’s Covid vaccine.

America’s top infectious disease expert said his country has already bought enough alternative jabs to inoculate all 330million people in the US.

He said this was not a ‘negative indictment’ of the Oxford University-developed jab, adding that it was ‘really quite good’. But Dr Fauci told BBC Radio 4: ‘It looks right now, at this point in time, that we will not need it.’

Dr Anthony Fauci

Dr Anthony Fauci

Officials across the Atlantic have already given at least one dose of either the Pfizer, Moderna or single-dose Johnson and Johnson jab to 120million people and have fully vaccinated 73million.

The abundance of American vaccines has meant Washington will likely not need to rely on foreign jabs this year, but Dr Fauci has not ruled out turning to AstraZeneca if there are future Covid outbreaks.

Dr Fauci — who has previously been critical of AstraZeneca’s trial data and the British regulator for ‘rushing’ vaccines through approval — tried to quell the growing lack of confidence in the vaccine due to its link to extremely are blood clots.

He said: ‘I think the AstraZeneca vaccine, from a standpoint of efficacy, is a good vaccine.

‘And if the safety issue gets straightened out in the European Union — which I understand is still in a bit of controversy about how to use it and when to use and what age groups to use it — the efficacy of that vaccine is really quite good.’ 

‘As of [April 12], 6.8m+ doses of the J&J vaccine have been administered in the US. CDC & FDA are reviewing data involving 6 reported US cases of a rare & severe type of blood clot in individuals after receiving the vaccine.  

‘Right now, these adverse events appear to be extremely rare.

‘Treatment of this specific type of blood clot is different from the treatment that might typically be administered. 

‘CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to further review these cases and assess their potential significance. FDA will review that analysis as it also investigates these cases. 

‘Until that process is complete, we are recommending this pause. This is important to ensure that the health care provider community is aware of the potential for these adverse events and can plan due to the unique treatment required with this type of blood clot.’

The European Medicines Agency last week launched a review of four blood clot cases in people who had received the Johnson & Johnson Covid vaccine.

Four serious cases of rare blood clots with low platelet counts were detected in people vaccinated with the jab in Europe. One of the people died, sparking a review from the European Medicines Authority (EMA). 

The blood clotting condition officials are worried about is called cerebral sinus vein thrombosis (CSVT).

It occurs when the vein that drains blood from the brain is blocked by a blood clot, resulting in potentially deadly bleeding.

Symptoms can quickly deteriorate from a headache, blurred vision and faintness to complete loss of control over movement and seizures.

According to Britain’s regulators, CSVT is so rare that experts aren’t even sure how common it is in the general population.

MHRA chief Dr June Raine said the blood clots in the vaccinated patients could also have been caused by Covid itself, rather than the vaccine.

John Hopkins University estimates CSVT affects five in a million people in the US every year, which would suggest 330 patients in Britain suffer from the condition annually.

According to the university, it can affect patients with low blood pressure, cancer, vascular diseases and those prone to blood clotting. Head injuries can also trigger the condition. 

The UK Medicines & Healthcare products Regulatory Agency said there still isn’t any proof of a link between CSVT and Covid vaccines.

It says the risk of dying of Covid is at least 1,000 times higher for most people, meaning getting the vaccine is still the safest option by far. 

UK VACCINE ROLLOUT EXPANDS TO 45 TO 49-YEAR-OLDS

The NHS website for booking Covid vaccine appointments crashed this morning just moments after the roll-out in England was widened to over-45s.

Health chiefs today opened up the national booking system for the next phase of the inoculation drive after No10 hit its April 15 goal of offering everyone in the top nine priority groups their first dose.

But the website ran into ‘technical difficulties’ when people in their 40s flocked online to book an appointment.

Users trying to get a jab were told: ‘The NHS site is currently experiencing technical difficulties. We are working to resolve these issues. Thank you for your patience.’ 

Others reported being placed in a queue with a holding screen which read: ‘You are in a queue. Lots of people [are] trying to book an appointment.’

Shortly after the site crashed, No10’s vaccine minister Nadhim Zahawi tweeted that the problem was ‘fixed’.

All over-50s in the UK have now been offered a first dose of a coronavirus vaccine

All over-50s in the UK have now been offered a first dose of a coronavirus vaccine

Moderna’s vaccine is also being dished out in England from today. But only 20 sites will get supplies of the US company’s jab this week, as supply trickles in at around 150,000 a week.

Ministers have bought 17million doses of Moderna’s vaccine, which is the third to be added to the NHS’ ‘armoury’, alongside jabs from Oxford/AstraZeneca and Pfizer.

Moderna’s jab — as well as leftover supplies of AstraZeneca and Pfizer that haven’t been reserved for second doses — will be used to move on to the next phase of the roll-out.

Boris Johnson hailed the ‘hugely significant milestone’ of offering jabs to everyone in phase one, as he revealed the Government would ‘move forward’ on its next goal of inviting every adult for a vaccine by the end of July.

He told reporters in Downing Street: ‘It’s great that we have managed to achieve the target of getting everyone in the one to nine (priority) groups vaccinated by the deadline, by the timetable – a little bit ahead actually, 32million people now have got their first dose, which is terrific.

‘We are going now to the 45-49 group, they are being asked to come forward.’

Asked about taking the next step in the vaccine roll-out despite warnings of supply issues, the PM said that April was ‘always going to be the second dose month’.

He added that No10 was ‘very confident about our vaccine supplies’. NHS officials had warned the first dose roll-out would drastically slow down in April because of a missing shipment of 5million doses of AstraZeneca’s jab manufactured India.

Read more at DailyMail.co.uk