Johnson and Johnson today revealed it would pause the roll-out of its single-dose Covid vaccine in Europe over blood clot fears.
The US pharmaceutical giant promised to deliver 50million doses to the continent by the end of June, with the first batch of supplies expected in the coming weeks.
But the firm has now taken the decision to ‘proactively delay’ the roll-out in Europe while experts review six cases of an extremely rare clotting disorder in the US.
American regulators today called for the jab to be temporarily suspended while they investigate the complication – also linked to AstraZeneca’s similar vaccine.
Health chiefs at the Food and Drug Administration (FDA) and the Center for Disease Control and Prevention (CDC) both recommended the move out of ‘an abundance of caution’. Around 7million Americans have already received the jab.
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.
British health officials have yet to approve the J&J vaccine but regulators are set to give it the green light within days, insiders claim. Health bosses today promised the safety data would be reviewed ‘very carefully’ and that they would keep a ‘very close eye on the American situation.
No10 has ordered 30million doses of the jab, which would be enough to immunise more than half of the adult population. But deliveries aren’t expected until July.
The Department of Health said J&J’s European delays would not derail the UK’s ambition of offering a jab to all adults by the end of July.
One of the UK’s top vaccine advisers said the jab could be restricted in younger age groups, as has been done with AstraZeneca’s, if its link to clots is shored up.
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. Experts say it is occurring in combination with low levels of blood platelets.
Officials insist the disorder — the same as the one seen in AstraZeneca’s vaccine — is extremely rare but seems to be happening slightly more often in young people who have been vaccinated.
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
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
The FDA can’t force American 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.
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
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.’
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.
Professor Anthony Harnden, deputy chair of the Joint Committee on Vaccination and Immunisation (JCVI), No10’s expert vaccine advisory group, suggested the J&J vaccine could be restricted in younger Brits.
He added: ‘The Jansen vaccine uses the same technology platform as the Oxford Astra Zeneca vaccine, albeit a different adenovirus vector.
‘So although the most recent data about this rare adverse event in the US still has many uncertainties it clearly requires both the MHRA and JCVI to scrutinise any new data related to both vaccines as it emerges.
‘The observation of cases of thrombosis and thrombocytopenia in those receiving the Jansen vaccine in the US will need to be carefully reviewed – depending on outcomes of any review there may be implications for the recommendation of the Janssen vaccine in the younger age groups in the UK where the risk from severe Covid is much less than in older age groups and in those with underlying illnesses.’
Both AstraZeneca and the J&J vaccines are viral vector types, which use a weakened version of a different virus to deliver instructions to human cells.
They tell the cells to produce a harmless piece of Covid, known as a spike protein, so the body can recognise it if the real virus infects them.
Scientists are interested in whether the clotting issues are related to the engineered spike protein specifically, a senior SAGE source revealed last week.
This could explain why clotting conditions have been widely reported in people who catch the real coronavirus.
However, the SAGE member said this would not account for why clotting issues have not been linked to the Pfizer or Moderna vaccines.
Those vaccines use different technology to deliver the genetic instruction to the cells but they also trigger the body to make and recognise spike proteins.
The Department of Health and Social Care (DHSC) insisted J&J’s decision to delay the rollout of its vaccine in Europe would not derail the UK’s programme to offer a jab to all adults by the end of July.
A DHSC spokesman said: ‘Our vaccination programme continues to make phenomenal progress – with over 40 million vaccines administered so far.
‘We have hit our target to offer a vaccine to everyone in phase one of the vaccination programme and we are on track to offer a jab to all adults by the end of July.’
The 30 million doses are expected to arrive in the second half of 2021 if approved by the MHRA.
The regulator’s director of licensing Dr Siu Ping Lam said: ‘No vaccine would be authorised for use in the UK unless the expected high standards of safety, quality and effectiveness have been met.
‘Vaccine safety is of paramount importance and we will monitor and evaluate any safety reports received promptly and robustly before a decision is made, working and sharing safety data with international regulators as necessary.’
Clinical trials suggest the J&J 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 60million 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.
‘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 — three of which occurred in the US.
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.
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
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.