European drug regulators could give Johnson and Johnson’s Covid vaccine the green light as early as today in a boost to the continent’s roll-out.
Plans to dish out the jab were put on ice by the company itself last week amid concerns over a handful of very rare blood clots reported in the US.
But now the European Medicines Agency (EMA) looks set to approve the one-shot vaccine as safe for use, after first approving it in March before the blood clot scare.
It will hold a meeting to discuss the issue today. J&J boss Joseph Wolk told CNBC he was ‘very hopeful that the benefit-risk profile will play out’ and that the firm hoped to have ‘some resolution’ to the EU and US suspensions by the end of the week.
Regulators have been assessing the potential risks of using the jab, as they did with AstraZeneca’s, and are expected to come to a decision this week.
The US pharmaceutical giant is aiming to get 50million doses to the continent by July, with European capitals told to stockpile them ahead of the EMA’s decision.
Britain has ordered 30million doses but it hasn’t yet been approved by the regulator and deliveries are not expected until summer.
Johnson and Johnson took the decision to ‘proactively delay’ their European roll-out after six cases of rare blood clots were identified in the US out of more than seven million doses given.
The US also suspended its use after health chiefs at the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) both recommended the move out of ‘an abundance of caution’. They are expected to start using it again this week.
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 and it can trigger strokes.
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.
Johnson and Johnson’s vaccine could be available for use in Europe again this week, with a ruling from the European Medicines Agency (EMA) expected today
The EMA said that there were only an ‘extremely small’ number of blood clots reported out of millions of people to have been given the vaccine.
And officials are expected to lift the suspension of the jab are get vaccines flowing again, hoping to speed up their rollout as summer approaches.
A senior EU official said the union will have enough vaccine doses to cover 70 per cent of its adult population by mid-July.
‘I am now certain of how many doses are currently in production and I know how many millions will be delivered each week,’ internal markets commissioner Thierry Breton told French newspaper Le Figaro.
‘This allows me to assure you that we well have by mid-July the number of doses necessary for vaccinating 70 per cent of the European Union’s adult population.’
The delay to the roll-out of J&J’s vaccine has been yet another dent in the bloc’s shambolic vaccination drive, which has lagged far behind Britain and the US.
The EU-run scheme has been plagued by supply shortages, logistical problems, and concerns over blood clots – which even earnt it criticism from the World Health Organization which called it ‘unacceptably slow’.
Experts warn this latest timetable hiccup could further shake vaccine confidence on the continent.
J&J ROLL-OUT PAUSE DENTED VACCINE CONFIDENCE IN THE US, STUDY SHOWS
Pauses to the Johnson and Johnson Covid vaccine roll-out has dented confidence in jabs in the US, research shows.
American regulators took the decision last week after a handful of cases of very rare blood shots were reported following vaccination.
Authorities hoped that by acting quickly, they would be able to boost public confidence in the jab.
But polling data from YouGov shows the decision had the opposite affect.
Around 50 per cent of Americans said the jab was safe before they took the decision, but this dropped to below 40 per cent following the suspensions.
At the same time the number who thought it was unsafe rose from around 25 per cent to 40 per cent.
The results were based on questionnaires given to 1,500 Americans and reported by The Economist.
The EU has ordered more than 200million doses of the vaccine, made by J&J’s Belgian partner firm Janssen. The first quarter of this batch is set to have arrived by July and Italy, Romania, the Netherlands, Denmark and Croatia have all already taken deliveries, according to the Associated Press.
The J&J jab first sparked concerns in the US when medical chiefs spotted cases of the rare CSVT clots were appearing in vaccinated people as they had done in Europe after the AstraZeneca jabs.
It is not clear what is triggering the clots, but experts say it may be down to adenovirus technology on which both vaccines rely. In very rare cases it can cause the immune system to overreact and begin attacking its own platelets instead of the virus.
When this happens the body may overproduce platelets, which are used to form clots, to replace those being destroyed by the immune system. This can then trigger clots.
Professor Eleanor Riley, an infectious diseases expert at Edinburgh University, said: ‘Suspicion is rising that these rare cases may be triggered by the adenovirus component of the AstraZeneca and J&J vaccines,’ she said.
‘It remains the case that for the vast majority of adults in Europe and the US, the risks associated with contracting Covid far, far outweigh any risk of being vaccinated.’
Johnson and Johnson claims blood clots have been recorded following vaccination with Pfizer and Moderna’s shots.
But experts say a background level of blood clots are expected, as a certain number of people will develop them regardless of whether they had the vaccine.
It comes as top US infectious diseases expert Dr Anthony Fauci said the country’s decision to hit the pause button on the jabs roll-out could be reversed within days.
He added there would likely be rules on how it is used, with either a ‘warning’ put on it or a recommendation that the jab is not offered to some age groups.
Announcing it was delaying the EU roll-out last week, J&J said in a statement: ‘The safety and well-being of the people who use our products is our number one priority.
‘We are aware of an extremely rare disorder involving people with blood clots in combination with low platelets in a small number of individuals who have received our Covid vaccine.
‘The CDC and FDA are reviewing data involving six reported US cases out of more than 6.8million doses administered.
WHAT IS CVST?
Cerebral venous sinus thrombosis (CVST) is an extremely rare type of blood clot in the brain.
It may also be abbreviated to CSVT or just CVT – they are all basically the same.
It occurs when the vein that drains blood from the brain is blocked by a blood clot, resulting in potentially deadly bleeding or a stroke.
Symptoms can quickly deteriorate from a headache, blurred vision and faintness to complete loss of control over movement and seizures.
John Hopkins University estimates it 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.
Britain’s regulator said CSVT is so rare they aren’t even sure how common it is in the general population.
‘Out of an abundance of caution, the CDC and FDA have recommended a pause in the use of our vaccine.
‘In addition, we have been reviewing these cases with European health authorities. We have made the decision to proactively delay the rollout of our vaccine in Europe.
‘We have been working closely with medical experts and health authorities, and we strongly support the open communication of this information to healthcare professionals and the public.’
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.
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.’