UK regulator FINALLY approves Johnson & Johnson’s single-dose Covid vaccine


Johnson & Johnson’s single-dose Covid vaccine has finally been authorised for use by the UK medicines regulator – but it won’t be available until later this year.

The Medicines and Healthcare products Regulatory Agency (MHRA), which polices the safety of drugs, today gave the jab the green light, three months after it was first submitted for approval.

No10’s vaccine minister Nadhim Zahawi hailed the jab as another ‘another weapon in our arsenal to beat the pandemic’.

Trials have shown the vaccine – which US regulators approved in February – to be 67 per cent effective at blocking Covid symptoms. Other studies have shown it is even better at preventing patients falling severely ill. 

Ministers originally hoped to give the jab to younger adults, with the promise of just one jab thought to appeal to twenty-somethings desperate to return to some degree of normality.

However, the vaccine works in a similar way to AstraZeneca’s and has been linked to blood clots. Belgium yesterday stopped offering the J&J jab to under-40s following the death of a woman who was given it. 

Britain has ordered 20million doses but these are not expected to start arriving until mid-summer. 

Ireland, where the jab has been dished out for several weeks, has warned of ‘serious concerns’ about supply. It is thought most of the supply in EU is made in Germany.  

Johnson & Johnson ‘s single-dose Covid vaccine has finally been authorised for use by the UK medicines regulator but it will not be available until later this year

Britain originally ordered 30million doses of the Johnson and Johnson, or Janssen, vaccine but its order has been reduced to 20million

Earlier this year, the single-dose vaccine was shown to be 67 per cent effective overall in preventing Covid infection

Earlier this year, the single-dose vaccine was shown to be 67 per cent effective overall in preventing Covid infection

GERMANY TO OFFER JOHNSON & JOHNSON JAB TO ALL AGE GROUPS 

Germany is to make Johnson & Johnson’s Covid vaccine available to all adults.

The country’s Health minister Jens Spahn announced the plans earlier this month, adding the shots will be offered on the advice of a doctor. 

Europe’s drug regulator backed J&J’s vaccine last month after examining cases of a rare blood clotting issue in US adults who received a dose. 

But it left it up to the European Union’s member states to decide how to use it.

Germany’s move to offer the J&J single-dose vaccine widely follows the lifting of restrictions last week on the AstraZeneca vaccine.

The AstraZeneca shot had been earmarked for people aged over 60 following similar reports of very rare but sometimes fatal clotting events in younger people, with women disproportionately affected.

Health and Social Care Secretary Matt Hancock said: ‘This is a further boost to the UK’s hugely successful vaccination programme, which has already saved over 13,000 lives, and means that we now have four safe and effective vaccines approved to help protect people from this awful virus.

‘As Janssen is a single-dose vaccine, it will play an important role in the months to come as we redouble our efforts to encourage everyone to get their jabs and potentially begin a booster programme later this year.’

As with all vaccines, the government is in regular contact with the manufacturers, including exploring how best to optimise supply across the current programme and preparing for a potential booster programme from later this year. 

The Vaccine Taskforce originally secured 30million doses of the Janssen vaccine last year, based on the predicted clinical need at the time. 

With the UK’s Covid vaccination programme continuing at an unprecedented scale and pace, the government has decided to amend its original order to 20million.

The Joint Committee on Vaccination and Immunisation (JCVI) will submit updated advice for the Janssen vaccine before doses become available. 

Vaccine Deployment Minister Nadhim Zahawi said: ‘The Janssen vaccine will be another weapon in our arsenal to beat this pandemic.

‘We are doing everything we can to vaccinate all adults as quickly as possible and I encourage everybody to come forward for a jab as soon as they are eligible.’  

In a clinical trial involving 43,783 people, published earlier this year, the level of protection against moderate to severe Covid infection was found to be 72 per cent in the United States arm of the trial.

It was 66 per cent in the Latin American arm of the trial, and 57 per cent in the South African arm, where a mutant variant of the virus has been dominating.

Data on clots has spooked health chiefs across Europe, with Denmark stopping the use of the jab completely and other nations restricting its use to older age groups. 

Britain has already recommended all under-40s should be offered an alternative to the AstraZeneca vaccine — which uses the same viral vector technology as Johnson & Johnson’s jab — but only because infection rates are so low.

UK health chiefs say the benefits of AstraZeneca’s two-dose jab for younger adults, who rarely get very ill with Covid, no longer clearly outweighs the risks.  

Regulators say the risk of suffering a blood clot after the jab is vanishingly small, but is higher in younger age groups at an estimated one in 60,000. Clots are happening alongside low platelet levels, a condition named thrombocytopenia.

J&J’s Covid vaccine uses the same technology as AstraZeneca’s, but the clot complication is likely even rarer. Studies in the US where it has already been dished out to millions, suggest the risk may be as low as one in 500,000. 

The European Medicines Agency has approved both vaccines, but said they should carry warnings about the possibility of blood clots.

Norway says it will still be able to get a first dose to all its 4.3million adults by the end of July, without the J&J or AstraZeneca vaccines.

It has ordered 8.4million shots of the two-dose mRNA Pfizer vaccine — or enough for 4.2million people — and will also receive several thousand doses of Moderna’s jab. 

Q&A: ALL YOU NEED TO KNOW ABOUT COVID VACCINES AND THEIR TINY RISK OF BLOOD CLOTS

IS THERE ANY PROOF THE JAB CAUSES THE BLOOD CLOTS?

Scientists have repeatedly insisted there is no proof yet that coronavirus vaccines cause the extremely rare complication — blood clots occurring alongside low platelet levels.

But officials are still investigating the link — found in recipients of both AstraZeneca and Johnson and Johnson’s vaccines — and can’t rule it out completely.

DO SCIENTISTS HAVE A THEORY FOR WHAT MAY BE THE LINK?  

Experts are stumped as to why the vaccines may be triggering blockages in very rare cases.

But one explanation gaining ground is that it may be down to an over-reaction in the immune system, making the body attack its own platelets — tiny chunks of cells inside blood that build clots to stop bleeding when someone is injured. 

Experts believe the jab could cause the body to produce antibodies – normally used to fight off viruses – which mistake platelets in the blood for foreign invaders and attack them.

To compensate, the body then overproduces platelets to replace those that are being attacked, causing the blood to thicken and raising the risk of clotting. This then causes levels of platelets to fall.

The researchers say the phenomenon is similar to one that can occur in heparin-induced thrombocytopenia (HIT), when sufferers take a drug called heparin.   

WHAT SYMPTOMS DO THEY CAUSE?

The EMA said symptoms can strike up to three weeks post-vaccination.

British regulators say the complication tends to occur four days after people first get jabbed. 

Symptoms of the two blood clots can include: 

  • Shortness of breath
  • Chest pain
  • Swollen legs
  • Persistent stomach pain
  • Severe or persistent headache
  • Blurred vision
  • Confusion
  • Seizures 
  • Skin bruising beyond the site of injection

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