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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 at the earliest. 

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. 

J&J has yet to brag that its vaccine works against the Indian variant, which is growing quickly in Britain. But experts are confident it should still beat the mutant strain, with other jabs known to still be effective.

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

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

BELGIUM HALTS JOHNSON & JOHNSON JABS FOR UNDER-40s

Belgium has stopped giving out Johnson & Johnson vaccines to people aged 40 or below after the death of a 37-year-old woman who was given it.  

Belgium’s health minister on Wednesday said: ‘The Inter-ministerial conference has decided to temporarily administer Janssen’s vaccine to the general population from the age of 41 years, pending a more detailed benefit-risk analysis by the EMA.’

The EMA, the European Union’s medicines regulator, said it was reviewing the ‘first fatal report’ of a 37-year-old woman in Belgium who had suffered from a blood clot with low platelets, a condition previously associated with the shot.

It added it had asked the US drugmaker to carry out a series of additional studies to assess a possible link between the shot and the rare clotting condition.

J&J said product safety was its paramount concern and that the EMA had left it to EU member states to decide on vaccine use, taking into account how fast the virus was spreading and whether alternative vaccines were available.

The company said: ‘As the global pandemic continues to devastate communities around the world, we believe a single-shot, easily transportable Covid-19 vaccine with demonstrated protection against multiple variants can help protect the health and safety of people everywhere.’

The woman died on May 21 after being admitted to hospital with severe thrombosis and platelet deficiency, the ministry’s statement said.

She was vaccinated through her employer, outside of the official Belgian vaccination campaign.

Belgium has so far administered about 40,000 J&J shots, with 80 per cent of those to people over 45 years old, the statement said.

The EMA said more than 1.34 million J&J doses had been administered within the EU.

J&J said on April 20 it would resume rolling out its Covid-19 vaccine in Europe with a warning on its label, after requesting countries, including Belgium, to pause its use amid concerns about possible links to rare blood clots.

J&J has said that no clear causal relationship has been established between the vaccine and the clots.

The Janssen one-dose vaccine is primarily used in Belgium for home vaccination of the elderly and a number of vulnerable groups including the homeless and undocumented migrants.

Most EU countries are using the J&J shot, although Denmark has excluded it from its vaccination programme and Italy has restricted its use to older people.

The approval makes it the fourth coronavirus vaccine to be given the green light in Britain, following ones made by Pfizer, AstraZeneca and Moderna. J&J’s jab is made by the firm’s Belgian subsidiary Janssen. 

All of the other jabs currently being rolled out in Britain require two doses given at least eight weeks apart. 

Health Secretary Matt Hancock said it was a ‘further boost to the hugely successful vaccination programme, which has already saved over 13,000 lives’.

He added: ‘It means that we now have four safe and effective vaccines approved to help protect people from this awful virus.

‘As it 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.’

Mr Zahawi said: ‘The 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.’

Meanwhile, Prime Minister Boris Johnson tweeted: ‘This is very welcome news and another boost to our hugely successful vaccination programme.

‘As we encourage everyone to get their jabs, the single-dose Janssen vaccine will play an important role in helping us protect people from the virus. When you get the call, get the jab.’ 

No10’s Vaccine Taskforce originally secured 30million doses of the vaccine last year, based on predicted demand at the time. 

But because of the huge success of UK’s vaccination programme, ministers reduced their order to 20m.  

The vaccine can be stored at fridge temperatures, between 2-8°C. It only takes three weeks for the jab to kick in and train the immune system to fight off Covid. But, like any vaccine, it is not perfect.  

In April, the European Medicines Agency ruled that the jab should come with a clear warning about a serious blood clotting disorder. It made the same recommendation for AstraZeneca’s jab.

Both vaccines have been linked to serious blood clots that have occurred alongside abnormally low blood platelet count, known as thrombocytopaenia.

The decision was made following eight cases of the disorder in more than 7million people vaccinated in the US. Updated figures show the J&J jab has now been linked to 28 cases from more than 10.4million shots. 

In April, the firm itself asked Europe to pause the roll-out of the jab to allow experts to probe the clot cases thoroughly. It later concluded the risk was rare and urged all countries to keep using it. 

Belgium yesterday it was suspending vaccinations with J&J’s jab for under-40s, after a 37-year-old woman died. 

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.

J&J say the vaccine works across multiple variants of coronavirus but there is no firm proof yet that it beats the Indian strain. 

Health Secretary Matt Hancock (pictured on Downing Street today) said the vaccine's approval was a 'further boost to the hugely successful vaccination programme'

Health Secretary Matt Hancock (pictured on Downing Street today) said the vaccine’s approval was a ‘further boost to the hugely successful vaccination programme’

Other jabs have been shown to be effective against B.1.617.2, so experts believe the jab will as well. 

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

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. 

J&J’s Covid vaccine uses the same adenovirus-based technology as AstraZeneca’s, but the clot complication appears even rarer.  

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 researchers in Germany believe the problem lies in the adenovirus vector — a common cold virus used so both vaccines can enter the body.

Academics investigating the issue say the complication is ‘completely absent’ in mRNA vaccines like Pfizer’s and Moderna’s because they have a different delivery mechanism.

Experts at Goethe-University of Frankfurt and Ulm University, in Helmholtz, say the AstraZeneca vaccine enters the nucleus of the cell – a blob of DNA in the middle. For comparison, the Pfizer jab enters the fluid around it that acts as a protein factory.

Bits of coronavirus proteins that get inside the nucleus can break up and the unusual fragments then get expelled out into the bloodstream, where they can trigger clotting in a tiny number of people, scientists claim.

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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