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 will not be available until later this year.

The Medicines and Healthcare products Regulatory Agency (MHRA) today announced the vaccine meets the expected standards of safety, quality and effectiveness. 

Health Secretary Matt Hancock hailed the jab as another ‘another weapon in our arsenal to beat the pandemic’.

Earlier this year, the single-dose vaccine was shown to be 67 per cent effective overall in preventing Covid infection and 85 per cent effective in preventing severe disease or hospitalisation.

The vaccine can be stored at fridge temperatures, between two to eight degrees, making it ideal for distribution to care homes and other locations across the UK.

Professor Jonathan Van-Tam, previously said could be used for hard-to-reach groups of people, where recalling them for a second jab is not always successful.

Health officials believe the one dose schedule could be more appealing to vaccine-hesitant Britons, who they fear are harder to convince to turn up for two appointments. 

It only takes three weeks following injection to achieve full protection.  

The vaccines currently being rolled out in Britain require two doses, given three months apart. 

Britain originally ordered 30million doses of J&J’s vaccine but the order has been reduced to 20million these are not expected to start arriving until mid-summer.

In April, the European Medicines Agency said a warning about unusual blood clots with low blood platelet count should be added to the product information for the vaccine.

This followed eight cases of blood clots in more than seven million people vaccinated in the US. 

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

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

GERMANY TO OFFER JOHNSON AND 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.

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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.’ 

Johnson & Johnson say the vaccine works across multiple variants of coronavirus.

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. 

Link hienalouca.com

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