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J&J's single-dose COVID-19 vaccine secures approval from the UK’s MHRA

Vaccine was found to be 67% effective in preventing COVID-19 infection in a phase 3 study

Johnson & Johnson’s (J&J) single-dose COVID-19 vaccine has secured authorisation from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), the regulator announced today.

Although the UK Vaccine Taskforce originally secured 30 million doses of the vaccine – also known as the Janssen COVID-19 vaccine – the UK has amended the amount and is now set to receive 20 million doses of the jab.

In a statement, the Department of Health and Social Care (DHSC) said the revised, lower amount of doses reflects the ‘unprecedented’ speed of the UK’s vaccination programme.

Earlier this week, the NHS announced that over 20 million people in England have now received both doses of a COVID-19 vaccine.

The NHS COVID-19 vaccination programme also opened to everyone in their thirties this week, as the health service revealed almost 32 million first vaccine doses have now been delivered.

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

He added: “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.”

The J&J COVID-19 vaccine has a 67% efficacy rate overall in preventing COVID-19 infection and is also 85% effective in preventing severe disease or hospitalisation, according to phase 3 study results.

Although J&J’s vaccine is administered in a single dose regimen, the UK government has included the vaccine as part of its Cov-Boost study, to assess its safety and efficacy as the third dose in a potential booster programme.

J&J is also continuing to explore a two-dose regimen of the vaccine, according to the DHSC.

The J&J COVID-19 vaccine is already approved in the EU and and the US, although the rollout of the jab was paused earlier this year following a small number of very rare blood clots observed in vaccinated individuals.

However, following a review,  US Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) recommended lifting the temporary pause on the jab, although regulators noted that women under the aged of 50 should be aware of the rare but increased risk of very rare blood clots with low platelets.

The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) also confirmed that the overall benefit-risk profile of J&J’s COVID-19 vaccine is positive.

The PRAC concluded, however, that a warning regarding unusual blood clots with low blood platelets should be added to the product information for the vaccine, after finding a possible link between the rare adverse events and the jab.

Article by
Lucy Parsons

1st June 2021

From: Regulatory



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