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Johnson & Johnson Seeks Emergency Use Authorisation Of Its COVID-19 Vaccine In US

Pharmaceutical giant Johnson & Johnson (J&J) on February 4, submitted an application for emergency authorization for its COVID-19 vaccine.

Johnson & Johnson seeks emergency authorisation of its COVID-19 jab in US

Pharmaceutical giant Johnson & Johnson (J&J) on February 4, submitted an application for emergency authorization for its COVID-19 vaccine with US health authorities. The vaccine developed by J&J has shown an efficacy rate of 66 per cent overall, as per the latest results of clinical trials conducted on 44,000 people. The developers revealed that the jabs were also 85 per cent effective in preventing severe cases of the infection.

“J&J subsidiary Janssen Biotech "has submitted an application to the US Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) for its investigational single-dose Janssen COVID-19 vaccine candidate," a company statement read.

As of now, the US Food and Drug Administration (FDA) has given emergency approval to the vaccines developed by Moderna Inc. and Pfizer/BioNTech. However, under the new appointed Biden administration, American officials were mulling strategies to expedite their inculcation drive. Since J&J jabs require only single-dose, experts believe there were high chances of it getting approved.

The FDA has now said that it would convene its advisory committee on vaccines and world review the vaccine’s clinical trial data. The committee, which has not announced its meeting date as of yet, is tasked with overlooking if the vaccine candidate’s benefits outweigh its risks. If approved, J& J has asserted that it would supply 100 million doses in the first half of 2021. 

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66 per cent efficacy

Johnson & Johnson on January 29 said that its COVID-19 vaccine’s single-shot efficacy is 66 per cent in preventing the moderate and severe disease in a global Phase 3 trial and 85 per cent efficient against severe disease. It also said in a statement that its vaccine was 72 per cent effective against moderate and severe disease in the United States. However, the interim analysis has revealed striking different results from the ones developed by Pfizer-BioNTech and Moderna.  It might reportedly further give pause to people uncertain about which jab to get or when they shall be administered. The COVID-19 vaccines that are already in the market have shown efficacy as high as 95 per cent with even higher in some cases.  

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