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J&J’s single-dose Covid vaccine gets US approval for emergency use

PT Jyothi Datta Mumbai | Updated on February 28, 2021

J&J files for emergency listing at WHO, other countries

The world’s first single-dose Covid-19 vaccine from Johnson and Johnson’s Janssen Pharmaceutical Companies has received a green signal in the United States, allowing its emergency use in individuals 18 years of age and older.

The approval of the single-dose vaccine by the US Food and Drug Administration (USFDA) comes at a critical time, as the world grapples with a short supply in vaccines and logistic issues force countries to delay giving the second shot of a two-dose vaccine.

The J&J vaccine becomes America’s third (after Pfizer-BionNTech and Moderna) to receive emergency-use authorisation (EUA) from the USFDA.

 

In fact, Paul Stoffels, J&J’s Vice-Chairman of the Executive Committee and Chief Scientific Officer, said the vaccine was a critical tool in fighting the global pandemic, “particularly as it shows protection across countries with different variants” .

Alliance with Biological E

India’s Biological E has a manufacturing alliance with J&J on this vaccine, J&J had announced last August. Mahima Datla, Managing Director of Biological E, was quoted earlier this month saying they were looking to make 600 million doses for J&J.

The vaccine requires standard storage and distribution conditions, and industry-watchers expect J&J to add to India’s basket of vaccines in the ongoing vaccination programme. But that can only be after approvals come from the Drug Controller General of India.

Meanwhile, J&J has made its submissions to the European Medicines Agency, besides filing for an Emergency-Use Listing (EUL) with the World Health Organisation. Rolling submissions have be initiated in several countries worldwideas well.

The vaccine was approximately 77 per cent effective in preventing severe/critical Covid-19 occurring at least 14 days after vaccination, and 85 per cent effective in preventing the same 28 days after vaccination, the USFDA said.

J&J officials have said in the past that the vaccine would be priced at $10. The company has committed about 500 million doses to GAVI, the vaccine alliance, by 2022. About 200 million of that was expected this year.

Vaccine features

The Janssen vaccine uses the adenovirus type 26 (Ad26) that helps deliver a piece of DNA (or genetic material) that is used to make the distinctive spike protein of the SARS-CoV-2 virus, the USFDA explained. On being vaccinated, the body can temporarily make the spike protein, which does not cause the disease, but triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2, it added.

The commonly reported side effects include pain at the injection site, headache, fatigue, muscle aches and nausea, the note said. And Janssen Biotech Inc (a Janssen Pharmaceutical Company) and vaccination providers must report serious adverse events, cases of Multisystem Inflammatory Syndrome and of Covid-19 that result in hospitalisation or death, it added.

The EUA was issued following analysis of data from 43,783 participants enrolled in an ongoing randomised, placebo-controlled study being conducted in South Africa, certain countries in South America, Mexico, and the US.

J&J said it has begun shipping its vaccine and expects to cover 20 million people in the US by March-end. About 100 million vaccines are expected to be delivered to the US during the first half of 2021.

Published on February 28, 2021

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