American healthcare company Johnson & Johnson said that real-world data from the US confirmed that their single-dose Covid vaccine provided “strong and long-lasting” protection against the disease.

The new data also showed that protection against Covid increased when a booster shot of the J&J vaccine was given, the company said. Taken two months after the first shot, the booster provided 94 per cent protection against Covid, and antibody levels rose four to six times higher than observed after the single shot, it added.

Besides, the safety profile of the vaccine also “remained consistent and was generally well-tolerated when administered as a booster”, said J&J.

Emergency-use approval

In fact, J&J’s vaccine is one of the foreign vaccines that have received an emergency-use approval in India, and according to reports, supply of the first lot could be as early as October. The company, however, did not comment on the reported development. J&J has a manufacturing and supply alliance in India with Biological E. Meanwhile, on the latest data that the company has made available, Mathai Mammen, Global Head, Janssen Research & Development, J&J, said: “Our large real-world evidence and Phase 3 studies confirm that the single-shot Johnson & Johnson vaccine provides strong and long-lasting protection against Covid-related hospitalisations. Additionally, our Phase 3 trial data further confirm protection against Covid-related death.” “It is critical to prioritise protecting as many people as possible against hospitalisation and death, given the continued spread of Covid. A single-shot vaccine that is easy to use, distribute and administer, and that provides strong and long-lasting protection is crucial to vaccinating the global population,” said Paul Stoffels, Vice-Chairman of the Executive Committee and Chief Scientific Officer at J&J.

J&J also said that it had provided available data to the US Food and Drug Administration (FDA) and that it plans to submit the data to other regulators, the World Health Organization (WHO) and National Immunization Technical Advisory Groups (NITAGs) worldwide, to inform decision-making on local vaccine administration strategies as needed.

Study data

Data from the US study demonstrated stable vaccine effectiveness of 79 per cent for Covid-related infections and 81 per cent for Covid-19-related hospitalisations, said the company.

“There was no evidence of reduced effectiveness over the study duration, including when the Delta variant became dominant in the US,” it added. The study included 3,90,000 people who received the J&J vaccine versus approximately 1.52 million unvaccinated people, and was conducted from March to late July 2021.

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