WHO issues EUL for J&J’s single-shot Covid-19 vaccine - Clinical Trials Arena
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WHO issues EUL for J&J’s single-shot Covid-19 vaccine

15 Mar 2021

The World Health Organization (WHO) has issued Emergency Use Listing (EUL) for the single-dose Covid-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) for individuals aged 18 years and above.

The World Health Organization (WHO) has issued Emergency Use Listing (EUL) for the single-dose Covid-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) for individuals aged 18 years and above.

Data from the Phase III ENSEMBLE study indicated that this vaccine was found to be well tolerated and showed a 67% reduction in symptomatic Covid-19 disease in participants who got the vaccine shot as against those given the placebo.

The study also found onset of protection from day 14, and this was maintained 28 days after vaccination.

Besides finding the vaccine to be 85% effective in preventing severe disease across all regions studied, the data also showed protection against Covid-19 associated hospitalisation and deaths across countries with several variants, commencing 28 days after vaccination.

Among the variants observed in the ongoing analysis in the ENSEMBLE study included the B.1.351 variant, which was detected in 95% of the Covid-19 cases in South Africa.

Johnson & Johnson (J&J) chairman and CEO Alex Gorsky said: “From the beginning of the pandemic, we have worked to develop and deliver a vaccine that could protect the health of people everywhere, and today’s milestone represents significant progress toward ensuring global access to our single-shot vaccine.

“We are moving forward with urgency and purpose to meet our commitments to the global community as we do all we can to help end the pandemic.”

The vaccine is expected to stay stable for two years at -25 to -15°C, and for a maximum of three months at routine refrigeration at temperatures of 2°-8°C.

The Phase III ENSEMBLE study is a randomised, double-blind, placebo-controlled clinical trial in individuals aged 18 years and above. The study enrolled a total of 43,783 participants.

The trial, carried out in eight countries, includes a broad population of which 34% of participants recruited were over the age of 60.

J&J vice chairman of the executive committee and chief scientific officer Paul Stoffels said: “The WHO listing of our single-shot Covid-19 vaccine advances our pledge to help stem this pandemic and our unwavering commitment to equitable access.

“Achieving this important prerequisite for distributing our vaccine through the Covax Facility which is co-led by Gavi is a major step forward in making our vaccine accessible for all.”

J&J signed an agreement in principle with Gavi, the Vaccine Alliance in support of the Covax facility, in December 2020.

The two entities expect to sign an advance purchase agreement to ensure availability of up to 500 million doses of J&J’s vaccine to Covax through 2022.

J&J’s Janssen Research & Development global head Mathai Mammen said: “A single-shot Covid-19 vaccine that can be distributed and stored using established supply chains has the potential to be very meaningful in the face of this global pandemic.

“In addition, the clinical data shared with WHO that informed the Emergency Use Listing demonstrated protection against disease across countries with multiple variants.”

The company secured Emergency Use Authorization (EUA) in the US for its single -shot vaccine on 27 February 2021. This vaccine was also secured Interim Order authorization in Canada on 5 March 2021 as well as Conditional Marketing Authorization (CMA) in the EU on 11 March 2021.

Meanwhile, India will manufacture the J&J’s single-shot Covid-19 vaccine as part of the Quad vaccine initiative. Japan and US will fund this project, while Australia will use the logistics capability to distribute the vaccines to countries in Southeast Asia and Pacific regions.