This is an archive article published on January 30, 2021
J&J single-shot vaccine found 66% effective in phase 3 clinical trials; what this means
The vaccine, developed at J&J’s Janssen Pharmaceutical Companies, will be the first single-dose vaccine introduced for commercial use, once cleared for emergency use.
New Delhi | Updated: January 30, 2021 08:21 PM IST
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Vials of Johnson and Johnson's vaccine for the novel coronavirus (Cheryl Gerber/Courtesy of Johnson & Johnson via AP)
In yet another promising development on Covid-19 vaccines, Johnson & Johnson announced on Friday that its single-shot candidate has been found 72% effective in the US; 66% effective overall at preventing “moderate to severe” Covid-19; and 85% effective in preventing severe disease across all regions studied, 28 days after vaccination in all adults 18 years and older.
The vaccine, developed at J&J’s Janssen Pharmaceutical Companies, will be the first single-dose vaccine introduced for commercial use, once cleared for emergency use. All other vaccines currently being administered require a booster second dose to trigger a robust immune response. J&J plans to file for US Emergency Use Authorisation in early February, and is expected to have the product ready to ship immediately following authorisation.
J&J is using its flagship AdVac vaccine platform , which was also used to develop and manufacture Janssen’s European Commission-approved Ebola vaccine regimen and construct its Zika, RSV, and HIV investigational vaccine candidates. Janssen’s AdVac vectors are based on a specific type of adenovirus — one genetically modified so that it can no longer replicate in humans and cause disease.
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The phase 3 trial is being conducted in eight countries across three continents — with 44% (19,302) of the participants in the US, 41% (17,905) in Central and South America (Argentina, Brazil, Chile, Colombia, Mexico, Peru) and 15% in South Africa. Nearly one-third (14,672) are over age 60.
“Efficacy against severe disease increased over time with no cases in vaccinated participants reported after day 49,” J&J said. It said the candidate demonstrated “complete protection” against Covid-related hospitalization and death, 28 days post-vaccination. “There was a clear effect of the vaccine on Covid-19 cases requiring medical intervention (hospitalization, ICU admission, mechanical ventilation, extracorporeal membrane oxygenation (ECMO), with no reported cases among participants who had received the Janssen Covid-19 vaccine, 28 days post-vaccination,” J&J said.
On safety, J&J said that overall fever rates were 9% with Grade 3 fever in just 0.2%. “Overall serious adverse events (SAEs) reported were higher in participants who received placebo as compared to the active vaccine candidate. No anaphylaxis was observed,” J&J said.
On Friday, AstraZeneca’s Covid-19 vaccine was recommended for conditional marketing authorisation (CMA) in the European Union. The EU announced that following a renewed request from the European Commission on January 27, AstraZeneca has agreed to publish a redacted contract signed between the two parties on August 27.
The announcement comes after AstraZeneca had announced it would only be able to deliver a fraction of the vaccine doses agreed upon for the first quarter. It claimed there were production problems at its European plants.
According to the contract, all EU member states can purchase 300 million doses of the AstraZeneca vaccine, with an option for a further 100 million doses, to be distributed on a population-based pro- rata basis; the contract also allows the member states to donate their doses to lower and middle income countries or to re-direct them to other European countries.
On Friday, the European Commission said it welcomed the company’s commitment “towards more transparency in its participation in the rollout of the EU Vaccines Strategy”.
Kaunain Sheriff M is an award-winning investigative journalist and the National Health Editor at The Indian Express. He is the author of Johnson & Johnson Files: The Indian Secrets of a Global Giant, an investigation into one of the world’s most powerful pharmaceutical companies.
With over a decade of experience, Kaunain brings deep expertise in three areas of investigative journalism: law, health, and data. He currently leads The Indian Express newsroom’s in-depth coverage of health.
His work has earned some of the most prestigious honours in journalism, including the Ramnath Goenka Award for Excellence in Journalism, the Society of Publishers in Asia (SOPA) Award, and the Mumbai Press Club’s Red Ink Award.
Kaunain has also collaborated on major global investigations. He was part of the Implant Files project with the International Consortium of Investigative Journalists (ICIJ), which exposed malpractices in the medical device industry across the world. He also contributed to an international investigation that uncovered how a Chinese big-data firm was monitoring thousands of prominent Indian individuals and institutions in real time.
Over the years, he has reported on several high-profile criminal trials, including the Hashimpura massacre, the 2G spectrum scam, and the coal block allocation case. Within The Indian Express, he has been honoured three times with the Indian Express Excellence Award for his investigations—on the anti-Sikh riots, the Vyapam exam scam, and the abuse of the National Security Act in Uttar Pradesh. ... Read More
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