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Johnson & Johnson’s Single-Dose COVID-19 Vaccine Gets Emergency Use Approval In India

The Johnson & Johnson’s single-dose vaccine will be brought to India through a supply agreement with homegrown vaccine maker Biological E Limited

Studies have shown that the Johnson & Johnson vaccine is 66 per cent effective in preventing cases of moderate to severe illness and 85 per cent effective against severe cases of COVID-19
Highlights
  • Five vaccines have been granted Emergency Use Authorisation in India
  • Covishield, Covaxin, Sputnik V, Moderna and J&J are these 5 vaccines
  • This will further boost our nation’s fight against #COVID19: Government

New Delhi: Johnson & Johnson’s single-dose COVID-19 vaccine has been given Emergency Use approval in India, Union Health Minister Mansukh Mandaviya said on Saturday. He said this will further boost the country’s collective fight against the coronavirus infection.

“India expands its vaccine basket! Johnson and Johnson’s single-dose COVID-19 vaccine is given approval for Emergency Use in India. Now India has five EUA vaccines. This will further boost our nation’s collective fight against #COVID19,” the minister tweeted.

Also Read: Mixing And Matching Of Vaccines Will Help Overcome Shortage: Dr Gagandeep Kang

The US-based pharmaceutical company had applied for Emergency Use Authorisation for its jab on Friday and was granted the approval the same day by the Drugs Controller General of India (DCGI), a senior official said.

In a statement, Johnson & Johnson India said this was an important step forward in accelerating the availability of its COVID-19 vaccine to help end the pandemic.

We are pleased to announce that on 7th August 2021, the government of India issued Emergency Use Authorization (EUA) for the Johnson & Johnson COVID-19 single-dose vaccine in India, to prevent COVID-19 in individuals 18 years of age and older, a company spokesperson said. This decision was based on topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, which demonstrated our single-shot vaccine was 85 per cent effective in preventing severe disease across all regions studied, and showed protection against COVID-19-related hospitalisation and death, beginning 28 days after vaccination,” the spokesperson added.

The five vaccines granted Emergency Use Authorisation in India are Serum Institute’s Covishield, Bharat Biotech’s Covaxin, Russia’s Sputnik V, Moderna and now Johnson & Johnson (J&J). J&J earlier had sought approval to conduct phase-3 clinical trial of its vaccine on approximately 600 participants in two age groups – those aged 18 and below 60 years and those aged 60 years and above – to evaluate the safety, reactogenicity and immunogenicity of the jab in healthy Indian adults. However, on July 29, the firm withdrew its proposal. A health ministry official at a recent press conference had clarified that J&J earlier applied for conducting phase-3 clinical trial of its vaccine.

Also Read: Flu Shot May Protect Against Severe Effects Of COVID-19: Study

The application was to undertake clinical trial and when we issued relaxed guidelines in which we said if you had approval from other regulatory bodies of other countries, then exemption would be given from clinical trials, and emergency use authorisation would be granted and trial could be continued later on, so now since they did not need it they withdrew that application, the official had said.

In a bid to fast-track emergency approvals for all foreign produced coronavirus jabs, the central government had announced that COVID-19 vaccines which were approved for restricted use by regulators in the US, UK, Europe and Japan, or which were on the World Health Organisation’s Emergency Use Listing, would not have to conduct bridging clinical trials in India.

(Except for the headline, this story has not been edited by NDTV staff and is published from a syndicated feed.)

NDTV – Dettol Banega Swasth India campaign is an extension of the five-year-old Banega Swachh India initiative helmed by Campaign Ambassador Amitabh Bachchan. It aims to spread awareness about critical health issues facing the country. In wake of the current COVID-19 pandemic, the need for WASH (WaterSanitation and Hygiene) is reaffirmed as handwashing is one of the ways to prevent Coronavirus infection and other diseases. The campaign highlights the importance of nutrition and healthcare for women and children to prevent maternal and child mortality, fight malnutrition, stunting, wasting, anaemia and disease prevention through vaccines. Importance of programmes like Public Distribution System (PDS), Mid-day Meal Scheme, POSHAN Abhiyan and the role of Aganwadis and ASHA workers are also covered. Only a Swachh or clean India where toilets are used and open defecation free (ODF) status achieved as part of the Swachh Bharat Abhiyan launched by Prime Minister Narendra Modi in 2014, can eradicate diseases like diahorrea and become a Swasth or healthy India. The campaign will continue to cover issues like air pollutionwaste managementplastic banmanual scavenging and sanitation workers and menstrual hygiene

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