India expands its COVID-19 vaccine basket, J&J's single dose jab approved for emergency use

India has approved its fifth COVID-19 vaccine following the Emergency Use Authorisation (EUA) given to Johnson and Johnson's (J&J) unit Janssen's single-dose COVID-19 vaccine.

"Johnson and Johnson's single-dose COVID-19 vaccine is given approval for Emergency Use in India. Now India has 5 EUA vaccines. This will further boost our nation's collective fight against COVID-19," Union Health Minister Mansukh Mandaviya tweeted on Saturday.

On August 5, 2021, Johnson & Johnson had applied EUA for its single-dose covid-19 vaccine to the Government of India. J&J also had said the EUA application is a key milestone that would pave the way for offering the vaccine to India and other countries through a partnership with Hyderabad based vaccine manufacturer Biological E.  

So far India had approved four Covid-19 vaccines - Covaxin, Covishield, Sputnik V and Moderna.

Also Read: Johnson & Johnson seeks approval for its single dose Covid-19 vaccine in India

After 28 days of inoculation J&J's Ad26.CoV2.S vaccine was found to have an efficacy of 85.4% against severe disease and 93.1 % against hospitalisation. 

A single dose of the same Ad26.COV2.S was found in clinical trials to have an efficacy of 66.9% against symptomatic moderate and severe SARS-CoV-2 infection. J&J claims its single-shot vaccine showed strong promise against the delta variant and other emerging strains.

J&J was planning to make its single-shot J&J vaccine in India under the Quad Vaccine Partnership, an alliance of India, the US, Australia and Japan to make over a billion doses for use in Asia by the end of 2022. 

Biological E was looking to contract manufacture about 600 million doses of J&J vaccine annually. J&J was in talks with India's government to begin clinical trials of its single-dose COVID-19 vaccine in the country, but as per a recent directive from the drug controller general of India (DCGI), such post bridging clinical trials are not required for globally approved COVID-19 vaccines. Based on this, J&J last week withdrew its Indian clinical trial application.

Biological E, which has an in-house vaccine candidate in the final stages of launch and developed with a technical license with Houston-based health sciences university Baylor College of Medicine, now has the capacity to make over a billion doses, the only company in India other than the Serum Institute of India. 

Also Read: US FDA adds rare reaction risk warning to J&J COVID-19 vaccine

In August last year, Biological E had acquired Akorn India, a subsidiary of Akorn Inc., USA, primarily to access the facilities at Akorn India's Paonta Sahib Plant in Himachal Pradesh for commercial-scale manufacturing of vaccines. 

The sterile injectable manufacturing facility has 39,000 square metres of built-up area spread over a 14-acre campus with an annual capacity of about 135 million units, with the potential for immediate expansion of a further 30 million units.

Biological E also has another agreement with Janssen Pharmaceutica NV, one of the Janssen Pharmaceutical companies of Johnson & Johnson, for the creation and enhancement of manufacturing capacities for drug substance and drug products for Johnson & Johnson's COVID-19 vaccine candidate, Ad26.COV2.S.

Biological E currently makes eight World Health Organization (WHO) pre-qualified vaccines for tetanus, measles and rubella, pentavalent vaccines and snake anti-venom, and sells to over 100 countries. 

The company was started by Dr DVK Raju and G.A.N. Raju in 1953 as India's first biological products company manufacturing liver extracts and anti-coagulants.