Saturday, Sep 18, 2021
Outlook.com
Outlook.com

J&J seeks permission for phase-3 trial of its single-shot COVID vaccine in India, import licence

J&J seeks permission for phase-3 trial of its single-shot COVID vaccine in India, import licence
outlookindia.com
1970-01-01T05:30:00+0530
By Payal Banerjee

(Eds: With additional inputs)

New Delhi, Apr 19 (PTI) Multinational pharma giant Johnson & Johnson has applied to India''s drug regulator seeking permission to conduct phase-3 clinical trial of its single-dose COVID-19 vaccine in India as well as import licence, sources said.

They said the company has sought an early meeting of the subject expert committee on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) to take a decision on its application.

This comes close to the heels of the central government last week deciding to fast-track emergency approvals for all foreign produced coronavirus jabs that have been given a similar nod by the World Health Organization or regulators in the United States, Europe, Britain or Japan.

Such vaccines will be given emergency use approval mandating the requirement of post-approval parallel bridging clinical trial in place of conduct of local clinical trial under the provisions of the New Drugs and Clinical Trials Rules 2019, the health ministry had said.

According to sources, Johnson & Johnson had applied on April 12 in the Global Clinical Trial Division through the Sugam online portal, instead of applying to the biological division which deals with vaccines and other biologicals.

"Due to the technicalities involved, Johnson & Johnson has resubmitted its application on Monday," a source said.

The J&J vaccine can be stored for up to three months in a temperature between 2 and 8 degrees Celsius.

Johnson & Johnson''s vaccine is a single-dose jab, whereas the three vaccines cleared by India so far are of doubles doses.

So far, two vaccines -- Oxford/Astrazeneca vaccine COVISHIELD manufactured by Serum Institute in India and indigenously developed COVAXIN by Bharat Biotech -- are being administered in India, while a third vaccine Sputnik V -- developed in Russia and to be imported and sold in India by Dr Reddy''s Laboratories -- has also been approved by the Indian drug regulator.

The government, meanwhile, on Monday decided to expand its vaccination drive by allowing everyone above 18 years of age eligible to be vaccinated from May 1 and permitted state governments, private hospitals and industrial establishments to procure the doses directly from manufacturers. PTI PLB BJ SMN

SMN


Disclaimer :- This story has not been edited by Outlook staff and is auto-generated from news agency feeds. Source: PTI

More from Website

Live Streaming Of Chennai Super Kings Vs Mumbai Indians, IPL 2021: Where To See Live Action

Live Streaming Of Chennai Super Kings Vs Mumbai Indians, IPL 2021: Where To See Live Action

Indian Premier League (IPL) 2021 resumes with a clash between Chennai Super Kings and Mumbai Indians at Dubai. Check match and telecast details

Centre Cuts Down Babul Supriyo's Security Cover As The Former BJP-MP Joins TMC

Centre Cuts Down Babul Supriyo's Security Cover As The Former BJP-MP Joins TMC

The cover has been reduced from the second-highest level of Z category to Y category, after an order was issued by the Union home ministry on Friday.

Raninder Singh, Son Of Capt. Amarinder Singh, Re-elected NRAI President For Fourth Time

Raninder Singh, Son Of Capt. Amarinder Singh, Re-elected NRAI President For Fourth Time

Raninder, son of incumbent Punjab chief minister and Congress leader Capt. Amarinder Singh, became the president of the NRAI for the first time in 2010.

More from Outlook Magazine

Crouching Tigers

Crouching Tigers

Ghee Bowman brings to light the forgotten story of an Indian force’s role in the Battle of France and their fighting withdrawal through Dunkirk. In this excerpt, individual units arrive in northern France and take their positions, awaiting the Wehrmacht onslaught.

Outlook-ICARE India’s Top Universities Rankings 2021: Top 21 Private Medical Universities

Outlook-ICARE India’s Top Universities Rankings 2021: Top 21 Private Medical Universities

Outlook's annual ranking of India’s top 21 Private Medical Universities in 2021 will help students make an informed choice.

Outlook-ICARE India’s Top Universities Rankings 2021: Top 15 Government Medical Universities

Outlook-ICARE India’s Top Universities Rankings 2021: Top 15 Government Medical Universities

Outlook's annual ranking of India’s top 15 Government Medical Universities in 2021 will help students make an informed choice.

Advertisement

Outlook Newsletters

Advertisement