Thursday 28th of March 2024
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Headlines : * Rain with temporary gusty wind likely over Country   * 3 die as bus hits auto-rickshaw in M`sing   * 15 ferries, 20 launches to ply on Daulatdia-Paturia route during Eid   * Six houses gutted in Rangamati fire   * Baltimore divers recover 2 bodies from harbor after bridge collapse   * Bangladeshi youth shot dead by police in US   * Govt to import 50,000 metric tons of onion from India   * Bangabandhu`s independence proclamation history was distorted after 1975: PM   * Dhaka Metro Rail operations to continue past 9 pm from Wednesday   * Jatri Kalyan Samity demands to extend Eid vacation by 2 days  

   Health
J&J Seeks Permission for Phase-3 Trial of Its Single-Shot Covid Vaccine in India, Import Licence
  Date : 28-03-2024

International Desk: 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.

o 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.



  
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