29 Jun 2021: Cipla gets DCGI nod to import Moderna COVID-19 vaccine
The Drugs Controller General of India (DCGI) has reportedly allowed the pharmaceutical firm Cipla to import the COVID-19 vaccine developed by US-based biotechnology company Moderna Inc. On Monday, the company had submitted an application seeking the DCGI's approval to import the vaccine. Moderna's mRNA vaccine will be the fourth shot to be available for use in India. It is over 90% effective.
Quote: 'Permission granted for restricted use in emergency situations'
An official source told PTI, "Drugs Controller General of India (DCGI) has granted permission to Cipla to import Moderna's COVID-19 vaccine for restricted emergency use in the country as per the provisions of the New Drugs and Clinical Trial Rules, 2019 under Drugs and Cosmetics Act, 1940." "This permission is for restricted use in emergency situations in public interest," the source said.
Details: 7 days' safety data required before roll-out: Official
The official said, "The firm has to submit seven days safety assessment of the vaccine in first 100 beneficiaries before rolling out of the vaccine for further immunization program, according to the approval order." Cipla is seeking clarity and guidance on factors such as pricing, quantity, and indemnity clause, sources informed CNBC TV-18. Reportedly, no commercial deal has been reached yet.
US: US to donate doses through COVAX: Moderna
Additionally, the US government has notably agreed to donate some vaccine doses through the global COVAX initiative to India and has sought approval from the Central Drugs Standard Control Organisation (CDSCO), Moderna had said on Sunday. Cipla was previously close to committing over $1 billion as advance to the US firm for 50 million vaccine doses, according to PTI.
Working mechanism: How does Moderna's vaccine work?
Moderna's two-dose vaccine is based on messenger RNA (mRNA) technology. The vaccine involves mRNA carrying the genetic information for SARS-CoV-2's spike protein, which it uses to invade host cells. After vaccination, this protein is translated into the viral spike protein, which triggers an immune response. The vaccine can be stored at -20°C for six months and 4°C for 30 days.
Vaccines: India already using Covishield, COVAXIN, Sputnik V
India is already using the AstraZeneca-Oxford vaccine (labeled Covishield in India), Bharat Biotech's COVAXIN, and Russia's Sputnik V in its vaccination drive, which was launched on January 16, 2021. On June 1, India had waived testing of batches at the Central Drugs Laboratory for foreign-made vaccines that have already been approved by the US FDA, the United Kingdom's MHRA, or the World Health Organization.
The news article, Cipla gets DCGI nod to import Moderna COVID-19 vaccine appeared first on NewsBytes.
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