New Delhi, February 5
Pfizer on Friday withdrew its application seeking grant of Emergency Use Authorisation (EUA) of its Covid vaccine in India after the regulators sought additional data.
Pfizer was the first to apply for EUA in India but has been repeatedly asked to update its data as the company never applied for any bridging studies here.
Under the Indian clinical trial rules, any company with a new drug or vaccine should apply for bridging studies in India to produce domestic safety data involving Indians.
Russia had very early on tied up with Dr Reddy’s Lab in Hyderabad to conduct bridging studies in India for Sputnik V vaccine.
Bird flu: No permission granted for vaccine use against avian influenza, Centre tells Parliament firstpost.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from firstpost.com Daily Mail and Mail on Sunday newspapers.
India has not given permission for use of any vaccine against bird flu nor other countries like the US, UK and the European Union have approved any such vaccine, the government informed Parliament on Friday. As per World Organization of Animal Health (OIE), vaccination is not considered the solution for the control of Avian Influenza (Bird Flu) if eradication is the desired result, Union Minister Sanjeev Kumar Balyan said in a written reply to the Rajya Sabha. Without the application of monitoring systems, strict biosecurity and depopulation in the face of infection, there is a possibility that these viruses could become endemic in vaccinated poultry populations, he said.
165 lakh COVID vaccine doses procured so far at cost of Rs 350.25 crore: MoS Health Ashwini Choubey
The existing infrastructure under Universal Immunization Programme is being used and simultaneously strengthened for deployment of vaccines, including storage and transportation.
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NEW DELHI: A total of 165 lakh doses of COVID-19 vaccines - Covishield and Covaxin - have been procured so far at a cost of Rs 350.25 crore, Minister of State for Health Ashwini Choubey told Lok Sabha on Friday.
Giving out the details of the number of vaccines already procured by the government, Choubey, in a written reply, said only two vaccines namely Covishield manufactured by the Serum Institute of India and Covaxin manufactured by Bharat Biotech International Limited have so far been granted permission for restricted use in emergency situation by the Drugs Controller General of India.
Read more about Centre to track casual links to determine Covid-19 vaccine liability on Business Standard. As for Serum Institute of India s Covishield approval, the drug regulator has mentioned in conditions to be met that the firm has to submit an India-specific risk management plan