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CORONAVIRUS CASUALTIES (Feb 28):- GLOBAL:- Total Cases: 11,44,64,297; Total Deaths: 25,39,067 Recovered: 9,00,08,036 BELGIUM:- Total Cases: 7,69,414; Total Deaths: 22,052 BRAZIL:- Total Cases: 1,05,17,232; Total deaths: 2,54,263 CANADA:- Total Cases: 8,64,196; Total Deaths: 21,960 CHINA:- Total Cases: 89,893 ; Total Deaths: 4,636 FRANCE:- Total Cases: 37,36,016; Total Deaths: 86,332 GERMANY:- Total Cases: 24,44,177 Total Deaths: 70,589 INDIA:- Total Cases: 1,10,96,731; Total Deaths: 1,57,087 INDONESIA:- Total Cases: 13,34,634; Total Deaths: 36,166 IRAN:- Total Cases: 16,31,169; Total Deaths: 60,073 ITALY:- Total Cases: 29,07,825; Total Deaths: 97,507 JAPAN:- Total Cases: 4,30,539; Total Deaths: 7,807 MEXICO:-Total Cases: 20,84,128; Total Deaths: 1,85,257 NETHERLANDS:- Total Cases: 10,84,021; Total Deaths: 15,543 PHILIPPINES:- Total Cases: 5,76,352; Total Deaths: 12,318 RUSSIA:- Total Cases: 42,46,079; Total Deaths: 86,122 S KOREA:- Total Cases: 89,676; Total Deaths: 1,603 SPAIN:-Total Cases: 31,88,553; Total Deaths: 69,142 SWEDEN:- Total Cases: 6,57,309 Total Deaths: 12,826 SWITZERLAND:-Total Cases: 5,54,932; Total Deaths: 9,966 UAE:- Total Cases: 3,91,524; Total Deaths: 1,221 UK:- Total Cases: 41,70,519; Total Deaths: 1,22,705; US:- Total Cases: 2,92,02,824; Total Deaths: 5,24,669 - India Travel Times.Com   [Estd: 1998]       * * *    Travel, More Travel, Travel Means A Million Things     * * *    
Pfizer's application for EUA for its mRNA vaccine rejected
Pfizer's application for emergency use authorisation (EUA) for its mRNA vaccine has been rejected by India as it has not conducted a clinical trial in the country as required. Besides, the vaccine is very costly and requires minus 70 deg C deep freeze storage.

NEW DELHI, Feb 5: The Central Drugs Standard Control Organization (CDSCO) has rejected Pfizer's application for emergency use authorisation (EUA) for its covid vaccine in the country. As per the rules, authorisation is given to a vaccine after clinical trials are conducted in the country and the data showing safety and efficacy is provided to the drugs regulator.

The vaccine is based on the new technology called mRNA, which is being used for the first time in the world by Pfizer and Moderna. Pfizer developed the vaccine jointly with BioNTech.

The subject expert committee of the CDSCO said on Wednesday, “The committee noted that incidents of palsy, anaphylaxis and other SAE’s have been reported during post marketing and the causality of the events with the vaccine is being investigated. Further, the firm has not proposed any plan to generate safety and immunogenicity data in Indian population."

The Drugs Controller General of India (DCGI) issues the authorisation only after the expert committee makes the necessary recommendation.

Earlier it was also reported that in clinical trials conducted elsewhere the vaccine had produced adverse events of side-effects. Four of the participants had suffered Bell's palsy, a facial paralysis, and a larger number presented anaphylactic symptoms.

Pfizer has since withdrawn its application for the EUA. “Based on the deliberations at the meeting and our understanding of additional information that the regulator may need, the company has decided to withdraw its application at this time. Pfizer will continue to engage with the authority and resubmit its approval request with additional information as it becomes available in the near future," the company said.

Pfizer had applied for EUA alongwith Bharat Biotech and Serum Institute of India, two Indian companies. While the latter two had provided the details of clinical trials, Pfizer did not have the data.

Pfizer vaccine is very costly and requires minus 70 deg C deep freeze storage which is difficult to manage with the Indian conditions, while the India-made vaccines - Covishield and Covaxin- are cheap and need only refrigerator temperature for storage.

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