PIB’S BULLETIN ON CORONA VIRUS

• India’s total Active Caseload has reached 12,64,698. It now comprises 9.24% of the country’s total Positive Cases. A net incline of 63,689 cases recorded from the total active caseload in the last 24 hours.
• The five States of Maharashtra, Chhattisgarh, Karnataka, Uttar Pradesh and Kerala cumulatively account for 68.85% of India’s total Active Cases. Maharashtra alone accounts for 44.78% of the total active caseload of the country.
• India’s cumulative recoveries stand at 1,22,53,697 today. The National Recovery Rate is 89.51%.
• 97,168 recoveries were registered in the last 24 hours.
• 879 deaths were reported in the last 24 hours.
• Thirteen States/UTs have not reported any COVID19 deaths in the last 24 hours. These are J&K (UT), Assam, Ladakh (UT), D&D & D&N, Tripura, Meghalaya, Sikkim, Nagaland, Mizoram,Manipur, Lakshadweep, A&N Islands and Arunachal Pradesh.

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The matter of augmenting the Basket of Vaccines available for fighting the pandemic as well as to accelerate the pace & coverage of domestic vaccination programme was discussed in the 23rd meeting of the National Expert Group on Vaccine Administration for COVID (NEGVAC) held on 11th April 2021, chaired by Dr. V K Paul, Member (Health), Niti Aayog.The NEGVAC, after comprehensive deliberation, recommended that vaccines for COVID, which have been developed & are being manufactured in foreign countries and which have been granted emergency approval for restricted use by USFDA, EMA, UK MHRA, PMDA Japan or which are listed in WHO(Emergency Use Listing) may be granted emergency use approval in India, mandating the requirement of post-approval parallel bridging clinical trial in place of conduct of local clinical trial as per the provisions prescribed under Second Schedule of the New Drugs & Clinical Trials Rules 2019.The Union Government, after due consideration, has accepted the recommendation of NEGVAC.This decision will facilitate quicker access to such foreign vaccines by India & would encourage imports including import of bulk drug material, optimal utilisation of domestic fill and finish capacity etc., which will in turn provide a fillip to vaccine manufacturing capacity and total vaccine availability for domestic.

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The approval of the vaccine in Russia along with its conditions/restrictions was also reviewed by the SEC. The SEC noted that the safety & immunogenicity data presented by the firm from the Indian study is comparable with that of the Phase III clinical trial interim data from Russia.After detailed deliberation the SEC recommended for grant of permission for restricted use in emergency situations subject to various regulatory provisions.The vaccine is indicated for active immunization to prevent COVID-19 disease in individuals of ≥ 18 years of age. The vaccine should be administered intramuscularly in two doses of 0.5 ml each with interval of 21 days. (Day 0: Component I & Day 21: Component II). The vaccine has to be stored at -18°C. The vaccine comprises of two components I & II, which are not interchangeable. After careful consideration, the recommendations of the SEC have been accepted by the Drugs Control General (India). M/s DRL will import the vaccine for use in the country.

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This funding has been awarded under the’Mission COVID Suraksha- The Indian COVID Vaccine Development Mission by DBT’s dedicated Mission Implementation Unit at Biotechnology Industry Research Assistance Council (BIRAC) after multiplerounds of evaluation of all the applications that were submitted in response to the ‘Request for Expression of Interest (REOI)’under Mission COVID Surakshafor the Development of COVID vaccine candidate’.

DBT has been hand holding Gennova’s right from the start and has facilitated establishing Gennova’s mRNA-based next-generation vaccine manufacturing platform by providing seed funding for the development of HGCO19. Gennova, in collaboration with HDT Biotech Corporation, USA,has developed theCOVID-19mRNA vaccine – HGCO19. HGCO19 has already demonstrated safety, immunogenicity, neutralization antibody activityin the rodent and non-human primate models. The neutralizing antibody response of the vaccine in mice and non-human primates was comparable with the sera from the convalescent patients of COVID. mRNA vaccines are considered safe as mRNA is non-infectious, nonintegrating in nature, and degraded by standard cellular mechanisms