The Drug Controller General of India on Sunday approved two made in India vaccine, the Covishield vaccine, manufactured by the Serum Institute of India and Oxford-AstraZeneca vaccine and the Covaxin manufactured by Bharat Biotech of India, for emergency use. The country’s national Drug regulator announced that the Central Drug Standard Control Organization (CDSCO) has decided to approve the recommendation of its Subject Expert Committee.
VG. Soumani, the drugs controller general said that the overall efficacy of the AstraZeneca/ Oxford vaccine is 70.42 per cent. The efficacy of the Covishield is quite low as compared to the Pfizer and Mondera vaccine but on the other hand way above than the 50 per cent threshold sent by other vaccines regulators.
According to Dr. Soumani, the firm submitted safety, immunogenicity and efficacy data generated on 23,745 participants aged 18 years or older from overseas clinical studies. Data of phase 2/3 clinical trials on 1000 participants within the country was also submitted and it was found comparable with the data from the overseas clinical studies. The government has not announced a timeline as of now however the process is likely to be very fast. It is reasonably expected that the mass vaccination program will be beginning very shortly, maybe even by next week. It is to be noted that the government has said that taking the vaccine is voluntarily and is not mandatory for anyone.
The government has initially announced that the 30 million healthcare workers who have helped India to fight the corona virus, the health minister announced that the vaccine will be administered to them for free of cost. The government is planning to finish the first trial of the vaccine by August 2021, the rest of the population will have to wait for the second phase of the vaccination programme. The Serum Institute has mentioned that it is ramping up its production of the vaccine in its facilities. Also, a number of other vaccines are supposed to be approved by India in the coming weeks.
Two rounds of dry run with the vaccine have already been held. The health minister has said that 96,000 vaccinators have been trained more than 75 lakh beneficiaries have been registered which will provide real time information on vaccine stocks, their storage, temperature, etc. The cold chain infrastructure has been upgraded to ensure last mile delivery and adequate supply of syringes and other logistics have also been arranged.
The center has said that it is advisable to receive the full vaccine of the diseases in spite of the past history of infection with the virus. This will help in building a strong immunity. Two doses of the vaccine 28 days apart must be taken by individuals. Protective anti bodies are generated two weeks after taking the second dosage of the vaccine. One cannot have two different types of vaccine; they should take only one type of vaccine twice to complete the dose.
As per reports the Covid-19 Vaccine Intelligent Network will be (Co-WIN) will be used to track the enlisted beneficiaries for vaccination and Covid-19 vaccine on a real time basis. The vaccination will not be done on spot, only pre-registered beneficiaries will be vaccinated on prioritization. One of the following documents will be required in order to register for the vaccination: Driving License, PAN Card, bank passbook, pension document, MENGRA job card, Voter ID, government issued service ID, official Ids of MPS/MLAs/ MLCs and health insurance smartcard. Photo ID is a must for both registration and verification of the beneficiary at the session site to ensure that the intended person is vaccinated with the state guidelines.