India approved the use of two Covid-19 vaccines for emergency use on Sunday, launching one of the biggest world inoculation drives. India has approved the use of shots produced by both Astra Zeneca and the University of Oxford, and the local pharmaceutical company Bharat Biotech said the drug regulatory body. India is the second-worst affected country.
As for safety concerns about vaccines, VG Somani, Drug Controller General of India, said, “If there is the slightest safety concern, we will never approve anything” Vaccines are 110% safe. For any vaccine, some side effects such as mild fever, pain & allergies are normal.”
In addition, Cadila Healthcare Ltd was also given the green light by the DCGI to perform Phase 3 clinical trials of its Covid-19 ZyCoV-D vaccine candidate. In the coming weeks, the Pfizer vaccine and Russia’s Sputnik-V are likely to be approved for use in India.
The government is now expected to embark on one of the largest immunization programs, with almost 3 crore healthcare and frontline staff scheduled for dosage in the first round.
Here Is All You Need To Know About The Covid-19 Vaccines Approved In India:
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Serum Institute of India’s Covishield vaccine
On Sunday, India became the fourth country to accept coronavirus vaccines developed by Oxford University and AstraZeneca, created in the country by the Pune-based Serum Institute, after the United Kingdom, Argentina, and El Salvador. To date, SII has stored more than 50 million Covishield doses and currently has the capacity to make approximately 50-60 million doses a month.
Type of vaccine: The ChAdOx1 (also called AZD1222) vaccine is made from a weakened variant of a common cold adenovirus that causes chimpanzee infections.
Effectiveness: The overall efficacy of the AstraZeneca/Oxford vaccine was found to be 70.42 percent, well below Pfizer and Moderna vaccines, but above the 50 per cent threshold set by many regulators, Drug Controller General of India VG Somani said.
“The firm submitted data on safety, immunogenicity and efficacy to 23,745 participants aged 18 years or older from overseas clinical trials. Phase 2/3 clinical trial data on 1,000 participants in the country were also submitted and were found to be comparable to data from overseas clinical trials,” Somani said.
However, because data reported in November showed that half a dose followed by a full dose had a 90 percent success rate, whereas two full shots were 62 percent effective, the vaccine has been plagued by confusion regarding the most effective dosage. In December, Oxford said the vaccine had a stronger immune response when a two-full-dose regimen was given, citing data from early trials.
Dosage, duration of protection, and storage: The Subject Expert Committee (SEC) recommended that two full doses of the vaccine, administered 4-6 weeks apart, be accepted. The immune response may last for a minimum of one year. At temperatures between 2 °C and 8 °C, the vaccine can be processed.
Pricing: Serum Institute of India CEO Adar Poonawalla says the Oxford vaccine will be sold to the government for Rs 200 and to the public for Rs 1000.
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Bharat Biotech’s Covaxin
In cooperation with the Indian Council of Medical Research (ICMR), Covaxin was indigenously developed by Hyderabad-based Bharat Biotech.
Type of vaccine: Covaxin is an ‘inactivated’ vaccine created by the use of the killed coronavirus particles, which prevent it from infecting or replicating. The injection of special doses of such particles helps to create immunity by allowing the body to develop antibodies to the dead virus.
Effectiveness: Bharat Biotech’s Covaxin was “safe and provides a robust immune response,” said Indian Drug Controller General VG Somani. In India, the vaccine has not yet completed late-stage human clinical trials and no efficacy rate has yet been made public.
Price– Although the price of Covaxin has not been addressed, reports have suggested that Bharat Biotech is pricing the vaccine at Rs 350. A letter of intent (LoI) with Ocugen has already been signed by the company to co-develop Covaxin for the US market.
