Covid-19 has infected more than 1 crore people and killed 1.5 lakh so far. On Sunday, the Drug Controller General of India (DCGI), the country’s national drug regulator, gave nod to two coronavirus vaccines for restricted emergency use — Serum Institute of India’s Covishield and Bharat Biotech’s Covaxin.
Drugs Controller General of India, VG Somani said, “We will never approve anything if there’s slightest of safety concern. Vaccines are 110 % safe. Some side effects like mild fever, pain & allergy are common for every vaccine.”
That’s not all, the DCGI also approved Cadila Healthcare Ltd to conduct Phase 3 clinical trials of its ZyCoV-D vaccine candidate for Covid-19. In the coming weeks, the Pfizer vaccine and Russia’s Sputnik-V are likely to be approved for use in India.
Here is all you need to know about the Covid-19 vaccines approved in India:
Serum Institute of India’s Covishield vaccine
On Sunday, India became the fourth country after the UK, Argentina and El Salvador to approve the Covid vaccine developed by Oxford University and AstraZeneca, which is being manufactured in the country by Pune-based Serum Institute. At present, more than 50 million doses of Covidshield have been stocked and currently has a capacity to make around 50-60 million doses a month.
Type of vaccine:
Made from a weakened version of a common cold adenovirus, the ChAdOx1 vaccine (also christened AZD1222) causes infections in chimpanzees.
Effectiveness:
Drugs Controller General of India VG Somani said the overall efficacy of the AstraZeneca/Oxford vaccine was found to be 70.42 per cent — well below vaccines from Pfizer and Moderna, but above the 50 per cent threshold set by many regulators.
“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 1,000 participants within the country was also submitted and it was found comparable with the data from the overseas clinical studies,” Somani said.
However, the vaccine is under question ever since data published in November showed a half dose followed by a full dose had a 90 per cent success rate while two full shots were 62 per cent effective. In December, citing data from early trials, Oxford said the vaccine had a better immune response when a two full-dose regime was given.
Dosage and storage:
According to the Subject Expert Committee (SEC), two full doses of the vaccines have been suggested to be administered around 4-6 weeks apart. It suggested that the immune response could last at least a year. The vaccine can be stored at temperatures between 2°C and 8°C.
Pricing:
Serum Institute of India has said it would price the vaccine at 440 rupees (about $3) for the government and around Rs 700-800 for the private market.
Bharat Biotech’s Covaxin
Covaxin has been indigenously developed by Hyderabad-based Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
Type of vaccine:
Covaxin is made by using particles of the coronavirus that were killed – it unable them to infect or replicate. Injecting particular doses of these particles helps in building immunity by helping the body create antibodies against the deadly virus.
Effectiveness:
Bharat Biotech’s Covaxin was “safe and provides a robust immune response”, said Drugs Controller General of India VG Somani. The vaccine is yet to complete late-stage human clinical trials in India and no efficacy rate has yet been made public.
“Phase 1 and Phase 2 clinical trials were conducted on about 800 subjects and the results have demonstrated that the vaccine is safe and provides a robust immune response. The Phase 3 efficacy trial was initiated in India on 25,800 volunteers and till date, approximately 22,500 participants have been vaccinated across the country and the vaccine has been found to be safe,” Somani said.
Dosage and storage:
The vaccine will be administered in two doses and stored at 2-8° degrees Celsius.
Pricing:
While there has been no talk on the price of Covaxin, reports have said Bharat Biotech will price the vaccine at Rs 350. The firm has already signed a letter of intent (LoI) with Ocugen to co-develop Covaxin for the US market.
Zydus Cadila ZyCov-D vaccine
Zydus Cadila has received the drug regulator’s nod to initiate Phase III clinical trials in around 30,000 volunteers.
Type of vaccine:
This is a “plasmid DNA” vaccine – DNA vaccines use genetically engineered plasmids–a type of DNA molecule. It is coded with the antigen against which the immune response is to be built.
Effectiveness:
In December, the company said the vaccine was administered to be safe and immunogenic in the Phase I/II clinical trials, which was conducted on around 1,000 volunteers.
With PTI inputs
