New Delhi: The Modi government Sunday granted emergency-use authorisation to Oxford-AstraZeneca’s Covid-19 vaccine Covishield, manufactured in India by the Pune-based Serum Institute of India, and Bharat Biotech’s Covaxin, clearing the way for immunisation to begin in the country.
The Drugs Controller General of India (DCGI) has granted “conditional approval” to the vaccine candidates.
“After adequate examination, CDSCO (Central Drugs Standard Control Organisation) has decided to accept the recommendations of the expert committee and accordingly, vaccines of M/s Serum and M/s Bharat Biotech are being approved for restricted use in emergency situation,” DCGI V.G. Somani said at a press conference Sunday.
Cadila Healthcare, he added, is being given permission to conduct Phase III clinical trial on its Covid vaccine.
Happy new year, everyone! All the risks @SerumInstIndia took with stockpiling the vaccine, have finally paid off. COVISHIELD, India's first COVID-19 vaccine is approved, safe, effective and ready to roll-out in the coming weeks. pic.twitter.com/TcKh4bZIKK
— Adar Poonawalla (@adarpoonawalla) January 3, 2021
The SII has already manufactured a stockpile of around five crore doses. The company claims to have the capacity to increase production to 10 crore doses a month by February.
On 7 December, the SII had sought emergency-use approval from the drug regulator. On 30 December, the UK approved the same vaccine for an immunisation drive aimed at the country’s most vulnerable groups. The vaccine was finally recommended for use at a meeting of the DCGI’s subject expert committee, which vets new vaccines and drugs, Friday.
Bharat Biotech had moved an application on 8 December, seeking approval for Covaxin, which it has developed in collaboration with the Indian Council of Medical Research (ICMR). It was recommended for approval after an SEC meeting Saturday.
Basis of the approval
According to Somani, the SII has submitted interim safety and immunogenicity data generated from the trial. He said the data was found comparable with that from overseas clinical studies. “After detailed deliberations, the subject expert committee has recommended for the grant of permission for restricted use in emergency situations subject to certain regulatory conditions. The clinical trial ongoing within the country by the firm will continue,” he said, without specifying the conditions.
Bharat Biotech, according to a press statement released by Somani during the presser, has generated safety and immunogenicity data in various animal species such as mice, rats, rabbits, Syrian hamster, and also conducted challenge studies on non-human primates (Rhesus macaques) and hamsters.
Challenge studies are those where study participants are deliberately infected with the virus that the vaccine in question seeks to protect against.
“The Phase 3 efficacy trial was initiated in India in 25,800 volunteers and till date, ~22,500 participants have been vaccinated across the country and the vaccine has been found to be safe as per the data available till date,” he added.
How the vaccination will take place
The Modi government has registered 70 lakh healthcare workers who will be the first beneficiaries of the immunisation drive across the country.
The government has put together a presentation, Preparedness for COVID-19 Vaccine, for the process.
According to the 25-slide presentation dated 31 December, accessed by ThePrint, a total of 70,33,338 healthcare workers have been registered on a mobile application — ‘Co-WIN’ — to kickstart the vaccination process.
Co-WIN will be used for everything, from registration for the vaccine to tracking the after-effects. The latest status of the database created by the central government, according to the presentation, includes registration of over 2.30 lakh vaccinators followed by more than 51,000 public health facilities and 1.62 lakh private health facilities.
Experts, WHO welcome launch of vaccines
Public health experts have welcomed the government’s decision.
“It is a welcome development as the vaccine can protect vulnerable persons, like the aged and those with comorbidities, from severe illness and shield persons providing essential services from becoming ill and being required to isolate themselves,” said K. Srinath Reddy, president of the Public Health Foundation of India (PHFI).
Reddy added that the vaccine “will help reduce deaths, ease pressure on hospitals and avoid disruption of essential services”.
“While we now have to see how smoothly the rollout happens, adequate planning and preparations appear to have been made,” he said. “Even as the programme rolls out, we need to ensure that public health measures and personal precautions must continue to prevent person to person spread and super spreader events.”
Another expert Dr Anant Bhan, who is a researcher in the fields of global health, health policy and bioethics, said that the country’s “ambitious” vaccination program will be “unique and yet challenging and will require the centre and states to work together, while ensuring that activities like routine immunisations are not adversely impacted”.
“Specifically with regards to the approval, it is important to release details about the rationale for the decision, the conditions of approval, and the background data based on which the decision was made,” he added. “This will help build confidence in the approval.”
Poonam Khetrapal Singh, Regional Director, South-East Asia Region, World Health Organisation, also welcomed the decision in a statement.
“WHO welcomes the first emergency use authorization given to COVID-19 vaccine in the WHO South-East Asia Region. This decision taken today by India will help intensify and strengthen the fight against COVID-19 pandemic in the Region,” Singh said.
“The use of vaccine in prioritized populations, along with continued implementation of other public health measures and community participation will be important in reducing the impact of COVID-19,” she added.