India approved two COVID-19 vaccines on Sunday, paving the way for a huge inoculation program to stop the coronavirus pandemic in the world’s second most populous country.
India’s drug regulator issued a state of emergency for the vaccines developed by Oxford University and the British pharmaceutical manufacturer AstraZeneca and another developed by the Indian company Bharat Biotech.
General Practitioner Dr. Venugopal G Somani said both vaccines will be given in two doses.
Somani said the decision to approve the vaccines was made after “careful examination” by the Central Drugs Standard Control Organization, India’s drug authority.
The country’s original vaccination plan aims to vaccinate 300 million people – healthcare workers, frontline staff including police and those considered vulnerable due to their age or other illnesses – by August 2021.
More than 20,000 health workers have so far been trained to administer the vaccine, the health ministry said.
The Serum Institute of India, the world’s largest vaccine manufacturing company, has been contracted by AstraZeneca to make one billion doses for developing countries, including India. On Wednesday, Britain became the first to approve the shot.
Partial results from studies for Oxford-AstraZeneca shots in almost 24,000 people in the UK, Brazil and South Africa indicate that the vaccine is safe and about 70% effective. This is not as good as some other vaccine candidates, and there are also concerns about how well the vaccine will protect older people.
Researchers had also claimed that the vaccine protected against the virus in 62% of people who received two doses and 90% in those who received half a dose due to a manufacturing defect. But the latter group included only 2741 people, which is too small to be decisive.
The vaccine does not need the ultra-cold storage facilities that some others do. Instead, it can be stored in the refrigerator. This makes it a viable candidate, not only for India but also for other developing countries.
Although the company does not have a written agreement with the Indian government, its CEO Adar Poonawalla said in a virtual review on Monday that India would be “prioritized” and would get most of its stock of about 50 million doses.
No serious side effects
The second vaccine known as COVAXIN was developed by Bharat Biotech in collaboration with authorities and is based on an inactivated form of coronavirus. The company has only completed two of three trial phases. The third, which tests for effect, began in mid-November.
Early clinical studies showed that the vaccine has no serious side effects and produces antibodies to COVID-19. With the second shot given 28 days after the first and an immune response called for two weeks later, it is not clear if the company has provided data on the vaccine’s effectiveness.
Somani said that “the vaccine has been shown to be safe.”
The Ministry of Health said in a statement that a permit was granted for Bharat Biotech’s shots for limited use in the “public interest as a prudent precaution in clinical trials, especially in connection with infection of mutant strains.”
Dr Gagandeep Kang at Christian Medical College in Vellore said the idea that the vaccine could help with a mutant variant of the virus was “hypothetical”.
India, with nearly 1.4 billion people, is the second worst-hit coronavirus after the United States, with over 10.3 million confirmed cases and 149,435 deaths, although the rate of infection has dropped significantly from a peak in mid-September.
Indian regulators are still considering approvals for other vaccines, including one by Pfizer.