Both vaccines will be administered in two doses and stored in standard refrigerator temperatures of 2 to 8 degrees Celsius (36 to 46 degrees Fahrenheit).
The approval is a crucial step in India’s effort to curb the coronavirus outbreak, which has infected more than 10 million people, second only to the United States in the total number of cases.
The Serum Institute of India, the world’s largest vaccine manufacturer, is producing the AstraZeneca and Oxford vaccines locally, having taken a huge risk of making the vaccine months before regulators approved it.
“It’s a big day for India and the world, because this is going to be the most affordable vaccine, which will be distributed as equitably as possible around the world,” the institute’s CEO, Adar Poonawalla, told CNN on Sunday.
But vaccines, from the local brand Covishield, will not be available to other countries until March or April, as the Indian government has restricted them for export, according to Poonawalla.
“This is not going to the private market, private hospitals and elsewhere now. We have a restricted license to just give and provide to the government of India, because they want to prioritize the most vulnerable and needy segments first,” he said.
India’s coronavirus vaccines are an important alternative for developing countries, which may not be able to afford the most expensive vaccines made in the West, or have cold storage capacity to transport vaccines that require ultra-cold temperatures, such as those developed by Pfizer and Moderna.
In September, the Serum Institute of India pledged to manufacture and deliver 200 million doses for COVAX – a World Health Organization vaccine alliance established to ensure fair access to Covid-19 vaccines. But the export of vaccines to “low and middle-income countries” may not begin until restrictions have eased.
Poonawalla said Covishield would initially be sold to the Indian government for $ 2.74 per dose – roughly its cost of production. It will be priced between $ 3 to $ 5 per dose for export and $ 13.70 for the private market, he added.
Mass vaccination campaign
The Serum Institute of India hopes to sign a formal agreement with the Indian government “soon”, and people will begin to be vaccinated “in the next seven to ten days,” said Poonawalla.
The institute has already stocked up to 50 million doses of the vaccine ready for distribution this month and is ready to send them to 30 to 40 government agencies across the country. From there, they will be distributed to the smaller centers and clinics that have been set up, he said.
India already has a vast network established under its Universal Immunization Program, which inoculates around 55 million people a year. Analysts said this means that the country’s health care system is relatively well prepared for Covid-19 vaccines.
Prior to the mass vaccination campaign, the Indian government has also recruited and trained additional vaccinators and increased its inventories of cold chain storage equipment, such as refrigerators and freezers, freezers and ice-lined refrigerators in recent months.
Lack of data
The Indian drug regulator also approved Covaxin, the first vaccine against coronavirus grown in the country jointly developed by Bharat Biotech and the government government of the Indian Council of Medical Research.
But the government has faced heated criticism from experts and opposition leaders for not revealing the results of the vaccine’s effectiveness or any other data from its clinical tests.
“Its use should be avoided until the complete tests are finished. Meanwhile, India can start with the AstraZeneca vaccine, ”he tweeted.
Dr. Randeep Guleria, director of the All India Institute of Medical Sciences, agrees.
“I would say that, in the first phase, we should concentrate predominantly on the Serum Institute of India – the Astra Zeneca vaccine, and Bharat Biotech is just a reserve or a reserve if there is an increase in the number of cases,” said Guleria, a member of the national task force on the management of Covid-19.
“USA for COVAXIN is different from COVISHIELD because its use will be in clinical trial mode. All COVAXIN containers must be screened, monitored as if they were being tested, ”he wrote.
In a press release on Sunday, Bharat Biotech said its Phase 3 clinical trial for Covaxin started in mid-November, with a goal of including 26,000 volunteers.
“COVAXIN ™ has been evaluated in approximately 1000 subjects in Phase I and Phase II clinical trials, with promising safety and immunogenicity results, with acceptance in peer-reviewed international scientific journals,” said the statement.
Launch of vaccines in Asia
Across Asia, an increasing number of countries have started vaccination against Covid-19.
The Chinese government plans to inoculate 50 million people against Covid-19 ahead of the Lunar New Year celebrations in February. The country has administered 4.5 million doses of Chinese experimental vaccines since June in its emergency use program, which included frontline officials such as health officials and customs officials.
The next step is to inoculate vulnerable groups, such as the elderly and people with underlying diseases, before vaccinating the general population, officials said last week.
In Beijing, the city government started vaccinating target groups of the population, including frontline workers and students and staff who need to travel abroad, on January 1. He set up 220 vaccination posts across the city and inoculated 73,500 people by Saturday.
In comparison to the rapid launches in India and China, the Japanese government faced criticism for its slow launch of vaccines.