Both vaccines are given in two doses and stored at standard refrigerator temperatures of 2 to 8 degrees Celsius (36 to 46 degrees Fahrenheit).
The approval is a critical step in India’s bid to contain the coronavirus outbreak, which has infected more than 10 million people, leaving only the United States in the overall caseload.
The Serum Institute of India, the world’s largest vaccine producer, is producing the AstraZeneca and Oxford vaccines locally, after taking a huge risk of producing the vaccine months before regulatory approval was approved.
“It is a great day for India and the world as this will be the most affordable vaccine that will be distributed as fairly as possible around the world,” Adar Poonawalla, CEO of the institute, told CNN on Sunday.
But the vaccines, with the local brand Covishield, won’t 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 other places at the moment. We have been given a limited license to only give and dispense these to the Indian government as 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 more expensive vaccines made in the West, or have the 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 supply 200 million doses for COVAX – a World Health Organization vaccine alliance created to ensure fair access to Covid-19 vaccines. But vaccine exports 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 the cost of production. It will be priced between $ 3 and $ 5 per dose for exports and $ 13.70 for the retail market, he added.
Mass vaccination
The Serum Institute of India expects to sign a formal agreement with the Indian government “soon” and the people will be vaccinated within “the next seven to 10 days,” Poonawalla said.
The institute has already stockpiled 50 million doses of the vaccine, ready for distribution this month, and is ready to ship them to 30 to 40 government locations across the country. From there, they will be divided among the smaller centers and clinics that have been set up, he said.
India already has an extensive, well-established network under its Universal Vaccination Program, inoculating approximately 55 million people per year. Analysts have said this means the country’s health system is relatively well prepared for the Covid-19 vaccinations.
In recent months, ahead of the massive vaccination campaign, the Indian government has also recruited and trained additional vaccinators and ramped up its supplies of refrigeration equipment such as walk-in coolers and freezers, freezers and ice-lined refrigerators. .
Shortage of data
The Indian drug regulator also approved Covaxin, the country’s first homegrown coronavirus vaccine jointly developed by Bharat Biotech and the government-led Indian Council of Medical Research.
But the government faced heated criticism from experts and opposition leaders for failing to disclose the vaccine’s efficacy results or other data from the clinical trials.
“Its use should be avoided until full trials are over. India may start using the AstraZeneca vaccine in the meantime,” he tweeted.
Dr. Randeep Guleria, director of the All India Institute of Medical Sciences, agreed.
“I would say in the first phase we should mainly focus on the Serum Institute of India – the Astra Zeneca vaccine, and the Bharat Biotech is only on standby or as a backup in case there is the number of cases, ”said Guleria, a member of the national task force for the management of Covid-19.
“EUA for COVAXIN differs from COVISHIELD in that it will be use in clinical trial mode. All COVAXIN recipients should be tracked, tracked as if in trial,” he wrote.
In a press release on Sunday, Bharat Biotech said the Phase 3 clinical trial for Covaxin has started in mid-November, with the aim of enrolling 26,000 volunteers.
“COVAXIN ™ has been evaluated in approximately 1,000 subjects in Phase I and Phase II clinical studies, with promising safety and immunogenicity results, with acceptance in international peer-reviewed scientific journals,” the publication said.
Roll out of vaccines in Asia
In Asia, more and more countries have started to vaccinate against Covid-19.
The Chinese government is aiming to vaccinate 50 million people against Covid-19 in the run-up to the New Year celebration in February. The country has already administered 4.5 million doses of experimental Chinese vaccines as part of its emergency program since June, including frontline workers such as health workers and customs officials.
The next step is to vaccinate vulnerable groups, such as the elderly and those with underlying diseases, before the general population is vaccinated, officials said last week.
In Beijing, on January 1, the municipal government began to vaccinate target groups of the population, including frontline workers and students and workers who have to go abroad. It has set up 220 vaccination sites in the city and has vaccinated 73,500 people as of Saturday.
Compared to the rapid rollout in India and China, the Japanese government has been criticized for the slowness in the rollout of the vaccines.