© Reuters. In a cold room of the Serum Institute of India in Pune, there are boxes with the vials of the COVISHIELD vaccine against coronavirus (COVID-19) from AstraZeneca
By Aftab Ahmed and Krishna N. Das
NEW DELHI (Reuters) – India's Medicines Agency on Sunday issued final approval for the emergency use of two coronavirus vaccines, one from AstraZeneca (NASDAQ 🙂 and Oxford University and the other from local company Bharat Biotech and a state-owned company Institute was developed.
The decisions mark the first vaccine approvals for the second most populous country in the world, which has had the most infections with coronavirus disease after the United States.
A massive vaccination program is now expected to start within a week, a government official said, and he hopes to vaccinate 300 million of his 1.35 billion people for free in the first six to eight months of this year.
The AstraZeneca / Oxford shot, which is already approved in the UK, Argentina and El Salvador, will take the lead and Bharat Biotech's COVAXIN will be given under stricter conditions as no efficacy data has been published on it.
"Now is the time to take advantage of the robust supply chain infrastructure we have put in place for the vaccine to be distributed quickly and fairly," said Harsh Vardhan, India's Minister of Health and the world's largest vaccine manufacturer and exporter.
"Urge all citizens to trust the strict protocols that are followed to ensure the safety, efficacy and immunogenicity of the approved vaccines."
Drugs Controller General of India V.G. Somani said the overall effectiveness of the AstraZeneca / Oxford vaccine is 70.42%, while Bharat Biotech's COVAXIN is "safe and offers a robust immune response".
The UK-developed AstraZeneca / Oxford shot is made locally by the Serum Institute of India (SII) and is branded COVISHIELD, while Bharat Biotech has partnered with the government-led Indian Council of Medical Research.
A lawmaker from Prime Minister Narendra Modi's nationalist party had previously been vaccinated about the apparent preference for the foreign-made vaccine over the local one, the approval of which also raises questions about the lack of transparency in the process.
"Vaccines against M / s Serum and M / s Bharat Biotech are approved for restricted use in emergency situations," said Somani, head of the Central Drugs Standards Control Organization, at a press conference and read from a written statement.
Somani took no questions.
Both vaccines are given in two doses and stored at 2-8 ° Celsius (36 to 48 ° F) with no clarification on what intervals between admissions were recommended. Sources said Saturday the doses would need to be given every four weeks.
Somani said the Bharat Biotech vaccine was "approved in the public interest as a common precaution in clinical trial mode to allow for more vaccination options, especially in the event of infection by mutant strains."
Prime Minister Narendra Modi welcomed the approvals.
"It would make any Indian proud that the two vaccines approved for emergency use are made in India!" he said on Twitter, calling it a sign of a "separate" country.
SII, the world's largest vaccine maker, already stocked more than 50 million doses of the AstraZeneca / Oxford vaccine before signing a formal supply agreement with the government.
"All the risks @SerumInstIndia took to stock up on the vaccine have finally paid off," CEO Adar Poonawalla said on Twitter. "COVISHIELD, India's first COVID-19 vaccine, is approved, safe, effective and ready to use in the coming weeks."
The AstraZeneca / Oxford vaccine, first approved by the UK last week, is cheaper and easier to use than some competing vaccines, such as B. one of Pfizer Inc (NYSE 🙂 – a huge benefit in fighting a pandemic that killed more than 1.8 million people worldwide.
However, the British shot has been plagued by uncertainty about its most effective dosage since data released in November showed that half a dose followed by a full dose had a 90% success rate, while two full shots had 62% effectiveness.
The effectiveness of the Indian vaccine could "increase by more than 60%" after two doses, a knowledgeable source told Reuters. Bharat Biotech previously said they could produce up to 300 million cans a year.
"While this vaccine addresses an unmet medical need during this pandemic, our goal is to provide global access to populations in need of it most," said company chairman Krishna Ella. "COVAXIN has generated excellent safety data with robust immune responses."
However, an oppositional legislature and former minister questioned the approval process for COVAXIN.
"Bharat Biotech is a top notch company, but it is puzzling that internationally recognized protocols for Phase 3 studies for Covaxin are changing," wrote Jairam Ramesh on Twitter.
The Indian regulatory agency has also received an emergency application for the COVID-19 vaccine from Pfizer and Germany's BioNTech – the first attempt at gaining regulatory approval in the west.
India has reported more than 10.3 million COVID-19 cases and around 150,000 deaths, although the infection rate has dropped significantly since mid-September.
SII plans to sell the AstraZeneca / Oxford vaccine to the Government of India in the private market for about 250 rupees ($ 3.42) per dose and 1,000 rupees.
Regulatory authorities also granted Cadila Healthcare Ltd permission on Sunday to conduct Phase III clinical trials with 26,000 Indian participants for their vaccine candidate on the DNA platform-dose regimen.
(Additional reporting by Nigam Prusty and Shilpa Jamkhandikar; editing by Neil Fullick)