NEW DELHI, Jan 3: The Drugs Controller General of India (DCGI) has approved
the covid vaccines of Oxford University-AstraZeneca and Bharat Biotech for
emergency use in the country.
"The vaccines of Serum Institute and Bharat Biotech are being approved for
restricted use in emergency situations," the Drugs Controller General of India,
VG Somani, said in New Delhi on Sunday.
"The vaccines are 110 % safe. Some side-effects like mild fever, pain and allergy
are common for every vaccine," he said.
"The DCGI granting approval to vaccines of @SerumInstIndia and @BharatBiotech
accelerates the road to a healthier and COVID-free nation," Prime Minister Narendra
Modi tweeted.
"It would make every Indian proud that the two vaccines that have been given
emergency use approval are made in India! This shows the eagerness of our scientific
community to fulfil the dream of an Aatmanirbhar Bharat, at the root of which
is care and compassion", Modi said.
While the vaccine developed by Oxford University-AstraZeneca was put to clinical
trials and is being manufactured by the Serum Institute of India, the world's
largest manufacturer of vaccines, the Bharat Biotech vaccine was developed indigenously
in association with the ICMR. The Oxford-AstraZeneca vaccine made in India is
called Covishield and the Bharat Biotech vaccine is called Covaxin.
The Subject Expert Committee (SEC) had on Friday recommended marketing authorisation
for Covishield and on Saturday it cleared Bharat Biotech's Covaxin, leading
to the approval of Emergency Use Authorisation (EUA) for both by the DCGI.
The Serum Institute of India, Pune, which had conducted the clinical trials
of Covishield, had submitted data on its safety, immunogenicity and efficacy
to the DCGI earlier for the EUA. Covishield is the Indian version of the Oxford-developed
vaccine in India.
Thereafter the drug regulator wanted them to submit the outcome of the UK regulator's
assessment of the data of trials done there before taking up the review. On
Wednesday, the MHRA issued the EUA for the vaccine to be administered in the
UK. Soon the SEC made its recommendation to the DCGI and now the EUA has come.
Unlike the Pfizer's which uses the latest mRNA technology manipulating the
human genes, Covishield and Covaxin are conventional vaccines that use the attenuated
(Covishield) or deactivated (Covaxin) virus. The former uses the common cold
virus called adenovirus. Both work by producing the spike protein in the human
body so as to prime the immune system to deactivate any virus when it infects
the body.
Both the covid vaccines, Covishield and Covaxin, are generally active against
new coronavirus mutant strains as seen in the UK also, it is claimed.
EUA has been given to Covaxin although the phase 3 trials are not over. They
are undertaking the last clinical trials on 26,000 participants.
An advantage of Covishield and Covaxin over Pfizer's is that both can be transported
and administered under normal fridge temperature of 2 to 8 deg C and no super
cold storage is required. Therefore, supply and administration become hassle-free and cost-effective.
Covishield has been found 90% effective if first dose is low and 62% if both
doses are given full, with one month's gap.
The Indian Central Drug Lab (CDL) has tested the Covishield (AZD1222).
According to the SII management, the vaccine may cost Rs 250 per dose in the
Indian market initially. Covaxin of Bharat Biotech will cost Rs 350 per dose. Both need two doses with a gap of a few weeks.
India is planning to vaccinate 30 crore people by July with the vaccines which
are ready for use in course of time. With the doses available presently, the
Government plans to vaccinate one crore health workers and two crore frontline
workers. Priorities for the 27 crore has not been finalised. 75 lakh beneficiaries
are already registered on co-WIN app.
India conducted a dry run of the vaccination in all the States and UTs successfully
on Saturday. And with the EUA approval, India with a population of 1.3 billion,
is ready to launch one of the world's largest vaccination drives. Twenty Ministries
and 23 Departments are engaged in the work and 57,000 participants have been
trained in 719 districts, apart from training 1,14,000 vaccinators.
India is the second worst affected country by coronavirus after the US with
over 10 million cases and 1,50,000 deaths.
Under the at-risk manufacturing and stockpiling licence it got from the DCGI,
the SII has already manufactured 40 million doses.
As per the agreement with AstraZeneca, the SII will produce 1 billion doses
in India to be supplied to underdeveloped countries.