Drugs Controller General
of India, DCGI has given approval for restricted use in emergency
situation of two Covid19 vaccines- Serum Institute of India's Covishield
and Bharat Biotech's Covaxin.
The announcement for granting permission to these two vaccines was made
by The Drug Controller General of India VG Somani during a press
conference this morning.
The DCGI said, the Central Drugs Standard Control Organisation (CDSCO)
gave its approval followed by the recommendation of the Subject Expert
Committee (SEC) that recommended both the vaccines for emergency use.
Mr Somani said that the Serum Institute of India, Pune submitted
safety, immunogenicity and efficacy data generated on 23,745
participants and the overall vaccine efficacy was found to be 70.42 per
cent.
Further, the Firm was granted permission to conduct Phase-II and III clinical trial on 1600 participants within the country.
He said, the firm also submitted the interim safety and immunogenicity
data generated from this trial and the data was found comparable with
the data from the overseas clinical studies.
After detailed deliberations the Subject Expert Committee has
recommended for the grant of permission for restricted use in emergency
situation subject to certain regulatory conditions. He said, the ongoing
clinical trial within the country by the firm will continue.
Mr Somani said, Bharat Biotech has developed a Whole Virion Inactivated
Coronavirus Vaccine - Covaxin in collaboration with Indian Council of
Medical Research-ICMR and National Institute of Virology, Pune, from
where they received the virus seed strains.
He said, this vaccine is developed on the Vero cell platform, which has
a well established track record of safety and efficacy in the country
and globally.
The DCGI said that the Phase III efficacy trial of Covaxin was
initiated in India in 25,800 volunteers and till date, 22,500
participants have been vaccinated across the country and the vaccine has
been found to be safe as per the data available till date.
He said, the Subject Expert Committee (SEC) has reviewed the data on
safety and immunogenicity of the vaccine and recommended for grant of
permission for restricted use in emergency situation in public interest
as an abundant precaution, in clinical trial mode, to have more options
for vaccinations, especially in case of infection by mutant strains. He
said, the ongoing clinical trial within the country by the firm will
continue.
He also informed that permission has also been granted to Cadila
Healthcare for conduct of the Phase III clinical trial which has
developed a Novel Corona Virus-2019-nCov-Vaccine using DNA platform
technology.
He also said that the vaccines of Serum Institute of India and
Bharat Biotech have to be administered in two doses and all the three
vaccines including the vaccine of Cadila have to be stored at 2 to 8
degree Celsius.
Soon after the the Drug Controller
General of India (DCGI) approved the emergency use of both
Oxford-AstraZeneca’s Covishield and Bharat Biotech’s Covaxin for
immunisation against Covid-19 in the country, CEO and Owner of Serum
Institute of India, Adar Poonawalla said that the vaccine will be rolled
out in the coming weeks.
In a tweet he said, COVISHIELD, India's first COVID-19 vaccine is
approved, safe, effective and ready to roll-out in the coming weeks and
thanked Prime Minister Narendra Modi, Union Health Minister, Dr. Harsh
Vardhan, Ministry of Health and Family Welfare and DCGI. Meanwhile,
Maharashtra COVID-19 task force head, Dr Sanjay Oak has said that
getting vaccinated with Covid-19 vaccine should be considered as the
national duty.
Media correspondent reports that Dr. Oak said that immunisation is the
need of the hour and added that by doing so a person protects himself by
the virtue of development of neutralising antibodies. Besides, the
recipient also promotes the development of herd immunity. He said,
taking shots of the vaccine should be considered as a national duty
similar to exercising right to franchise during election.
Meanwhile, public health officials of the BMC have stated that the
civic body is ready to inoculate the frontline workers of the city
within 24 hours after the stock arrives. BMC health officials led by
additional municipal commissioner, Suresh Kakani yesterday visited the
eight civic-run hospitals and the Kanjurmarg facility, where the
inoculation drives will take place.
Cooper, Bandra-Bhabha, Rajawadi, VN Desai and Dr. Babasaheb Ambedkar
General Hospital have been equipped with storage facilities for the
vaccines.
One of the health official informed that at present the civic body is
equipped with 21 Ice Lined Refrigerator (ILR) and each of these
refrigerators has a capacity to store more than 60,000 vaccine vials at a
time.
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