NEW DELHI: The Drug Controller General of India V.G. Somani has approved Serum Institute of India Pvt Ltd’s indigenous pneumococcal polysaccharide conjugate vaccine, making it the first indigenously developed vaccine against pneumonia, the government said in a statement on Wednesday.
The company’s vaccine is used for immunization against invasive disease and pneumonia in infants and is administered as an intramuscular dose.
Serum Institute received the approval from the DCGI on Tuesday after a three-phase trial in India and Gambia, the government said.
As per the government’s clinical trial registry, the first phase of the trial was conducted in 2013 in 34 young Indian adults, while the second phase in 114 toddlers of 12-15 months.
The third phase of trials for the pneumococcal conjugate vaccine was conducted on 448 infants between the age of six to eight weeks old, and this was completed in October last year, as per the registry.
“The application along with the clinical trial data has been reviewed by the Office of Drug Controller General of India with the help of Special Expert Committee (SEC) for vaccines. The Committee recommended for grant of permission of market authorization to the said vaccine," the government statement said.
Earlier, India’s demand for the pneumococcal conjugate vaccine was substantially met by licensed importers in the country since the manufacturers were all vaccine companies based outside India, the government said.
Source - LiveMint
SII’s Adar Poonawalla on Covid vaccine, pricing and rollout at Hindustan Times Leadership Summit 2020
COVISHIELD Completes Enrolment of Phase III clinical trials under partnership of ICMR and Serum Institute of India
Government Secures Vaccine Supplies For Half Of The Indian Population From Serum Institute And Novavax
IAVI, Merck, and Serum Institute of India Join Forces to Develop Monoclonal Antibodies for COVID-19 and Ensure Prompt and Equitable Global Access
Serum Institute Of India Takes A Multipronged Approach In Quest To Produce World’s First Covid-19 Vaccines
Serum Institute of India to produce up to an additional 100 million covid 19 vaccine doses for india and low and midle income countries in 2021
Adar Poonawalla CEO of Serum Institute of India, the world’s largest vaccine manufacturer, explains the timing, challenges & cost of vaccinating the world against COVID-19
Serum Institute looking for a $1 billion shot to fight covid, talks on with Blackstone, KKR and others
Serum Institute of India Says Covid Vaccine Likely to Be Ready by End of 2020, Final Pricing in 2 Months
Serum institute of india to produce up to 100 million covid-19 vaccine doses for india and low-and middle-income countries as early as 2021
50% of our Covid vaccines will be for India, people won't have to buy them, govts will pay: Adar Poonawalla
AstraZeneca vaccine's success in early human trials, Will Begin AstraZeneca Vaccine Trial in India After Applying for Licence Next Week, Says Serum Institute
Serum Institute of India CEO: ‘We plan to make millions of doses of Covid vaccine over three months’:’
New supply agreement between UNICEF and Serum Institute of India makes pneumococcal conjugate vaccine available at US$2.00 per dose, a 43 % reduction from the Gavi price at the start of the Advance Market Commitment
Serum Institute confident of manufacturing Covid vaccine’s 100 million doses if trials establish efficacy
Serum Institute’s Journey To Success | ET NOW Covid-19 vaccine possible by Q2 of 2022: Adar Poonawalla
Adar Poonawalla discusses Serum Institute's progress in the global battle against COVID-19 with Shereen Bhan, CNBC-TV18
Adar Poonawalla talks with Aabha Bakaya about the success story of Serum Institute of India. Tune in to know all about the journey of the company.
Bill Gates confers Indian Council of Medical Research "Lifetime Achievement Medal" on Dr. Cyrus Poonawalla
Dr. Cyrus Poonawalla conferred with 'Lifetime Achievement Award’ by the Asian Business Leadership Forum
Dr. Cyrus Poonawalla conferred with the prestigious honorary degree by the University of Oxford, U.K.