AstraZeneca is engaging with governments, multilateral organisations and other partners around the world for broad and equitable access to the vaccine without profit for the duration of the pandemic.
A hospital Staff member holds a vial of Covishield vaccine (Bloomberg)
NEW DELHI : Pune-based Serum Institute of India’s (SII) Covishield vaccine developed by Oxford University and AstraZeneca, which recently got Indian drug regulator’s nod for use in covid-19 vaccination drive in India, may also get a green signal for global use from the World Health Organisation (WHO).
The global public health agency has indicated that it is looking forward to SII’s full data sets for rapid assessment to consider it for emergency use globally. “We look forward to Serum Institute of India submitting full data sets for rapid assessment so WHO can determine whether we can recommend their AstraZeneca vaccine for international use," said Tedros Adhanom Ghebreyesus, director general of the WHO during a press conference on Monday.
The WHO on December 31st 2020, listed the Comirnaty covid-19 mRNA vaccine for emergency use, making the Pfizer/BioNTech vaccine the first to receive emergency validation from the global health agency since the covid-19 outbreak. The WHO’s Emergency Use Listing (EUL) opens the door for countries to expedite their own regulatory approval processes to import and administer the vaccine. It also enables UNICEF and the Pan-American Health Organization to procure the vaccine for distribution to countries in need.
AstraZeneca has said that it is engaging with governments, multilateral organisations and other partners around the world for broad and equitable access to the vaccine without profit for the duration of the pandemic. “We have moved at pace during 2020 to build more than a dozen regional supply chains. The vaccine can be stored, transported and handled at normal refrigerated conditions (two-eight degrees Celsius/ 36-46 degrees Fahrenheit) for at least six months and administered within existing healthcare settings," Gagan Singh, Managing Director – AstraZeneca India told Mint.
Following the first authorisation for the vaccine by the UK Medicines and Healthcare products Regulatory Agency (MHRA) on 29 December 2020, oxford university-AstraZeneca vaccine has now seen approvals granted for emergency use in India as well as Argentina, Dominican Republic, El Salvador, Mexico and Morocco for the active immunisation of adults age 18 years or older.
“AstraZeneca has already submitted a substantial data package to support a conditional marketing authorisation for its covid-19 vaccine to the European Medicines Agency (EMA), as part of an ongoing rolling review process and will continue to work closely with the EMA to seek approval in the coming weeks," said Singh.
“AstraZeneca is also seeking Emergency Use Listing from the World Health Organization for an accelerated pathway to vaccine availability in low-income countries during this health crisis and has ongoing rolling reviews with many other regulatory authorities around the world," he added.
The Indian drug regulator reviewed the data generated from the AstraZeneca-University of Oxford clinical trial from the UK and Brazil before giving approval to the vaccine for use. The interim data for safety and immunogenicity of all participants from the SII's Phase 2/3 bridging trial in India was also reviewed.
Currently, SII has produced 50 million doses of Covishield. The pharmaceutical company’s capacity is 60-70 million doses per month, which will be increased further up to 100 million a month by February 2021. The Indian government on Monday signed a deal with SII to procure 11 million shots of the vaccine at ₹200 per dose.
Source - liveMint
Oxford R21/Matrix-M™ malaria vaccine receives WHO recommendation for use paving the way for global roll-out
Adar Poonawalla awarded 'Business Leader of the Year' 2023 by the International Advertising Association (IAA) India Chapter
Cyrus Poonawalla Group appoints Keki Mistry as Strategic Advisor to all the Financial Services Ventures led by Adar Poonawalla
R21/Matrix-M™ malaria vaccine developed by University of Oxford receives regulatory clearance for use in Ghana
Department of Biotechnology announces the scientific completion of India's first qHPV vaccine ‘CERVAVAC’
Adar Poonawalla, CEO, Serum Institute of India, receives the award for the Outstanding Business Leader of the Year
Novavax and Serum Institute of India Receive Emergency Use Authorization for COVID-19 Vaccine in the Philippines
Novavax and Serum Institute of India Receive Emergency Use Authorization for COVID-19 Vaccine in Indonesia
Serum Institute Of India sends out Covishield vaccine - Consignment of Covishield Vaccine arrived in Delhi, Chennai, Kolkata, Guwahati, Shillong, Ahmedabad, Hydrabad, Vijayawada, Bhubaneswar, Patna, Bengaluru, Lucknow, Chandigarh
Serum Institute of India launches India’s first fully indigenously developed pneumococcal vaccine, 'PNEUMOSIL'
Oxford COVID-19 vaccine: Serum Institute likely to submit final Covishield trial data within 10 days
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.