Milestones :: Perspectives :: Research
COVID Vaccines Development/Procurement/Distribution/Policy – Russia, China, India
We include the coverage immediately below to help assure a reasonably comprehensive view of COVID vaccines regulatory action and deployment occurring globally – even as we recognize that the evidentiary thresholds employed in the underlying decisions are highly variable, weak or even absent.
Russia: Sputnik V – “the first registered COVID-19 vaccine” [to 9 Jan 2021]
Bolivia has registered Sputnik V vaccine based on Russian clinical trial data
Press release, 06.01.2021
… The vaccine was registered under the emergency use authorization procedure and was approved by AGEMED based on the results of Phase III clinical trials in Russia, without additional trials in Bolivia. Sputnik V was registered by Argentina’s regulator ANMAT under the same procedure on December 23, 2020…
RDIF to supply 2 million doses of Sputnik V vaccine to Serbia
Press release, 06.01.2021
… The agreement between RDIF and the Government of Serbia will enable the vaccination of 1 million people. The supplies will help Serbia secure a diversified portfolio of vaccines against coronavirus. Deliveries will be facilitated by RDIF’s international partners in India, China, South Korea and other countries…
China: COVID-19 Vaccines – Regulatory Actions/Deployment
National Health Commission of the People’s Republic of China [to 9 Jan 2021]
China pledges safety, effectiveness as vaccination to be carried out nationwide
BEIJING — China’s State Council joint prevention and control mechanism against COVID-19 has ordered the strict inspection of vaccine quality, safety and smooth cold-chain transportation, as well as timely and accurate delivery of vaccines, as the country’s first self-developed vaccine got market approval with the vaccination campaign to be carried out nationwide gradually.
China has always attached great importance to the safety and effectiveness of COVID-19 vaccines. The mechanism has also emphasized the importance of providing medical support and service. It especially applies to timely treatment and reporting of adverse reactions during the vaccination drive.
The National Medical Products Administration also established a traceability information system for the management of approved vaccines.
China approved the emergency use of COVID-19 vaccines in June, targeting groups with high risks of infection. By the end of November, more than 1.5 million doses of Chinese COVID-19 vaccines had been distributed for emergency use, and 60,000 vaccinated people have traveled abroad to high-risk regions, with no severe adverse reactions reported.
On Dec 15, China officially launched a vaccination program for this winter-spring period targeting a number of key groups, including those engaged in handling imported cold-chain products, customs officers, medical workers and people working in public transport and fresh markets. The COVID-19 vaccines will be provided free of charge to all Chinese people…
… Some countries, including the United Arab Emirates and Bahrain, have approved the Chinese inactivated vaccine registration according to the World Health Organization technical standards. Egypt licensed China’s inactivated COVID-19 vaccine for emergency use on Saturday. Countries, including Brazil, Indonesia, Turkey, Chile and Malaysia, have ordered vaccines developed by Sinovac Biotech.
“China will vaccinate the eligible population as widely as possible, and gradually build an immune barrier in the whole population to control the epidemic,” said Zeng. He added that 60 or even 70 percent of the vaccination rate is needed to establish universal protection.
India: COVID-19 Vaccines – Regulatory Actions/Deployment
Bharat Biotech’s ‘COVAXIN™’ Emergency Use Authorization approval by DCGI-CDSCO, MoH&FW, a significant landmark in India’s Scientific Discovery, and Scientists Capability
Hyderabad, January 03, 2021:
Expressing delight about Ministry of Health & Family Welfare announcement today from the statement from DCGI – Central Standards Control Organization (CDSCO) Grant of permission for emergency use of its Covid-19 Vaccine, the Chairman and Managing Director of Bharat Biotech Dr. Krishna Ella said “The approval of COVAXIN™ for emergency use is a giant leap for Innovation and novel product development in India. It is a proud moment for the nation and a great milestone in India’s scientific capability, a kickstart to the innovation ecosystem in India. While this vaccine addresses an unmet medical need during this pandemic, our goal is to provide global access to populations that need it the most. COVAXIN™ has generated excellent safety data with robust immune responses to multiple viral proteins that persist.”…
…The Phase III human clinical trials of COVAXIN™ began mid-November, targeted to be done in “26,000” volunteers across India, this is India’s first and only Phase III efficacy study for a COVID-19 vaccine, and the largest phase III efficacy trial ever conducted for any vaccine in India. COVAXIN™ has been evaluated in approximately 1000 subjects in Phase I and Phase II clinical trials, with promising safety and immunogenicity results, with acceptance in international peer reviewed scientific journals…
PRESS INFORMATION BUREAU – GOVERNMENT OF INDIA
Press Statement by the Drugs Controller General of India (DCGI) on Restricted Emergency approval of COVID-19 virus vaccine
New Delhi, 3rd January, 2021
The Subject Expert Committee of Central Drugs Standard Control Organisation (CDSCO) met on 1st and 2nd January, 2021 and made recommendations in respect of proposal for Restricted Emergency Approval of COVID-19 virus vaccine of M/s Serum Institute of India and M/s Bharat Biotech as well as Phase III clinical trial of M/s Cadila Healthcare Ltd…
… M/s Bharat Biotech has developed a Whole Virion Inactivated Corona Virus Vaccine (Covaxin) in collaboration with ICMR and NIV (Pune), from where they received the virus seed strains. This vaccine is developed on Vero cell platform, which has well established track record of safety and efficacy in the country & globally.
The firm has generated safety and immunogenicity data in various animal species such as mice, rats, rabbits, Syrian hamster, and also conducted challenge studies on non-human primates (Rhesus macaques) and hamsters. All these data has been shared by the firm with CDSCO. Phase I and Phase II clinical trials were conducted in approx.800 subjects and the results have demonstrated that the vaccine is safe and provides a robust immune response. The Phase III efficacy trial 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.
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. The clinical trial ongoing within the country by the firm will continue….