The World Health Organization (WHO) issued an emergency use listing (EUL) for COVAXIN® (developed by the Indian company Bharat Biotech), elevating to eight the growing portfolio of vaccines validated by WHO for the prevention of COVID-19 caused by SARS-CoV-2.
The vaccine is formulated from an inactivated SARS-CoV-2 antigen and is presented in single dose vials and multidose vials of 5, 10 and 20 doses.
There are not still available data on compatibility and effects if combined with other vaccines against the COVID-19.
“This emergency use listing expands the availability of vaccines, the most effective medical tools we have to end the pandemic,” said Dr Mariângela Simão, WHO Assistant-Director General for Access to Medicines and Health Products. “But we must keep up the pressure to meet the needs of all populations, giving priority to the at-risk groups who are still waiting for their first dose, before we can start declaring victory.”
WHO’s EUL procedure assesses the quality, safety and efficacy of COVID-19 vaccines and is a prerequisite for COVAX vaccine supply. It also allows countries to expedite their own regulatory approval to import and administer COVID-19 vaccines.
Two doses vaccine with in a78% effective to protect against contagion
The SAGE (WHO Advisory Group of Experts on Immunization) recommended use of the vaccine in two doses, with a dose interval of four weeks, in all age groups 18 and above. COVAXIN® was found to have 78% efficacy against COVID-19 of any severity, 14 or more days after the second dose, and is extremely suitable for low- and middle-income countries due to easy storage requirements.
COVAXIN® has been evaluated through neutralizing antibody responses against several variants of concern, namely B.1.617.2 (Delta), B.1.617.1 (Kappa), B.1.1.7 (Alpha), B.1.351 (Beta), P2- B.1.1.28 (Gamma). The data from these studies and others have been extensively published in more than 12 peerreviewed journals and available for review in the public domain.
Available data on vaccination of pregnant women with the vaccine are insufficient to assess vaccine safety or efficacy in pregnancy; studies in pregnant women are planned, including a pregnancy sub-study and a pregnancy registry.
A third or booster dose may be recommended within a reasonable period after second dose administration.
Easy to store between +2º and 8º
The BBV152 vaccine is presented as a 10-dose vial (5 ml per dose) delivered in cartons each containing 10 multidose vials.
Unopened multidose vials should be stored at a temperature of +2 °C to +8 °C and should not be frozen. Frozen vaccine supply should be discarded according to national policy. The vaccine must be protected from light and well shaken before use.
Opened vials should be kept at +2 °C to +8 °C during the immunization session and discarded within 6 hours of opening (first puncture) or at the end of the session, whichever comes first (12, 13). Each vial comes with a vaccine vial monitor (VVM7) on the vial label.
Not opened COVAXIN vaccine vials provide an effective protection against COVID-19 duing 9 months after manufacturing if correctly stored between +2 °C to +8 °C.
India’s first indigenous Covid-19 vaccine
Dr. Krishna Ella, Chairman and Managing Director, Bharat Biotech, said, “Validation by WHO is a very significant step towards ensuring global access to India’s widely administered, safe, and efficacious COVAXIN®. As an organization, we have focused on maintaining stringent quality and safety standards that meet rigorous assessment, and scientific standards established by WHO, as a result, many of our vaccines have received WHO prequalification. The EUL authorisation for COVAXIN® will enable us to contribute to accelerating the equitable access of Covid-19 vaccine, and the access to our vaccine globally thereby addressing the current public health emergency.”
Suchitra Ella, Joint Managing Director, Bharat Biotech, said, “The WHO nod for COVAXIN® is a validation of the tremendous effort made by everyone at Bharat Biotech and our partners. It is also an opportunity for us to create meaningful impact at a global level. Such an impact can only be orchestrated when multiple stakeholders come together to work towards a common goal. COVAXIN® is a great example of a successful public-private partnership in developing a world-class COVID-19 vaccine. We look forward to playing a larger role to help the efforts by both the developed and developing nations to control the pandemic.”
Manufacturing capacity to reach 1Bn doses a year by the end of 2021
The Indian company informs that Manufacturing capacity expansion was started during Q1 2021, as the first phase 3 efficacy readouts were available.
Within a short period of circa 9 months, the capacity was scaled up to 50-55 million doses per month, as of October 2021.
Bharat Biotech has established COVAXIN® manufacturing to reach an annualized capacity of 1Bn doses by the end of 2021.
Technology transfer activities are also in progress to companies in India, the United States, and other countries.
About Bharat Biotech
Located in Genome Valley in Hyderabad, India, a hub for the global biotech industry, Bharat Biotech has built a world-class vaccine & bio-therapeutics, research & product development, Bio-Safety Level 3 manufacturing, and vaccine supply and distribution. Having delivered more than 4 billion doses of vaccines worldwide, Bharat Biotech has developed vaccines for influenza H1N1, Rotavirus, Japanese Encephalitis (JENVAC®), Rabies, Chikungunya, Zika, Cholera, and the world’s first tetanustoxoid conjugated vaccine for Typhoid.
Bharat’s commitment to global social innovation programs and the public-private partnership resulted in introducing path-breaking WHO pre-qualified vaccines BIOPOLIO®, ROTAVAC®, and Typbar TCV® combatting polio, rotavirus, typhoid infections, respectively.
The acquisition of Chiron Behring Vaccines has positioned Bharat Biotech as the world’s largest rabies vaccine manufacturer with Chirorab® and Indirab®.