With the vaccine drive having begun across the country, how many doses has Bharat Biotech shipped out already and to which states?
After having received the government purchase order for 55 lakh doses, Bharat Biotech shipped the first batch of Covaxin to 11 cities including Ganavaram, Guwahati, Patna, Delhi, Kurukshetra, Bangalore, Pune, Bhubaneswar, Jaipur, Chennai and Lucknow. We have donated 16.5 lakh doses to the government of India. The doses required for this purchase are being shipped out on a rolling basis, based on the supply schedule provided by the Ministry of Health.
Would the vaccine be distributed internationally as well? A team of 70 ambassadors and high commissioners visited us last month to learn more about our work. The delegation led by the Ministry of External Affairs comprised of high commissioners and government representatives of 70 countries. We have also recently signed an agreement with Precisa Medicamentos for the supply of Covaxin to Brazil. In principle, it is understood that supplies of Covaxin will be prioritised for the public market, through a direct procurement by the government of Brazil. Supplies to the private market would be based upon receipt of market authorisation from ANVISA, the Brazilian regulatory authority. Submissions for EUA are in process in several countries across the world. We are also preparing to ship Covaxin internationally to our neighbouring countries and other countries based on donations by the government of India. This is an important moment for India, where several countries would be receiving vaccines and healthcare solutions from India.
Please tell us about the efficacy of the vaccine, the dosage schedule and any side effects.
Covaxin is a highly purified and inactivated two dose SARS-CoV-2 vaccine, manufactured in a Vero cell manufacturing platform with an excellent safety track record of more than 300 million doses. This vaccine by Bharat Biotech is India’s totally indigenous Covid-19 vaccine developed in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV). The evaluation of Covaxin has resulted in several unique product characteristics including long-term persistence of immune responses to multiple viral proteins, as opposed to only the spike protein, and has demonstrated broad spectrum neutralising capability with heterologous SARS-CoV-2 strains, thus potentially reducing or eliminating escape mutants. Covaxin has also proven efficacy in Hamsters and non-human primates, with excellent results from challenge studies. This vaccine has also shown to generate memory T cell responses, for its multiple epitopes, indicating longevity and a rapid antibody response to future infections. Its most critical characteristic is the demonstrated safety profile, which is significantly lower than several other vaccines with published data.
The dosage schedules are two intramuscular vaccines doses administered four weeks apart.
In addition to the development of Covaxin, what else has Bharat Biotech been doing?
Bharat Biotech has established an excellent track record of innovation with more than 145 global patents, a wide product portfolio of more than 16 vaccines, 4 bio-therapeutics with registrations in more than 123 countries and WHO pre-qualifications of its products. Having delivered more than 4 billion doses of vaccines worldwide, Bharat Biotech continues to lead innovation.
The process of development of the Covid-19 vaccine was hastened — would this in any way hamper efficacy?
Covaxin has been evaluated in approximately 1,000 subjects in Phase I and Phase II clinical trials, with promising safety and immunogenicity results. The main reason behind the decision to develop Covaxin, a whole virion inactivated vaccine, using a well-established vero cell manufacturing platform is to ensure safety in the face of a pandemic. A pandemic is not the time to experiment with new technologies, but rather fall back on well-established manufacturing platforms, with emphasis on safety and only safety. Once safety is established, the efficacy is being evaluated in Phase III human clinical trials of Covaxin which began in November, involving 26,000 volunteers across India. This is India’s first and the largest Phase III efficacy trial conducted for any vaccine.
How many Covid-19 candidates is Bharat Biotech working on apart from Covaxin?
In addition to Covaxin, Bharat Biotech is working on three more vaccine candidates. It includes a licensing agreement with Washington University School of Medicine in St. Louis for a novel chimp adenovirus, a single-dose intranasal vaccine for Covid-19. Bharat Biotech owns the rights to distribute the vaccine in all markets except the US, Japan, and Europe. The second is a partnership with Thomas Jefferson University to pursue a promising vaccine candidate against Covid-19. The vector used in this new Covid-19 vaccine is a deactivated rabies vaccine that is known to produce a strong immune response and is approved for the whole population including children and pregnant women. An international collaboration of virologists at the University of Wisconsin–Madison and vaccine companies FluGen and Bharat Biotech has begun the development and testing of a unique vaccine against Covid-19 called CoroFlu. CoroFlu will build on the backbone of FluGen’s flu vaccine candidate known as M2SR, based on an invention by UW–Madison virologists and FluGen.