the indian pharmaceutical Bharat Biotech manufacturer of Covaxin, launched this Thursday (26) an intranasal vaccine against Covid-19.
Called Incovacc, the vaccine was developed for primary series and heterologous reinforcement. According to the laboratory, the vaccine is the first nasal application with this vaccine regimen and received approval from the Central Drugs Standard Control Organization (CDSCO).
Incovacc is available through the Indian vaccination initiative CoWIN. The private market value per dose is around R$50 and approximately R$20 for supplies to the Government of India and state governments.
How the immunization works
Incovacc uses a non-replicating adenovirus as a vector for a stabilized coronavirus Spike protein. According to the company, the vaccine was evaluated in clinical trials of phases I, II and III with successful results.
The vaccine has been formulated to allow administration through the nose through drops, without the use of needles. The nasal delivery system was designed and developed to be cost-effective in low- and middle-income countries.
According to Bharat Biotech, the launch should start with private hospitals that have placed advance orders. Initial manufacturing capacity of millions of doses per year has been established, which can be expanded to a billion doses as needed.
Studies
Phase III trials (as a 2-dose regimen), which allow assessment of safety and ability to induce immune response, were conducted in approximately 3,100 subjects at 14 trial sites across India.
Heterologous booster dose studies, which consist of a vaccination schedule with different immunizers, were conducted in about 875 people, with the intranasal vaccine administered to those who had previously completed a regimen of common Covid-19 vaccines, given by intramuscular injection. Tests were conducted at nine locations across the country.
Volunteers who received Incovacc showed significant levels of antibodies of the IgA type, present in the nasal mucosa and measured in saliva. Mucosal IgA antibodies in the upper respiratory tract may provide benefits in reducing infections and disease transmission.
Intranasal vaccine can be stored at a temperature of 2 to 8°C, designed for efficient delivery and easy pain-free administration. The vaccine was developed in partnership with Washington University, St. Louis, who designed and developed the recombinant adenoviral vector design and evaluated efficacy in preclinical studies.
Bharat Biotech conducted pre-clinical safety assessment, scale-up production, formulation and development of delivery devices, including human clinical trials.
“Today, India contributes 65% of the world’s need for vaccines, saving the lives of children, adolescents and adults. It is also great to see that in the global dialogue, India’s manufacturing, research and innovation capabilities are admired. India will not only be known as the pharmacy of the world, but will be known for its research and innovation in vaccines,” said Indian Health Minister Mansukh Mandaviya.
“Bharat Biotech and the science and technology department are natural collaborators and we owe this vaccine innovation to the world. India has taken the lead in vaccine innovation as we have a legacy of dealing with communicable diseases,” said Jitendra Singh, Minister of Science and Technology.
Source: CNN Brasil
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