Bharat Bio seeks nod to conduct trials of nasal Covid vaccine
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Bharat Biotech, which has developed India’s indigenous Covid-19 vaccine, Covaxin, has sought regulatory approval to start phase-1 and phase-2 trials of its intranasal vaccine for coronavirus.
AP
Phase I human clinical trials will be conducted in India, Bharat Biotech said.
New Delhi: Bharat Biotech, which has developed India’s indigenous Covid-19 vaccine, Covaxin, has sought regulatory approval to start phase-1 and phase-2 trials of its intranasal vaccine for coronavirus. The Subject Expert Committee (SEC) under India’s drug regulator is likely to meet next week to decide on the company’s application, said a government official. The Hyderabad-based company received an emergency approval for Covaxin on January 3, even as it is still conducting phase-3 trials.
BBV154 (intranasal Covid-19 vaccine), preclinical testing has been completed for toxicology, immunogenicity and challenge studies. These studies have been conducted in the USA and India. Phase I human clinical trials will commence during Feb-March 2021, an email reply from the city-based vaccine maker told P T I.
Phase I human clinical trials will be conducted in India, Bharat Biotech added.
The Phase-1 trials will be conducted in Saint Louis University s Vaccine and Treatment Evaluation Unit, the company sources said adding Bharat Biotech owns the rights to distribute the vaccine in all markets except USA, Japan and Europe.
Krishna Ella, Chairman of Bharat Biotech had earlier said the company is focusing on the intranasal vaccine as the existing vaccines require two dose intramuscular injections and a country like India needs 2.6 billion syringes and needles which may add up to pollution.
Bharat Biotech to begin Phase-1 trials of its intranasal vaccine for COVID-19 in February-March
Besides Covaxin, Bharat Biotech has been actively working on developing another vaccine, for which it tied up with Washington University School of Medicine in St Louis for the novel chimp-adenovirus (Chimpanzee adenovirus), a single dose in tranasal vaccine for COVID-19. PTI January 08, 2021 / 11:29 AM IST
Buoyed by the Emergency Use Authorisation approval from the Drug Controller General of India (DCGI)for its COVID-19 vaccine Covaxin, Bharat Biotech has said Phase-1 clinical trials of its new intranasal antidote for the killer virus will begin during February-March this year.