The Drugs Controller General of India (DCGI) on January 28 granted permission to Bharat Biotech to start conducting booster dose trials for its intranasal coronavirus vaccine.
The approval has been granted to conduct phase-3 trials. The trials would evaluate the nasal vaccine for both the two-dose primary schedule and also to use as booster dose schedule, company sources told PTI.
The trials will be conducted at nine different sites by Bharat Biotech -- the makers of Covaxin.
Earlier this month, in a bid to prevent the spread of coronavirus infection driven by its Omicron variant, India has started administering the precautionary dose of COVID-19 vaccine to healthcare and frontline workers and comorbid people aged 60 years and above.
Bharat Biotech had received regulatory approval for mid-to-late-stage trials for its intranasal vaccine BBV154 in August last year.
Frequently Asked Questions
A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.
There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.
Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.
The vaccine maker submitted the late-stage trial application to the Drugs Controller General of India in December 2021 stating that an intranasal vaccine as a booster dose will be easier to administer in mass vaccination campaigns.
The development came a day after the Central Drugs Standard Control Organisation (CDSCO) upgraded the permission for COVAXIN and Covishield from restricted use in emergency situations to normal new drug permission in the adult population with certain conditions.
Notably, Bharat Biotech chairman Krishna Ella and his co-founder Suchitra Ella will be honoured with the prestigious Padma Bhushan, President Ram Nath Kovind announced on January 25.
(With ANI, PTI inputs)Follow our coverage of the coronavirus crisis here