NEW DELHI, Jan 29: The Drugs Controller General of India (DCGI) has given approval
to Bharat Biotech for Phase III trials of a first-of-its-kind intranasal covid
vaccine in the country.
The BBV154 is a chimpanzee adenovirus SARS-CoV-2 vectored intranasal vaccine
spray. The vaccine is easy to administer (self-administer) as it is like any
other nasal spray requiring no paraphernalia. Besides, it will be available
over the counter and for almost free of cost. It doesn't need costly cold storage
transportation too.
The local vaccine immunises the nasal mucosa. Nostrils are the only entry points
for the corona virus and it needs to take hold of the nasal mucosa to spread
further into the lungs where it does the damage. By stopping the virus in its
passage, the local immunisation greatly helps reduce infections as also transmission
from infective people. It works like a two-way protective shield.
The company claims:
- The nasal route has excellent potential for vaccination due to the organized
immune systems of the nasal mucosa.
- Non-invasive, Needle-free.
- Ease of administration – does not require trained health care workers.
- Elimination of needle-associated risks (injuries and infections).
- High compliance (Ideally suits for children and adults).
- Scalable manufacturing – able to meet global demand.
Bharat Biotech has explained that an intranasal vaccine stimulates a broad
immune response – neutralizing IgG, mucosal IgA, and T cell responses. It produces
immune responses at the site of infection (in the nasal mucosa) – essential
for blocking both infection and transmission of COVID-19.
Bharat Biotech has the technical licence from Washington University in St Louis,
US.
The company will enrol 900 healthy subjects, who have already received the
two-dose Covaxin of Bharat Biotech or Covishield of the Serum Institute of India
(SII) vaccine, for the trial of the nasal vaccine as a booster. It will be conducted
at nine sites across the country. The trial sites identified are: All India
Institute of Medical Sciences, Delhi, AIIMS, Patna, Aatman Hopsital, Ahmedabad,
Oyster and Pearl Hospitals, Pune, Acharya Vinobha Bhave Rural Hospital, Wardha,
PGIMS, Rohtak, Prakhar Hospital, Kanpur, Rana Hospital, Gorakhpur and Jeevan
Rekha Hospital, Belagavi.
The DCGI Subject Experts Committee (SEC) had early this month granted approval
to Bharat Biotech for initiating Phase III and heterologous clinical trials
of its booster dose of the Covid-19 intranasal vaccine.
The SEC minutes of the meeting reads: “After detailed deliberation, the SEC
‘in principle’ agreed for the conduct of both Phase III superiority study and
Phase III booster dose study in parallel in the light of the pandemic situation.”
In August 2021, the company had received approval from the country’s drug regulator
to carry out the Phase II trial of the intranasal vaccine. In the Phase I trials
in people aged 18 to 60 years, the vaccine was found to be well tolerated.
