Bharat Biotech receives approval for Phase III trials of intranasal covid vaccine |
Bharat Biotech's intranasal covid vaccine spray is easy to administer, cheap and
will be available over the counter. It immunises the only passage of the corona
virus - the nasal passage - blocking it from replicating in the nasal mucosa and
its onward transmission to the lungs where the infection matures. By stopping
the virus in its passage, the local immunisation greatly helps reduce infections.
It works like a protective shield. Bharat Biotech has the technical licence from
Washington University in St Louis, US. |
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.
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SELECTIONS FROM OUR ARCHIVES |
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The incident has triggered a debate on social media whether the officer refused to take orders from a party leader or he was accused of any corruption, some netizens justifying the handling in either case, that Ratnakar was blocking public welfare work! It is true the Govt machinery has been the enemy Number One of the people of this country, existing for itself and for these politicians, for well over seven decades. India will never make an inch of progress - real progress, not make-believe-progress - unless and until this machinery is eliminated.
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Although its immediate job was to save American taxpayers billions by slashing waste, eliminating fraud, cutting Government bloat and ensuring utmost efficiency in administration for the good of the people.
(Today's headlines )
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Ailing Asiatic lion Pataudi too dies of bird flu at Kanpur zoo
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48 tourist destinations closed in Kashmir following Pahalgam terror attack
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What motivated Trump's newfound policy, apart from being a stunt to justify his existence in the White House, is a false realisation that increased tariff will make foreign goods prohibitive, thereby boosting local production, and create more jobs, and more prosperity will ring in! If that is true, India would have been shining by now: Producing own Rolls-Royce La Rose Noire Droptail and Scotch Whiskies! And what about coconut and palm oil by America!
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All 80k health workers in US offered $25,000 voluntary buyout: Administering wrong prescriptions!
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The terminations are part of a large-scale exercise going on all across Fed departments and organisations to reduce wasteful Government expenditure as decided by a Trump in a mess gone berserk, and improve administrative efficiency following the whims of billionaire and his associate Elon MusK and his DOGE. It has not been shared how terminations are going to raise the efficiency bar! It looks like Trump has stolen some of the prescriptions meant for India. But the American problems are quite different.
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