After reports claimed that filings in patent offices in India, the US, and Europe did not mention ICMR or its scientists, but only BBIL and its scientists, the Hyderabad-based biotechnology (biotech) company clarified that in the "rush" to develop vaccines and file appropriate patents, BBIL had missed adding ICMR's name in the original filings.
WHO has urged people at risk to keep up with their vaccinations with boosters.
The company said it had conducted two separate trials for its intranasal Covid vaccine, one as a primary dose schedule and another as a booster dose, for subjects who have been double vaccinated with the two commonly administered Covid vaccines in India.
'iNCOVACC' is priced at Rs 800 for private markets and at Rs 325 for supplies to the government of India and state governments.
iNCOVACC is the world's first intranasal vaccine for COVID-19 to receive approval for the primary two-dose schedule, and as a heterologous booster dose.
The first vaccine candidate will be an intra-muscular one, followed by intra-dermal and nasal ones, depending on test results.
The Hyderabad-based firm completed clinical trials of the nasal vaccine with about 4,000 volunteers and there is no side effect or adverse reaction reported so far, company sources had said.
Bharat Biotech's Covaxin has demonstrated 77.8 per cent effectiveness against symptomatic COVID-19 and 65.2 per cent protection against the new Delta variant.
Bharat Biotech is in the middle of conducting a phase 3 trial with 22,000 subjects.
An expert panel of India's central drug authority on Wednesday recommended granting regular market approval to COVID vaccines Covishield and Covaxin for use in adult population subject to certain conditions, official sources said.
Efforts are being ramped up for massive production of vaccines and make them available in the shortest possible time, a top government official said on Wednesday, stressing that India currently has a promising pipeline of four-five Covid-19 vaccine candidates, while three have already been approved for emergency use.
"The compensation for serious adverse event will be paid by sponsor (BBIL) in case if the SAE is proven to be causally related to the vaccine," the consent form said.
The vaccine candidate, ZyCoV-D, showed a "strong immune response" in animal studies, and the antibodies produced were able to completely neutralise the wild type virus, Zydus said. The 12 institutes have been asked by the ICMR to fast track clinical trials of the vaccine as it is being considered as one of the top priority projects which are being monitored at the topmost level of the government.
The Indian government and private firms have stepped up efforts to develop a vaccine to halt the spread of COVID-19 which has claimed over 3,700 lives with more than 1,25,000 cases in the country.
'Forcing the development of an indigenous vaccine as a cure for COVID-19, bypassing all health & safety norms, to be announced by PM Modi on Independence Day is fraught with horrendous human costs'
Pfizer sought to participate in the Subject Expert Committee consultations towards an emergency use authorisation for its Covid-19 vaccine. However, the company representatives have been unable to participate in the meetings because of extremely short notices of a few hours or less and time-zone limitations.
First a scientist and then a businessman, founder chairman Krishna Ella quit his faculty position at the Medical University of South Carolina in Charleston, United States, in 1996 to return to India.
ICMR says it is following all globally accepted norms to fast-track vaccine and wants to 'cut red tape'.
History shows us that even effective vaccines could have unknown side effects that could develop over time, warns former Cabinet Secetary K M Chandrasekhar.
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