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.
In a joint statement posted on their respective twitter accounts, the companies said Serum Institute Chief Executive Officer Adar Poonawalla and Bharat Biotech Chairman Krishna Ella communicated their combined intent to develop, manufacture and supply the COVID-19 vaccines.
The approval by the Drugs Controller General of India (DCGI) was given on the basis of recommendations submitted by a COVID-19 subject expert committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO).
An expert committee of the Central Drugs Standard Control Organisation (CDSCO) on Wednesday sought additional safety and efficacy data for COVID-19 vaccine candidates of Serum Institute and Bharat Biotech, after deliberating upon their applications seeking emergency use authorisation for the shots, official sources said.
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.
The phase 3 clinical trial will cover around 28,500 subjects, aged 18 years and above, and it will be conducted in 21 sites across ten states, including Delhi, Mumbai, Patna and Lucknow.
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 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.
The Brazilian health regulator's decision comes after the vaccine maker informed the South American country about the termination of its pact with its partners in that country.
Several states and UTs including Delhi, Maharashtra, Karnataka and Telangana have decided to opt for global tenders for procurement of anti-coronavirus shots with the domestic supply falling short to meet the rising demand.
The vaccine candidate -- 'Covaxin' -- is being indigenously developed by the Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
The Hyderabad-based Bharat Biotech has fixed the price of its COVID-19 vaccine, Covaxin, at Rs 600 per dose for state governments and at Rs 1,200 per dose for private hospitals. The Pune-based Serum Institute of India, the world's largest vaccine maker in terms of volume, has announced a price of Rs 400 per dose for its COVID-19 vaccine, 'Covishield', for state governments and Rs 600 per dose for private hospitals.
Under the conditions, the firms shall submit data of ongoing clinical trials and the vaccines to be supplied for programmatic setting.Adverse event following immunisation will continue to be monitored.
Three entities are at the centre of this controversy: The Brazilian government, Bharat Biotech and a Singapore-based company called Madison Biotech.
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.
Nearly 50 million doses of Bharat Biotech's COVID-19 vaccine, Covaxin lying with the firm are set to expire early next year as there are no takers owing to poor demand, company sources said.
The vaccine would not have production scalability issues unlike Covaxin, Bharat Biotech's COVID-19 virus vaccine.
Sources close to the development said the company had no further supply commitments to the WHO, and therefore, there was no suspension of any upcoming orders, reports Sohini Das.
The Union health ministry on Thursday termed as 'misleading' and 'fallacious' media reports which claimed that regulatory approval for COVID-19 vaccine Covaxin was rushed due to political pressure.
The World Health Organisation's technical advisory group will meet on October 26 to consider the Emergency Use Listing (EUL) of Covaxin, a vaccine developed by Hyderabad-based Bharat Biotech protecting against COVID-19, the global health agency's chief scientist said.
A statement issued by the WHO on Saturday said the suspension is in response to the outcomes of its post EUL (emergency use authorisation) inspection held between March 14-22, 2022 and the need to conduct process and facility upgrade to address recently identified GMP (good manufacturing practice) deficiencies.
Safety and Efficacy results from the final analysis will be available in June, and the final report will be submitted to a peer-reviewed publication.
The global health agency also emphasized that it must evaluate a vaccine thoroughly to make sure it is "safe and effective".
India's apex drug regulator has granted permission for conducting the phase II/III clinical trial of Bharat Biotech's Covaxin COVID-19 vaccine in the age group of 2 to 18 years, the Union Health Ministry said on Thursday.
Bharat Biotech is in the middle of conducting a phase 3 trial with 22,000 subjects.
Covaxin is being developed by Bharat Biotech, in collaboration with the Indian Council of Medical Research - National Institute of Virology.
A technical advisory group of the World Health Organisation was on Tuesday reviewing data on Covaxin for the emergency use listing of India's indigenously-made vaccine and it could pronounce its decision within the next 24 hours or so, a spokesperson said.
'WHO & an independent group of experts are scheduled to meet next week to carry out the risk/benefit assessment and come to a final decision whether to grant Emergency Use Listing to Covaxin,' the global health body tweeted.
Covaxin is an anti-coronavirus vaccine of Bharat Biotech
"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.
Australia's medicines and medical devices regulator on Monday formally recognised India's Covaxin, a vaccine against the coronavirus as the country's border was reopened for the first time in nearly 20 months.
Reacting to it, the vaccine maker said it is working towards resolving the issues cited during the inspection and the order of 20 million doses from the Brazilian government is still active.
A technical advisory group of the UN health agency which met on Tuesday has sought "additional clarifications" from Bharat Biotech for Covaxin to conduct a final "risk-benefit assessment" for Emergency Use Listing of the vaccine.
Covaxin was found to have 78 per cent efficacy against COVID-19 of any severity, 14 or more days after the second dose, and is extremely suitable for low- and middle-income countries due to easy storage requirements, said the global health body.
Bharat Biotech is also looking at nasal vaccine as a booster dose as its scaling up capacity is very easy when compared with Covaxin, he added.
To address the shortage of COVID-19 jabs in the country, the government is exploring the possibility of boosting production of vaccines, including identifying manufacturing sites for indigenously developed Covaxin outside India, sources said.
Out of the 45 lakh doses, the Hyderabad-based vaccine maker will be supplying over eight lakh to some of the friendly countries such as Mauritius, Philippines and Myanmar, free of cost as good will gesture sources added.
The production of Covaxin will increase from the current 10 million doses per month to 60 million-70 million by July-August.
The trial will take place in 525 subjects at various sites, including AIIMS, Delhi, AIIMS, Patna and Meditrina Institute of Medical Sciences, Nagpur.
Covaxin, a whole-virion inactivated SARS-CoV-2 vaccine used for mass immunization in the country, showed a 65.2 per cent protection against the Delta variant in a double-blind, randomized, multicentre, phase 3 clinical trial.
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