'Our problem is not a budget deficit but a trust deficit. We need to trust our institutions and industries to innovate and lead. That is the way forward for India.'
The method of data collection has a high risk of bias, the ICMR DG said.
Karnataka Chief Minister Siddaramaiah alleged that the rushed approval and distribution of the COVID-19 vaccine may be a contributing factor to cardiac arrest deaths, citing several international studies that recently suggested a possible link between the vaccines and a rise in heart attacks.
Serious AESI, which included stroke and Guillain-Barre syndrome, were reported in one per cent of individuals, the study, which looked at long-term safety of the BBV152 vaccine in adolescents and adults, claimed.
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.
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 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.
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.
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.
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.
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.
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.
"We have received feedback that certain immunisation centres are recommending taking three paracetamol 500 mg tablets along with Covaxin for children. No paracetamol or painkillers are recommended after being vaccinated with Covaxin," Bharat Biotech said in a Twitter post.
Bharat Biotech is targeting to manufacture one billion doses of its intra-nasal vaccine in 2022 which is under clinical trials now.
The termination of the pact comes after the deal with the Brazilian government for supply of 20 million doses of the vaccine landed in controversy and attracted investigation by authorities in that country.
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.
Results of an interim study recently published in The Lancet showed that two doses of Covaxin, also known as BBV152, had 77.8 per cent efficacy against symptomatic disease and present no serious safety concerns.
According to sources close to ANI, "Bharat Biotech has informed Union health ministry that it will rectify the issues pointed out by WHO in 15 to 20 days." "World Health Organisation (WHO)'s suspension is not related to safety or efficacy issues but limited only to supply for United Nations agencies."
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.
Bharat Biotech on Wednesday said a study has demonstrated that a booster dose of Covaxin has a neutralising effect on the Omicron and Delta variants of COVID-19.
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.
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.
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.
The global health agency also emphasized that it must evaluate a vaccine thoroughly to make sure it is "safe and effective".
Bharat Biotech is in the middle of conducting a phase 3 trial with 22,000 subjects.
The company had in December said that the CDSCO had approved a 12-month shelf life for Covaxin, which was nine months earlier, Sohini Das reports.
The production of Covaxin will increase from the current 10 million doses per month to 60 million-70 million by July-August.
The NIH said results of two studies of blood serum from people who had received Covaxin suggest that the vaccine generates antibodies that effectively neutralise the B.1.1.7 (Alpha) and B.1.617 (Delta) variants of SARS-CoV-2, first identified in the United Kingdom and India, respectively.
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.
This is for the first time that a booster dose that is different from the one used for primary vaccination against COVID has been allowed in the country.
A nasal vaccine, one expert said, is a "fantastic idea" for two reasons -- one, it can potentially create sterile immunity, and two, it is easy to administer and thus scalable.
Three entities are at the centre of this controversy: The Brazilian government, Bharat Biotech and a Singapore-based company called Madison Biotech.
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.
The study by a group of doctors showed that after two shots of the vaccines, 98 per cent recipients of Covishield showed antibody response, while the same was 80 per cent among Covaxin recipients. Sohini Das and Ruchika Chitravanshi report.
Bharat Biotech said that it is disheartening to listen to some states complaining about company's intentions regarding supply of COVID vaccine Covaxin.
An expert panel of the Central Drugs Standard Control Organisation on July 29 had recommended granting permission for conducting the study.
500 million doses per annum from its two sites in Hyderabad and 200 million doses each from its Ankleshwar and Kolar facilities.
The phase 3 trial findings indicate that Covaxin induces a robust antibody response with no severe vaccine-related adverse events or deaths reported among the trial participants, the authors of the study said.
Bharat Biotech has completed the Phase 2/3 trials of COVID-19 vaccine, Covaxin for use in children under 18 years of age and is expected to submit the data by next week to the Drugs Controller General of India (DCGI), Chairman and Managing Director of Bharat Biotech International Ltd, Krishna Ella said
The decline in the effectiveness of Covaxin, India's indigenous COVID-19 vaccine, from 77.8 per cent to 50 per cent during a Delta-driven case surge in April and May this year is neither bad nor surprising, say scientists.
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