Bharat Biotech agrees to give COVAXIN formula to other manufacturers: Centre

Good decision to help poor countries but I think it will take atleast 1-10rs per dose normal price to get some income which is use in r&d and other experiment 😇
To improve our country technology 😇

First batch of DRDO’s anti-Covid drug to be released on Monday, May 17

The first batch of anti-COVID drug 2-DG, developed by the DRDO, will be released on Monday, May 17 by defence minister Rajnath Singh and health minister Harsh Vardhan, officials said.

The Drugs Controller General of India (DGCI) has approved the oral drug for emergency use as an adjunct therapy in moderate to severe coronavirus patients, the defence ministry said earlier this month.

Ref: https://www.desidime.com/discussions/centre-app...

Hope its true.
Not a new Jhumla from BJP.

This is relieving news in these horrible times.
Meanwhile Dr.Reddy’s

Covaxin production volumes ramped up by Bharat Biotech, by an additional 200 million

Bharat Biotech a global leader in vaccine innovation, developing vaccines for infectious diseases, announced today, the quick ramp up of additional manufacturing capacities for Covaxin, India’s 1st Indigenous Covid 19 Vaccine at CHIRON BEHRING Vaccines, Ankleshwar Gujarat, a wholly owned subsidiary of Bharat Biotech.

The company plans to produce 200 million doses of Covaxin per annum in the GMP facilities that are already operational for the production of vaccines based on Inactivated Vero Cell Platform Technology, under stringent levels of GMP and biosafety. Product availability at Ankleshwar to commence from Q4 2021.

Bharat Biotech expects EUA from WHO for Covaxin in July-September

Bharat Biotech on Tuesday said it expects approval for Covaxin from the World Health Organisation for Emergency Use Authorisation during July-September.

The company said regulatory approvals for Covaxin are in process in more than 60 countries including the USA, Brazil and Hungary among others. “

Application for EUL has been submitted to WHO-Geneva, regulatory approvals are expected July-September 2021,” it said in a release.

Bharat Biotech further said it has got EUA in 13 countries with more to follow. (PTI)

@Sigma999 I’m removing these 2DG updates (duplicates) from THIS thread as they have been there in the correct one. Avoid doing the same in future.

good move by Bharat Biotech.

HBPCL to start manufacturing Covaxin in 8 months

Haffkine Bio-Pharmaceutical Corporation Limited (HBPCL), a Maharashtra government undertaking, is preparing to produce Bharat Biotech’s Covaxin vaccine in the next eight months, ANI reported.

Once the requisite facilities are put in place, the company aims to produce over 22 crore doses of the vaccine every year.

The company has been given permission by the Department of Biotechnology under Project Sulekha.

“We’ve received approval for Covaxin production & are in talks with Bharat Biotech for further process. We’ll be initiating production in 8 months,” HBPCL MD Sandeep Rathod said

Bharat Biotech to conduct Covaxin phase-4 trials to check real-world effectiveness

According to the company, the phase-4 trials will not just help check the real-world effectiveness but also ensure that “its vaccine met every rigorous scientific standard for safety, effectiveness, and manufacturing quality needed to support emergency use authorization (EUA)”

Bharat Biotech will conduct phase 4 trials of Covaxin to check the real-world effectiveness of the vaccine. The company is currently carrying out its phase 3 trial and it will publish the data in July following which it plans to apply for the full licensure of Covaxin.

“It is critical to understand, and further emphasise the Phase-3 data will first be submitted to Central Drugs Standard Control Organisation (CDSCO), followed by peer-reviewed journals, with a timeline of 3 months for publication.

Bharat Biotech said that, “Vaccine efficacy refers to the ability of a vaccine to bring about the intended beneficial effects on vaccinated individuals in a defined population under ideal conditions of use. When it comes to efficacy and safety, the efficacy data of Covaxin have been reported at overall efficacy is 78 per cent and efficacy against hospitalizations is 100 per cent."

Covaxin phase 3 full trial data will be made public in July, says Bharat Biotech

The submission of the phase-3 trial data is also mandatory to get the World Health Organization’s Emergency Use Listing

The phase-3 trial data of the Covid-19 vaccine, Covaxin, will be out in July, the Hyderabad-based Bharat Biotech, which is manufacturing the indigenous vaccine, told ANI.

Once data from the final analysis of phase 3 studies are available, Bharat Biotech will reportedly apply for full licensure for Covaxin.

FDA rejects EUA for Covaxin, ‘suggests’ Biologics Licence Application route for approval in US

In a setback to Bharat Biotech’s COVID-19 vaccine Covaxin, the US Food and Drug Administration has “recommended” Ocugen Inc, the US partner of the Indian vaccine maker, to go for Biologics Licence Application (BLA) route with additional data, nixinghopes of Emergency Use Authorisation.

Ocugen in a statement on Thursday announced that as recommended by theFDA,it will pursue submission of a biologics licence application (BLA) for Covaxin. BLA,isa “full approval” mechanism by the FDA for drugs and vaccines. "The company will no longer pursue an Emergency Use Authorization (EUA) for Covaxin.

The FDA provided feedback to Ocugen regarding the Master File. The company had previously submitted and recommended that Ocugen pursue a BLA submission instead of an EUA application for its vaccine candidate and requested additional information and data," Ocugen said. (PTI)

Efficacy data from phase 3 trials of Covaxin will be published in 7-8 days:

Publication of crucial phase 3 trial data of Bharat Biotech’s Covaxin, which will detail the efficacy of the indigenous Covid vaccine developed by ICMR and Bharat Biotech, will done in the next “7-8 days”.

…good move….

…we are already running very late….GOI should get out of this slumber…

Bharat Biotech will be carrying out clinical trials in the United States to support the marketing application for Covaxin, company says

Recruitment for clinical trial of Covaxin in 6-12 age group to start at AIIMS from Tuesday, June 15.

The recruitment for the clinical trial of the country’s first indigenously-developed COVID-19 vaccine, Covaxin, among children in the age group of 6-12 years will begin at the AIIMS here from Tuesday.

This will be followed by the clinical trial of children in the age-group of 2-6 years. The enrolment of children volunteers aged 12-18 years at the All India Institute of Medical Sciences (AIIMS) has been completed and they have been given the first dose of Covaxin.

The Drugs Controller General of India (DCGI) had granted permission for conducting the phase 2/3 clinical trial of Bharat Biotech’s Covaxin among children aged two to 18 years on May 12. The trial is to be conducted in three parts — 175 volunteers each in the groups aged 12-18, 6-12 and 2-6 years. —PTI

Supply price of Covaxin to Govt at Rs 150/dose is not sustainable in long run, says Bharat Biotech

The supply price of COVAXIN to Govt of India at Rs 150/dose, is a non-competitive price & clearly not sustainable in the long run. Hence a higher price in private markets is required to offset part of the costs: Bharat Biotech

Govt clarifies myth regarding composition of Covaxin

There have been some social media posts regarding composition of the COVAXIN where it has been suggested that COVAXIN contains the newborn calf serum. Facts have been twisted and misrepresented in these posts – Ministry of Health and Family Welfare

Newborn Calf Serum is used only for preparation of vero cells…The vero cells are completely destroyed in process of viral growth. The grown virus is also killed & purified. This is then used to make final vaccine &in final vaccine formulation no calf serum used.

Hence, the final vaccine (COVAXIN) does not contain newborn calf serum at all and the calf serum is not an ingredient of the final vaccine product. – (ANI)

Bharat Biotech-WHO’s pre-submission meeting on June 23

Bharat Biotech and World Health Organisation’s (WHO) pre-submission meeting on June 23rd, says a WHO document. #COVAXIN (ANI)

Happy to see that Bharat biotech has done this, Business in need is business indeed.

Bharat Biotech submits Covaxin phase-III clinical trial data to DCGI

Hyderabad-based biotechnology company Bharat Biotech has submitted phase-III clinical trial data of its COVID-19 vaccine Covaxin to the Drugs Controller General of India (DCGI).

Covaxin is one of the three vaccines being used in India’s vaccination programme against COVID-19 currently. The company has been facing questions over the delay in announcing results of phase-III trials.

“Bharat Biotech submitted Phase 3 clinical trials data of Covaxin to Drugs Controller General of India (DCGI) over the weekend,” news agency ANI said quoting government sources.

Trial data for phase-III is crucial as it will provide details of the efficacy of the vaccine, which was developed in association with the Indian Council of Medical Research (ICMR). Phase-III trial data is also required for getting emergency use listing (EUL) from the World Health Organisation (WHO).

WHO has accepted Bharat Biotech’s Expression of Interest (EoI) for EUL for Covaxin and scheduled a pre-submission meeting on June 23.

Covaxin has shown 77.8 per cent efficacy against virus: Report

Bharat Biotech’s Covaxin is likely to get clearance from Drugs Controller General of India (DCGI) today: Source

India’s Covaxin has shown 77.8 per cent efficacy against coronavirus in phase 3 trial data in review by the subject expert committee, news agency ANI quoting sources reported.

According to ANI sources, Covaxin is likely to get clearance from the Drugs Controller General of India (DCGI) today.

SEC nod to phase 3 data

Now that the data from phase 3 trials has been reviewed by the drug regulator of the country of origin, the firm can present it before the World Health Organization

The Drugs Controller General of India’s Subject Expert Committee (SEC) has approved Bharat Biotech’ Phase 3 trial efficacy data after questions were raised over the delay in announcing results.

The WHO has accepted Bharat Biotech’s Expression of Interest (EoI) for EUL for Covaxin and scheduled a pre-submission meeting today, June 23. The complete results of Covaxin’s phase-III trial data will be made public during July.

Biotech’s Covaxin, India’s first indigenous vaccine against Covid-19, has shown 77.6 per cent efficacy in the final analysis of phase 3 clinical trials, according to sources in the expert panel that reviewed the data.

The vaccine has shown an efficacy rate of 93 per cent against severe disease and 60 per cent against asymptomatic Covid-19.

The Hyderabad-based vaccine manufacturer sought a full marketing authorisation for Covaxin after presenting the final analysis of phase 3 data before the Subject Expert Committee (SEC), which is advising the Drugs Controller General of India (DCGI), a source said.

“A full marketing authorisation has not yet been recommended by the SEC. More data on safety has been sought before a full authorisation can be granted,” the person cited above said. The SEC will now pass on the data to the DCGI for review.

that the data from phase 3 trials has been reviewed by the drug regulator of the country of origin, the firm can present it before the World Health Organization (WHO). Bharat Biotech is set to present the data before the WHO on Wednesday as it seeks to be part of the WHO-Emergency Use List (EUL).

Once Covaxin features in the WHO-EUL, it would address concerns around those vaccinated with this jab travelling abroad as most countries are allowing travelers who are vaccinated by one of the doses that feature in the list.

Bharat Biotech indicated earlier that it was engaging with the WHO and presenting data from the analysis of trials from time to time. The company has said it expects a WHO nod between July and September.

Bharat Biotech has noted on its website that “Covaxin demonstrated 78 per cent vaccine efficacy against mild, moderate, and severe Covid-19 disease. The efficacy against severe Covid-19 disease was 100 per cent with an impact on reduction in hospitalisations”.

Of the 25,800 participants in the phase 3 trials, over 2,400 volunteers were above 60 years of age and over 4,500 with comorbid conditions.

Philippines Approves Emergency Use Of Covaxin

The Philippines’ food and drug agency said it has approved the emergency use of the COVID-19 vaccine developed by Indian company Bharat Biotech.

Bharat Biotech has received “full emergency use authorisation” for its Covaxin brand after the company completed documentary requirements," Food and Drug Administration chief Rolando Enrique Domingo told a news briefing.

Very nice initiative!

Centre is in talks with the WHO to expedite prequalification process for Covaxin’s Emergency Use Listing Procedure (EUL).

The government wants WHO to consider a fast track approval and reduce a 6 month long process to 2 months.

Pre-submission meet held, Covaxin’s “Rolling Data” to start in July, says WHO

Taking the approval process ahead, World Health Organisation (WHO) which is currently approached by Bharat Biotech for an Emergency Use Listing of its COVID-19 vaccine Covaxin, has said pre-submission meeting for it was held and the “Rolling Data will starting in July.”

The information was provided in theWHOwebsite in the Status of COVID-19 vaccines withinWHOEUL-PQ evaluation process document. Emergency Use Listing (EUL) is a procedure to streamline the process by which new or unlicensed products can be used during public health emergencies, WHO guidelines said.

Meanwhile, stating that its COVID-19 vaccine Covaxin adheres to international standards, Bharat Biotech’s joint managing director Suchitra Ella on Tuesday said external timelines are in the company’s hands. "Covaxin will cross new frontiers, adhering highest international regulatory guidelines.

A new vaccine from (India) is all set to make history once again, with proven data, safety & quality. We stand committed to deliver no matter what, external timelines not in our control," Ella tweeted. Her tweet assumes significance in the wake of the company trying to get EUL from the WHO even as its US partner Ocugen preparing to get US Food and Drug Administrations nod to use the jab in that country. Ella also tweeted a table of states and cities in which Covaxin is currently available. (PTI)

Covaxin effectively neutralises Delta variant of Covid, says NIH

India’s Covaxin, developed by Bharat Biotech in collaboration with the Indian Council of Medical Research, effectively neutralises both Alpha and Delta variants of coronavirus, the US’ National Institute of Health has said.

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 UK and India, respectively.

The top American health research institute, which has a history of strong scientific collaboration with India, also said that an adjuvant developed with funding from it has contributed to the success of the highly efficacious Covaxin, which has been administered to roughly 25 million people till date in India and elsewhere. – PTI

COVAXIN has now received Emergency Use Authorizations in 16 countries – Bharat Biotech

COVAXIN has now received Emergency Use Authorizations in 16 countries including, Brazil, India, Philippines, Iran, Mexico, etc. with EUA’s in process in 50 countries worldwide.

The pricing of COVAXIN has been clearly established between $15-20 per dose for supplies to Governments outside India. The pricing for Brazil has also been indicated at $ 5 per dose.