bharat biotech

Covaxin-maker Bharat Biotech MD D Krishna Ella and Suchitra Ella conferred “Padma Bhushan”

New Delhi [India]: Bharat Biotech Managing Director (MD) D Krishna Ella and Joint MD Suchitra Ella received the Padma Bhushan award from President Ram Nath Kovind on Monday.

Bharat Biotech founders received the award for their contribution to the field of medicine.

Hyderabad-based Bharat Biotech is the manufacturer of Covaxin, the indigenous vaccine against COVID-19.

Padma Awards, one of the highest civilian Awards of the country, are conferred in three categories, namely, Padma Vibhushan, Padma Bhushan and Padma Shri. The Awards are given in various disciplines/ fields of activities, viz. art, social work, public affairs, science and engineering, trade and industry, medicine, literature and education, sports, civil service, etc. ‘Padma Vibhushan’ is awarded for exceptional and distinguished service; ‘Padma Bhushan’ for distinguished service of high order and ‘Padma Shri’ for distinguished service in any field. The awards are announced on the occasion of Republic Day every year.

These awards are conferred by the President of India at ceremonial functions which are held at Rashtrapati Bhavan usually around March/ April every year. This year the President has approved conferment of 128 Padma Awards including two duo cases (in a duo case, the Award is counted as one).

The list comprises 4 Padma Vibhushan, 17 Padma Bhushan and 107 Padma Shri Awards. 34 of the awardees are women and the list also includes 10 persons from the category of Foreigners/NRI/PIO/OCI and 13 posthumous awardees. (ANI)

Warning! no paracetamol after anti-covid vaccine otherwise….


New Delhi [India]: Experts said that those children who are getting anti-COVID vaccines should not take paracetamol before the consultation of doctors.

The advice was issued in response to growing concerns that some immunisation centres are advising children to take three paracetamol 500 mg tablets after receiving the COVID vaccine.
“Paracetamol is not recommended as prophylaxis, before and after any Covid vaccination as we don’t know how it alters the immune response of vaccine. A low-grade fever, muscle ache, lethargy, headache, soreness at the injection site is common in the first 2 days after vaccination, which usually subsides on its own, without any medication. However, if the fever persists or the intensity increases then paracetamol or other painkiller is advised after consultation with a physician. So paracetamol is to be taken only after consultation and not as prophylaxis for fever, which happens because of immune response of the body to the vaccine components,” said Dr Akshay Budhraja, Sr. Consultant, Respiratory and Sleep Medicine, Aakash Healthcare.

To combat the third wave of Omicron cases, the Union government has begun administering the Covid vaccination to teenagers aged 15 to 18. On January 3, the first day of the children’s vaccination programme, over 41 lakh such children received their first dose of vaccine. However, it has been discovered that when children have a fever, they are given paracetamol without consulting a doctor, which can harm them.

“Giving paracetamol to children (15-18 years old) who are receiving COVID vaccines is not recommended these days. It is because it has the potential to cause hepatotoxicity (liver damage caused by drug exposure) in them. If children develop a fever after receiving the COVID vaccine, they should be given Mefenamic acid or Meftal syrup. Adults over the age of 18 who have a fever after receiving the Covid vaccine are safe to take paracetamol,” says Dr Col.Vijay Dutta, Senior Consultant, Internal Medicine, Indian Spinal Injuries Centre.

“It says it is not recommended to take it as a rule – that definitely after taking the vaccine you shouldn’t take Paracetamol. Vaccine-related fever usually occurs within 24 hours of vaccine administration and 1-2 spikes. Other symptoms like some muscle pain, weakness can be there which do not need any medication! Fever 99 and above may need age and weight-specific dose only after consulting with the treating paediatrician. Waiting at the vaccination centre for half an hour post-vaccination. Adequate hydration, rest, and sleep – going about the day, as usual, is sufficient precautions to take while getting vaccinated,” Dr Swetha Reddy Pasam, Consultant-Paediatrics, Apollo TeleHealth.

Previously, Bharat Biotech, which developed India’s first indigenous Covid vaccine, Covaxin, stated that no painkillers or paracetamol are recommended following vaccination with its COVID-19 vaccine Covaxin.

Bharat Biotech gets SEC approval for phase 3 clinical trials of COVID booster intranasal vaccine

New Delhi [India]: The Subject Experts Committee (SEC) of the Drug Controller General of India (DCGI) on Wednesday granted approval to Bharat Biotech for conducting intranasal phase 3 trials and heterologous trials for COVID-19 booster intranasal vaccine for those who have taken both the doses of Covaxin and Covishield.
The SEC has asked the Hyderabad-based vaccine manufacturer to submit its revised protocol for trials. “After detailed deliberation, the SEC ‘in principle’ agreed for the conduct of both phase 3 superiority study and phase 3 booster dose study in parallel in the light of the pandemic situation. Accordingly, Bharat Biotech has been asked to submit the protocol(s) as recommended for approval,” reads the SEC minutes of the meeting.
The vaccine manufacturer plans to conduct clinical trials on 5,000 healthy individuals, 50 per cent of whom have received Covishield and the other 50 per cent have been inoculated with Covaxin.
The report submitted by Bharat Biotech also recommended inoculating the COVID-19 Booster dose after 6 months of getting both the primary doses.
The company had applied for permission sometime around mid-December to conduct clinical trials for its intranasal booster dose vaccine.

Covaxin found to be safe, immunogenic in 2-18 age group in phase 2, 3 study: Bharat Biotech

Hyderabad (Telangana) [India]: Hyderabad based vaccine manufacturer Bharat Biotech on Thursday announced that Covaxin (BBV152) has been found to be “safe, well-tolerated, and immunogenic” in the age group of 2-18 years in phase II/III study, said a company’s statement. Bharat Biotech had conducted phase II/III, open-label, and multicenter studies to evaluate the safety, reactogenicity, and immunogenicity of COVAXIN in healthy children and adolescents in the 2-18 age group, added the statement.
The clinical trials conducted in the paediatric population between June 2021 to September 2021 have shown robust safety, reactogenicity, and immunogenicity. The data was submitted to the Central Drugs Standard Control Organisation (CDSCO) during October 2021 and received an emergency use nod for children aged 12-18 from the Drugs Controller General of India (DCGI), recently.
In the study, no serious adverse event was reported. 374 subjects reported either mild or moderate severity symptoms with 78.6 per cent getting resolved within one day, stated the statement.
Pain at the injection site was the most commonly reported adverse event, as per the statement.

Dr Krishna Ella, Chairman and Managing Director, Bharat Biotech, said, “Covaxin’s clinical trial data from the paediatric population is very encouraging. The safety of the vaccine is critical for children and we are glad to share that Covaxin has now proven data for safety and immunogenicity in children.”
“We have now achieved our goal of developing a safe and efficacious COVID-19 vaccine for adults and children. Vaccines are a great preventive tool; the power of vaccines can only be harnessed if used prophylactically,” he added.
For the trial, 976 subjects were screened for SARS-CoV-2 by RT-PCR and ELISA testing. Out of these, 525 eligible participants were enrolled. Based on the age, participants were distinguished into three groups in an age de-escalatory manner, the statement said.

Covaxin for 2-18 yrs: Centre examining Expert Committee recommendations

New Delhi [India] : The Central government is examining the recommendation of the Subject Expert Committee (SEC) regarding the grant of market authorization of Covaxin for the age group of 2 to 18 years for restricted use in an emergency situation subject to various conditions, Ministry of Health and Family Welfare (MoHF) told Rajya Sabha on Tuesday.
Union Minister of State for Health Bharati Pravin Pawar shared the information through a written reply, mentioning “this recommendation is being examined and additional information has been requested at the level of Central Drugs Standard Control Organisation (CDSCO)”. “The Interim Phase II/III clinical trial data of COVAXIN on healthy volunteers aged 2 to 18 years submitted by Bharat Biotech was deliberated in the meeting of Subject Expert Committee (SEC),” Pawar said.
“The committee recommended for grant of market authorization for the age group of 2 to 18 years for Restricted Use in Emergency Situation subject to various conditions,” the MoS added.
The Minister was replying to the question asked by Dravida Munnetra Kazhagam (DMK) leader and Rajya Sabha member Tiruchi Siva.
The MP had asked whether it is a fact that the expert panel has recommended Bharat Biotech’s COVID-19 vaccine Covaxin for use on children between the ages 2-18 years and the time taken for starting vaccination programme for children helping them in recovering from the fear of COVID-19 and opening of schools fully.
Bharat Biotech’s Covaxin for Children, the vaccine against coronavirus disease (COVID-19) for children, is being eagerly awaited as schools are now opening.
Amid growing concern of a new Omicron variant of the COVID-19, authorization of the COVID-19 vaccine for children will be significant.

Bharat Biotech’s Covaxin phase 3 data shows 77.8 pc efficacy against COVID-19, says Lancet

Hyderabad (Telangana) [India]: Hyderabad-based Bharat Biotech on Friday announced that the Lancet peer-review confirmed the efficacy analysis of Bharat Biotech’s Covaxin.
As per phase-three clinical trials data, Covaxin demonstrates 77.8 per cent efficacy against symptomatic COVID-19. “COVAXIN is the only COVID-19 vaccine to have demonstrated efficacy data from phase III clinical trials against the delta variant at 65.2 per cent,” the official statement issued by Bharat Biotech said citing the study by the Lancet.
“Efficacy analysis demonstrates Covaxin to be 77.8 per cent effective against symptomatic COVID-19, through evaluation of 130 confirmed cases, with 24 observed in the vaccine group versus 106 in the placebo group,” said the company’s statement.
Further, it said that Covaxin will be 93.4 per cent effective against severe symptomatic COVID-19.
“Safety analysis demonstrates adverse events reported were similar to placebo, with 12 per cent of subjects experiencing commonly known side effects and less than 0.5 per cent of subjects experiencing serious adverse events,” it said.
“Efficacy data demonstrates 63.6 per cent protection against asymptomatic COVID-19, 65.2 per cent protection against the SARS-CoV-2, B.1.617.2 Delta and 70.8 per cent protection against all variants of SARS-CoV-2 virus,” Bharat Biotech added.
Dr Krishna Ella, Chairman and Managing Director (CMD) of Bharat Biotech said, “The data from our product development and clinical trials have been published in 10 peer-reviewed journals, making Covaxin one of the most highly published COVID-19 vaccines in the world,” he said.
“I am delighted to see that the phase III efficacy data has also been published in the Lancet. This itself speaks high about the strong position of Covaxin amongst other global front-runners COVID-19 vaccines,” Dr Balram Bhargava, Director General, Indian Council of Medical Research (ICMR) said.
“The bench to bedside journey of Covaxin in less than 10 months showcases the immense strength of “Atmanirbhar Bharat” along with the Indian academia and industry in fighting against the odds and carving a niche in the global community,” Bhargava added.
Recently, the World Health Organization granted emergency use listing to Covaxin enabling countries to expedite their regulatory approval to import and administer doses. It has also received emergency use authorizations in several countries with applications in process in more than 50 countries worldwide, the statement added.

Bharat Biotech’s partner seeks Covaxin approval in US for children below 18 years

New Delhi [India] ): Bharat Biotech’s US partner Ocugen has announced that it had asked the US Food and Drug Administration (FDA) for Emergency Use Authorisation (EUA) of Covaxin for children below 18.
“We are pleased to announce our EUA filing to the US-Food and Drug Administration (FDA) through our partners- Ocugen,” tweeted Dr Raches Ella, Bharat Biotech’s clinical lead for Covid-19 vaccines. The World Health Organisation (WHO) on Wednesday granted approval for Emergency Use Listing (EUL) for Bharat Biotech’s COVID-19 vaccine, Covaxin.
The approval was done on the recommendation of the Technical Advisory Group (TAG) for Emergency Use Listing (TAG-EUL), an independent advisory panel that provides recommendations to WHO on whether a COVID-19 vaccine can be listed for emergency use under the EUL procedure.
Bharat Biotech’s Covaxin and AstraZeneca and Serum Institute’s Covishield are the two widely used vaccines in India.

Guyana adds Bharat Biotech’s Covaxin to list of recognised COVID-19 vaccines

Georgetown [Guyana] : Guyana has recognised Bharat Biotech’s Covaxin COVID-19 vaccine, said High Commission of India in Georgetown, Guyana on Tuesday.
“#Guyana has recognized #India’s indigenous vaccine #COVAXIN-important step forward in the post-COVID partnership between India and Guyana,” the Indian Embassy tweeted. On Monday, Australian government gave recognition to Covaxin for the purpose of establishing a traveller’s vaccination status in the country.
The UN health body — World Health Organisation — has sought additional clarifications from Bharat Biotech, which manufactures Covaxin, and a decision on emergency use authorisation is expected soon.
Foreign Secretary Harsh Vardhan Shringla has said that the government is carefully following the discussions taking place within the health body and hoped that approval for the indigenous COVID-19 vaccine will be granted soon.
“WHO’s technical advisory group (TAG), which is a regulatory body, met Bharat Biotech officials on October 26. They had a few questions for Bharat Biotech. From what we understand, the company will submit its reply soon. According to me, once the regulatory group is satisfied with the response, the approval for Covaxin should be given soon,” Shringla said.

Australia adds Covaxin to list of ‘recognised’ COVID-19 vaccines

Canberra [Australia] : Australian government on Monday gave recognition to Bharat Biotech’s Covaxin COVID-19 vaccine for the purpose of establishing a traveller’s vaccination status in the country.
“Today, the Therapeutic Goods Administration determined that Covaxin (manufactured by BharatBiotech) vaccine would be ‘recognised’ for the purpose of establishing a traveller’s vaccination status,” Australia’s High Commissioner to India Barry O’Farrell informed in a tweet. “Importantly, recognition of Covaxin, along with the previously announced recognition of Covishield (manufactured by AstraZeneca India, means many citizens, as well as other countries, will now be considered fully vaccinated on entry to Australia,” the High Commissioner added in the tweet.
COVID-19 vaccines are approved for use in Australia by the Therapeutic Goods Administration (TGA) after an assessment and approval process.

“In recent weeks, the TGA has obtained additional information demonstrating these vaccines provide protection and potentially reduce the likelihood that an incoming traveller would transmit COVID-19 infection to others while in Australia or become acutely unwell due to COVID-19,” a statement from Australia’s Department of Health informed.
Recognition of Covaxin, along with the previously announced recognition of Covishield (manufactured by AstraZeneca, India), means many citizens of India, as well as other countries where these vaccines have been widely deployed, will now be considered fully vaccinated on entry to Australia, the statement said.
“This will have significant impacts for the return of international students, and travel of skilled and unskilled workers to Australia,” the statement added.
From 1 November 2021, vaccinated Australians and permanent residents aged 12 and over may depart Australia without the need to seek a travel exemption, the Australian Health Department said.
The UN health body — World Health Organisation — has sought additional clarifications from Bharat Biotech, which manufactures Covaxin and a decision on emergency use authorisation is expected early next month.
WHO giving approval for Emergency Use Authorisation for India’s indigenous COVID-19 vaccine ‘Covaxin’ would facilitate the process of assisting other countries, Foreign Secretary Harsh Vardhan Shringla said on Saturday addressing a media briefing on the first day of G20 summit in Rome.

Approval for Covaxin on basis of WHO meeting today: Mansukh Mandaviya

New Delhi [India] : Union Health Minister Mansukh Mandaviya on Tuesday said that approval for Hyderabad-based Bharat Biotech’s COVID-19 vaccine Covaxin will be given on the basis of the meeting which will be convened by the World Health Organization (WHO) today.
“WHO has a system in which there is a technical committee which has approved it (Covaxin) while the other committee is meeting today. The approval for Covaxin will be given on the basis of today’s meeting,” said Union Health Minister during a press briefing here. Earlier this month, WHO chief scientist Dr Soumya Swaminathan had said that WHO’s technical advisory group will meet on October 26 to consider emergency use listing (EUL) for Covaxin.
The WHO last week had said a vaccine recommended by it for emergency use must be evaluated thoroughly.
“We are aware that many people are waiting for WHO’s recommendation for Covaxin to be included in the COVID19 Emergency Use Listing, but we cannot cut corners – before recommending a product for emergency use, we must evaluate it thoroughly to make sure it is safe and effective,” the organisation had said.
The WHO had said that the timeframe for the WHO Emergency Use Listing procedure depends on how quickly a company producing the vaccine is able to provide the required data.
“The timeframe for the WHO Emergency Use Listing procedure is dependent on how quickly a company producing the vaccine is able to provide the data required for WHO to evaluate the vaccine’s quality, safety, efficacy and its suitability for low- and middle-income countries,” it said.
Bharat Biotech has been submitting data to WHO on a rolling basis and submitted additional information at WHO’s request on September 27.
Covaxin, India’s first indigenous COVID-19 vaccine, has been developed by Hyderabad-based Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).

Validation awaited to Covaxin for children aged between 2-18 years

New Delhi [India] : After the evaluation of data Covaxin is yet to get approval by the Drugs Controller General of India (DCGI) for children between 2-18 years old, according to official sources.
Bharat Biotech, the manufacturer of Covaxin, has submitted data for clinical trials in the age group of 2-18 years to Central Drugs Standard Control Organisation (CDSCO). The data has been thoroughly reviewed by the CDSCO and Subject Experts Committee and has provided their positive recommendations.

WHO to decide on Bharat Biotech’s Covaxin emergency usage in October

The World Health Organisation (WHO) on Wednesday informed that the final decision on Bharat Biotech’s submission on emergency use listing (EUL) for its Covaxin COVID-19 vaccine will be made in October 2021.

New Delhi [India] September 30 : The status of assessment for Covaxin is “ongoing” as of now, the WHO informed in a document citing the status of COVID vaccines. On the WHO website, the decision date for Bharat Biotech’s Covaxin is October 2021.
Bharat Biotech had submitted EOI (Expression of Interest) on April 19 for its vaccine.
The duration of the emergency use listing process depends on the quality of the data which is submitted by the vaccine manufacturer.
The WHO has also asked for additional data from Bharat Biotech for Covaxin, sources from the WHO informed ANI.
“There is a procedure of submitting the documents for approval, WHO’s emergency use authorization to Covaxin is expected soon,” Dr Bharati Pravin Pawar, MoS, Health had informed ANI.
According to Bharat Biotech Covaxin Phase 3 clinical trials of Covaxin demonstrated an efficacy rate of 77.8 per cent.
Bharat Biotech had also informed that the company has responded to clarifications sought by WHO and is awaiting further feedback.
“As a responsible manufacturer with several prequalified vaccines, we do not find it appropriate to speculate or comment on the approval process and its timelines,” a statement from Bharat Biotech informed.
Speaking to ANI, Chairman of the National Expert Committee on Vaccine Administration and Member of Health for NITI Aayog Dr VK Paul had also said that the WHO’s approval for Bharat Biotech’s COVID-19 vaccine, Covaxin, is likely to come before the end of this month.
The strategic advisory group of experts on Immunization (SAGE) of the WHO will be meeting in October to make its recommendations on Bharat Biotech’s COVID-19 vaccine Covaxin on EUL.
SAGE is authorised with advising WHO on overall global policies and strategies ranging in vaccines, technology, research and other health interventions.

Bharat Biotech awaits feedback from WHO for COVID-19 vaccine Covaxin’s emergency use listing

Bharat Biotech on Friday said it has submitted all the data to the World Health Organisation (WHO) for Emergency Use Listing (EUL) of its COVID-19 vaccine Covaxin and is awaiting feedback from the UN Public Health Agency.

New Delhi [India], September 17 : In a series of tweets, Bharat Biotech said that Covaxin clinical trial was fully compiled and available in June 2021. “#COVAXIN clinical trial data was fully compiled and available in June 2021. All Data was submitted for Emergency Use Listing (EUL) Application to World Health Organization in early July. We have responded to any clarifications sought by #WHO and are awaiting further feedback,” Bharat Biotech tweeted.
As a responsible manufacturer with past approvals for its other vaccines, the company said it would not find it appropriate to speculate or comment on the approval process and its timelines, it further said.
“We are continuing to work diligently on obtaining WHO EUL at the earliest,” it added.
Earlier on Monday, the sources said that the World Health Organisation’s (WHO) approval for Covaxin, is expected this week.
Bharat Biotech has submitted its Phase 3 clinical trials data that demonstrated 77.8 per cent efficacy to the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO).
Earlier in June, a pre-submission meeting for WHO Emergency Use Listing Procedure (EUL), which provides advice before the submission of the final dossier, was also held.
Union Health Minister Mansukh Mandaviya had also earlier met WHO Chief Scientist Dr Soumya Swaminathan and held discussions over the approval of Bharat Biotech’s Covid-19 vaccine Covaxin.
Covaxin was developed by Hyderabad-based Bharat Biotech in association with the Indian Council of Medical Research and the National Institute of Virology. Covaxin, which has been developed in collaboration with the Indian Council of Medical Research (ICMR), contains a whole virion inactivated SARS-CoV-2 vaccine, which is produced in Vero cells.
The vaccine is stable at 2 degrees Celsius to 8 degrees Celsius (refrigerated) and is shipped in a ready-to-use liquid formulation that permits distribution using existing vaccine supply chain channels.
The WHO has approved COVID-19 vaccines by Pfizer-BioNTech, AstraZeneca, Johnson and Johnson, Moderna and Sinopharm.

Indian Immunologicals hands over first lot of Covaxin drug substance to Bharat Biotech

Hyderabad (Telangana) [India]: In order to augment the Covid-19 vaccine production capacity in our country so that a significant percentage of the population can get vaccinated at the earliest, the Central Government requested that Indian Immunologicals Limited (IIL) and Bharat Biotech International Limited (BBIL) to join hands in April 2021.
IIL in a short period of time has performed several activities including the signing of four agreements with BBIL, repurposing its manufacturing facility in Hyderabad, procurement of key raw materials and consumables, procurement of key equipment for the process, technology transfer, trials at Research and Development scale, training etc. These activities were all done at breakneck speed and production commenced in July 2021. The batches so produced at IIL’s manufacturing facility have been tested at BBIL and IIL and meets the quality specifications for the drug substance. The yields are more than expected.
In a simple handing over function, Dr K Anand Kumar, MD, IIL handed over the first lot of Covaxin drug substance to Dr Krishna Ella, CMD, Bharat Biotech today.
Speaking on this occasion, Dr K Anand Kumar, MD, IIL said that “This is team India’s at work. It could not have been possible without the coming together of several stake holders to achieve a common goal. Our capable and competent team worked tirelessly round the clock to ensure that the committed timelines and product quality are met. It is a proud moment for IIL to have played a vital role in supporting our nation’s interest during this unprecedented time. This would have not been possible without the constant support provided by NITI-Aayog, Biotechnology Industry Research Assistance Council (BIRAC), DBT, Mission Covid Suraksha Team, Central and State drug control authorities”.
Speaking on this achievement Dr Renu Swarup, Secretary, DBT and Chairperson, BIRAC said, “The government has worked relentlessly to provide all possible support for ramping up Covaxin production in the country and speed up Covaxin inoculation drive. The loan license agreement by CDSCO for Indian Immunologicals Ltd to produce Covaxin Drug Substance is a major milestone, achieved in a very short span of time. The DBT-BIRAC support under Mission Covid Suraksha aims to meet the Covid-19 vaccine requirement of our country. I congratulate the team for the efforts put in for this achievement”.
“IIL is also working on another COVID -19 vaccine and the animal trials are underway currently and is expected to come out by next year for human vaccination,” said Dr K Anand Kumar, MD, IIL.
Under Atmanirbhar Bharat 3.0 “Mission COVID Suraksha” was announced by the Government of India, to accelerate the development and production of Indigenous COVID Vaccines. This is being implemented by the Department of Biotechnology. The Indian Immunologicals Limited (IIL), Hyderabad has been sanctioned a grant of Rs 60 crore towards enhancing production capabilities.

Every batch of Covaxin subjected to over 200 quality control tests: Bharat Biotech over vaccine’s quality concerns

Hyderabad (Telangana) [India]: Amid the reports of delayed production of its COVID-19 vaccine due to unsatisfactory test batch and quality issues, Hyderabad-based manufacturer Bharat Biotech on Thursday said every batch of Covaxin[?] is subjected to more than 200 quality control tests, followed by submission samples to Central Drugs Laboratory (CDL).
“Every batch of Covaxin[?] is subjected to more than 200 quality control tests at our facilities, followed by submission samples to Central Drugs Laboratory (CDL) Government of India, only based on approval/release by CDL, are batches released commercially,” read Bharat Biotech’s statement. The statement came after reports that test batches of Covaxin from the Bengaluru plant were not satisfactory and got rejected leading to delayed production.
Earlier, speaking to ANI, NK Arora, chairperson of the Working Group of the National Technical Advisory Group on Immunisation said, “The test batches of that plant were not satisfactory and got rejected which led to delay in ramping up production, but now the batches have been approved by the competent authority and will be available for public consumption.”
The Hyderabad-based company said all batches of Covaxin are manufactured and released only from our manufacturing facilities at Genome Valley Hyderabad, which are fully audited and approved by regulatory authorities. Hence we wish to put to rest any concerns on the quality of Covaxin, it said.
Giving details of its manufacturing and quality checks, Bharat Biotech said it maintains an uncompromising policy on safety and quality. “Bharat Biotech has not sought Indemnity from the Government of India for any adverse events from Covaxin,” [?]the statement added.
Bharat Biotech informed that manufacturing of Covaxin[?] commenced at Malur, Karnataka and Ankleshwar, Gujarat, prior to which engineering batches were also executed to study equipment functionality.
Products manufactured from these facilities will be available for supplies during September. This is based on the company’s 120-day timeline for manufacturing, testing, release, regulatory approvals and distribution,” read the release.
The vaccine manufacturer said it is the only company to develop a vaccine indigenously in India and manufacture it large scale. “Covaxin is the only vaccine to have demonstrated efficacy against the delta variant in phase III human clinical trials,” the statement claimed.
The company said fake news and false and misleading narratives result in unintended consequences of creating panic in the country’s population resulting in vaccine hesitancy.

Covaxin receives certificate of Good Manufacturing Practice from Hungarian authorities

New Delhi [India], August 5 : Bharat Biotech manufactured COVID-19 vaccine Covaxin on Thursday received a certificate of Good Manufacturing Practice (GMP) compliance from the Hungarian authorities.
“Another milestone in our account as COVAXIN® receives GMP certificate from Hungary. This marks the 1st EUDRAGDMP compliance certificate received by Bharat Biotech from European regulatories. #BharatBiotech #COVAXIN #covaxininhungary,” tweeted Bharat Biotech. The approval was received from the National Institute of Pharmacy and Nutrition Hungary certifying the GMP for the manufacture of Covaxin.
With this approval, Bharat Biotech achieved another significant milestone in innovating and manufacturing vaccines at global quality standards and moving forward in the ongoing fight against the COVID-19 pandemic, read Bharat Biotech statement.

The certificate of GMP is now listed on the EudraGMDP database, which is the database of the European Community of manufacturing authorizations and certificates of the good manufacturing practice.
Bharat Biotech also intends to submit documentation for Emergency Use Authorization (EUA) in several additional countries worldwide.
“The recognition complements our commitment to driving world-class innovation and being a frontrunner in the research and development of vaccines,” read the company’s statement.
Meanwhile, Bharat Biotech’s COVID-19 vaccine Covaxin has shown less reduction in ‘neutralizing activity’ while comparing with Delta and Delta AY.1 (Delta plus) variants in those who are fully vaccinated with the vaccine according to a study by the Indian Council of Medical Research-National Institute of Virology (NIV).
This means that people vaccinated with Covaxin will be protected against the current variants Delta, Delta AY.1 and B.1.617.3

Bharat Biotech concludes phase 3 Covaxin trial, claims 77.8% efficacy against COVID 19

Hyderabad-based Bharat Biotech on Saturday concluded a final analysis for its vaccine Covaxin efficacy from phase-3 clinical trial claiming it to be 77.8 per cent effective against COVID-19. It also added that Covaxin gives 65.2 per cent protection against the SARS-CoV-2, B.1.617.2 Delta variant.

“Efficacy analysis demonstrates Covaxin to be 77.8 per cent effective against symptomatic COVID-19, through evaluation of 130 confirmed cases, with 24 observed in the vaccine group versus 106 in the placebo group. Efficacy analysis demonstrates Covaxin to be 93.4 per cent effective against severe symptomatic COVID-19,” the company said.

As per the company, safety analysis demonstrates adverse events reported were similar to placebo, with 12 per cent of subjects experiencing commonly known side effects and less than 0.5 per cent of subjects feeling serious adverse events.

“Efficacy data demonstrates 63.6 per cent protection against asymptomatic COVID-19. Efficacy data demonstrates 65.2 per cent protection against the SARS-CoV-2, B.1.617.2 Delta variant”, Bharat Biotech said.

Hyderabad-based vaccine manufacturer claimed Covaxin was well tolerated and the Data Safety Monitoring Board has not reported any safety concerns related to the vaccine, adding, “The overall rate of adverse events observed in Covaxin was lower than that seen in other COVID-19 vaccines. Bharat Biotech has so far not sought indemnity for Covaxin from the governments.”

“The successful safety and efficacy readouts of Covaxin as a result of conducting the largest ever COVID vaccines trials in India establishes the ability of India and developing world countries to focus towards innovation and novel product development. We are proud to state that innovation from India will now be available to protect global populations,” said Dr Krishna Ella, Chairman and Managing Director, Bharat Biotech.

Bharat Biotech also added that its commitment to continuous improvement of Covaxin is well underway with additional clinical trials to establish safety and efficacy in children between 2-18 years of age.

“A clinical trial to determine the safety and immunogenicity of a booster dose is also in process. Several research activities are being carried out to study variants of concern and to assess their suitability for follow up booster doses”, the company said.

It claims Covaxin has been evaluated through neutralizing antibody responses against several variants of concern, namely B.1.617.2 (Delta), B.1.617.1 (Kappa), B.1.1.7 (Alpha), B.1.351 (Beta), P2- B.1.1.28 (Gamma).

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