Bharat Biotech launches Nucelion Therapeutics, a CRDMO focused on advanced cell and gene therapies for global life science innovators. File

Biovet says Biolumpivaxin is the first Differentiating Infected from Vaccinated Animals (DIVA) marker vaccine globally for LSD and will be launched shortly.
| Photo Credit: Special arrangement

Animal health vaccine maker and Bharat Biotech group firm Biovet on Monday (February 10, 2025) said it has received the Central Drug Standards Control Organization (CDSCO) licence for the lumpy skin disease (LSD) vaccine for dairy cattle and buffaloes Biolumpivaxin it developed in collaboration with Indian Council of Agriculture Research (ICAR).

As the first Differentiation of Infected from Vaccinated Animals (DIVA) marker vaccine globally for LSD, it offers a high safety and efficacy profile while enabling serological differentiation between naturally infected and vaccinated animals, the Karnataka-based Biovet said in a release on Monday.

The vaccine will soon be made commercially available. Biovet’s Mallur facility can produce 500 million doses of the vaccine annually, it said

ICAR and its scientists made significant contributions and played a crucial role in the development of this collaborative, world-class vaccine for animal health. The novel indigenous live-attenuated marker vaccine was developed using the LSD virus/Ranchi/2019 vaccine strain from ICAR-National Research Centre on Equines, Hisar. The quality, safety and efficacy of the vaccine was tested at ICAR-NRCE and at the Indian Veterinary Research Institute (IVRI).

The vaccine is the result of three years of research by scientists at NRCE led by Naveen Kumar (now Director, NIV-Pune) under the leadership of B.N.Tripathi, former DDG, Animal Sciences, ICAR and presently Vice Chancellor, SKUAST, Jammu, Biovet said.

“The CDSCO licensure is a significant step toward India’s self-reliance in veterinary healthcare, which avoids dependency on imported vaccines. This DIVA marker vaccine is a game-changer for veterinary medicine for disease surveillance and eradication programmes and poised to play a crucial role in ensuring the dairy industry’s sustainability,“ Biovet founder Krishna Ella said.

Over the past two years in India, approximately 2 lakh cattle died and many more lost their milk production capabilities due to LSD. Biolumpivaxin, which comes in freeze-dried form, is a single vaccination regimen given once in a year to cattle and buffaloes above 3 months of age.

Krishna Ella, Chairman of Bharat Biotech. File | Photo: Bijoy Ghosh

Dr. Krishna Ella, co-founder and Executive Chairman of Bharat Biotech International, one of India’s leading vaccine makers, was earlier this week conferred with the India Fellowship of the Indian National Science Academy (INSA) – among the country’s science academies – for the year 2025. This is the first year that the INSA has awarded fellowships to representatives from the industry.

“Dr. Krishna Ella, a prominent Indian scientist and entrepreneur, leads Bharat Biotech in ground-breaking vaccine development. His achievements include India’s Covaxin, the world’s first clinically proven conjugated Typhoid Vaccine, ROTAVAC, and the first preservative-free vaccine, Revac-B mcf Hepatitis B Vaccine. Bharat Biotech also introduced India’s first cell-cultured Swine Flu vaccine and manufactures the world’s most affordable Hepatitis vaccines. Additionally, they were the first globally to develop a vaccine for the Zika virus,” said the citation on the website of INSA.

Other notable scientists and technologists who were conferred an INSA fellowship this year included Anil Kakodkar, Chairman of the Atomic Energy Commission of India; V.K. Saraswat, Former Director General, DRDO; S. Somanath, Chairman ISRO; S. Kris Gopalakrishnan, Co-founder, Infosys; Samir V. Kamat, Secretary DDR&D and Chairman, DRDO.

This year a total of 61 fellowships were awarded. Elected INSA fellows may attend and vote at INSA general meetings and can propose other individuals for fellowships or INSA awards.

“I deeply appreciate and am thankful to be recognized for my contribution in the field of vaccines and biotechnology by INSA. I look forward to continuing to support its initiatives, to improve public health, and make India self-reliant and a dominant force in discovering novel vaccines as an Indian fellow,” Dr. Ella said in a statement. “I share this honour with all of my highly motivated team at Bharat Biotech, research fellows, and other collaborators who have contributed enormously to improve public health,” he added.

Hyderabad-based vaccine maker Bharat Biotech and clinical-stage U.S. biotechnology firm Alopexx Inc. will collaborate to co-develop and commercialise anti-microbial vaccine AV0328 in India and other low income and lower middle-income countries.

A proprietary broad-spectrum anti-microbial vaccine candidate of Alopexx, AV0328 is a synthetic vaccine designed to target poly N-acetyl glucosamine (PNAG) found on the surface of a wide range of bacterial, fungal, and parasitic pathogens.

Under the collaboration, Alopexx would be entitled to a one-time upfront and milestone payments as well as royalties on future sales in the licensed territories, Bharat Biotech said on Wednesday (September 11, 2024).

Pre-clinical studies targeting PNAG showed effectiveness in preventing and treating infections caused by over 15 different pathogens. A phase I, first-in-human trial has been completed, demonstrating AV0328 is well-tolerated with no serious adverse events observed. The vaccine induced antibodies are capable of killing a wide range of PNAG-expressing pathogens, reaffirming its potential as a broad-spectrum antimicrobial solution, it said in a release.

To queries from The Hindu on the roadmap, regulatory requirements, time line and the likely investments, Bharat Biotech said AV0328 is an early stage product development. It will go through the regulatory approval process in India and several other countries.

“Our goal is to develop solutions to reduce anti-microbial resistance through vaccination,” Bharat Biotech Executive Chairman Krishna Ella said in the release.

Alopexx CEO Daniel Vlock said the “collaboration brings us one step closer to addressing the critical need for affordable, broad-spectrum antimicrobial solutions, especially in low-and middle-income countries.”

Appreciating the collaborative support provided by Bharat Biotech, he said the “support is not only crucial for advancement of AV0328, but will also significantly bolster our overall clinical programmes.”

Image for representation.
| Photo Credit: The Hindu

The story so far: The maker of the indigenous coronavirus vaccine, Covaxin, Bharat Biotech International Limited (BBIL), has admitted to an “inadvertent error” in patent filings to protect the vaccine’s Intellectual Property Rights (IPR). One of India’s leading biotechnology companies, it had failed to include scientists from the Indian Council of Medical Research (ICMR) as co-inventors in the Covaxin patent filings.

What kind of rights govern vaccine patents?

India’s patent laws govern both product and process patents. Product patents grant an inventor a monopoly over, say, a drug. Process patents bar competitors from making a similar drug using the same sequence of steps. In response to queries from The Hindu, Bharat Biotech said it had patented the process, namely of making a batch of vaccines from the virus strains that were provided by the ICMR-NIV (National Institute of Virology). This is the lab that has expertise in extracting viruses from blood samples, identifying its characteristics, conducting various tests to gauge its infectiousness and qualify it in comparison to related strains. However, preparing a vaccine out of this at an industrial scale is beyond the capabilities of a lab and requires a different order of facilities that only established vaccine manufacturers have. Covaxin is an inactivated version of COVID-causing coronavirus; once injected into the body it coaxes it into producing antibodies that can potentially protect against severe disease from a coronavirus infection. To do this effectively, an ‘adjuvant’ is added which increases the vaccine’s potency. Vaccine makers may have their own ways of bringing all of these steps together and, given the competitive nature of the field, strive to ward off competitors from imitating these processes to gain a temporary monopoly in the market and rake profits.

To be sure, while companies are free to file for a product or process patent in as many countries as they can afford, a patent is only granted after regulatory authorities grant them one or are convinced that this process is indeed novel or inventive. BBIL, as far is publicly known, hasn’t yet been granted these patents.

What were the roles of BBIL and ICMR?

BBIL had collaborated with the ICMR-NIV for all the steps in developing a vaccine. The two organisations had signed an agreement that spelt out each entity’s responsibilities. As ICMR is a public entity and because of the scale of the COVID crisis, there were Right To Information requests to make this agreement public. However, it was only in July 2021, that parts of the agreement were made public in Rajya Sabha.

Beyond transferring the strains and making vaccines, the agreement said, ICMR would also test these vaccines on animals — rodents to monkeys — and then on people to establish that the vaccine worked as intended. The ICMR also funded these clinical trials — ₹35 crore — and incurred costs in developing Covaxin. In return it was to get 5% of royalties that BBIL earned from the sale of Covaxin. Since the announcement of the BBIL and ICMR collaboration, it was generally accepted that both entities would contribute to the vaccine and would therefore hold “joint intellectual property rights,” as was stated in Parliament.

However, BBIL first told The Hindu that it made a distinction between the rights governing the making of the vaccine and the rights over the data generated from clinical trials. The ICMR hadn’t invested in the actual making of the vaccine and so wasn’t included in patent applications. However, a day after the matter became public, BBIL said it had made a mistake, and that it would be making amends by filing fresh applications that listed ICMR personnel as inventors. It is unclear what prompted this.

Why does being cited as an inventor matter?

IPR is a vast, complex domain and spans the minutest parts of the product invention process. As the development of pharmaceutical products involves a wide range of expertise, it is hard for single firms or entities to develop everything in-house. Just like the BBIL-ICMR collaboration, companies may enter into several licensing agreements — BBIL for instance had a technology licensing agreement with Virovax for the adjuvant — with other companies. If a single product thus involves multiple entities and collaborators, being listed as an inventor has a bearing on the sharing of intellectual property rights, royalties and even determining how a product can be used. There is no field of human activity that is untouched by disputes over IPR. In patent filings, not listing out all the inventors — in the U.S especially — could even lead to patent applications being rejected.

Students from various organisation protest over the NEET-UG and UGC-NET examinations issue outside Ministry of Education in New Delhi.
| Photo Credit: SHASHI SHEKHAR KASHYAP

NEET-PG postponed, CBI to probe NEET-UG allegations, NTA chief removed, as panel set up for agency overhaul

With questions being raised about the “integrity of certain competitive examinations”, the Health Ministry announced the postponement of the NEET-PG entrance examination “as a precautionary measure”, just hours before it was due to be held on June 23 morning. This followed on the heels of decision to remove Subodh Kumar Singh from his position as Director-General of the National Testing Agency, which has come under fire for an alleged paper leak and irregularities in the NEET-UG examination, and other examinations which it conducts.

1,563 candidates to retake NEET-UG on June 23

The retest is being conducted after the National Testing Agency (NTA) cancelled the scorecards of 1,563 students who were granted compensatory marks for loss of time due to a delay in six centres in Meghalaya, Haryana, Chhattisgarh, Gujarat and Chandigarh.

Six arrested in Jharkhand in NEET case; Sanjeev Mukhiya kingpin, says Economic Offences Unit

Investigation into the NEET paper leak case led the Bihar Police to neighbouring Jharkhand where police arrested six people from Deoghar on Friday night. A team led by officials of the Economic Offences Unit (EOU) brought the six to Patna for questioning. Deoghar Police said five Nalanda residents Paramjit Singh, Baldev Kumar, Prashant Kumar, Ajit Kumar, Rajiv Kumar, and one Panku Kumar, were arrested from a house near AIIMS-Deoghar.

Erred in not crediting ICMR as co-inventor of Covaxin, says Bharat Biotech

Hyderabad-based Bharat Biotech International Limited (BBIL) and manufacturer of Covaxin, India’s first indigenous Covid-19 vaccine, said it had made an “inadvertent mistake” in not including scientists from the Indian Council of Medical Research (ICMR) as ‘co-inventors’ in patent applications filed in India and abroad to protect the intellectual property rights around the vaccine. It would include their names in fresh filings for patent purposes, it said in a statement late on Saturday.

BSF to recalibrate deployment along Pakistan border in Jammu in the wake of terror strikes

The Border Security Force (BSF) is likely to “recalibrate deployment” along the Pakistan border in Jammu, in the wake of at least four terror strikes in the past few weeks .In just four days, between June 9 and June 12, ten people — including a jawan from the Central Reserve Police Force (CRPF) — were killed in militant attacks in the Reasi, Doda, and Kathua districts.

PM Modi likely to skip SCO summit in Kazakhstan in July; Putin, Xi, Sharif may attend

Prime Minister Narendra Modi is likely to skip the Summit of the Shanghai Cooperation Organisation (SCO) to be held in Kazakhstan next month, and External Affairs Minister S. Jaishankar is expected to officiate in his place. According to sources aware of the decision, Mr. Modi has decided not to travel to Astana for the summit to be held on July 3-4, although he had earlier confirmed his presence, and an advance security team had conducted its reconnaissance survey there. 

Hinduja family ‘appalled’ by jail term order; files appeal in higher court

Britain’s wealthiest family, the Hindujas, have said they were “appalled” by a Swiss court’s ruling of jail terms for some members and have filed an appeal in a higher court challenging the verdict finding them guilty of exploiting vulnerable domestic workers from India at their villa in Geneva. In a statement issued on behalf of the family on Friday, lawyers from Switzerland stressed their clients – Prakash and Kamal Hinduja, both in their 70s and their son Ajay and his wife Namrata – had been acquitted of all human trafficking charges.

ICC T20 World Cup 2024: Hardik, Kuldeep sparkle as India outclass Bangladesh by 50 runs, move closer to semis

Hardik Pandya produced an all-round show while Kuldeep Yadav foxed Bangladesh batters with his guile as India all but assured themselves of a semifinals berth through a dominant 50-run victory in their second Super 8 game of the T20 World Cup here on Saturday.

Euro 2024: Schick saves Czech Republic in draw against gutsy Georgia

Patrik Schick chested home to earn the Czech Republic a 1-1 draw against debutants Georgia on June 22 in an entertaining match, but it leaves both teams in a tricky spot in Euro 2024 Group F. 

Archery World Cup Stage 3 | Indian women trio claim gold

The Indian trio of V. Jyothi Surekha, Parneet Kaur and Aditi Swami claimed its third consecutive compound women’s team gold medal of the season in the Archery World Cup Stage-3 in Antalya, Turkey, on Saturday.

Hyderabad:

Bharat Biotech has added the Indian Council of Medical Research (ICMR) as co-owner of the Covid-19 vaccine patent.

Notably, Bharat Biotech was working on developing the Covid-19 vaccine as a top priority to ensure product availability at the earliest. The Covid vaccine development of Bharat Biotech International Limited (BBIL) was faced with multiple challenges and all organizations were in a rush to develop vaccines and file the appropriate patents, prior to any other entity or prior to any data being published in journals.

Bharat Biotech’s covid vaccine application was filed in the above circumstances and since BBIL-ICMR agreement copy, being a confidential document, was not accessible. Hence, ICMR was not included in the original application, the press release said.

Though this was purely unintentional, such mistakes are not uncommon for the Patent office and therefore, Patent Law provides provisions to rectify such mistakes, the release added.

“BBIL has great respect for ICMR and is thankful to ICMR for their continuous support on various projects therefore as soon as this inadvertent mistake was noticed, BBIL has already started the process to rectify it by including ICMR as co-owner of the patent applications for Covid-19 vaccine,” the press release said.

It further informed that necessary legal documents are being prepared for it and BBIL will file those documents in the Patent office as soon as they are ready and signed.

Notably, these actions are in accordance with the Memorandum of Understanding (MoU) signed between ICMR-NIV Pune and BBIL for joint development of the Covid-19 vaccine in April 2020, the press release informed.

(Except for the headline, this story has not been edited by NDTV staff and is published from a syndicated feed.)

New Delhi:

The Indian Council of Medical Research, or ICMR, has distanced itself from a follow-up study by two Banaras Hindu University professors that said nearly a third of 926 individuals who received the India-made Covaxin COVID-19 vaccine reported serious side-effects.

The study claimed that around one per cent of respondents reported strokes and an autoimmune disorder called Guillain-Barre Syndrome, which causes weakness in nerves in the arms and legs.

Conducted between January 2022 and August 2023, the study also said 50 per cent of the sample size complained of respiratory infections, and over 30 per cent reported assorted physical problems, ranging from skin and nervous system disorders to bone and muscle problems.

READ | Over 30% Covaxin Takers Had Health Issues After Year: Study

Specifically, between adolescents and adults respondents the study claimed 10.5 per cent reported new-onset skin and subcutaneous disorders and 10.2 per cent claimed nervous system concerns.

Among female respondents, 4.6 per cent claimed menstrual disorders.

ICMR Criticises Study Flagging Covaxin AESIs

However, the ICMR faulted the study – ‘Long-Term Safety Analysis of BBVl52 Coronavirus Vaccine in Adolescents and Adults: Findings From a 1-Year Prospective Study in North India’ published by Springer Nature – for poor methodology, and objected to it “acknowledging” the medical body.

ICMR Director-General Rajiv Bahl said the study had no control arm (of unvaccinated individuals) to compare rate of AESIs, or Adverse Events of Special Interest, and, therefore, the reported side-effects could not be linked or attributed to being administered Covaxin as COVID-19 vaccination.

Continuing a long list of critical observations, the ICMR boss also declared the study does not provide background rates of observed events in the population, making it impossible to assess change in such incidences in the post-vaccination period.

FACT CHECK | Can Covaxin Lead To Death After 2 Years Of Vaccination?

The method of data collection – study participants were contacted via telephone a year after vaccination and their responses were recorded without confirming them via medical records or examination by doctors – was also severely criticised.

Dr Bahl stressed that the ICMR is not associated with the study claiming side-effects from the India-developed vaccine, and had not provided any support – technical or financial – to the study authors.

The study authors and publishers have been urged to remove the acknowledgement to the ICMR.

“The authors are urged to rectify acknowledgment to ICMR and publish an erratum. Additionally, they are asked to address methodological concerns raised,” the ICMR chief said.

“Failure to do so may prompt ICMR to consider legal and administrative action.”

What Study Authors Said

Among the points made, the researchers acknowledged that understanding the AESIs-vaccines link required a control arm of unvaccinated individuals to compare rates of reported serious side-effects.

The authors also said that in the absence of data on background rates of observed AESIs, no comments were possible on changes in incidence of observed events in post-vaccination periods.

“Our findings are confined to BBV152 (Covaxin) and should not be extrapolated to viral vector or mRNA vaccines. The study primarily involved adolescents and the sample size of adults was relatively small. Larger adult-based studies are needed to understand long-term safety of BBV152 in adults.”

Bharat Biotech Responds

The study has also been questioned by Covaxin developers and manufacturers Bharat Biotech, which pointed to multiple alternate studies to emphasise its drug’s “excellent safety track record”.

READ | Bharat Biotech Flags Covaxin’s Excellent Safety Record In Risks Row

The ICMR’s strong reaction to the study comes amid concern over potentially fatal side-effects for those who received the vaccine developed by British pharma giant AstraZeneca and Oxford University, and manufactured and sold in India – as Covishield – by the Serum Institute.

Concerns Over Covishield

Given the questions about Covishield and Covaxin’s long-term safety records, a group of doctors last week called for a review all the science behind all Covid vaccines, as well implementation of surveillance and monitoring measures to ensure vaccine AESIs are identified as early as possible.

READ | Covishield Safety Row: Doctors Urge Centre To Review All Vaccines

The spotlight, so far, has been squarely on Covishield after AstraZeneca was hit by multiple lawsuits in the United Kingdom, with at least one patient claiming he suffered a serious brain injury following a blood clot that formed after he was injected in April 2021.

Fact Check | Are Indians Who Got Covishield Vaccine Susceptible To TTS?

AstraZeneca initially contested the claim but later said its vaccine could “in very rare cases” cause Thrombosis with Thrombocytopenia Syndrome, or TTS, which is a medical condition that can cause blood clots and low platelet counts, and has been linked to over 80 deaths in the UK alone.

READ | AstraZeneca Drops Covid Vaccine After Rare Side Effect Report

The company has expressed sympathy for those who have lost loved ones or reported health problems, but has reiterated its commitment to patient safety and adherence to “stringent (safety) standards”

It has also announced a global withdrawal of all vaccine stock, but attributed the withdrawal to commercial reasons, i.e., to a “surplus of available updated vaccines” for COVID-19.

Vaccinations In India

As of this morning, approximately 17 per cent of all vaccines administered were Covaxin, according to data from the government’s CoWIN dashboard.

The overwhelming majority of the population received the Covishield vaccine, while a small section got the Corbevac jab.

Serum Institute On Covishield

The SII told NDTV that all its product packaging had “disclosed all rare to very rare side-effects”, including TTS, and pointed out the vaccine had been “instrumental” in saving lives worldwide.

READ | “We Disclosed All Rare Side-Effects”: Covid Vaccine Maker On Safety Row

The company also said it discontinued Covishield manufacture from 2021 due to “the emergence of new mutant variant strains”, which had led to decreased demand for previous vaccines”.

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The Covaxin was developed with a single-minded focus on safety first, said its maker Bharat Biotech on Thursday, days after British pharma giant AstraZeneca admitted that its Covid vaccine can cause rare side effects.

The Hyderabad-based Bharat Biotech underlined that Covaxin was the only Covid-19 vaccine in the Indian government’s Covid-19 immunisation programme to have conducted efficacy trials in India.

“Covaxin was evaluated in more than 27,000 subjects as part of its licensure process. It was licensed under restricted use in clinical trial mode, where detailed safety reporting was carried out for several hundred thousand subjects,” the vaccine manufacturer said.

The safety of Covaxin was also evaluated by the Ministry of Health, said the company.

“Ongoing safety monitoring (pharmacovigilance) was continued throughout the product life cycle of Covaxin. All the above studies and safety follow-up activities have demonstrated an excellent safety record for Covaxin without any vaccine-associated incidents of blood clots, Thrombocytopenia, TTS, VITT, pericarditis, myocarditis, etc.,” it said.

@bharatbiotech announcement – #COVAXIN was developed with a single-minded focus on #safety first, followed by #efficacy. #BharatBiotech#COVID19pic.twitter.com/DgO2hfKu4y

— Bharat Biotech (@BharatBiotech) May 2, 2024

“As seasoned innovators and product developers, the Bharat Biotech team was well aware that, while the efficacy of Covid-19 vaccines may be short-lived, the impact on patient safety could last a lifetime. Hence safety is the primary focus for all our vaccines,” it added.

Covidshield and Covaxin were the vaccines that were primarily administered in India during the Covid pandemic.

According to several UK media reports, AstraZeneca had made the admission in court documents in connection with a case that alleges that the vaccine, developed with the University of Oxford, caused death and serious injury in dozens of cases.

“Our sympathy goes out to anyone who has lost loved ones or reported health problems. Patient safety is our highest priority, and regulatory authorities have clear and stringent standards to ensure the safe use of all medicines, including vaccines,” said an AstraZeneca spokesperson following the reports. 

Krishna Ella, Chairman, Bharat Biotech. File
| Photo Credit: BIJOY GHOSH

The Indian Vaccine Manufacturers Association (IVMA) has announced that Krishna Ella, co-founder and executive chairman of Bharat Biotech, will be the association’s new president for two years from April 2024.

A press release from Bharat Biotech said Mr. Ella is taking over the presidency from Adar C. Poonawala, who held the post from 2019 to March 2024.

For the current two-year term, Mahima Datla, managing director of Biological E, assumes the role of Vice President, T. Srinivas, CFO of Bharat Biotech, will be the treasurer and Dr. Harshavardhan, will continue as Director General of IVMA.

“Vaccines are the vital pillar of global health, and the IVMA mission is to ensure that every individual, regardless of where they live, has access to life-saving immunizations,” Mr. Ella said, adding, “Innovation, sustainability, and equity are the foundations of our collective vision, and I am pleased to serve IVMA along with its distinguished members and contribute to its vision to protect and enhance public health in India and the developing world.”

He urged IVMA members to support African nations’ public health vision and emphasised the need to formulate policies and regulations in line with WHO and USFDA, which will help the industry to be not only globally competitive but also fortify India’s vision to boost the level playing field world-over in preventive care.

“Dr. Ella’s expertise and entrepreneurial spirit are exactly what the vaccine industry needs to navigate the complex challenges of the 21st century.” Dr. Harshavardhan said.

IVMA’s mission is to bring to the fore the Indian private sector human vaccine manufacturers’ concerns related to the progress and profitability of the industry and streamlining regulatory pathways and matters related to audits and inspections in consultations with the national Central Drugs Standard and Control Organisation.