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.

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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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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.