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.

Vaccine maker Bharat Biotech is conducting the trials in partnership with Spanish biopharmaceutical company Biofabri. File

Clinical trials of Spanish tuberculosis (TB) vaccine MTBVAC have begun in India.

Vaccine maker Bharat Biotech is conducting the trials in partnership with Spanish biopharmaceutical company Biofabri that is responsible for clinical and industrial development of the vaccine developed in the laboratory of the University of Zaragoza with Dr. Brigitte Gicquel of the Pasteur Institute, Paris.

MTBVAC is the only vaccine against tuberculosis in clinical trials based on a genetically modified form of the pathogen isolated from humans Mycobacterium tuberculosis which, unlike the BCG vaccine, contains all the antigens present in strains that infect humans. While the trials to evaluate the safety and immunogenicity of MTBVAC in India have begun, a pivotal safety, immunogenicity and efficacy trial is planned in 2025, Bharat Biotech said in an announcement coinciding with World Tuberculosis Day on March 24.

Bharat Biotech will be conducting Phase 3 trial as Biofabri has completed the Phase 1 and 2 trials in other countries, a spokesperson replied to a query.

“Our quest for a more effective vaccine against tuberculosis received a big boost today, with clinical trials in India. The MTBVAC vaccine has passed several milestones before entering clinical trials in India,” executive chairman Krishna Ella said in a release.

Studying the safety, immunogenicity and efficacy of the vaccine in the most populated country and the one with the highest number of cases of the infectious disease is key to continue advancing this vaccine. MTBVAC has been being developed to be a more effective and potentially longer-lasting vaccine than BCG for newborns and for prevention of TB in adults and adolescents, for whom there is currently no effective vaccine, the Hyderabad-based company said.

“It is a giant step to test in adults and adolescents in the country where 28% of the world’s TB cases accumulate,” Biofabri CEO Esteban Rodriguez said. BCG is an attenuated variant of the bovine TB pathogen and more than a hundred years old with a limited effect on pulmonary tuberculosis that is responsible for transmission of the disease, he said.