Bharat Biotech sees rivals’ conspiracy in all the criticism for the approval for Covaxin

• Bharat Biotech CEO Krishna Ella believes that pharmaceutical rivals are conspiring to undermine the authority of Covaxin.
• The concerns raised around the vaccine include the lack of data and incomplete phase-III clinical trials to provide efficacy.
• According to Ella, Covaxin has the largest pool of Indian candidates, showed 100% efficacy during animal challenging (trials) and a long-term persistence of immune response.

The past 24 hours have been a whirlwind for the Indian vaccine manufacturer, Bharat Biotech. It received provisional approval from the Drug Controller General of India (DCGI) on January 3, but that was soon followed by a heavy wave of criticism, with experts raising concerns if there is enough data to support the safety of the vaccine.

Bharat Biotech chairman and managing director, Krishna Ella, believes that the gossip-mongering is an expansive conspiracy by its peers to undermine the reputation of Indian companies.

“Many people are just gossiping to push things in a different direction to create backlash on Indian companies,” he told the press on January 4.”That is not right for us. We do not deserve that.”

Ella asserted that Bharat Biotech’s data is, in fact, publicly available in five different papers that have been published. “Our animal challenging data is the best compared to all other vaccines,” he said. However, he did cop to the fact that there is a shortage of phase-III trial candidates and until that data comes in, the efficacy of the vaccine cannot be determined for sure.

“We are the only vaccine for people above 12 years of age right now. We are planning to do even children trials soon, as per the protocol,” he said. Bharat Biotech currently has 20 million doses of the vaccine with plans to expand its capacity to 700 million by setting up four new manufacturing facilities — three in Hyderabad and one in Bangalore.

Covaxin EUA:

‘We’re the only company with safety data of 25,000 people,’ says Bharat Biotech CEO
Without taking names, he targetted Astrazeneca and the Serum Institute of India (SII). Ella hinted that one of the vaccines only has data due to the number of candidates from the UK. According to him, SII only has the safety data of around 100 Indians in its total pool.

Bharat Biotech, on the other hand, has the safety data of 25,000 Indians and the immunisation profiles of 1,000 people.

“Some local company, in a press release yesterday, said safety is like water for other companies — that only 2-3 companies have done actual efficacy. I want to deny that. It hurts us as scientists. We don’t deserve that bashing from people,” said Ella.

The pharmaceutical company’s CEO also highlighted that the participants of the Oxford-AstraZeneca clinical trials were given four grams paracetamol to suppress side effects, whereas no paracetamol was given to participants in the Covaxin trial.

Phase-III trial data is not necessary for EUA
“2019 CDSCO has issued a gazette notification which clearly says if you have a proven platform technology, safe platform technology and good technical trial data is available then you can give the product emergency license,” said Ella. “Even the US government says that if you have good immunization data, a vaccine can be given emergency authorisation.”

He cited examples of Ebola and H1N1 2009 vaccines, which were approved and used with emergency licenses based on phase-II data. Johnson and Johnson, for instance, got an emergency license of its Ebola vaccine after conducting just phase-I trials on 87 people back in 2016. Official approval only came through three years later, in 2019.

The data for Bharat Biotech’s clinical trials of the COVID-19 vaccine have been published in five journals so far, three of which are international. “We are in no way inferior to Pfizer in terms of publication,” said the CEO.

ICMR director general, Balram Bharagava, asserts that Covaxin has the potential to target mutated strains, which was one of the major reasons behind the vaccine getting a ‘conditional’ nod.

However, some experts have questioned the government’s assertion that Bharat Biotech’s Covaxin may be used as a ‘backup.’ According to AIIMS director Randeep Guleria, the approval has only been given for emergency situations.

“It is a vaccine. It is not a backup. People should be responsible before making such statements,” said Ella.

mRNA vs inactivated COVID-19 vaccines
Without naming specific vaccines, he also clarified that more than 90% of them are mRNA vaccines, which means they are made using fragments of the original virus and only target the Spike protein. While effective, the method is new and there are currently no DNA or RNA vaccines for medical use in humans. This is why they are also sometimes called next-generation vaccines.

“Covaxin is an inactivated vaccine generating immune responses in both the Spike and Nucleocapsid protein,” said Ella.

Inactivated vaccines are one of the most tried and tested methods of immunisation globally. Since it’s so well known, it’s generally considered safe and has the added benefit of being safe for people with a weakened immune system.