HYDERABAD: Dismissing comments made by the makers of the other approved vaccine in India who compared Bharat Biotech's Covaxin shot to water, the Managing Director of the company Dr Krishna Ella said the country was not standing by its own scientists' efforts and discrediting it merely on the fact that it was created in India and not in the UK or US.
The press meet by Dr Ella gave an elaborate defence on the controversy surrounding the hasty approvals given to Covaxin by the Drug Controller General of India (DCGI). He said that not just his company’s vaccine but others in the past during the swine flu pandemic and other occasions have been given emergency use authorisation (EUA) without completion of clinical trials and efficacy studies.
“It is not the first time that a vaccine has been given emergency use authorisation without efficacy trials. Previously during the swine flu pandemic, this was given before completion of Phase 3 trials keeping in mind the pandemic situation. Similarly, in the Ebola vaccine development history, the EUA had given authorisation in November 2019, even before phase 3 of the trials were complete for two different vaccine manufacturers- Merck & Co and Johnsons & Johnsons,” stated Dr Ella, adding that it had been allowed before as a global practice and that people were targeting Bharat Biotech only because it was an Indian company.
It may be recalled that Bharat Biotech was given approval by DCGI for emergency use even before it gave all the 26,000 volunteers in phase 3 trials the first dose of Covaxin. The company is still scouting for nearly 1800 candidates to give the first shot of the vaccine in its phase 3 trials and is likely to complete it this week. “This is the first time such a large clinical trial has taken place indigenously and the country must support the innovation and effort of all the investigators and the volunteers, We at least have safety data on 25000 people, no other Indian company has such data on more than 1000 people,” added Dr Ella.
He further defended such use by citing a CDSCO gazette notification from 2019 which permits such emergency use of vaccines based on phase 2 results due to the fact that it uses a proven and safe platform which had good results in animal trials.
“Now the vaccine will be given in a clinical trial mode to the beneficiaries and all their symptoms will be monitored. We are confident that our vaccine will have a cover against the virus for atleast 120 days to 1 year from my experience. What makes it better than any other candidate is the fact that it has only 15% side effects when compared to Oxford, Pfizer, Moderna whose side effects range from 65%-70%. Oxford vaccine in fact is being given along with 4 mg paracetamol,” added Dr Ella.
He further dismissed the question of a backup vaccine. “Human life has no backup, so this concept of backup vaccine is wrong. We are global science professionals who are catering to the world and our efficacy study for phase 3 trials is by a US-based third party independent company which shows we are transparent,” added Ella.
Dr Ella also stated it has 20 million doses ready for emergency use and further capacity to increase production up to 700 million doses across its four facilities in Hyderabad and Bengaluru. The MD stated that the decision on pricing and purchase agreements with the government was still underway and modalities were yet to be worked out.
“We have sent 5 million doses to Kasauli and if we get the go-ahead we can send it across tomorrow,” added Dr Ella.
He further clarified that while data on the efficacy of the Covaxin vaccine on the new COVID-19 UK strain was available, “The Bharat Biotech vaccine is the only one where not just the spike protein, but the nucleoprotein and the M and S proteins on the inactivated virus will trigger an antigen response and give the best efficacy. We will give a clear picture on whether our vaccine will be effective on the new strain within a week’s time. However, we are confident,” added Dr Ella.
He further reiterated that no adverse reactions were noted to his vaccine product and it has one of the lowest adverse health reaction after administration when compared to other vaccines. “Other vaccine candidates especially MRNA also have reported reactions like Bell's palsy. However, no adverse reactions have been noted in our candidate making it safest even for children,”
Elaborating on this, he further explained how the Phase 3 trials will include children between 12 years to 16 years as against Phase 2 where only those above 16 were administered the vaccine. “The technology used in Bharat Biotech is a safe inactivated vaccine which is almost like a polio vaccine. Our vaccine will be the most efficacious for young children and in fact also useful for the global market especially the US where no inactivated virus vaccine is currently in trials. We are aiming to help the global public health community to come out of the pandemic at the earliest,” he said.