The head of Bharat Biotech expressed confidence in a press conference on Monday that Covaxin, the candidate vaccine developed by the company, will be effective in mutant strains of the new coronavirus, one of the main reasons approval has been granted for use restricted to candidate.
The company will be able to “hypothesize” the candidate’s ability to protect against mutations within a week, said President and Managing Director Dr. Krishna Ella.
“It’s just a hypothesis at this point … but just give me a week (and) I’ll give confirmatory data,” said Dr. Ella. I was answering a question about whether there was data to show that Covaxin is effective against the mutant strain of the SARS-CoV-2 virus that was first detected in the UK and has since been found in more than 30 countries.
Evidence from vaccines for other viruses like rabies supports the hypothesis, Dr. Ella said: Because of the platform it uses, Covaxin would be very effective against such mutations. The vaccine uses an inactivated platform: it was developed using killed strains of the SARS-CoV-2 virus.
Bharat Biotech, which has submitted around 5 million doses of its candidate for quality checks and clearances at the Central Drug Laboratory in Kasauli, hopes to be able to launch the vaccine for use among the public as soon as possible. It has stocked about 10 million doses and will be ready with another 10 million in February, Dr. Ella said. “We will be ready with 150 million doses by July-August,” he added.
Covaxin to protect against mutants, data in a week: Bharat Biotech
Extra shot in the arsenal
The firm is also preparing a protocol to expand testing of its vaccine to children ages 2 to 15, which will soon be presented to a committee of experts from the country’s drug regulatory body, he said.
However, no acquisition agreement has yet been concluded. The company has not said what the cost of the two-dose vaccine might be.
“Right now, the government is talking to us,” said Dr. Ella. “The cost is (based on) the size of the volume / scale. At first, the cost may be a little higher in the field of vaccines, but as production increases, when competition in the market increases, the price is automatically controlled by the market, ”he said.
“We are trying to understand many things… just give us time; we will solve all those things. “
Bharat Biotech has been criticized for seeking approval for Covaxin without providing data on the efficacy of the vaccine, that is, its ability to reduce the number of symptomatic cases of Covid-19.
Although Comptroller General of Drugs of India (DCGI) Dr. VG Somani on Sunday granted restricted use approval “in clinical trial mode” to Covaxin “in the public interest”, the regulator did not clarify whether approval had been granted on the efficacy database. The company has submitted pre-clinical test data and phase 1 and 2 safety and immunogenicity data.
Dr. Ella said the approval means the company will no longer be required to have a placebo group in its ongoing clinical trial and will vaccinate people in an open-label format. “Their safety and efficacy, we will monitor them,” he said.
He added that the firm was still trying to find out various vaccination modalities and clinical trials for Covaxin after approval, including whether a new clinical trial protocol would have to be submitted and whether they would be responsible for any serious adverse events that develop. during this vaccination phase.
AIIMS director Dr. Randeep Guleria, a member of the Covid-19 national task force, told The Indian Express on Sunday that the approval given to Covaxin was “like an endorsement.”
“If we find that the cases are not increasing, we stick with IBS (Serum Institute of India, which has made the Indian variant of the Oxford-AstraZeneca vaccine) until the Bharat Biotech data comes in early next month … They ( regulators) have given, I would say, a green signal to start stocking in case we need it, ”Dr. Guleria had said.
Responding to a question from The Indian Express at Monday’s virtual press conference, Dr. Ella said: “We have not submitted any provisional efficacy data. What we’ve done is produce (data on the) higher antibody response, long-term immunogenicity, and neutralization protection. “
The efficacy of the late-stage trials of Covaxin in nearly 26,000 participants will become clearer between March and October 2021, which is the established efficacy reading schedule for the vaccine based on the trial design.
The inactivated platform is “proven” and the technology allows the vaccine to target various components of the virus, such as the membrane glycoprotein and nucleoprotein, in addition to the spike protein, Dr. Ella said.
“A lot of people are (targeting) spike protein. If the spike protein doesn’t work, what will happen … then the nucleocapsid (protein coat of the virus that encases its genetic material) can also take responsibility for the response to the vaccine. And that’s why we are confident that this (Covaxin) will also protect against any mutant strains from the UK… ”.
There is also a precedent for granting emergency approvals despite a lack of efficacy data, Dr. Ella said. Vaccines approved in India and abroad against H1N1 flu in 2009 had not been tested for efficacy, he said.
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