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Experts Question Government Claim on Efficacy of Covaxin Against New Strains of Coronavirus | India News

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NEW DELHI: Some health experts on Monday questioned the government’s claim that Bharat Biotech’s Covid-19 Covaxin vaccine may target mutated coronavirus strains and perhaps use us as ‘backup’ as they asked for the scientific basis for the claim and the safety and efficacy of the vaccine. .
The country’s drug regulator on Sunday granted emergency use approval to Oxford-AstraZeneca’s Covishield and also indigenously developed Covaxin despite insufficient data on the latter’s efficacy and safety, which sparked a debate.
Noted virologist Shahid Jameel said he does not believe that Covaxin will eventually prove safe and show greater than 70 percent efficacy.
“I say this based on the platform, which is widely used, and Bharat Biotech’s track record of successfully manufacturing inactivated viral vaccines,” he said.
He also said that his concerns are based on the processes adopted for the approval of the vaccine and also on the statements of people in positions of responsibility.
“If approval requires safety and efficacy data for a representative population, the safety and immunogenicity of phase 2 does not meet that criteria,” he said.
“That is why we carried out phase 3. It is the closest thing to a population. Where is that data? Vaccines are not drugs. They are given to healthy people. They are prevention, not treatment. It requires both safety and efficiency, “he said.
He also questioned what is an approval for a “endorsement”? “Does this mean that a vaccine of unproven efficacy would be used if necessary?”
The biggest concern, he said, is that “circumventing” processes and poor / complex communication will fuel questions about vaccines in India.
“There is already evidence of that due to accelerated development timescales. Our country has one of the best immunization programs. It will also undermine the global value of India’s vaccine industry, which is top notch by any measure.” said.
The Director General of the Medical Research Council of India, Dr. Balram Bhargava, had said on Sunday that Covaxin is based on an inactivated whole virus, which has the potential to target mutated coronavirus strains, including the UK variant, and which was one of the main reasons for giving conditional assent.
However, he had also said that so far there are no clear data on the efficacy of the vaccine.
“The data generated so far demonstrate a strong immune response (both antibody and T-cell) and viral neutralization in vitro. The ongoing clinical trial is the largest trial involving 25,800 subjects, with 23,000 volunteers already enrolled, including subjects with comorbid conditions, and the vaccine has been shown to be safe to date, “Bhargava said.
All India Institute of Medical Sciences (AIIMS) director Randeep Guleria said on Monday that Bharat Biotech’s vaccine has been approved only in emergency situations as a backup.
“If there is an increase in cases, we may need higher doses of vaccine, then we can go for the Bharat Biotech vaccine. The Bharat Biotech vaccine is more of a backup,” he said.
He also rejected claims to speed up the process.
“None of the clinical trials were accelerated in terms of safety and efficacy. They were quickly followed up to obtain regulatory approval, which generally takes a long time to move from one phase to another,” he said.
The All India Drugs Action Network (AIDAN) also questioned the claim that Covaxin may work better against the British strain of the virus, which is more transmissible.
“It is not clear whether there is any scientific basis to claim that Covaxin will be effective in the setting of infection by mutant strains when its efficacy has not been established and is currently unknown against any strain of the virus,” said AIDAN.
“The spreading claim that the whole virion inactivated vaccine is likely to be effective against virus mutations is not supported by any trial efficacy because data has not yet been generated in the phase 3 trial,” AIDAN said in a statement.
There has also been a political battle over Covaxin’s approval.
Some congressional leaders, including Anand Sharma, Shashi Tharoor and Jairam Ramesh, raised serious concerns about the green signal to al on Sunday, saying it is “premature” and may prove dangerous.
The BJP, in response, lashed out in Congress with the party’s chairman, JP Nadda, claiming that every time India achieves something commendable, the opposition party comes up with “crazy theories” to “ridicule” the achievements.

Times of India

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