Bharat Biotech mulls booster dose six months after second shot of COVID-19 vaccine

Bharat Biotech, the maker of Covaxin vaccine, is evaluating the option of adding a booster dose to its two-shot jab, amid concerns that emerging variants may weaken the effectiveness of vaccines designed to fight against older strains of coronavirus, a government official said.

The company is studying administration of a booster dose in a separate Phase-2 trial. It has approached the Subject Expert Committee (SEC) under India’s drug regulator with a proposal to administer the booster dose after six months of the second dose. “The company has presented amendments in the approved protocol, proposing administration of a booster dose. It is examining what would be a potential of a booster dose,” added the official.

In a meeting held last week, the SEC recommended that the company should conduct the booster dose study only with 6 mcg (microgram) strength and also follow up with the participants for six months after the booster dose.

“The firm should present the details of the primary and secondary objectives and various assessments to be carried out in the subjects,” state the minutes of the meeting. The committee has asked the company to submit the revised clinical trial protocol for evaluation.

The SEC is the body that recommends the use of new vaccines and drugs to the drug controller. Bharat Biotech will have to take its approval for adding a booster dose.

Separately, the SEC has permitted the company to ‘unblind’ participants above the age of 45. This means people who participated in the clinicals trials will be told whether they were given the vaccine or a placebo.

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Free jabs for placebo recipients

The committee has said Bharat Biotech should offer to administer the vaccine for free to those who were given placebos.

“This will affect the trial to the extent that from this point it will not be possible to evaluate efficacy in participants above 45 years which unfortunately also includes those who are at most risk,” said Malini Aisola of All India Drugs Action Network (AIDAN).

However, she said that the decision appears to have been taken based on ethical considerations.

“Persons were enrolled in the trial when no vaccine had been approved but now many have become eligible to receive either of the two vaccines that have received emergency approval. It would not be ethically tenable to deny participants the choice of being vaccinated in case they have received the placebo in the trial,” she said.



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