No Booster Dose Can Be Recommended Without Clinical Trial: Experts

The new coronavirus variant Omicron has given rise to discussions on a booster dose which is taken after two doses of the vaccine. The Serum Institute of India (SII) had sent an application for approvals on the booster dose. On December 10, the Subject Expert Committee (SEC) said that it cannot be recommended without a clinical trial.

The Subject Expert Committee works under the Central Drugs Standard Control Organisation (CDSCO). According to the ANI report, the SEC has asked for additional data from the Institute and will be conducting another meeting.

Booster Dose Omicron Variant Concerns:

The SII had submitted an application for the approval for a booster dose of its vaccine, Covishield after there was an increase in demand for the booster dose. The Director of the Government and Regulatory Affairs at SII Prakash Kumar Singh had said that the booster dose of the AstraZeneca ChAdOx1 nCoV-19 vaccine was already approved by the Medicines and the Healthcare Products Regulatory Agency in the United Kingdom.

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In their report, SII stated, "People of our country, as well as citizens of other countries who have already been fully vaccinated with two doses of Covishield, are also continuously requesting our firm for a booster dose."

This application was submitted to the Drugs Control General of India (DGCI). A clarification report has also been released by the Indian SARS-CoV-2 Genomics Consortium (INSACOG) also clarified in a statement that they have "never" recommended a booster dose.

Recently, the Indian Medical Association had demanded a booster dose for frontline workers and medical staff. The worry is arising for the new strain of coronavirus which was declared as a 'Variant of Concern' (VOC) on November 26.

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But the worry still looms as recently in Singapore two people who were infected with the new coronavirus strain had taken a booster dose. The World Health Organisation (WHO) is still unclear whether the booster doses are needed to protect from the new strain. They have asked countries not to stockpile on jabs as it might create inequality in access to the vaccine.