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Gap between Covishield vaccine doses extended; Covaxin Ph 2-3 clinical trials in 2-18 age group allowed

Vaccine vial. Stock photo: By Ali Raza/Pixabay

New Delhi, May 13 (MNN) The gap between the first and second doses of Covishield vaccine has been increased to 12-16 weeks from earlier 6-8 weeks on the basis of recommendation of the COVID Working Group, the Indian government said on Thursday.

No change in interval of COVAXIN vaccine doses was recommended.

Based on available real-life evidences, particularly from the UK, COVID-19 Working Group chaired by Dr NK Arora had recommended for increasing the Covishield dose interval to 12-16 weeks.

The COVID Working Group recommendation was accepted by the National Expert Group on Vaccine Administration for Covid-19 (NEGVAC), headed by Dr V K Paul, Member (Health), Niti Aayog, in its meeting on May 12, 2021. The Ministry of Health and Family Welfare also accepted the recommendation.

The COVID Working Group comprises of the following members: Dr N K Arora, Director, INCLEN Trust; Dr Rakesh Agarwal, Director and dean, GIPMER, Puducherry; Dr Gagandeep Kang, Professor, Christian Medical College, Vellore; Dr J P Mulliyal, retired Professor, Christian Medical College, Vellore; Dr Naveen Khanna, Group Leader, International Centre For Genetic Engineering And Biotechnology (ICGEB), JNU, New Delhi; Dr Amulya Panda, Director, National Institute of Immunology, New Delhi; and Dr V G Somani, Drugs Controller General of India (DCGI).

Meanwhile, the government also said that the Drugs Controller General of India had accepted the recommendation of Subject Expert Committee (SEC) to accord permission for Phase II/III clinical trial of Covaxin in the 2-18 age group, to its manufacturer Bharat Biotech Ltd May 12.

Bharat Biotech International Ltd, Hyderabad, had proposed to carry out the clinical trial on 525 healthy volunteers who will be given two doses each at day 0 and day 28 through the intramuscular route.

As rapid regulatory response, the proposal was deliberated in the SEC (COVID-19) on May 11. After detailed deliberation, the panel recommended grant of permission to the clinical trial subject to certain conditions.

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