After UK, India May Approve Serum Institute’s Covid Vaccine

Serum Institute of India (SII) may get emergency use approval of its Covid-19 vaccine, Covishield once it gets a green signal from the UK. It is to be noted that the Medicines and Healthcare products Regulatory Agency (MHRA) is yet to pass the vaccine, which is likely to be available before the year end.

At present, MHRA is performing the evaluation of data. Furthermore, it is analyzing the dosage regimen type that would be the best to use for the Covid-19 vaccine, developed by Oxford and AstraZeneca in the UK. According to the regulatory sources, the approval by MHRA is possible before Christmas, after which India may give it an approval.

According to the officials, the UK’s regulatory approval is highly important to strengthen application by Serum Institute of India for emergency use authorisation EUA in India. The trials being conducted in the UK and Brazil will form a base for the vaccine proposal in the country. In addition, the vaccine has not received approval in any country as of now. Since it is a sensitive matter, India can only provide approval once it is sure of the vaccine's safety, efficacy and immunogenicity.

The data evaluation that is being done by MHRA is said to shed light on the dosage of the vaccine, which has showcased effectiveness of 62% when two full doses were given. On the contrary, the effectiveness of the vaccine when a half dose and then a full dose was given to a smaller subgroup was 90%.

In an inter-ministerial meeting, Harsh Vardhan, Health Minister said, “We are expecting the vaccine to be available in the forthcoming weeks and the vaccination process to commence in India as soon as it gets approved by the concerned regulatory authorities”. The meeting organized by the World Bank addressed vaccination of South Asia.