Serum Institute of India, which is currently manufacturing AstraZeneca Plc’s vaccine developed in collaboration with Oxford, is expected to get approval for emergency use authorization as soon as UK drug regulator give it a go.
According to a TOI report, the Medicines and Healthcare Products Regulatory Agency is currently evaluating the data to determine the best dosage regimen for the AstraZeneca-Oxford vaccine.
An official, as quoted by TOI, said that the regulatory approval in the UK will strengthen SII’s application which have sought emergency use of its vaccine candidate -Covishield — in India. The official further said that it is a sensitive matter as none of the countries have approved the vaccine yet. He said that the permission can only be granted once they ensure the safety and efficacy of the vaccine.
The regulatory approval in the UK is crucial to strengthen SII’s application seeking emergency use authorisation in India because the proposal here refres to trials being conducted in the UK and Brazil. Moreover, the vaccine is yet ot be approved in any country. It is a sensitive amtter and only once we are sure of the safety, efficacy and immunogenicity of the vaccine, we can grant apporoval.
Covishield has shown different efficacy rates in different dose regimens. While two full doses regimen showed 62 per cent efficacy, half dose and full dose regimen turned out to be 90 per cent effective.
Apart from SII, Bharat Biotech and Pfizer have also applied for emergency use authorization of their vaccine candidates in the country.
Considering the overall situation, it is most likely that Pfizer may get approval as it has an efficacy rate of over 95 per cent. Moreover the vaccine has been approved by a number of countries including the UK, Bahrain and Canada.
On the other hand, Bharat Biotech is still conducting phase 3 trials and has only sought the permission on the basis of successful phase 1 and phase 2 trials.
