The decision on Covaxin approval will be made by the second week of August, 2021

Yesterday, Bharat Biotech’s joint managing director Suchitra Ella said the vaccine is moving towards emergency use listing. “Approval from WHO is not expected to be a long drawn process as cell line and majority of our facilities have already been audited and approved by WHO for our other vaccines in the past,” Ms Ella said in a tweet.

Dr Swaminathan’s remark today came on the heels of a row over approval for Covaxin and Covishield by the European Union.

After India’s tough stance on “vaccine passport” insisting on reciprocity, nine European nations cleared Serum Institute of India’s Covishield, sources said.

India had said that unless the European Union accepts Covishield and Covaxin certificates, their covid-19 vaccine certificates will not be accepted in the country and people from EU will face mandatory quarantine upon arrival in India.

The coronavirus vaccine manufactured by the Serum Institute has already received emergency approval from WHO and there were questions on why it did not get approval of the European Medicines Agency, which has already approved the vaccine’s European version, manufactured by AstraZeneca.

Covax – the worldwide initiative aimed at equitable access to COVID-19 vaccines – has pushed for universal approval of vaccines okayed by WHO.

In a strong statement, Covax urged “all regional, national and local government authorities to recognise as fully vaccinated all people who have received COVID-19 vaccines that have been deemed safe and effective by the World Health Organization and/or the 11 Stringent Regulatory Authorities (SRAs) approved for COVID-19 vaccines,

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An SOP i.e. Standard Operating Procedure document has reached Mumbai hospitals on Tuesday, according to which private hospitals will get only double the dose of the average vaccine consumed daily in a particular week last month. However, private hospitals will have the flexibility to choose the week of their choice to calculate the daily average for the vaccine. Its information will be taken from the Covin portal.

For example, if a private immunization center selected the week 10-16 to place an order for July, during which 630 doses were given, the average daily dose for that hospital would be 90 (630/7 = 90). This way a private hospital can order a maximum of 5,400 doses (90 x 30 x 2 = 5,400) for July. The SOP states that the maximum limit of one month may be revised in the second fortnight depending on the consumption of the vaccine during the first 15 days.

According to the SOP from the central government of India, as well as for those hospitals who are planning to participate in the vaccination campaign and do not already have a record of covid-19 vaccine consumption. The vaccine ceiling will be decided based on the number of beds available to them. A 50-bed hospital can order a maximum of 3,000 doses, while a 50-300-bed hospital can order up to 6,000 doses and a 300-bed hospital can order up to 10,000 doses.

The SOP states that private immunization centers can order the vaccine in four installments in a month. No approval will be required from any government authority for the purchase of corona vaccine. It will be enough just to successfully place the purchase order on Covin. Once the demand is submitted, Covin will aggregate the district and state-wise numbers before delivering them to the manufacturers. Private centers will have to pay for the vaccine on the National Health Authority portal. Earlier the rule was that private hospitals could buy 25 per cent of the vaccine directly from the manufacturers and 75 per cent was shared by the centre.

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