Ajency – Approvals by the national regulator are based on comprehensive analysis and examination of data

The past few days have see some misleading and incorrect information published by a few news publications regarding Covaxin, the Covid-19 vaccine manufactured by the Hyderabad-based Bharat Biotech.

Some of the points made by these publications are clearly wide off the mark.

‘There is no Emergency Use Listing from WHO for 15-18 years’

It is suprising that this even became an issue for some news outlets.

Guidelines issued by the Union Ministry of Health & Family Welfare, for vaccination in the age group 15-18 years, do not mention anything about an Emergency Use Listing by the World Health Organisation (WHO).

The health ministry on Friday reiterated a key point mentioned in the guidelines issued on December 27, 2021.

The guidelines, under the heading “New beneficiaries aged 15-18 years” at sub-heading (e), page 4 state that “For such beneficiaries, option for vaccination would only be available for Covaxin as this is the only vaccine with EUL for the age-group 15-18”.

This was in line with the EUL given by India’s national regulator, the Central Drugs Standard Control Organization (CDSCO) on December 24 for Covaxin vaccine for the 12-18 year age group.

The Union Health Ministry issued the guidelines for vaccination of the 15-18 year age group of young adults and ‘precaution dose’ for other identified categories, three days later, on December 27, 2021.

The same day, Chairman of India’s COVID-19 Working Group of the National Technical Advisory Group on Immunisation (NTAGI) NK Arora said Covaxin had shown that it had a very good immune response in children in trials.

In an interview to NDTV, he said, “The point is that we have a vaccine, which is approved for children. Covaxin has shown that it has a very good immune response in children in trials. In fact, it is slightly better than adults. Secondly, this vaccine is a safe vaccine, and even local effects like pain, swelling in the arms is much less as compared to adults. We would like to offer this protection to our adolescents”.

It is also worth noting that the government’s decision to vaccinate the 15-18 age group came amidst fears of a looming third wave due to the Omicron variant that has now spread all across the world.

The unnecessary ‘shelf life’ controversy

The shelf life of vaccines is extended by the national regulator based on comprehensive analysis and examination of stability study data furnished by the vaccine manufacturers.

This process appears to have been duly followed in this instance as well.

The Central Drugs Standard Control Organization (CDSCO) extended the shelf life of Covaxin from nine to 12 months in October last year, well over two months before this ‘controversy’ erupted.

According to information released by the Union Ministry of Health and Family Welfare on January 3, “The Central Drugs Standard Control Organization (CDSCO) on 25th October 2021, in response to M/s Bharat Biotech International Limited’s letter no: BBIL/RA/21/567 has approved the extension of shelf life of Covaxin (Whole Virion, Inactivated Coronavirus Vaccine) from 9 months to 12 months. Similarly, the shelf life of Covishield has been extended by the National Regulator from 6 months to 9 months on 22nd February 2021”.

There does, however, exist a point of view that this entire exercise could have been handled better by the vaccine manufacturers themselves as well as by the health ministry to avoid any confusion at the onset of the vaccination drive for children. (As mentioned earlier in this article, Covaxin is the vaccine that has been accorded Emergency Use Listing for the 12-18 age group by the national drug regulator).

Source – India News Network