Covaxin approved for use in children: When can kids actually expect to get the COVID-19 vaccine? What does emergency use authorisation mean?

The emergency approval granted for Covaxin use in the pediatric population in India has been hailed as a much-needed welcome move, which can protect kids from lurking dangers of the third wave. As per reports, the SEC (Subject Expert Committee), has recommended authorizing the vaccine to be used in kids aged between 2-18 years of age, which will be further reviewed by the DGCI.

Also read: What do we know about Covaxin being approved for use for kids

Now, not only is Covaxin a fully homegrown vaccine, many feel that since the vaccine is already pushed into use, the immunization drive for kids could be kickstarted earlier than expected. But when will kids actually get their hands on the COVID-19 vaccine in India? If yes, would there also be conditions and prioritizations to be followed? Here's all what we can expect with Covaxin approved for use by kids:

The third wave of coronavirus, expected to swell anytime post the festive season is said to be a big threat for kids, with multiple studies predicting that there could be a surge of pediatric cases when cases peak. Schools, too, have opened up. Of course, the matter becomes more perilous since kids in India, until yesterday (October 12) did not have any officially available vaccine for use. While the approval and ready availability of Covaxin resources makes the process easier, there is yet no official confirmation on when we could actually see kids getting immunized. However, there are reports which suggest that further action and approvals for kids vaccination could be expected in the coming week or two.

Covaxin use has been currently granted emergency use authorisation in India- and not full access. EUA refers to a mechanism whereby authorities allow the use of certain vaccines and medicines in light of a life-threatening emergency (such as COVID), after reviewing clinical trials and lab-based data. While Covaxin is still undergoing critical last stage study, the necessary EUA has been granted on a risk vs benefit evaluation. This is also the same way most other vaccines have been pushed for use, including Moderna's and Pfizer's vaccines made for kids.

While Covaxin is still undergoing trials, it has been found that the vaccine demonstrates good efficacy and antibody protection in kids, much like the adults. Hence, going by global guidelines, the go-ahead has been granted, clinical data has been reviewed well. However, since it's still a vaccine which has been granted nods without completing all stages of trials, the makers of Covaxin have been asked to follow some factors to meet the criteria.

As per recommendations from the Subject Expert Committee (SEC), the developers of Covaxin, Bharat Biotech will have to bear a few must-follow terms and conditions if their vaccine is to be used on kids. Not only will Bharat Biotech have to continue the study based on the inactive strain of coronavirus (used in the vaccine), they must also provide necessary data on the factsheet, product characteristics, data on AEFI and AESI every 15 days for the first two months. This will help authorities monitor if the vaccine is safe and effective in the long run as well.

Now, while Covaxin is the first vaccine officially approved for pediatric use, there are also several other vaccines being planned to inoculate vulnerable children in India. Zydus Cadila's needle-less DNA vaccine, ZyCOV-D is one such vaccine, which has been granted selective nods for use in kids aged above 12. However, trials are still underway and it could be a longer wait before the vaccine sees the light of the day.

Other vaccine candidates being considered for pediatric use include Corbevex and Covovax. Both the vaccines have been given the go-ahead to conduct mid-stage trials on kids aged between 7-14 years old.

Vaccination drives opening up for kids sparks big relief for parents and educational institutions. However, it's still unknown as to how long further could the wait be, and if at all, kids would require different dosing schedules and patterns than adults. Pharma companies who have received emergency-use authorisation are waiting for further guidelines to know how to get ahead with vaccinating kids, issue awareness on side-effects one can expect, and the total doses which would be made available.