SII And COVID19 Vaccinations Update

With never-before surges in Covid-19 infection every day, a vaccine shortage in India couldn’t have come at a worse time, as India breaks daily records of spikes in COVID positive cases. Mumbai is experiencing its worst-ever wave of Covid-19 yet, and the most acute vaccine shortage in the country. The State has sent repeated requests to the central government for fresh stocks. This shortage also coincides with the momentum India has gained in vaccinating its population, with over 117 million doses administered as of April 16, 2021. India is far from its August target of inoculating 300 million Indians, and this shortage has renewed the criticism against India’s vaccine diplomacy.

Covishield, the AstraZeneca vaccine manufactured in India by Serum Institute of India (SII) constitutes the majority of the immunisation programme. SII has been under fire for not delivering vaccines on time, especially to countries with whom AstraZeneca has binding contracts, and has been served a legal notice as well for delays. As the world’s largest maker of the covid jab – Covishield – developed by Oxford and AstraZeneca, SII has multiple export contracts to fulfil – including 550 million doses to Covax, a global initiative for the equitable distribution of vaccines among poor countries, and also bilateral deals for the supply of 900 million doses to other nations, a few of which have balked at news of blood clots linked in rare cases to the vaccine it makes. 

Last month, even as foreign recipients awaited shipments, SII found vaccine exports clamped by our government. Faced with a second wave of covid, the state needed all the vials being churned out for its own centrally-planned vaccination drive. Caught between clients, Poonawalla has since described SII’s facilities as “very stressed”, pledged to produce doses only for India (for two months), and asked the Centre for a ₹3,000-crore grant to expand capacity.

As per media reports, the GoI is considering financial assistance to SII and Bharat Biotech said COVID-19 task force head, VK Paul. He also confirmed that bridging trials could happen simultaneously with inoculations. The need for trial, he said, has been given away for foreign vaccines approved by certain foreign regulators and World Health Organization (WHO). He added these moves would open up the market for Pfizer, J&J and Moderna vaccines. He added that India’s vaccine availability will improve July onwards. 

To further boost the availability of vaccines in India, the Centre is doing away with the need for conducting phased clinical trials for vaccines approved by the US, UK, and the World Health Organisation (WHO), informed Paul.

While India’s Subject Expert Committee (SEC) on Covid-19 vaccines granted Covaxin a Restricted Approval even without Phase 3 trial data, and allowed Covishield to be used despite a lack of India-specific trial data, the same leeway hasn’t been granted to Sputnik V, the Russian coronavirus vaccine, which is in tie-ups with five Indian companies including Dr. Reddy’s (for 250 mn. doses) and Panacea Biotech (for 100 mn. Doses), once approved. India could also review its hesitance over allowing Pfizer’s mRNA vaccine from being approved in the country. The company was among the first to apply for an emergency authorisation in December 2020 but eventually withdrew its application because of demands for data that it could not fulfil at the time.