Serum Institute of India to partner with Novavax to launch another COVID-19 vaccine 'Covovax' by June

A file photograph of Adar Poonawalla, SII CEO.

Announcing plans to start its clinical trials in India soon, Serum Institute of India (SII) CEO Adar Poonawalla said on Twitter that they hope to launch a new COVID-19 vaccine by June of this year. This comes after encouraging results of Novavax’s phase-3 trials in the United Kingdom, even against the new strain.

An official at SII told Frontline that they have applied for the Phase 2/3 bridging trials, which will be conducted on 1600 participants. The bridging study is necessary to test a vaccine’s safety and immunogenicity if its earlier phases’ trials were done in a different country.

Covovax, the protein-based vaccine candidate of SII and Novavax, an American biotechnology company, “met the primary endpoint, with a vaccine efficacy of 89.3%, in its Phase 3 clinical trial conducted in the United Kingdom. The study assessed efficacy during a period with high transmission and with a new UK variant strain of the virus emerging and circulating widely.” a press release by Novavax stated. The efficacy figure was an average of phase three trials against the new and original strains of the coronavirus.

As per the press release, Novavax’s UK study enrolled over 15,000 participants between 18-84 years. “These are spectacular results, and we are very pleased to have helped Novavax with the development of this vaccine. The efficacy shown against the emerging variants is also extremely encouraging. This is an incredible achievement that will ensure we can protect individuals in the UK and the rest of the world from this virus,” Clive Dix, Chair of the UK Vaccine Taskforce, said.

The Maryland-based vaccine giant also announced the results of its phase 2-b study conducted in South Africa on 4400 patients, saying that clinical efficacy against the Coronavirus variant in South Africa was seen. The Coalition for Epidemic Preparedness Innovations funded the doses that had to be manufactured for this trial, partly supported by a $15 million grant from the Bill & Melinda Gates Foundation.

Apart from the Covishield vaccine, which SII has launched in India after licensing it from Oxford University and AstraZeneca, the Pune-based institute has begun the manufacturing and pre-clinical trials of a nasally-administered single-dose vaccine of the US-based Codagenix Incorporated. Adar Poonawalla had earlier told the media that SII would begin to manufacture around 50 million doses of the Covovax from April.