Serum eyes early nod for Covovax
Serum Institute of India (SII) is considering applying for an expedited emergency licence for Covovax under the government’s revised norms if the vaccine’s developer Novavax secures authorization from the US regulator
Serum Institute of India (SII) is considering applying for an expedited emergency licence for Covovax under the government’s revised norms if the vaccine’s developer Novavax secures authorization from the US regulator.
“Once Novavax receives all the necessary global regulatory approvals, we can look at launching it (Covovax). That said, we would still want to continue with trials in India to ensure its immunogenicity and efficacy,” Serum Institute chief executive officer Adar Poonawalla said in a statement to Mint.
In March, Novavax CEO Stanley Erck told business channel CNBC that if the US Food and Drug Administration (USFDA) agrees to review the data from the firm’s UK trial of 15,000 participants, the vaccine could receive an emergency use authorization (EUA) as early as May.
In case USFDA gives its authorization by next month, Serum Institute could potentially get a similar authorization in India as early as the first half of June. According to the revised government norms, a foreign vaccine with authorization from USFDA or four other top regulators could be eligible for expedited authorization in India.
The entire process from submission of application to the Drugs Controller General of India to securing an authorization is to be completed in about a week, according to the norms.
Poonawalla said Serum Institute plans to stockpile Covovax starting this month but declined to comment on the capacity, saying that it is too early to comment.
For now, with no USFDA authorization for Novavax’s vaccine in place, Serum Institute is planning to launch Covovax by September, Poonawalla said, adding “with new policies in place, we may launch earlier only if quality is proven.”
Novavax in February announced the rolling review process—review of efficacy trial data as it is generated—of its application for EUA from USFDA, European Medicines Agency (EMA), UK Medicines and Healthcare products Regulatory Agency (MHRA) and Health Canada. The announcement came after the company published its interim efficacy data from its trial in the UK and South Africa in late January.
It produced a second set of interim efficacy data from trials in March. In the UK, the vaccine showed the efficacy of the protein subunit vaccine it developed was 96.4% against the original strain of SARS-COV2, the highest for all vaccines with efficacy data so far.
Against the mutant variant from UK, the efficacy dropped to 86.3%, while in a trial in South Africa, where another mutant strain was dominant, the efficacy dropped further to 48.6%, which was slightly lower than the benchmark for overall efficacy but still better than most other vaccines currently available.
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First Published:23 Apr 2021, 12:59 AM IST
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