Covid-19 pandemic: Novavax shot may get nod in India even before US

Covid vaccine from US major Novavax may get a nod from the Indian drug regulator even before the vaccine is approved in the US.
 
The company and its partner Serum Institute of India (SII) have, on August 5, applied for an emergency use authorisation with the Drugs Controller General of India (DCGI) and regulatory bodies in Indonesia and the Philippines. India has said any vaccine, which has approval from stringent regulatory bodies like the US Food and Drug Administration (USFDA) and the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK, among others, would be approved for use in India.
 
Novavax’s protein nano-particle two-dose Covid vaccine is not yet approved in the US or the UK. This raised concerns around its approval timelines in India.
 
However, a senior government official clarified: “Indian regulator can review the global data from phase 3 trials, as well as the bridging trial data from the 1,600 volunteers in India to consider granting an approval. Whe­ther or not it is appr­oved in the US does not matter. The Indian regulator can conduct an independent review.”
 
SII and Novavax have now completed submission of all modules required by regulatory agencies in India, Indonesia and the Philippines for the initiation of review of the vaccine, including preclinical, clinical, and chemistry, manufacturing and controls data, Novavax said.
 
A ‘good manufacturing practice’ joint site inspection of SII was successfully completed by DCGI in May 2021, it added.
 
SII chief executive officer (CEO) Adar Poonawalla said a few days ago that he is hopeful that Covovax, the Novavax vaccine made by SII, will be launched around October this year for adults and for children by the first quarter of next year, depending on DCGI approvals.

A Novavax spokesperson told Business Standard that the company also intends to apply for emergency use authorisation with the World Health Organisation (WHO), UK-MHRA, European Medicines Agency (EMA), and other stringent regulatory authorities.
 
“We continue to work with these authorities to ensure we are aligned. Regulators in different countries have different requirements. We are leveraging the expertise and knowledge of our many partners to progress as rapidly as possible, while ensuring that we meet all stringent requirements that guarantee safety and quality,” the spokesperson said.
 
She added that in the US, the company continues to work with the FDA for emergency use authorisation.
 
“SII is manufacturing, and developing it, and is responsible for commercialising the vaccine in India. Novavax and SII have cumulative commitments to provide more than 1.1 billion doses to the COVAX facility,” Novavax said.
 
However, before supplies to the COVAX can begin, a World Health Organisation (WHO) pre-qualification wou­ld be necessary. A submission to the WHO for emergency use listing, based on the DCGI submission, is expected to be filed in August, Novavax said.
 
The Maryland-based company expects to achieve a global production target of 100 million doses per month by the end of the third quarter of 2021 and 150 million doses a month by the end of the fourth quarter.
 
Covovax has been evaluated in two pivotal phase 3 trials — the UK trial has shown an efficacy of 96.4 per cent against the original virus strain, and 86.3 per cent against the Alpha variant. The US trials showed 90.4 per cent efficacy.