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Tuesday, July 27, 2021

SII-partner Novavax reports 90% efficacy, says focused first on developing countries

The Maryland-headquartered company said its vaccine had demonstrated 100 per cent protection in late-stage trials against moderate and severe disease caused by SARS-CoV-2 — a boost for the prospects of its Indian version, Covovax.

Written by Prabha Raghavan | New Delhi |
Updated: June 15, 2021 7:05:53 am
Novavax, Taiwan Novavax, Covid vaccine via COVAX, Covax, Taiwan covid news, world news, Indian expressVials labelled "Covid-19 Coronavirus Vaccine" and syringe are seen in front of displayed Novavax logo in this illustration taken, February 9, 2021. (Reuters Photo)

Novavax will prioritise developing countries for the initial supplies of its Covid-19 vaccine, the Chief Executive Officer of the American biotechnology company said on Monday.

The Maryland-headquartered company said its vaccine had demonstrated 100 per cent protection in late-stage trials against moderate and severe disease caused by SARS-CoV-2 — a boost for the prospects of its Indian version, Covovax.

Overall, the efficacy of the vaccine was 90.4 per cent — that is, it showed the ability to bring down symptomatic Covid-19 cases by more than 90 per cent compared with those who had not received a vaccine.

“It should be noted… that, given that we’ve got a commitment of 1.1 billion doses with COVAX along with our partner Serum Institute (of India), a lot of our first doses are going to go into low- and middle-income countries, as they should,” CEO Stanley C Erck said in a conference call on Monday after announcing the vaccine’s performance in phase 3 trials in the United States and Mexico.

Several high-income countries have already inoculated large sections of their populations with vaccines manufactured by other companies, even as low- and middle-income countries have been struggling with acute vaccine shortages.

Novavax, a small company that received huge support from the Trump administration’s Operation Warp Speed last year, also plans to fulfill its advance purchase agreements (APAs) with “four or five” high-income countries.

“But in the very early days, it’s going to be low- and middle-income countries,” Erck said.

The company expects to “transition” next year from its APAs and commitment towards supplying vaccines to developed and underdeveloped countries to “eventually” provide its jabs as a “booster” dose.

“I think, particularly in the United States, our vaccine is going to be probably most importantly used as a booster,” Erck said.

In the short run, Novavax has a “tiered” pricing scheme for lower-, upper-, and middle-income countries that are “in line” with most other manufacturers.


Hope and caution for India

Novavax’s commitment to developing countries, and India’s ability to produce this vaccine are promising. However, attention needs to be paid to the fine print, including how effective the vaccine is against specific variants.

Against what the US Centres for Disease Control and Prevention (CDC) considers “variants of concern” and “variants of interest”, the vaccine’s efficacy was found to be around 93 per cent, Novavax said in its announcement about the PREVENT-19 phase 3 trial in the US and Mexico.

However, in its release, the company grouped together the Alpha (B.1.1.7) and Delta (B.1.617.2) variants of the virus — while B.1.1.7 made up the “majority” of the variant-of-concern cases, B.1.617 figured in the 17 per cent of cases caused by the variant of interest.

The company intends to file for regulatory authorisation in multiple countries between July and September. This would bring Serum Institute of India (SII) a step closer to launching Covovax in a similar timeframe.

“Upon regulatory approvals, Novavax remains on track to reach (a) manufacturing capacity of 100 million doses per month by the end of the third quarter and 150 million doses per month by the end of the fourth quarter of 2021,” the company said in its release.

“We expect to file with the US FDA, with the UK MHRA, with the EU EMA and also, importantly…in India and Korea,” Erck said during the conference call.

“We intend to have those filings done in the third quarter and the different agencies will take different times to evaluate it (the data) but a lot of them are working on it right now because we’ve had rolling submissions,” he said.

However, with the US easing its urgent focus on adding newer vaccines to its armoury against the coronavirus, it is likely that Novavax will have to seek full licensure as opposed to fast-tracked emergency approval. Erck has “acknowledged” that the company would “probably win its first authorisation elsewhere,” The New York Times reported.

It was not immediately clear if this would in turn slow down SII’s ability to bring Covovax to the market in India. Queries to the Pune-headquartered vaccine maker about this, as well as whether it would be able to seek restricted emergency use permission in India without the vaccine having received Emergency Use Authorisation (EUA) in other countries, remained unanswered by press time on Monday.

In April, the government eased requirements to seek approvals for certain foreign Covid-19 vaccines, allowing a waiver on the need for local bridging studies for vaccines that have received EUAs from regulators such as the US FDA, EMA, UK MHRA, and Japan’s PDMA, or a WHO Emergency Use Listing.

An approval from the MHRA, EMA or FDA would allow SII to approach the Indian regulator for emergency licence for Covovax while awaiting results from the ongoing bridging studies. The vaccine is being tested in a phase 2/3 trial involving 1,600 participants; volunteers in the phase 3 leg of the study are still in the process of being vaccinated, said a source who did not wish to be identified.

In a projection made last month, the government had anticipated a supply of 50 million doses of Covovax from SII every month starting September. However, considering that the US in early June removed restrictions on exports of raw materials that SII had been heavily dependent on to make this vaccine, it is likely that the company’s ability to manufacture and stockpile doses of Covovax has increased.

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