Explained | What Novavax data means to India, approval timelines, volumes and price

Novavax coronavirus vaccine | Representative image

Novovax Inc has announced that its COVID-19 vaccine had passed the efficacy test with a score of 90.4%, meeting the primary target of its pivotal Phase 3 trial, offering another antidote to the coronavirus and its variants.

The protein-based vaccine, called NVX-CoV2373, demonstrated 100% protection against moderate and severe forms of viral disease, the US-based biotechnology firm said on June 14. More importantly, the vaccine scored 93.2% in efficacy trials on variants of the virus.

NVX-CoV2373 has a good safety profile and requires to be stored at a temperature of 2-8 degrees Celsius, meaning it can be preserved in household refrigerators as well/

The Nvovax vaccine has generated a lot of interest in India. Serum Institute of India (SII) is conducting bridge trials on the jab and manufacturing the vaccine not only for India, but for dozens of lower- and middle-income countries (LMIC) through Covax, the global alliance aimed at accelerating the development, production and equitable access to COVID-19 vaccines.

SII will be distributing the vaccine under the brand name Covavax.

Questions sent to SII on its manufacturing capacity, launch timelines and price had elicited no response as of press time.

Here is a Moneycontrol ready reckoner on what the Novavax data means for India, approval timelines, likely production volumes and pricing. Will the vaccine offer protection against the deadly Delta variant of the virus?

When can we expect approval of the vaccine in India?Novavax said it will soon approach the US Food and Drug Administration,  the European Medicines Agency and the Medicines and Healthcare Products Regulatory Agency for emergency use authorisation of its vaccine.

The company said it would expect the vaccine to be approved in India and South Korea -- the two important manufacturing hubs for the vaccine -- in the third quarter of 2021.
The Drugs Controller General of India (DCGI) has approved the revision in the protocol for conducting the Phase 3 clinical trial on Covovax. SII will be testing the vaccine on 1,400 volunteers above 18 years of age across 20 sites in the country.

Production volume
The Indian government has indicated that it expects 200 million doses of the Novavax vaccine to be available from August to December. The government is yet to sign any firm order with SII for supply of the vaccine.

Pricing
Novavax has indicated that it would price the vaccine in line with the economic category to which a country purchasing the doses belongs. The vaccine will be supplied at a tentative price of Rs 1,114 per dose. Novavax and SII have agreed to supply 1.1 billion doses of the vaccine manufactured by the latter to the Covax facility. SII has an existing deal with the Gavi, the vaccine alliance.

Is it effective against the dominant Delta variant?
Novavax said the efficacy of its vaccine was 93.2% against “variants of concern” and “variants of interest,” which made up 82% of the cases during trials. The efficacy endpoint accrual happened between January 25 and April 30, when the Delta variant hadn't been dominant in the US.

Of the 54 cases sequenced, only one case that tested positive was of the Delta variant, the strain that's dominant in India. In the US, Delta is still a variant of interest. In contrast with the Alpha variant of concern, B.1.1.7 has a UK origin and was responsible for 28 cases.

D0ata from the bridging trial in India would be interesting to find out how effective this vaccine is against the Delta variant. Another interesting aspect is that of the 29,960 participants enrolled in the Phase 3 study of the Novavax vaccine, about 5% were Asia Americans. Indians are grouped in the Asian American category.

Manufacturing challenge
Novavax said manufacturing challenges have eased but still supplies of equipment and raw material remain tight. The company said it faced challenges with raw materials in the first half. But company president and CEO Stanley Erck told analysts that the company stands by its earlier projection of manufacturing 100 million doses per month by the end of the third quarter of 2021, and 150 million doses per month by the end of quarter four.

Erck said much of those supplies will go to lower and middle-income countries, and the vaccine will be used in the developed world as booster shots. Erck said the trials of mix and match versions of the vaccines are underway. Novavax is manufacturing the vaccine in eight plants spread across eight countries including India.