The Drugs Controller General of India (DCGI) has granted emergency use authorisation (EUA) for Novavax’ protein-based Covid-19 vaccine, Covovax, with Matrix-M adjuvant.
In August this year, Novavax has teamed up with Serum Institute of India (SIIPL) to supply its Covid‑19 vaccine (NVX‑CoV2373) in low- and middle-income countries (LMIC) and India.
The EUA indicates administration of Covovax in two 5mcg doses, 21 days apart, in adults aged 18 years and above, to induce immunity against SARS-CoV-2.
NVX-CoV2373 is designed using the company’s recombinant nanoparticle technology, and is formulated using its patented saponin-based Matrix-M adjuvant.
The Matrix-M adjuvant boosts immune response by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation, said Novavax.
Novavax president and chief executive officer Stanley C Erck said: “No one is safe until everyone is safe, and today’s authorization marks a vital step for India, where additional vaccine options and millions of doses are needed in the country’s ongoing efforts to control the pandemic.
“Novavax and SII will not rest in our partnership to deliver our vaccine to those in India and across the globe, as we work to protect the health of people everywhere.”
The Novavax/SII vaccine was recently granted EUA in Indonesia and the Philippines, along with World Health Organization (WHO) Emergency Use Listing (EUL).
Novavax said that its partners SK bioscience and Takeda have been pursuing regulatory approval for the vaccine in South Korea and Japan, respectively.
In a separate development, Biological E’s Covid-19 vaccine CORBEVAX, with Dynavax’s CpG 1018 adjuvant, has received the emergency use approval from DCGI.
Dynavax and Biological E have previously reached a commercial supply agreement (CSA) for Dynavax to supply its CpG 1018 adjuvant for use in Biological E’s CORBEVAX.
The CpG 1018 adjuvant has been developed to provide enhanced vaccine immune response with an improved tolerability profile.
Dynavax chief executive officer Ryan Spencer said: “We have secured the capacity to deliver on our commitment to supply CpG 1018 adjuvant to Biological E to meet their needs for their existing contract with the Indian Government for 300 million doses, as well as any additional adjuvant required to fulfill future demand in 2022 and beyond.
“We are proud of the impact we are having on the pandemic by supporting equitable access to quality vaccines across the globe.”
