The Drugs Controller General of India has approved the manufacture of this Sars-CoV-2 spike protein recombinant nano-particle vaccine for ‘examination, test, and analysis’, reports Sohini Das.
Serum Institute of India is getting ready to work with its United States partner Novavax on an Omicron variant specific vaccine for COVID-19 that would be different from the original shot developed by the US major using the Wuhan strain of the Sars-CoV-2 virus.
The Pune-based company has also got a nod from the Indian drug regulator’s office to manufacture trial batches of this vaccine for the purpose of testing, sources indicated.
SII did not wish to comment on the matter.
Sources, however, indicated that the Drugs Controller General of India has approved the manufacture of this Sars-CoV-2 spike protein recombinant nano-particle vaccine for ‘examination, test, and analysis’.
Globally, Novavax is testing this Omicron BA.1 specific vaccine as a booster after two shots of mRNA vaccine.
The company has indicated in the first quarter earnings call that it has reached a major milestone in its pathway to an emergency use authorisation from the US Food and Drugs Administration and a Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting is now set for June 7, following ‘successful completion’ of an inspection of the manufacturing site at SII.
Novavax expects an approval from the USFDA for its COVID-19 vaccine this summer.
The vaccine has already been approved in Indonesia and as Covovax in India.
However, the company is developing a vaccine using the Omicron strain as the Sars-CoV-2 virus has mutated from the original Wuhan strain.
Omicron has hit over 60 countries in the world and is now the dominant strain in circulation.
Novavax is planning two types of Omicron vaccines -- a monovalent and a bivalent option -- and these are expected to be in the clinic (in clinical trials) later this month.
Stanley C Erck, president and CEO of Novavax, said in the first quarter earnings call that they are advancing an Omicron monovalent and bivalent option and it is expected to be in clinic later this month.
Erck said it is advancing its COVID-19 influenza combination vaccine through a phase 1 and 2 trial with the goal to advance this candidate into a phase 2 trial before the end of this year.
Novavax’s Omicron specific vaccine is called NVX-CoV2515 that uses the Omicron BA.1 strain.
The company has said it induces superior antibody responses against the Omicron variant compared to its Wuhan prototype vaccine -- NVX-CoV2373.
There is also a bivalent vaccine containing both NVX-CoV2515 and NVX-CoV2373.
Last week, it said it is initiating a randomised, blinded trial in Australia over 1,340 participants to assess the bivalent vaccine after two shots of either the Pfizer or Moderna mRNA shots.
India has not allowed any mRNA vaccine so far. An indigenous candidate from Gennova Biopharma, another Pune-based company, is awaiting a nod from the DCGI.
SII would need to generate safety and immunogenicity data for the Omicron specific vaccine before it can seek the DCGI nod.