Vaccine research and development
In January 2020, Novavax announced development of a vaccine candidate, named NVX-CoV2373, to establish immunity to SARS-CoV-2.[30] NVX-CoV2373 is a protein subunit vaccine that contains the spike protein of the SARS-CoV-2 virus.[31] Novavax's work is in competition for vaccine development among dozens of other companies.
In January 2021, the company released phase III trials showing that it has 89% efficacy against Covid-19, and also provides strong immunity against new variants.[33] It has applied for emergency use in the US and UK but will be distributed in the UK first. As of, the company does not anticipate that it will file for approval in the UK "until July at the earliest".[34] On 14 June 2021, Novavax announced overall 90.4% efficacy in the Phase 3 US and Mexico trial. Of the total 77 cases of COVID-19 among the trial's volunteers, 14 occurred in the vaccine group, while 63 occurred in the placebo group.[35]
On 22 May 2021, Novavax and Moderna announced a deal with the South Korean government to manufacture their COVID-19 vaccines.[36] The vaccine is also being co-developed (with the Coalition for Epidemic Preparedness Innovations) in India under the brand name Covovax.[37] CEPI granted Novavax up to $399 million to support the development of the candidate vaccine.[38]
On 6 September 2021, Novavax and Takeda Pharmaceutical Company announced that the Government of Japan's Ministry of Health, Labour and Welfare will purchase 150 million doses of Novavax's vaccine candidate TAK-019 pending regulatory approval.[39] The Government of Japan's Ministry of Health, Labour and Welfare signed an agreement with Takeda Pharmaceutical Company for Takeda to manufacture and distribute Novavax's TAK-019 upon regulatory approval.[40]
On 22 December 2021, Novavax confirmed the efficacy of two doses of vaccine against the omicron variant of SARS-CoV-2. The new data suggest that the vaccine provides an immune response against the Omicron variant and other variants of COVID-19. The response of antibodies against omicron is four times lower than the original variant. A third dose of the vaccine given to adults, six months after the first two doses, increased the level of neutralizing antibodies against the omicron variant by 73.5 times, making it more effective in preventing omicron from entering human cells.
The data shows that the 73.5-fold increase in antibody level following a third dose of Novavax vaccine (protein subunit vaccine) was higher than the booster doses of Pfizer and Moderna (mRNA vaccines), which increased the antibody levels 25-fold and 37-fold, respectively.[41][42][43][44]
The Novavax COVID-19 vaccine was approved in the European Union at the end of 2021,[45] and in Canada in February 2022,[46] as the fifth vaccine against COVID-19, following Pfizer/BioNTech, Moderna, Janssen and AstraZeneca.
Authorization and application
On 1 November 2021, Novavax and Serum Institute of India announced that the National Agency of Drug and Food Control of Indonesia, or Badan Peng was Obat dan Makanan (Badan POM), has granted emergency use authorization (EUA) for Novavax' recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M adjuvant. It will be manufactured by SII in India and marketed by SII in Indonesia under the brand name Covovax.[47]
On 17 December 2021, the World Health Organization (WHO) added Novavax's Covovax vaccine, jointly developed with the Serum Institute of India (SII), to the list of approved coronavirus vaccines for emergency use. The vaccine can then be used in the Covax programme for the supply of vaccines to low and middle income countries. Novavax and SII provide Covax program with 1.1 billion doses of vaccine.[48]
On 20 December 2021, the European Medicines Agency recommended Novavax's Nuvaxovid vaccine for conditional marketing authorisation, which was formally approved by the European Commission, making it the fifth approved COVID-19 vaccine in the European Union after Pfizer/BioNTech, Moderna, Janssen and AstraZeneca.[45]
