Vaccine research and development In January 2020, Novavax announced development of a vaccine candidate, named
NVX-CoV2373, to establish immunity to
SARS-CoV-2. NVX-CoV2373 is a protein
subunit vaccine that contains the spike protein of the SARS-CoV-2 virus. Novavax's work is in competition for vaccine development among dozens of other companies. at Novavax's future Vaccines Innovation Campus and global headquarters in
Maryland 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. It has applied for emergency use in the US and UK but will be distributed in the UK first. , the company does not anticipate that it will file for approval in the UK "until July at the earliest". 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. On 22 May 2021, Novavax and
Moderna announced a deal with the South Korean government to manufacture their
COVID-19 vaccines. The vaccine is also being co-developed (with the
Coalition for Epidemic Preparedness Innovations) in India under the brand name Covovax. CEPI granted Novavax up to $399 million to support the development of the candidate vaccine. 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. 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. On 22 December 2021, Novavax confirmed the efficacy of two doses of vaccine against the
omicron variant of
SARS-CoV-2. The
Novavax COVID-19 vaccine was approved in the European Union at the end of 2021, and in Canada in February 2022, 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. 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. 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. On 31 January 2022, Novavax applied to the
Federal Drug Administration (FDA) for
Emergency Use Authorization (EUA) for
NVX-CoV2373, and on 7 June, FDA's panel of outside advisors recommended FDA grant the EUA. In February 2022,
Health Canada authorized Nuvaxovid for the prevention of COVID-19 in adults 18 years of age and older. In July 2023, Novavax announced that it has received full Marketing Authorization from the
European Commission for its
COVID-19 vaccine, Nuvaxovid (
NVX-CoV2373), allowing its use as a primary series in individuals aged 12 and older and as a booster dose in adults aged 18 and older. The authorization establishes a foundation for future regulatory approvals and Novavax plans to seek full approval in the United States and other markets while emphasizing the importance of vaccine choice in public health measures. In early October 2023, the FDA amended the EUA to include the reformulated Novavax vaccine "updated to include the spike protein from the SARS-CoV-2 Omicron variant lineage XBB.1.5 (2023–2024 formula)" for age 12 and above. In December 2023, the WHO provided prequalification status to the R21/Matrix-M malaria vaccine developed by the University of Oxford and the Serum Institute of India. The COVID vaccine targeting the JN.1 strain was authorized for use in the European union in October 2024. In April 2025, Novavax was still in the process of obtaining full licensure for its COVID-19 vaccine, having submitted a Biologics License Application to the FDA, who requested Novavax complete an additional clinical trial. In May 2025, Novavax received FDA approval for its COVID-19 vaccine for adults 65 years or over. Nuvaxovid is also indicated for individuals 12 through 64 who have at least one underlying condition that puts them at high risk for severe outcomes from COVID-19. ==References==