Novavax COVID-19 vaccine
Technology
NVX-CoV2373 has been described as both a protein subunit vaccine and a virus-like particle vaccine, though the producers call it a "recombinant nanoparticle vaccine".
The vaccine is produced by creating an engineered baculovirus containing a gene for a modified SARS-CoV-2 spike protein. The spike protein was modified by incorporating two proline amino acids in order to stabilize the pre-fusion form of the protein; this same 2P modification is being used in several other COVID-19 vaccines. The baculovirus then infects a culture of Sf9 moth cells, which create the spike protein and display it on their cell membranes. The spike proteins are then harvested and assembled onto a synthetic lipid nanoparticle about 50 nanometers across, each displaying up to 14 spike proteins.
The formulation includes a saponin-based adjuvant.
The vaccine is given in two doses administered 21 days apart, and is stable at 2 to 8 °C (36 to 46 °F) refrigerated temperatures.
Development
In January 2020, Novavax announced development of a vaccine candidate, codenamed NVX-CoV2373, to establish immunity to SARS-CoV-2. Novavax's work is in competition for vaccine development among dozens of other companies.
In March 2020, Novavax announced a collaboration with Emergent BioSolutions for preclinical and early-stage human research on the vaccine candidate. Under the partnership, Emergent BioSolutions was supposed to manufacture the vaccine at large scale at their Baltimore facility. However, following production issues with the Johnson & Johnson and Oxford–AstraZeneca vaccines at its Baltimore plant and to decrease the burden on the plant, Novavax subsequently partnered with a different manufacturer in a new agreement overseen by the U.S. government.
Trials have also taken place in the United Kingdom, and subject to regulatory approval, at least 60 million doses will be manufactured by Fujifilm Diosynth Biotechnologies in Billingham for purchase by the UK government. They also signed an agreement with Serum Institute of India for mass scale production for developing and low-income countries. It has also been reported, that the vaccine will be manufactured in Spain and in Poland by the Mabion company. The first human safety studies of the candidate, codenamed NVX-CoV2373, started in May 2020 in Australia.
In July 2020, the company announced it might receive $1.6 billion from Operation Warp Speed to expedite development of its coronavirus vaccine candidate by 2021 – if clinical trials show the vaccine to be effective. A spokesperson for Novavax stated that the $1.6 billion was coming from a "collaboration" between the Department of Health and Human Services and Department of Defense, where Gen. Gustave F. Perna has been selected as COO for Warp Speed. In late September, Novavax entered the final stages of testing its coronavirus vaccine in the UK. Another large trial was announced to start by October in the US.
In December 2020, Novavax started the PREVENT-19 (NCT04611802) phase 3 trial in the US and Mexico, funded by NIAID and BARDA. On 3 May 2021, Novavax initiated a pediatric expansion for the phase 3 clinical trial, with 3,000 adolescents 12–17 years old.
Later developments
On 24 February 2021, Novavax partnered with Takeda Pharmaceutical Company in Japan, where the vaccine is known as TAK-019.
On 26 May 2021, Serum Institute of India said that it has started the production of Novavax vaccine (marketed as Covovax in India) after receiving permission from the Indian government.
Efficacy
On 28 January 2021, Novavax reported that preliminary results from the United Kingdom trial showed that its vaccine candidate was more than 89% effective. However, interim results from a trial in South Africa showed a lower effectiveness rate against the Beta variant (lineage B.1.351), at around 50–60%.
On 12 March 2021, Novavax announced their vaccine candidate was 96.4% effective in preventing the original strain of COVID-19 and 86% effective against the Alpha variant. It proved 55% effective against the Beta variant in people without HIV/AIDS. It was also 100% effective at preventing severe illness.
On 14 June 2021, Novavax announced overall 90.4% efficacy in the Phase 3 U.S. & Mexico trial that involved nearly 30,000 people ages 18 years and older. From the total 77 COVID-19 cases found in the trial participants, 14 occurred in the vaccine group, while 63 occurred in the placebo group.
Deployment
On 2 February 2021, the Canadian Prime Minister Justin Trudeau announced that Canada has signed a tentative agreement for Novavax to produce millions of doses of its COVID-19 vaccine in Montreal, Canada, once it is approved for use by Health Canada, making it the first COVID-19 vaccine to be produced domestically.
On 29 March 2021, the UK government announced that their order for 60 million doses of the Novavax vaccine, which will be manufactured in the UK by FUJIFILM Diosynth Biotechnologies, will also be filled and finished in the UK by GlaxoSmithKline.
Novavax plans on seeking authorization for the vaccine in the U.S., Europe, and other countries by the end of September 2021, with the goal of producing 100 million doses a month by then.
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