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🌏 | NVX-CoV Postpones Vaccine Approval Application to FDA


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Novabax re-postpones vaccine approval application to FDA

 
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Novabax has shown that a single booster dose, six months after the second dose of its vaccine, results in a 2-fold increase in antibodies.
 

[Reuters] – US biopharmacy company Novabax announced on the XNUMXth that the new coronavirus vaccine will be used urgently in the US ... → Continue reading

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Novavax COVID-19 vaccine

Novavax COVID-19 vaccine(Code name: NVX-CoV2373) IsThe United States of America OfBiotechnologyCompany Novavax(English edition) Developed byCOVID-19 vaccine.

Overview

Manipulated containing the modified SARS-CoV-2 pesplomer geneVaculovirusGenerated by creating[1].

For the formulationsaponinContains a base adjuvant.

This vaccine is given twice every 21 days andCelsiusCan be stably refrigerated in the range of 2 to 8 degrees.

2021May 2, Nova BucksTakeda PharmaceuticalAffiliated with.

History of development

Development started in January 2020.In March of the same year, Nova Bucks announced a vaccine candidate.PreclinicalAnd announced a partnership with Emergent BioSolutions (EBS) for early clinical trials.Novabax was supposed to manufacture large-scale vaccines at EBS's Baltimore plant in partnership with EBS, but due to continued production problems with Johnson & Johnson and Oxford-AstraZeneca vaccines at the Baltimore plant. To ease the burden on the EBS, Novavacs then partnered with another manufacturer under a new agreement overseen by the US government.

In the UK, with regulatory approval, it will be manufactured for the UK government at least 6000 million times at the Fujifilm Diosins Biotechnology Billingham site.Novabax has also signed an agreement with the Indian Serum Institute for mass production for developing and low-income countries, and it is reported that it will be manufactured by Mabion in Spain and Poland.

In May 2020, the first human safety study of the candidate codenamed NVX-CoV5 began in Australia.

In July 2020, Novabax launched Operation Warp Speed ​​to facilitate the development of coronavirus vaccine candidates if clinical trials showed that the vaccine was effective.[Annotation 1]Announced that it could receive $ 2021 billion by 16."$ 16 billion comes from a collaboration between the Department of Health and Human Services and the Pentagon," said a Novabax spokesman.In late September of the same year, Novavax entered the final stages of testing the coronavirus vaccine in the United Kingdom.It was announced that another large-scale trial will begin in the United States by October.

In December 2020, Novabax is in the PREVENT-12 (NCT19) phase in the United States and Mexico, funded by the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Agency (BARDA) of the US Department of Health and Human Services. 04611802 Start the test.

On May 2021, 5, Novabax began a phase 3 clinical trial in 12 adolescents aged 17 to 3,000 years.

Technology

A protein called a recombinant nanoparticle vaccineSubunit vaccineHas the characteristics of both and virus-like particle (VLP) vaccines[1]..This vaccine is produced by creating an engineered baculovirus that contains the modified SARS-CoV-2 peplomer gene.

Peplomers are altered by incorporating two proline amino acids to stabilize the pre-fusion form of the protein.This same 2P modification has been used in several other COVID-2 vaccines.The baculovirus then infects a culture of Sf19 moth cells, producing peplomer proteins and displaying them on the cell membrane.Spike proteins are then collected and assembled onto synthetic lipid nanoparticles.They are about 9 nanometers in diameter, each displaying up to 50 peplomers.

Effectiveness

On January 2021, 1, Novabax announced that it was "28% effective in an interim analysis of a phase 3 clinical trial in the United Kingdom."[2]..However, the efficacy rate for 501.V2 mutants is about 50-60%.

On March 2021, 3, Novabax announced that the vaccine candidate was 12% effective against the original strain of COVID-19 and 96.4% effective against the Alpha variant.It has proven to be 86% effective against beta mutants in people without HIV / AIDS.It was also 55% effective in preventing serious illness.

2021年6月14日、ノババックスは米国およびメキシコにおいて、18歳以上の約30,000人が参加した第3相試験で、全体で90.4%の有効性を発表した。試験参加者で発見された合計77のCOVID-19症例のうち、14がワクチン群で発生し、63がプラセボ群で発生した。

footnote

注 釈

  1. ^ Gustav F. Perna is the COO.

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ScholiaToNovavax COVID-19 vaccine (Q97154235)I have a profile about.

 

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