The European Union could sign a supply deal with Novavax this week or next for the U.S. company's COVID-19 vaccine candidate, two EU officials involved in the talks with the firm said. [ Ссылка ] The EU concluded in December preliminary negotiations with Novavax for the supply of 100 million doses and an option for another 100 million.

"Talks with Novavax have intensified and we aim to agree the contract this week or next," one EU official said.

#eudebates #NOVAVAX #Covid_19 #coronavirus #Corona #COVD19 #Health #COVID #vaccine

A second EU official, involved in talks, confirmed that possible timetable for a deal, but added that discussions with the company's lawyers were still underway, declining to elaborate on what were the outstanding issues.

Last week Europe's drug regulator said it had launched a real-time review of Novavax's vaccine to speed up potential approvals.

The vaccine is still being trialled, but preliminary data showed the vaccine was 89.3% effective in preventing COVID-19 in a trial conducted in the United Kingdom, and was nearly as effective in protecting against the more highly contagious variant first discovered in the UK.

The possible deal with Novavax would be the seventh sealed by the EU with vaccine makers for the supply of COVID-19 shots. It already has agreements with AstraZeneca, Johnson & Johnson, Pfizer-BioNTech, CureVac, Moderna and Sanofi-GSK for a total of about 2.3 billion doses.

EMA starts rolling review of Novavax’s COVID-19 vaccine

EMA’s human medicines committee (CHMP) has started a rolling review of NVX-CoV2373, a COVID‑19 vaccine being developed by Novavax CZ AS (a subsidiary of Novavax, Inc.).

The CHMP’s decision to start the rolling review is based on preliminary results from laboratory studies (non-clinical data) and early clinical studies in adults. These studies suggest that the vaccine triggers the production of antibodies and immune cells that target SARS-CoV-2, the virus that causes COVID‑19.

The company is currently conducting trials in people to assess its safety, immunogenicity (how well it triggers a response against the virus) and its effectiveness against COVID-19. EMA will evaluate data from these and other clinical trials as they become available.

The rolling review will continue until enough evidence is available for a formal marketing authorisation application.

EMA will assess the vaccine’s compliance with the usual standards for effectiveness, safety and pharmaceutical quality. While EMA cannot predict the overall timelines, it should take less time than normal to evaluate an eventual application because of the work done during the rolling review.

How is the vaccine expected to work?
Like other vaccines, NVX-CoV2373 is expected to prepare the body to defend itself against infection. The vaccine is a protein-based vaccine which contains tiny particles made from a laboratory-grown version of the spike (S) protein found on the surface of SARS-CoV-2 coronavirus. It also contains an ‘adjuvant’, a substance to help strengthen the immune responses to the vaccine.

When a person is given the vaccine, their immune system will identify the protein particles as foreign and produce natural defences — antibodies and T cells — against them. If later on, the vaccinated person comes into contact with SARS-CoV-2, the immune system will recognise the spike protein on the virus and be prepared to attack it. The antibodies and immune cells can protect against COVID-19 by working together to kill the virus, prevent its entry into the body’s cells and destroy infected cells.
[ Ссылка ] #eudebates

свернуть