https://ec.europa.eu/commission/presscorner/detail/en/ip_21_4061
https://www.theatlantic.com/health/archive/2021/06/novavax-now-best-covid-19-vaccine/619276/
https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/mRNA.html
https://www.ema.europa.eu/en/news/ema-starts-rolling-review-novavaxs-covid-19-vaccine-nvx-cov2373
Today, we are going to discuss a new contract for a potential COVID-19 vaccine with Novavax, a biotechnology company promoting improved health globally through the discovery, development and commercialization of innovative vaccines in order to prevent serious infectious diseases.
The firm has extended experience contending with some of the world’s most devastating diseases, including COVID-19, seasonal influenza, Ebola, RSV, SARS and MERS.
Their vaccine is genetically engineered using three-dimensional nanostructures of recombinant proteins critical to disease pathogenesis.
The mRNA vaccines are extraordinary, as experienced by Pfizer-BioNTech, but Novavax might be significantly better.
In fact, mRNA vaccines teach our cells how to make a protein -or even just a piece of a protein- that triggers an immune response inside our bodies.
Whereas, novavax’ patented saponin-based Matrix-M adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune responses.
A new chapter of this pandemic is signed, on the 4th of August 2021, by the approval of the EU Commission’s contract.
Its seventh Advanced Purchase Agreement (APA) with a pharmaceutical company to ensure access to a potential vaccine against COVID-19.
The President of the European Commission, Ursula von der Leyen, said: “As new coronavirus variants are spreading in Europe and around the world, this new contract with a company that is already testing its vaccine successfully against these variants is an additional safeguard for the protection of our population. It further strengthens our broad vaccine portfolio, to the benefit of Europeans and our partners worldwide.”
Stella Kyriakides, Commissioner for Health and Food Safety, said: “Vaccinations in the EU are advancing and we are closer to our target of 70% fully vaccinated citizens by the end of summer. Our new agreement with Novavax expands our vaccine portfolio to include one more protein-based vaccine, a technology platform showing promise in clinical trials. We will continue working tirelessly to ensure that our vaccines continue to reach citizens in Europe and around the world, to end the pandemic as quickly as possible.”
NovaVax, the new vaccine
Single booster dose at six months of NVX-CoV2373 increased wild-type neutralizing antibodies more than four-fold versus primary vaccination series.
First, six-fold increase in cross-reactive functional antibodies to Delta variant compared to primary vaccination series. Secondly, analysis of sera from primary vaccination series also showed cross-reactive functional antibodies to Alpha, Beta and Delta variants, all of which increased 6- to 10-fold with boost. And thirdly, study reinforces mostly mild and transient side effect profile.
“We thank the European Commission for their partnership in this important step to expand vaccine options for the citizens of Europe and globally as we work to bring the first COVID-19 protein subunit vaccine to the market,” said Stanley C. Erck, President and Chief Executive Officer, Novavax.
“With clinical data from our trials showing strong efficacy against Variants of Concern and Variants of Interest, we believe that our vaccine candidate will play a critical role in the effort to help control the pandemic in the EU and other regions in the world.”
The European Commission has taken the decision to support this vaccine based on a scientific assessment, the technology used, the company’s experience in vaccine development and particularly its production capacity to supply the whole of the EU.
Novavax is now working to complete its rolling submission for NVX-CoV2373 to the European Medicines Agency (EMA) in the third quarter of 2021.
Once reviewed and approved by a decentralised agency of the European Union (EU) responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU, (EMA) as safe as effective, member states will be able to purchase up to 100 million doses of the Novavax vaccine, with an option for 100 million additional doses over the course of 2021, 2022, and 2023.
Furthermore, they will have the opportunity to donate these vaccines to lower and middle-income countries or even to redirect to other EU countries.
How is the Novavax vaccine expected to work?
Like other vaccines, it is expected to prepare the body to defend itself against infection.
This kind of vaccine is a protein-based containing 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’ (Matrix-M), a substance to help strengthen the immune responses to the vaccine.
When a person is given the shot 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, because trained, the spike protein on the virus and prepared to attack it.
The antibodies and immune cells are able to protect against COVID-19 by working together to kill the virus, prevent its entry into the body’s cells and destroy infected cells.