BRUSSELS, Aug 4 (Reuters) – The European Commission has approved a supply contract with U.S. firm Novavax (NVAX.O) to buy up to 200 million doses of its potential COVID-19 vaccine, the Commission said on Wednesday.
The move is part of the EU’s strategy to diversify its vaccine portfolio after the bloc betted heavily for the coming years on messenger RNA (mRNA) shots produced by Pfizer-BioNTech (PFE.N), (22UAy.DE) and Moderna (MRNA.O).
“Our new agreement with Novavax expands our vaccine portfolio to include one more protein-based vaccine, a platform showing promise in clinical trials,” EU health commissioner Stella Kyriakides said in a statement.
French drugmaker Sanofi (SASY.PA), in partnership with British firm GlaxoSmithKline (GSK.L), is also trying to produce a protein-based COVID-19 vaccine and has already signed a supply deal with the EU. But their trials suffered a setback in December, delaying development.
Categories: Vaccine
The EU has approved a deal with Novavax to secure up to 200 million doses of the company’s protein-based coronavirus vaccine after more than half a year of talks, the Commission announced today.
EU countries will secure 100 million doses and have the option to purchase another 100 million doses through 2023.
The EU announced it had completed “exploratory talks” with the company back in December 2020, but the deal was held up over issues securing a delivery schedule and establishing the U.S. company’s European supply chain.
The Commission wrote today that the vaccines will be available in the fourth quarter of 2021 and in 2022. Countries can also donate or sell the vaccines to other countries.
The vaccine uses a different technology than the mRNA and viral vector vaccines currently in use. It’s the same technology behind Sanofi’s vaccine — which the EU is slated to buy up to 300 million doses’ worth — but that shot was delayed at the end of 2020.
“Our new agreement with Novavax expands our vaccine portfolio to include one more protein-based vaccine, a platform showing promise in clinical trials,” Health Commissioner Stella Kyriakides wrote in a statement.
The vaccine looks promising. In June, clinical trials showed it’s 90 percent effective in preventing COVID-19 cases — even with variants circulating.
“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,” Commission President Ursula von der Leyen wrote.
The European Medicines Agency is conducting a rolling review of the vaccine, and the company still has to submit a formal marketing application for EU approval.
https://www.politico.eu/article/commission-approves-novavax-coronavirus-vaccine-deal-finally/
Biotech company Novavax has announced it will be initially prioritizing regulatory submissions for its promising COVID-19 vaccine in countries with urgent needs such as India, Indonesia and the Philippines. The long-anticipated vaccine is also being trialed as a third booster in people initially administered other vaccines.
Novavax’s COVID-19 vaccine is what’s known as a protein subunit vaccine. Currently available COVID-19 vaccines are designed to coax cells into producing a part of the SARS-CoV-2 virus which then trigger the immune system to recognize it. Novavax’s candidate is a little different. It directly delivers lab-grown coronavirus spike proteins into the body in the form of nanoparticles created to mimic the structure of the virus.
Early data from an ongoing booster study indicate very effective antibody responses are generated by a third dose against new virus variants such as Delta. While that data is from trials investigating individuals vaccinated solely with Novavax’s candidate, a large mix-and-match booster trial in the United Kingdom is set to deliver valuable insights into the efficacy of different vaccines given as a third dose.
The study is called COV-Boost, and it’s studying immune responses in people given a third dose of a COVID-19 vaccine at least three months after initial vaccination with either Pfizer or AstraZeneca vaccines.
Almost 3,000 subjects have been recruited for the booster study, with each participant randomly administered a booster of one of seven different COVID-19 vaccines. Initial data will evaluate immune biomarkers such as antibody responses, but subjects will be followed for a year, with subsequent infection data collected over the longer follow-up.
https://newatlas.com/health-wellbeing/novavax-coronavirus-vaccine-universal-booster-launch-india-indonesia-philippines/