by Jan HENNOP
THE HAGUE, Netherlands (AFP) — Pharmaceutical giant Novavax has applied for authorization for their coronavirus vaccine in the EU with a decision possible “within weeks”, Europe’s drugs regulator said Wednesday.
The jab, if approved, would be the fifth authorized for use within the EU — the other four are made by Pfizer/BioNTech, AstraZeneca/Oxford, Moderna and Johnson & Johnson.
The assessment of the vaccine, which goes under the brand name Nuvaxovid, would be carried out “under an accelerated timeline”, the European Medicines Agency said.
An opinion on the marketing authorization could be issued within weeks “if the data submitted are sufficiently robust and complete to show the efficacy, safety and quality of the vaccine”, the medicines watchdog said.
“If EMA concludes that the benefits of Nuvaxovid outweigh its risks in protecting against Covid-19, it will recommend granting a conditional marketing authorization,” it said.
Working differently to other vaccines, Nuvaxovid contains tiny particles made from a version of a protein found on the surface of the coronavirus spike protein, made in a laboratory.
It also contains 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 defenses — antibodies and T cells — against them,” the EMA said.
If a vaccinated person later came into contact with the coronavirus, “the immune system will recognize 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,” the EMA said.
The vaccination regimen calls for two 0.5 milliliter jabs, given intramuscularly 21 days apart, Novavax said in a statement.
Nuvaxovid is stored between 2 – 8 degrees Celsius “enabling the use of existing vaccine supply and cold chain channels,” it added.
Novavax, a company based in the US state of Maryland, says its vaccine has 90 percent efficacy against Covid-19, based on a North American study.
The European Commission said in August it has signed a preliminary deal to buy up to 200 million doses of the Novavax vaccine.
“Today’s announcement from EMA brings Novavax another step closer to our goal of ensuring broad global access to our protein-based Covid-19 vaccine across Europe,” said Novavax chief executive Stanley C. Erck in the statement.
Hard-hit by the pandemic, Indonesia became the first country to approve the Novavax vaccine in the beginning of November, the company said.
On Wednesday, Novavax said it also received approval from the Philippines to use the vaccine under the brand name COVOVAX.
© Agence France-Presse