Europe will soon have another weapon in its arsenal against the highly contagious Omicron variant after speeding through the approval of a new COVID-19 vaccine.
Barely two hours after the European Medicines Agency recommended on Monday that the EU grant conditional approval for the use of Nuvaxovid, a protein-based vaccine developed by Novavax, in people over 18 years of age, the European Commission announced it had given conditional marketing authorization (CMA) to the jab. This makes it the fifth vaccine approved for use in the euro zone.
“At a time where the Omicron variant is rapidly spreading, and where we need to step up vaccination and the administration of boosters, I am particularly pleased with today’s authorisation of the Novavax vaccine,” EU Commission President Ursula von der Leyen said in a statement.
Even still, shares tumbled in volatile trade. At noon E.T., shares in the Nasdaq-listed company fell 2.3%.
The urgency shown by the European Union’s executive council reflects the worrisome situation the bloc faces with Omicron’s spread. Equity markets started Monday firmly in the red, as investors worried about the specter of strict lockdowns and pandemic restrictions being reimposed across various European countries to ward off the new, highly contagious variant. Germany meanwhile has warned it is running out of doses, prompting the EU to trigger an option to order another 180 million from BioNTech and Pfizer.
There’s been growing buzz that a protein-based vaccine like the kind Novavax has developed will do a better job of winning over the vaccine hesitant, a problematically large group in central and eastern Europe. Moreover, protein-based vaccines have a safety track record that goes back decades.
A vaccine for the hesitant is a stance the company itself has been pushing in recent weeks.
“In the US, the primary market I think in 2022 is going to be to supply a vaccine, our normal two-dose regimen, to a lot of people who have been hesitant to get other vaccines,” Novavax chief executive Stanley Erck said in November.
Only approved vaccines are counted towards an individual’s vaccination status in the bloc, which confers certain rights in terms of freedom of movement over those that have not been inoculated against the virus.
“May this authorisation offer a strong encouragement to everyone who has not yet been vaccinated or boosted, that now is the time to do so,” von der Leyen said.
Delta and Omicron?
Requiring two doses administered three weeks apart, Nuvaxovid contains tiny particles made from a laboratory-grown version of the spike protein found on the surface of the COVID-19 virus.
When a person receives the vaccine, their immune system identifies the protein as foreign and produces natural defenses. Should the individual then come into contact with the actual virus, their immune system will recognize its spike protein and attack it.
Two trials involving more than 45,000 people in the U.S., Mexico and the U,K, had shown efficacy of around 90% with only mild or moderate side effects, although the studies were largely conducted prior to the outbreak of the Delta strain.
“There is currently limited data on the efficacy of Nuvaxovid against other variants of concern, including Omicron,” the EMA said.
Novavax and the European Commission agreed in August on an advance purchase agreement for up to 200 million doses of the vaccine through 2023.
Other EU-approved vaccines include the two mRNA-based vaccines from Moderna and BioNTech, the latter including its partner Pfizer, as well as the virus-vector vaccines from AstraZeneca and Johnson & Johnson.
EU member states ordered around 27 million doses of Nuvaxovid for delivery in the first quarter of next year. This will add to the total of 2.4 billion dose of the BioNTech-Pfizer vaccine, 460 million doses of the vaccine by Moderna, 400 million by AstraZeneca as well as 400 million doses by Johnson & Johnson.
Despite being approved for use, this is not the end of the regulatory obligations for Novavax. Pharma companies must still provide further data from ongoing or new studies within pre-defined deadlines to confirm that the benefits continue to outweigh the risks.
The U.S. biotech firm aims to deliver all the documentation for FDA approval by the end of the year.
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