Europe authorizes a new vaccine against the coronavirus on its market: here is Novavax, vaccine validated this Monday by the European Medicines Agency.
This vaccine works by protein, far from messenger RNA at Pfizer and Moderna, and could therefore convince some skeptics.
Is Novavax going to be a game-changer for us in Europe?
The European Union has just authorized the marketing of five vaccines against the coronavirus.
The fifth, the Novavax vaccine, received this Monday the approval of the European Medicines Agency (EMA) while the European Commission has already pre-ordered 200 million doses.
If this American vaccine is seen as a potential solution for messenger RNA recalcitrant, its effectiveness against Omicron and the lack of doses raise some questions.
Where does Novavax come from and what are the results of its clinical trials?
Novavax is an American pharmaceutical company specializing in vaccines. In 2020, she begins research for a vaccine against the coronavirus: NVX-CoV2373. A vaccine called Nuvaxovid in Europe and Covovax in southern countries. For the sake of simplicity, it is also nicknamed the Novavax vaccine, after its company name. It is done in two doses, three weeks apart.
In June, Novavax presented the excellent results of its vaccine in phase III clinical trials, including "100% protection against moderate and severe forms of the disease and 90.4% overall", out of 30,000 Americans and Mexicans tested .
The American pharmaceutical company has requested a conditional European marketing authorization that the EMA is studying from November 17, and therefore valid this Monday.
The European Commission, which has already pre-ordered 200 million doses, has also just given the green light for the use in the EU of the American vaccine.
Only the approval of the High Authority for Health in France (HAS) is therefore still awaited.
Nuvaxovid is already authorized in the Philippines and Indonesia.
Japan has also pre-ordered 150 million doses.
And compared to Omicron, what does Novavax give?
That's the whole point, and one of the main reservations about the vaccine. Phase III clinical trials were carried out in early 2021, at a time when only the original strain of the virus and the Alpha variant were actively circulating in the world. We therefore do not know the effectiveness of this vaccine on the Delta variant, now the majority in Europe, and on the Omicron variant, which should become dominant on the old continent within a few weeks. However, "it was also the case for messenger RNA vaccines," recalls Eric Billy, and these have since been effective against Delta and Omicron [with three doses] to prevent serious forms. The Novavax vaccine is already looking at a third booster dose.
"There are currently limited data on the effectiveness of Nuvaxovid against other variants of concern, including Omicron", for its part indicated the EMA on Monday, ensuring that "the safety and effectiveness of the vaccine will continue to d 'be monitored as it is used across the EU'.
How is Novavax different from other vaccines on the market?
Europe, like France, has ordered enough doses of the four previous vaccines already authorized - AstraZeneca, Jansen, Moderna and Pfizer - to triple immunize its entire population. However, AstraZeneca has sometimes presented unwanted effects. It would also be the cause of several deaths from thrombosis, which explains why the vaccine is largely shunned. As for Jansen, he has never met the expected success - and is less effective than expected in a single dose. Pfizer and Moderna fail to convince all those eligible for vaccines. In France, 9.1% of them are still not vaccinated. Part of the percentage can be explained by skepticism and even fear towards the “new technology” of messenger RNA.And Pfizer and Moderna are using this innovative technology that injects strands of genetic instructions into the body that tell the patient's cells what to make to fight the disease.
However, Novavax does not use messenger RNA technology but recombinant proteins.
The immune response is triggered not by a weakened viral agent, but by proteins that mimic the "spike" protein [vaccine receptor protein type] of the coronavirus.
“It is still based on a new technology, it is a vaccine with proteins in nanoparticles.
The proteins are distributed on a particle that is mimicked on nanospheres, ”explains Eric Billy.
This so-called "subunit" vaccine technology has important similarities with vaccines against hepatitis B or pertussis.
Will Novavax soon be distributed in France?
For Stanley Erck, CEO of Novavax quoted by AFP, the vaccine "could help overcome the main obstacles to global vaccination, including challenges of global distribution and reluctance to vaccination."
As for the President of the Commission, she welcomed this Monday "a welcome addition to the arsenal to protect Europeans".
"May it be a solid encouragement for the unvaccinated or those who haven't been recalled!"
», Continued Ursula von der Leyen.
So will this vaccine make it possible to reach 100% of eligible people vaccinated in France?
A last problem arises and not the least: the data are good but the doses are sorely lacking.
Our file on the anti-Covid vaccine
"Novavax is facing very big industrial production difficulties, which gives little hope for a rapid arrival of doses in Europe," notes Eric Billy.
Increasing production by a factor of 100 is already a problem for Novavax.
"For lack of sufficient doses and" difficulties in the supply of certain raw materials linked to the pandemic context ", part of the phase III study would have been suspended at the end of December 2020, already explained Reuters last March.
This is without taking into account that one of Novavax's production sites located in the Czech Republic would not have "insufficient production capacity to meet the needs of the Twenty-Seven".
Between wanting and being able, there is a step and the Novavax miracle will wait.
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