Novavax vaccine: validated by the HAS in France for the reluctant

[Mise à jour le 14 janvier 2022 à 18h22] After the green light from the European Medicines Agency (EMA) in December, it is the turn of the High Authority of Health to show up favorable to the administration of the Nuvaxovid vaccine from Novavax. HAS always recommends give preference to mRNA vaccines for primary and booster vaccination from Pfizer and Moderna: “They are very efficient, their immunogenicity (the immune response against the virus) is better than that of booster adenovirus vaccines and the decline in their use is significant” she explains in her communicated of January 14. “Corn, when people do not wish or cannot receive this type of vaccine, HAS considers that the Nuvaxovid vaccine from Novavax represents an additional option.” Concretely, the people not yet vaccinated against Covid-19 can be vaccinated with the vaccine of Novavax according to a primary vaccination schedule two doses spaced three weeks apart. Moreover, the people over 18 who have received a single dose of any vaccine, and who refuse or cannot receive a second dose of the same vaccine, may complete their primary vaccination with the Novavax vaccine. HAS considers that in the absence of Marketing Authorization in this indication and because it does not have no real life data making it possible to justify its administration, this cannot be used as a reminder. The Novavax vaccine is a recombinant protein vaccine that uses the Spike protein of SARS-CoV-2 combined with an adjuvant. These two components will promote the immune response of B and T lymphocytes against the Spike protein, and stimulate the production of neutralizing antibodies. most common side effects are usually “of mild to moderate severity and of short duration” : sensitivity (69%) and pain (58%) at the injection site, fatigue (47%), headache (43%) and discomfort (37%). Their frequency is higher in adults under 65 years of age. Side efficiency, the HAS indicates that the data from the various studies highlight a almost 90% efficiency against symptomatic forms of Covid-19 by almost 100% against severe forms. “Efficacy against Sars-Cov-2 transmission and efficacy against Delta and Omicron (which emerged after the end of clinical trial follow-up) remain to be confirmed.” For the vaccination of pregnant women, pending additional data with Nuvaxovid®, HAS maintains its recommendation to use mRNA vaccines (Comirnaty® or Spikevax®). What’s this the Novavax vaccine? How it worksdoes he?

Origin: what country does he come from?

Nuvaxovid is the Novavax candidate vaccine against Covid-19, a biotech company american. The development of the vaccine was carried out with the financial support of the CEPI, (Coalition for Epidemic Prepardness Innovations) already involved in the development of the Moderna and AstraZeneca vaccines.

What is the name of this vaccine?

The American vaccine from Novavax is called Nuvaxovid.

What is its composition?

The Novavax vaccine “consists of the Spike (S) protein of Sars-Cov-2, inserted into a lipid nanoparticle which reproduces its natural presentation. To this is added an adjuvant, Matrix-M – a derivative of saponin from the wood of panama – which allows stimulate the immune response”, explained Prof. Mathieu Molimard, head of the medical pharmacology department at the Bordeaux University Hospital, contacted by the Journal des Femmes in August 2021. , used by the Novavax vaccine is produced in insect cells. It cannot duplicate itself or cause Covid-19.

Principle: is it an RNA vaccine?

The Novavax vaccine does not rely on so-called messenger RNA technology, such as that used by vaccines from Pfizer/BioNTech and Moderna. It is a vaccine based on the principle of recombinant proteins or “sub-unit”, made with the S protein of the virus which triggers a virus-free immune response. According to the Inserm definition, “subunit vaccines contain purified microbe fragments, necessary and sufficient to teach the immune system to recognize the whole germ. This is the case with vaccines against pneumococcus, meningococcus or whooping cough (…) Subunit vaccines do not present no infectious risks and are better tolerated than inactivated vaccines. But their ability to induce an immune response may be weak (poorly immunogenic vaccines). They therefore require several injections and boosters for long-term immunization, as well as theaddition of adjuvants enhancing the induced immune response.” Hence theaddition of Matrix-M adjuvant, developed by Novavax, which triggers the immune response and stimulates neutralizing antibodies.

→ When a person receives the vaccine, its immune system identifies protein particles as foreign and produces natural defenses – antibodies and T cells – against them. If later the vaccinated person comes into contact with Sars-CoV-2, the immune system will recognize the spike protein about the virus and will be ready to attack it. Antibodies and immune cells can protect against Covid-19 by working together to kill the virus, prevent its entry into body cells and destroy infected cells.

When in France?

The High Authority of Health showed up in favor of the administration of the Nuvaxovid vaccine from Novavax on January 14, 2022 as a primary vaccination. This is the 4th vaccine against Covid authorized in France. The European Medicines Agency (EMA) at valid marketing authorization for Novavax’s anti-covid vaccine called Nuvaxovid, December 20, 2021. This vaccine based on recombinant protein nanoparticles had been under investigation since February 3.

How many doses?

Nuvaxovid is administered in two shots, usually in the muscle of the upper arm, 3 weeks apart.

How effective against the coronavirus?

The HAS indicated on January 14 that the data from the various studies show a almost 90% efficiency against symptomatic forms of Covid-19 by almost 100% against severe forms. “Efficacy against Sars-Cov-2 transmission and efficacy against Delta and Omicron (which emerged after the end of clinical trial follow-up) remain to be confirmed.” “Results of two main clinical trials revealed that Nuvaxovid was effective in preventing Covid-19 in people over the age of 18“, confirmed the EMA in December 2021. The studies involved more than 45,000 people in total. In the first study, about two-thirds of the participants received the vaccine and the rest received a placebo injection; in the other study, participants were evenly split between Nuvaxovid and placebo. People did not know if they had received Nuvaxovid or a placebo. The first study, conducted in Mexico and the United States, revealed a 90.4% reduction in the number of symptomatic cases of Covid-19 starting 7 days after the second dose in people who received Nuvaxovid. The second study conducted in the UK showed an effectiveness of 89.7%. The original strain of SARS-CoV-2 and some variants of concern such as Alpha and Beta were the most common viral strains circulating when the studies were in progress. “There are currently limited data on the efficacy of Nuvaxovid against other variants of concern, including Omicron“ specifies the EMA.

What side effects?

The side effects observed with Nuvaxovid in the studies were generally mild to moderate and disappeared for a few days after vaccination. According to the HAS, the most common were : sensitivity (69%) and pain (58%) at the injection site, fatigue (47%), headache (43%) and discomfort (37%). Their frequency is higher in adults under 65. “Lsafety and efficacy of the vaccine will continue to be monitored as it is used across the EU, via the EU pharmacovigilance system and further studies by the company and European authorities” specified the EMA in its press release of December 20.

This vaccine can be stored in the refrigerator between 2°C and 8°C, protected from light, for up to 6 months. After first opening, the multidose vial can be stored for a maximum of 6 hours at room temperature (up to 25°C).

Sources:

• Covid-19: two new alternatives to mRNA vaccines. HAS. January 14, 2022

• EMA recommends Nuvaxovid for authorization in the EU. 20/12/2021

• Novavax COVID-19 Vaccine Demonstrates 90% Overall Efficacy and 100% Protection Against Moderate and Severe Disease in PREVENT-19 Phase 3 Trial. June 14, 2021

• Novavax Initiates COVID-19 Vaccine Clinical Trial Crossover. April 5, 2021.

• Novavax Confirms High Levels of Efficacy Against Original and Variant COVID-19 Strains in United Kingdom and South Africa Trials. March 11, 2021.

Thanks to Pr. Mathieu Molimard, head of the medical pharmacology department at the Bordeaux University Hospital, contacted in August 2021..