validated by HAS in France for the reluctant

The Novavax vaccine (Nuvaxovid) received the green light from the High Authority for Health on January 14 for people reluctant to RNA vaccines (Pfizer, Moderna) or who have a contraindication. Novavax’s Nuvaxovid vaccine using a different technology. This vaccine can be used as a first vaccination only.

[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 off favorable administration of Novavax Nuvaxovid vaccine. HAS always recommends give preference to mRNA vaccines for primary vaccination and for booster from Pfizer and Moderna: “They are very efficient, their immunogenicity (the immune response against the virus) is better than that of the booster adenovirus vaccines and the decline in their use is significant “ she explains in her communicated January 14. “Most, when people do not wish or cannot receive this type of vaccine, the 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 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 for 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 which uses the Spike protein of SARS-CoV-2 in combination 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 discomforts (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. “The efficacy against the transmission of Sars-Cov-2 and the efficacy against the Delta variants and Omicron (which emerged after the end of clinical trials follow-up) remain to be confirmed.” For the vaccination of pregnant women, Pending further data with Nuvaxovid®, the HAS maintains its recommendation to use mRNA vaccines (Comirnaty® or Spikevax®). What’s this the Novavax vaccine? How it workshe?

Origin: what country does it come from?

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

What is the name of this vaccine?

The US vaccine for 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 allows it to reproduce its natural presentation. To this is added an adjuvant, Matrix-M – a derivative of saponin from 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. Protein S, the peak protein of the SARS-CoV-2 virus which binds the cells of the body , used by the Novavax vaccine is produced in insect cells. It can neither duplicate itself nor 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 “subunit”, made with the S protein of the virus which triggers an immune response without virus. According to the Inserm definition, “subunit vaccines contain purified microbe fragments, necessary and sufficient to train 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 low (weakly immunogenic vaccines). They therefore require several injections and boosters for long-term immunization, as well as” addition of adjuvants to improve the induced immune response. “ Hence the” addition 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 on 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 it from entering body cells, and destroy infected cells.

When in France?

The High Authority of Health showed favorable to 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) a valid the marketing authorization for Novavax’s anti-covid vaccine called Nuvaxovid, December 20, 2021. This vaccine based on recombinant protein nanoparticles was under study since February 3.

How many doses?

Nuvaxovid is administered in two injections, 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 highlight a almost 90% efficiency against symptomatic forms of Covid-19 by almost 100% against severe forms. “The efficacy against the transmission of Sars-Cov-2 and the efficacy against the Delta variants and Omicron (which emerged after the end of clinical trials follow-up) remain to be confirmed. “” The results of two main clinical trials revealed that Nuvaxovid was effective in preventing Covid-19 in people aged 18 and over“, 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 an injection of placebo; in the other study, participants were evenly split between Nuvaxovid and placebo. People did not know whether they had received Nuvaxovid or a placebo. The first study, conducted in Mexico and the United States, found a 90.4% reduction in the number of symptomatic cases of Covid-19 from 7 days after the second dose in people who have received Nuvaxovid. The second study conducted in the UK showed an effectiveness of 89.7%. The original strain SARS-CoV-2 and some variants of concern such as Alpha and Beta were the most common viral strains circulating when studies were underway. “There are currently limited data on the effectiveness of Nuvaxovid against other variants of concern, including Omicron specifies the EMA.

What side effects?

The side effects seen with Nuvaxovid in studies were generally mild or moderate and were disappeared a few days after vaccination. According to HAS, the most common were : sensitivity (69%) and pain (58%) at the injection site, fatigue (47%), headache (43%) and discomforts (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, through the EU pharmacovigilance system and additional studies by society and European authorities ” EMA clarified in its December 20 press release.

This vaccine can be stored in the refrigerator at 2 ° C to 8 ° C, protected from light, for up to 6 months. After first opening, the multidose vial can be stored for up to 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 authorisation 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. 14 juin 2021

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

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

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

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