Novavax vaccine: validated by the EMA, when in France?

[Mise à jour le 20 décembre 2021 à 15h25] The European Medicines Agency (EMA) valid the marketing authorization for Novavax’s anti-covid vaccine called Nuvaxovid, December 20. This vaccine contains a version of a protein found on the surface of SARS-CoV-2 (the spike protein), which was produced in the laboratory. It also contains a “adjuvant” a substance that helps strengthen immune responses to the vaccine. It was under study by the EMA since February 3. “The results of two main clinical trials showed that Nuvaxovid was effective in preventing Covid-19 in people aged 18 and over“, confirms the EMA. 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 the studies were in progress. “There are currently limited data on the effectiveness of Nuvaxovid against other variants of concern, including Omicron“ specifies the EMA. The side effects seen with Nuvaxovid in studies were generally mild or moderate and were disappeared a few days after vaccination. The most common were tenderness or pain at the injection site of the tired, from muscle aches, from headache, generally feeling unwell, joint pain, and nausea or vomiting. “Lsafety and efficacy of the vaccine will continue to be monitored as it is used across the EU, through the EU pharmacovigilance system and further studies by society and European authorities. ” The European Commission will now speed up the decision-making process to grant a decision on theconditional marketing authorization of Nuvaxovid, allowing this vaccine to be included in vaccination programs across the EU. The HAS will then have to give the green light for vaccine to be authorized in France. If so, it would be the 5th vaccine against the coronavirus to be administered in the country. What’s this the Novavax vaccine? How it workshe? When in France?

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 European Medicines Agency (EMA) 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. The High Authority of Health (HAS) must now give the green light for the vaccine to be authorized in France. If so, it would be the 5th vaccine against the coronavirus to be administered in the country. On August 4, 2021, the European Commission approved a advance purchase contract with Novavax to guarantee access to a potential vaccine against COVID-19 in the 4th quarter of 2021 and in 2022. “Under this contract, member states will be able to purchase up to 100 million doses of the Novavax vaccine, with an option for an additional 100 million doses, in 2021, 2022 and 2023, once the vaccine has been reviewed and approved by the EMA as safe and effective. Member states will also have the option of donating vaccines to low- and middle-income countries or redirecting them to other European countries “ specifies the press release.

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 results of two main clinical trials showed that Nuvaxovid was effective in preventing Covid-19 in people aged 18 and over“, confirms the EMA. 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. The most common were tenderness or pain at the injection site of the tired, from muscle aches, from headache, generally feeling unwell, joint pain, and nausea or vomiting. “Lsafety and efficacy of the vaccine will continue to be monitored as it is used across the EU, through the EU pharmacovigilance system and further studies by society and European authorities ” EMA specified in its December 20 press release.

Novavax vaccine can be stored between 2 degrees and 8 degrees and is administered in two doses 21 days apart. It is packaged in liquid form in 10 dose vials.

Sources:

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

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