authorized in France, when and for whom?

authorized in France when and for whom

NUVAXOVID. The High Health Authority gave the green light this Friday to Novavax’s anti-Covid vaccine, Nuvaxovid. For the executive, the Novavax serum crystallizes the hope of pushing the 9.2% still recalcitrant to vaccination.

[Mis à jour le 14 janvier 2022, à 18h51] with his last opinion, released this Friday, the High Authority for Health (HAS) made anti-Covid serum designed by Novavax, named Nuvaxovid, the fifth vaccine authorized in France. His particuliarity ? It does not use messenger RNA technology, used by other vaccines authorized in France. This is why the green light from the health authority was eagerly awaited by the executive, who hopes to convince the last unvaccinated fearing mRNA to change their minds about vaccination. The HAS seems to share the ambition of the government since it specifies in its opinion that Nuvaxovid represents a “useful alternative” for people reluctant to be injected with the Pfizer or Moderna vaccines. Proof of this hope that Nuvaxovid represents: the order, a few days ago, and while the HAS had not yet given its opinion, of 3.2 million doses of its vaccine to Novavax, as well as an option for 3.2 million additional doses raised for the second quarter. Doses which will have to be received by France at the end of January in order to be able to start the first injections with the Novavax vaccine at the beginning of February, as the Ministry of Health wanted.

As a reminder, Nuvaxovid had already become the fifth vaccine authorized in the EU, having been approved by the European Medicines Agency (EMA) on December 20 and by the WHO on December 21. In addition, the Nuvaxovid vaccine says “subunit” uses a different technology from messenger RNA, that of recombinant proteins, and that may be the reason for the ministry’s optimism. The product contains only a small portion of the virus, not the whole virus like Pfizer or Moderna vaccines, which is enough to trigger an immune response. Behind this vaccine therefore hides the hope of the Ministry of Health to convince the non-vaccinated to reconsider their choice.

After the announcement of the green light from the EMA for Covid vaccine of Novavax, the opinion of the High Authority for Health (HAS) was issued on January 14, 2022. Deliveries of the first doses of the Nuvaxovid vaccine are expected at the end of January – the executive has, as a reminder, ordered them a few days ago. The first injections should therefore, at best according to the government, begin at the beginning of next February.

Now that it is authorized, who can be vaccinated with Nuvaxovid? In its opinion, the High Authority for Health details the list of audiences who will be able to use the Novavax vaccine:

  • People not yet vaccinated against Covid-19 and aged 55 and over can be vaccinated with the Nuvaxovid® vaccine from Novavax according to a primary vaccination schedule with two doses spaced three weeks apart;
  • Unvaccinated persons under the age of 55 can be vaccinated with the Nuvaxovid® vaccine from Novavax according to a two-dose vaccination schedule, spaced three weeks apart. Exceptionally, and within the framework of a shared medical decision making it possible to inform people of the risks presented by this vaccine, the use of the Janssen vaccine may be considered in the event of the unavailability of the Nuvaxovid® vaccine from Novavax;
  • People over the age of 18 who have received a single dose of any vaccine, and who refuse or cannot receive a second dose of the same vaccine, can complete their primary vaccination with the Novavax vaccine.

However, the HAS specifies that, “in the absence of MA” in Nuvaxovid, “and because it does not have real-life data to justify its administration, it cannot be used on reminder”.

Nuvaxovid has similar or even superior vaccine efficacy to other currently authorized vaccines. Thus, Novavax had affirmed, last Monday June 14, that its anti-Covid vaccine was, overall, effective at 90.4%, including against the variants, and at 100% against the moderate and severe forms, at the end of a phase 3 clinical trial conducted on 30,000 people in the United States and Mexico.

The EMA specified the conditions and results of the clinical trials in its press release authorizing Novavax’s vaccine in the EU: “The studies involved more than 45,000 people in total. In the first study, approximately two thirds of the participants received the vaccine and the others received an injection of placebo (dummy); in the other study, the participants were evenly split between Nuvaxovid and placebo. People did not know if they had received Nuvaxovid or a placebo”, details the health agency.

And to add: “The first study, conducted in Mexico and the United States, revealed a 90.4% reduction in the number of symptomatic cases of COVID-19 from 7 days after the second dose in people with received Nuvaxovid (14 cases out of 17,312 people) compared to people who received placebo (63 out of 8,140 people).This means that the vaccine had a efficiency of 90.4% in this study. The second study conducted in the UK also showed a similar reduction in the number of symptomatic cases of COVID-19 in people who received Nuvaxovid (10 cases out of 7,020 people) compared to people who received a placebo (96 out of 7,019 people) ; in this study, the efficiency of the vaccine was 89.7%”.

Despite these results, some question the impact of Novavax’s vaccine technology (see below) on the effectiveness of Nuvaxovid. Although the phase 3 clinical trials of the Novavax vaccine were carried out at the time when the original strain of the coronavirus and the Alpha variant were the only forms of Covid-19 in circulation, this is also the case for the vaccines. messenger RNA. These have demonstrated, in recent weeks, their effectiveness against the Omicron variant, which can already reassure on the efficiency of Nuvaxovid. In his communicated of December 20, the EMA insists that the results of the two main clinical trials confirm that the Novavax vaccine is “effective in preventing COVID-19 in people from 18 years of age”.

The Novavax vaccine uses a different technology than those employed by messenger RNA vaccines. Thus, if “the vaccines of Pfizer and Moderna provide genetic instructions which allow the body to manufacture a protein, this famous protein ‘Spike’, advanced which will drive the immune response”, specifies Jean-Michel Dogné, director of the pharmacy department of UNamur and member of the Vaccination Task Force, Nuvaxovid is a so-called “subunit” vaccine. In other words, it relies on proteins to trigger an immune response and does not contain viruses.

This protein subunit technology is already known, being used in particular in vaccines against hepatitis B or against human papillomavirus infections. However, it has been improved in the context of Nuvaxovid: the subunit has been assembled there into nanoparticles and the adjuvant (in a vaccine, the adjuvant is essential to allow an immune response resulting in protection) used is new and has not yet been used in other vaccines.

Although it uses a different technology, Nuvaxovid is to be administered in the same way as messenger RNA vaccines, in two doses approximately 21 days apart. In this regard, the WHO vaccination expert committee recommends the use of Nuvaxovid from the age of 18 and specifies that the doses must be administered “at an interval of between 3 to 4 weeks”. “The vaccine should not be given at an interval of less than 3 weeks,” he adds. In addition, Novavax’s anti-Covid vaccine is easier to store (therefore to distribute) than its competitors: it can be stored between 2°C and 8°C, so it will be easier to store in developing countries, its distribution would therefore, if authorized, be greatly facilitated.

In his communicated, the European regulator specifies that “the adverse effects observed with Nuvaxovid in the studies were generally mild or moderate and disappeared a few days after vaccination. The most common were tenderness or pain at the injection site, fatigue, muscle pain, headache, generally feeling unwell, joint pain and nausea or vomiting.”