NUVAXOVID. If the government is still awaiting the opinion of the High Authority of Health on Novavax’s anti-Covid vaccine, the Ministry of Health has argued that Nuvaxovid should be able to start being injected at the beginning of February.
[Mis à jour le 7 janvier 2022 à 16h31] Nuvaxovid soon in syringes? This is what the government hopes, already planning the first injections with the anti-Covid vaccine from Novavax for early February. However, the executive will have to wait for the opinion of the High Authority for Health (HAS) on the Novavax serum, whose voice will determine the adoption, or not, of this fifth vaccine in France. A wait that could be short since, according to the Ministry of Health, this opinion is expected “in the days to come”. As a reminder, Nuvaxovid has already become the fifth vaccine authorized in the EU, after being approved by the European Medicines Agency (EMA) on December 20 and by the WHO on December 21. , the executive has already announced that it has ordered 3.2 million doses of its vaccine from Novavax, as well as an option for 3.2 million additional doses for the second quarter. If deliveries are expected “at the end of January”, “signals indicate that there could be delays”, also indicated the Ministry of Health.
As a reminder, the so-called “subunit” Nuvaxovid vaccine uses a technology different from messenger RNA, that of recombinant proteins, and this is perhaps the reason for the optimism of the ministry. The product contains only a small part 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 unvaccinated to reconsider their choice.
After the announcement of the green light from the EMA of the anti-Covid vaccine from Novavax, the opinion of the High Authority for Health (HAS) is expected in January according to a source from the Ministry of Health interviewed by South West. The deliveries of the first doses of the Nuvaxovid vaccine are also expected at the end of January, according to the same source who hopes to see injections of the vaccine begin in February.
It is therefore now up to the European Commission and then the Member States to approve or not, on a case-by-case basis, the vaccine on their territory. The EMA thus clarified that “the European Commission will now accelerate the decision-making process to grant a decision on the conditional marketing authorization of Nuvaxovid, allowing this vaccine to be included in the vaccination programs deployed in any the EU “. As a reminder, Novavax has already seen the 1er last November, its vaccine was authorized for the first time by Indonesia. It is now produced there by the Serum Institute of India (SII).
Nuvaxovid has similar or even better vaccine efficacy than other currently authorized vaccines. Thus, Novavax had affirmed, last Monday, June 14, that its anti-Covid vaccine was, overall, 90.4% effective, including against variants, and 100% against moderate and severe forms, at the end of ‘a phase 3 clinical trial involving 30,000 people in the United States and Mexico.
The EMA clarified the conditions and results of the clinical trials in its press release authorizing the Novavax vaccine in the EU: “The studies involved more than 45,000 people in total. In the first study, around two-thirds of the participants had received the vaccine and the others were given a (dummy) placebo injection; in the other study, participants were evenly split between Nuvaxovid and the placebo. People did not know whether they had received Nuvaxovid or a placebo, “explains the health agency.
He added: “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 with received Nuvaxovid (14 cases out of 17,312 people) compared to people who received placebo (63 out of 8,140 people). efficiency of 90.4% in this study. The second UK study also showed a similar reduction in the number of symptomatic cases of COVID-19 in people who received Nuvaxovid (10 in 7,020 people) compared to people given placebo (96 in 7,019 people) ; in this study, the efficiency of the vaccine was 89.7% “.
Despite these results, some wonder about the impact of the technology (see below) of the Novavax vaccine on the effectiveness of Nuvaxovid. Although phase 3 clinical trials of the Novavax vaccine were carried out during 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 vaccines with Messenger RNA. These have demonstrated, in recent weeks, their effectiveness against the Omicron variant, which can already be reassuring about the effectiveness of Nuvaxovid. In his communicated of December 20, the EMA hammers as well as the results of the two main clinical trials confirm that the vaccine of Novavax is “effective in preventing COVID-19 in people from the age of 18”.
The Novavax vaccine uses a different technology than that used 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 ‘Spike’ protein, of advanced which will induce the immune response”, specifies Jean-Michel Dogné, director of the pharmacy department from 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 within the framework of Nuvaxovid: the subunit there has been assembled into nanoparticles and the adjuvant (in a vaccine, the adjuvant is essential to allow an immune response leading to protection) used is new and has not yet been used in other vaccines.
Although it uses a different technology, Nuvaxovid is administered in the same way as messenger RNA vaccines, in two doses approximately 21 days apart. In this regard, the WHO expert committee on vaccination recommends the use of Nuvaxovid from the age of 18 and specifies that the doses should be administered “at an interval of 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 (and 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. would therefore, if it were authorized, be greatly facilitated.
In his communicated, the European regulator specifies that “the side effects observed with Nuvaxovid in the studies were generally mild or moderate and disappeared a few days after the 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. “