COVID-19

Novavax vaccine: finally authorized, when and for whom?

NUVAXOVID. Authorized by the HAS on January 14, the Novavax vaccine will be used from February. The executive like the doctors are betting on this fifth serum to push the 9.2% of the French who are still recalcitrant to vaccination.

Summary

[Mis à jour le 17 janvier 2022, à 16h11] The Novavax vaccine is finally authorized in France and scientists and politicians pin their hopes on it. The High Health Authority gave the green light to the use of the Nuvaxovid serum from the Novavax laboratory last Friday, January 14, and specified in its opinion that this vaccine is a “useful alternative” for people reluctant to inject themselves with Pfizer or Moderna products. The fifth vaccine authorized in France uses a different technology, that of recombinant proteins. This process allows an immune response to be triggered by injecting a small part of the virus and not the whole virus as occurs with mRNA. The argument is already enough for some unvaccinated to lean towards vaccination and for the most recalcitrant, doctors multiply the speeches to convince. The professor of public health at Lille University Hospital, Philippe Amouyel, explained in particular at LCI that Novavax’s technology is “much more classic” and has proven its effectiveness with vaccines used against “whooping cough or hepatitis B”, among other. And the doctor added: “Many people put things off, they want a French vaccine, not messenger RNA but still effective…Novavax could meet certain criteria.”

The government is betting heavily on this new vaccine. The proof of this hope that the Novavax serum represents is the order for 3.2 million doses made by the executive even before the HAS has issued its opinion. An order that is accompanied by an option for the delivery of an additional 3.2 million doses for the second quarter. France should receive these doses at the end of January in order to start the first injections with the Novavax vaccine in early February, as the Ministry of Health wanted. As a reminder, Nuvaxovid had already become the fifth authorized vaccine in the EU, after being approved by the European Medicines Agency (EMA) on December 20 and by the WHO on December 21.

Following the green light announcement from the EMA for the Novavax anti-Covid vaccine, the opinion of the High Health Authority (HAS) was issued on January 14, 2022. Deliveries of the first doses of the Nuvaxovid vaccine – the executive, as a reminder, I ordered them a few days ago. Therefore, the first injections should, in the best case according to the government, start at the beginning of next February.

Now that it is licensed, who can get vaccinated with Nuvaxovid? In its opinion, the High Health Authority details the list of audiences that may use the Novavax vaccine:

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

However, the HAS specifies that, “in the absence of MA” in Nuvaxovid, “and because it has no real-life data to justify its administration, it cannot be used as a reminder.”

Nuvaxovid has similar or even higher vaccine efficacy than other currently licensed vaccines. Thus, Novavax had stated, last Monday, June 14, that its anti-Covid vaccine was, as a whole, 90.4% effective, even against variants, and 100% against 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 the Novavax vaccine in the EU: “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 (dummy) 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, “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 who received Nuvaxovid (14 cases of 17,312 people) compared with people who received placebo (63 of 8140 people). This means that the vaccine was 90.4% effective in this study. The second UK study also showed a similar reduction in the number of symptomatic COVID-19 cases. 19 in people who received Nuvaxovid (10 cases out of 7,020 people) compared with people who received a placebo (96 out of 7,019 people); in this study, the efficacy 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. While Phase 3 clinical trials of the Novavax vaccine were conducted at a 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 Novavax vaccines. messenger RNA. These have shown, in recent weeks, their efficacy against the Omicron variant, which can already reassure about the efficacy of Nuvaxovid. In its press release dated 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 aged 18 years and over”.

The Novavax vaccine uses a different technology than those used by messenger RNA vaccines. Thus, if “the Pfizer and Moderna vaccines provide genetic instructions that allow the body to manufacture a protein, this famous ‘Spike’ protein, advanced, which will boost the immune response”, specifies Jean-Michel Dogné, director of the UNamur pharmacy department and a member of the Vaccine Working Group, Nuvaxovid is a so-called “subunit” vaccine. In other words, it is protein-based to trigger an immune response and contains no viruses.

This technology of protein subunits 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 must be given in the same way as messenger RNA vaccines, in two doses about 21 days apart. In this sense, the WHO vaccination expert committee recommends the use of Nuvaxovid from the age of 18 and specifies that the doses should be administered “with an interval of between 3 to 4 weeks”. “The vaccine should not be administered with 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. , so its distribution would, if authorized, be greatly facilitated.

In its press release, 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 injection site tenderness or pain, fatigue, muscle aches, headaches, malaise, joint pain, and nausea or vomiting.”

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