Green light for Nuvaxovid. This vaccine from the American biotechnology company Novavax against Covid-19 was authorized on Monday, December 20 by the European Medicines Agency (EMA) and can now be used in the European Union. Last August, 200 million doses of this vaccine had already been ordered by Brussels. Unlike the four other vaccines available in Europe, this product does not use messenger RNA but a more traditional technique, called “protein subunits”. Franceinfo takes stock of this new weapon in the fight against the Covid-19 epidemic.
1How does this vaccine work?
Nuvaxovid is a subunit vaccine, a principle that has been used for decades to combat against whooping cough, meningococcal meningitis and hepatitis B in particular. This involves injecting only the target antigen, by inoculating one or more proteins of the virus synthesized in the laboratory, which will trigger an immune response. This technique is known to be safe because it does not employ the entire virus. She however, requires the addition of adjuvants to elicit a sufficient reaction of the immune system. In the case of Nuvaxovid, this substance called “Matrix M” is a derivative of molecules extracted from Panama wood, which is produced internally by Novavax.
The vaccination schedule is essentially the same as for vaccines already used in Europe. It should be given in two doses, most often injected into the upper arm. These two injections should be spaced three weeks apart. In a press release (in English), the European Medicines Agency specifies that the side effects of this vaccine are “weak or even moderate” and disappear completely after a few days. This new vaccine brings a significant logistical advantage: it does not need to be stored at very cold temperatures, but only between 2 and 8 ° C.
2Is it already in use?
While Novavax has submitted authorization requests in many countries, only Indonesia and the Philippines have so far chosen to offer it to their populations. Nuvaxovid was cleared by the World Health Organization on December 17 for emergency use under the name Covovax. This intermediate validation is just as rigorous, assures the WHO, and allows in particular the rapid distribution of a vaccine abroad.
After having benefited from the funds of the “Warp Speed” operation in the United States, Novavax has so far struggled to convince the American government, which has above all questioned the production capacities of the company. That hasn’t stopped the company from announcing in a recent statement. (in English) that an authorization request would be filed in the United States “before the end of the year 2021”. Similar requests have already been submitted to Canada, the United Kingdom, Japan, South Korea and Australia in particular.
3How effective is it?
According to numerous trials carried out in recent months, this new vaccine is more than 90% effective against all forms of the disease, including those caused by variants of the virus. A rate of protection that rivals those of Pfizer-BioNTech and Moderna vaccines, the most effective currently. In June 2021, at the end of the last phase of its tests, Novavax explained in a press release (in English) that his vaccine showed “100% protection against moderate and severe forms of the disease and 90.4% overall”. These results were observed during a large study carried out on nearly 30,000 people (in English) in a hundred places in the United States and Mexico.
Important clarification: the European Medicines Agency notes that these tests were carried out at a time when the Alpha and Beta strains of Sars-CoV-2, the virus responsible for Covid-19, were in the majority. In other words, the epidemic situation was very different from the one we know at the end of 2021. “Currently, there are limited data regarding the efficacy of Nuvaxovid against variants of concern, including Omicron”, underlines the EMA. This limit is known to Novavax, which ensured what “was evaluating its vaccine against the Omicron variant” and was still working on a specific version to combat this far more contagious variant.
4When will it be available in France?
Authorization from the European Medicines Agency is a necessary condition, but not sufficient. It is now the turn of the High Authority for Health (HAS) to look into this new vaccine, in order to authorize it or not but also to formulate recommendations on its use. – by reserving it for certain populations or an age group, for example. However, HAS intends to take its time to give an opinion on Nuvaxovid, “because the first doses of this vaccine should arrive mid-January at the earliest”, explains a person in charge of the organization to franceinfo.