Covid-19: European regulator authorizes Novavax vaccine


The European Medicines Agency (EMA) gave the green light on Monday for Novavax’s anti-Covid vaccine, using more conventional technology than those used for already authorized vaccines, which could reduce skepticism among the unvaccinated. The American firm’s Nuvaxovid vaccine thus becomes “the fifth vaccine recommended in the EU to prevent Covid-19” in people over 18, the EMA said in a press release.

Nuvaxovid is a so-called “subunit” vaccine, based on proteins that trigger an immune response, without viruses. The technology is similar to that used in the decades-old hepatitis B and pertussis vaccines that are widely used around the world. For company CEO Stanley C. Erck, the vaccine “could help overcome major obstacles to global immunization, including challenges of global distribution and vaccine reluctance.”

Nuvaxovid is given as two injections, usually into the muscle of the upper arm, three weeks apart. The side effects seen with the serum in the studies were generally mild or moderate, and resolved within days of vaccination. The European Commission, which had contracted with Novavax for the advance purchase of 200 million doses of its vaccine, will now speed up the decision-making process to allow this vaccine to be included in vaccination programs deployed across the EU .

Strong data

“After a thorough evaluation, the EMA’s Committee for Medicinal Products for Human Use (CHMP) concluded by consensus that the data on the vaccine were strong and met EU criteria for efficacy, safety and suitability. quality “, underlined the EMA. The main clinical trials – one in Britain and the other in the United States and Mexico – involving more than 45,000 people, have shown between 89 and 90% effectiveness in reducing the number of symptomatic cases of Covid.

The EMA also noted that “the original strain of SARS-CoV-2 and some variants of concern such as Alpha and Beta were the most common viral strains circulating when studies were underway.”

Fuzzy around effectiveness against Omicron

“There are currently limited data on the efficacy of Nuvaxovid against other variants of concern, including Omicron,” the EMA stressed, indicating that “the safety and efficacy of the vaccine will continue to be monitored as and as it is used across the EU “. The American company had for its part recognized that it “was evaluating its vaccine against the Omicron variant” and was still working on a specific version to combat this particularly contagious variant.

Novavax’s vaccine “will support vaccination campaigns in EU member states during a crucial phase of the pandemic,” praised the EMA as warnings mount around the world over the spread of the Omicron variant particularly contagious.



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