The European Medicines Agency (EMA) supported this Monday the use of the American vaccine Novavax for being safe and effective, for which he recommended authorizing its license, becoming the fifth vaccine to overcome the European scientific filter in this pandemic.
This vaccine is recommended for adults over 18 years of age, should be given in two doses, 21 days apart, and can be stored, handled and distributed at refrigerator temperature.
The EMA ruling is the first step before the European Commission grants the conditional marketing authorization (CMA), subject to the pharmaceutical company researching, studying and sharing emerging data on the vaccine over the next few years.
The Committee for Human Medicines (CHMP), which met this Monday in a special meeting to conclude its evaluation of the Novavax vaccine, endorsed by consensus that the data is “robust and met EU criteria for efficacy, safety and quality ”.
When the vaccine studies were done, the SARS-CoV-2 variants that circulated were the original, as well as Alpha and Beta, for which the EMA emphasizes that “there is limited data on the efficacy of Nuvaxovid (the commercial name of the vaccine) against other variants, including omicron”.
To reach your conclusion, the CHMP analyzed the results of two clinical trials involving more than 45,000 people in total: in the first one – carried out in Mexico and the United States – there was a 90.4% reduction in the number of symptomatic cases from seven days after the second dose.
In the second study, which was conducted in the United Kingdom, a similar reduction was seen in symptomatic patients who received the vaccine, which placed its efficiency at 89.7%. “Together, the results of the two studies show a vaccine efficacy for Nuvaxovid of around 90%,” says the EMA.
The most common side effects were “mild or moderate” and disappeared a couple of days after vaccination, and included injection site tenderness and pain, fatigue, muscle, headache, and joint pain, malaise, and nausea or vomiting.
This vaccine, also known as NVX-CoV2373, is based on a stabilized form of protein S (Spike) of the virus, for which a recombinant protein nanoparticle technology has been used. The antigens of the purified protein in the vaccine cannot replicate or cause COVID-19.
It is the first protein-based vaccine that the EMA recommends against covid-19 and “will support vaccination campaigns in EU member states during a crucial phase of the pandemic,” adds the agency.
Mario Twitchell is an accomplished author and journalist, known for his insightful and thought-provoking writing on a wide range of topics including general and opinion. He currently works as a writer at 247 news agency, where he has established himself as a respected voice in the industry.
