The European Medicines Agency (EMA) supported on Monday the use of the American vaccine Novavax for being safe and effective, for which it 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, must be administered 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 an extraordinary meeting to conclude its evaluation of the vaccine for Novavax, endorsed by consensus that the data are “robust and met EU criteria for efficacy, safety and quality.”
When the vaccine studies were carried out, the circulating variants of SARS-CoV-2 were the original, as well as Alpha and Beta, so the EMA emphasizes that “there is limited data on the efficacy of Nuvaxovid (trade name of the vaccine) against other variants, including omicron ”.
To reach its conclusion, the CHMP analyzed the results of two clinical trials involving more than 45,000 people in total: in the first – conducted in Mexico and the United States – there was a 90.4% reduction in the number of symptomatic cases since seven days after the second dose.
In the second study, which was carried out in the United Kingdom, a similar reduction was observed in symptomatic patients who received the vaccine, putting its efficacy at 89.7%. “Together, the results of the two studies show an efficacy of the vaccine for Nuvaxovid of around 90%”, says the EMA.
The most common side effects were “mild or moderate” and disappeared within a couple of days after vaccination, and included injection site tenderness and pain, tiredness, joint, headache and muscle 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 the COVID-19.
It is the first protein-based vaccine that the EMA recommends against the COVID-19 and “will support vaccination campaigns in EU member states during a crucial phase of the pandemic,” the agency adds.