The EMA endorses the European license of the American vaccine Novavax

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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 European Medicines Agency (EMA) has supported this Monday the use of the American vaccine Novavax for being safe and effective. Thus, it has recommended authorizing its license, becoming the fifth shot to overcome the European scientific filter in this pandemic.

This vaccine is recommended for adults over 18 years oldIt 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 the evaluation of the Novavax vaccine, has endorsed by consensus that the data is “robust and met the criteria of the EU in terms of efficacy, safety and quality “.

When the vaccine studies were carried out, the circulating SARS-CoV-2 variants 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 that involved 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.

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In the second study, which was conducted 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 a vaccine efficacy for Nuvaxovid of around 90%,” says the EMA.

The side effects The most common were “mild or moderate” and disappeared within a couple of days after vaccination, and included injection site tenderness and pain, tiredness, 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’s 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,” the agency adds.



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George Holan

George Holan is chief editor at Plainsmen Post and has articles published in many notable publications in the last decade.

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