Monday, January 24

The EMA recommends Novavax, the fifth vaccine against covid-19 in the EU

The European Medicines Agency (EMA) supported the use of the American Novavax vaccine 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.

Who can get this vaccine?

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 in a special meeting on Monday to conclude its evaluation of the Novavax vaccine, endorsed by consensus that the data is “Robust and met the EU criteria for efficacy, safety and quality”.

The “traditional” vaccine that could convince the undecided

Its manufacturer claims that Nuvaxovid (the brand name for the vaccine) can help governments win over vaccine skeptics. This new vaccine uses a more conventional technology than that used by the other vaccines on the market – messenger RNA (Pfizer / BioNTech and Moderna) or viral vectors (Johnson & Johnson and AstraZeneca) -. Its recombinant protein nanoparticle technology is similar to that applied in vaccines against hepatitis B and pertussis.

It is the first protein-based vaccine that the EMA recommends against covid-19 and “will support vaccination campaigns in the Member States of the European Union (EU) during a crucial phase of the pandemic,” adds the agency.

Does it work against variants?

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 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 a vaccine efficacy for Nuvaxovid of around 90%,” says the EMA.

Side effects

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.

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