Green light for Novavax covid-19 vaccine in Europe

The European Medicines Agency (EMA) on Monday supported the use of the Novavax vaccine because it is safe and effective. The institution recommends authorizing its license, becoming the fifth shot to overcome the European scientific filter in this pandemic.

It is recommended for people over 18 years old, must be administered in two doses With 21 days apart and can be stored, handled and distributed at refrigerator temperature.

It is recommended for people 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 decision is the first step before the European Commission grants the conditional marketing authorization (CMA), subject to research, study and sharing of emerging data on the vaccine by the pharmaceutical company in the coming years.

The Committee for Medicinal Products for Human Use (CHMP), which met this Monday at an extraordinary meeting to complete its evaluation of the Novavax vaccine, endorsed by consensus that the data is “robust and meets EU criteria for effectiveness, safety and quality”.

When the vaccine studies were performed, the circulating variants of SARS-CoV-2 were the original ones, as were alpha and beta, so the EMA emphasizes that “data on efficacy are limited. Nuvaxovid (brand name of the vaccine) against other variants, including omicron”.

To reach its conclusion, the CHMP analyzed the results of the two clinical trials which involved more than 45,000 people in total. In the first, carried out in Mexico and the United States, there was a reduction of 90.4% in the number of symptomatic cases from seven days after the second dose.

In the second study, carried out in the United Kingdom, a similar reduction was observed in symptomatic patients who received the vaccine, with its efficacy being 89.7%. “Together, the results of the two studies show a vaccine efficacy for Nuvaxovid around 90%,” says the EMA.

Nanoparticle Technology

The most common side effects were “mild or moderate” and disappeared a few days after vaccination and included injection site tenderness and pain, tiredness, joints, headache and muscle pain, malaise and nausea or vomiting.

This vaccine, also known as NVX-CoV2373, is based on a stabilized form of the protein S (Thorn, in English) of the virus, for which a nanoparticle technology of recombinant protein. The purified protein antigens 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.

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