The green light of the Ema al vaccino Novavax, the fifth against the coronavirus authorized in Europe. The European drug agency has given the green light for the vaccine to be placed on the EU conditional market Nuvaxovid (NVX-CoV2373), produced by Novavax, an American pharmaceutical company. The green light was decided by the CHMP, the EMA Technical Committee for Medicinal Products for Human Use after an extraordinary meeting.
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The CHMP recommended granting a conditional marketing authorization for the product from 18 years of age. Nuvaxovid, based on proteins, is the fifth vaccine recommended in the EU to prevent Covid-19 after those of Pfizer, Moderna, AstraZeneca e Johnson&Johnson. After careful evaluation, the EMA CHMP concluded that the vaccine data were robust and met the EU criteria for efficacy, safety and quality.
The two clinical trials of the Novavax vaccine
The results of two main clinical studies reviewed by CHMP experts show that Nuvaxovid has been shown to be effective in preventing Covid-19 in people over 18 years of age. The trials involved a total of over 45,000 people. In the first study, about two thirds of the participants received the vaccine and the rest were given a placebo injection; in the other, the participants were equally divided between Nuvaxovid and placebo. The first study, conducted in Mexico and the United States, found one 90.4% reduction in the number of symptomatic cases of Covid-19 7 days after the second dose in people who received Nuvaxovid (14 cases out of 17,312 people) versus those who received placebo (63 out of 8,140). This means, the Ema points out in a note, that the vaccine was 90.4% effective in this study.
Even the second study conducted in the UK showed a similar reduction in the number of symptomatic cases of Covid-19 in people who received Nuvaxovid (10 cases out of 7,020 people) compared to the group that received placebo (96 out of 7,019), with an efficacy of 89, 7%. Taken together, therefore, the results of the two studies show an efficacy of Nuvaxovid vaccine by approximately 90%. The original Sars-CoV-2 strain and some disturbing variants such as Alpha and Beta were the most common viral strains circulating during the trials. Currently, the EMA specifies, they are available Limited data on the efficacy of Nuvaxovid against other variants of concern, including Omicron.
Side effects: mild or moderate
The side effects seen with Nuvaxovid in studies, Ema explains, were generally mild or moderate and disappeared within a couple of days after vaccination. The most common are results tenderness or pain at the injection site, tiredness, body aches, headache, generally feeling unwell, joint pain and nausea or vomiting. The safety and efficacy of the vaccine will continue to be monitored as it is used across the EU, through the system of pharmacovigilance Union and further studies by the company and the European authorities.
Last updated: Monday 20 December 2021, 20:09
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Novavax vaccine, Ema’s okay: “90% effective against the disease”