The European Medicines Agency (EMA) recommended this Monday the authorization of a new vaccine against Covid-19.
It is the
Novavax
vaccine
, called
Novaxovid
.
It is indicated for people over 18 years of age.
The Novavax product is the fifth vaccine to receive the green light from the European body and comes at a height of the pandemic on the continent.
As the EMA has advanced in a statement, the vaccine has received, by consensus and after a thorough evaluation, the positive recommendation of the Human Drugs Committee.
It meets the criteria of efficacy, safety and quality
, the statement remarks.
The recommendation is based primarily on the results of two clinical trials that have shown Novaxovid to be effective in preventing Covid-19 in people over 18 years of age.
These studies have been conducted on around 45,000 people.
In the first study, about two-thirds of the participants received the vaccine while the rest were given a placebo.
In the other study, the groups were divided in half, with none of the participants knowing whether they were in the vaccine group or the control.
The first study, which was carried out in Mexico and the US, showed a reduction of 90.4% in symptomatic cases after seven days after the administration of the two doses.
In total, 14 cases among the 17,312 people who received the vaccine developed the disease compared to 63 of the 8,140 who did so in the control group.
The second study, which was carried out in the United Kingdom, showed a similar reduction in the number of symptomatic cases, notes the EMA.
Specifically, in this trial, the vaccine efficacy was 89.7%.
"Together, the results of these studies show an efficacy of Nuvaxovid of around 90%," notes the agency.
When both tests were performed, the circulating variants were alpha and beta.
Therefore, there are currently limited data on the drug's usefulness against other variants of concern, such as
omicron
.
Side
effects
that have been seen with Nuvaxovid are generally "mild or moderate" and resolve within a few days after vaccination, the agency notes.
The most common include injection site tenderness and pain, tiredness, muscle pain, headache, malaise, joint pain, nausea, and vomiting.
The safety and efficacy of the vaccine will continue to be monitored through pharmacovigilance systems and additional studies, recalls the EMA.
Novaxovid contains a version of
SARS-CoV-2
protein S
, one of the proteins found on the surface of the pathogen and the key that the virus uses to infect cells.
This protein, which is also targeted by other approved vaccines, has been produced in the laboratory.
In addition, the product contains an adjuvant, a substance that helps boost the immune response.
Nuvaxovid is also given as
two intramuscular doses
about three weeks
apart
.
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