Ema has approved the Nuvaxovid Anti-Covid vaccine, produced by Novavax, a US company based in Maryland.
At the end of an extraordinary meeting, the Technical Committee for Medicinal Products for Human Use of the European Medicines Agency gave the green light to the conditional marketing of the drug in EU countries. It is suitable for people aged 18 and over.
After Pfizer, Moderna, AstraZeneca and Johnson & Johnson, it is the fifth vaccine against SarsCov2 authorized in Europe.
The vaccine is based on a technology that has been in use for many years that could theoretically even people skeptical of Pfizer and Moderna mRna vaccines. That of "recombinant proteins", which assemble to form viral-like particles that induce the immune system to produce antibodies.
The Noavavax vaccine should be administered in two equal doses 21 days apart, it can be stored for up to 6 months at refrigerator temperatures so it could also be useful in poor countries.
STUDIES AND DATA - Two of the most important studies. The first, conducted in Mexico and the US, found a 90.4% reduction in the number of symptomatic cases from 7 days after the second dose. It also shows 100% protection against serious illness. The second study, in the UK, showed a similar reduction in symptomatic cases, at 89.7%.
"The safety and efficacy of the vaccine - concludes the note - will continue to be monitored as it is used throughout the EU, through the EU pharmacovigilance system and further studies by the company and the European authorities" .
INCOGNITA OMICRON - However, the main studies on which Ema was based to evaluate Nuvaxovid are on old variants and "currently limited data are available" on the efficacy against the Omicron variant, Ema said.
"The original strain of SarsCov2 and some disturbing variants such as Alpha and Beta were the most common viral strains in circulation when the studies were underway - reads a note from the Agency -, currently limited data are available on the effectiveness of Nuvaxovid against other worrying variants, including Omicron ”.
(Unioneonline / L)
