Green light from the European Medicines Agency Ema to the use of Nuvaxovid *, the anti-Covid vaccine from the US company Novavax, as a homologous and heterologous booster dose in adults aged 18 years and over. The company announced in a note the positive opinion on the extension of the conditional marketing authorization, issued by the EMA Committee for Medicinal Products for Human Use (CHMP). Once approved by the European Commission, the company adds, Nuvaxovid will become “the first protein subunit vaccine to be authorized in the EU for both primary and booster doses, regardless of the primary vaccine used”. It is “an important milestone that gives us the opportunity to offer the first protein vaccine suitable for both primary dose and booster use, regardless of the primary cycle vaccine used – commented Stanley C. Erck, president and CEO. di Novavax – Given the persistence of the Covid epidemic, our commitment remains to guarantee the widest possible access to diversified vaccination options “. The CHMP recommendation is based on the results of two phase 2 studies and the ‘Cov-Boost’ study. In the phase 2 studies, a single booster dose of Nuvaxovid was administered to healthy adult participants approximately six months after the primary course with two doses of Nuvaxovid. The third dose produced an increase in immune responses “comparable to or above” the levels associated with protection in the Phase 3 clinical trials, the note reads. In the Cov-Boost study, Nuvaxovid induced “a robust antibody response” when used as a third heterologous booster dose. In the Novavax-sponsored studies, after the booster, local and systemic reactions were “generally of short duration (an average of about two days). The incidence of grade 3 or higher events remained relatively low,” they point out. agency. Safety reporting of reactogenicity events showed an increasing incidence in all three doses of Nuvaxovid, reflecting the increase in immunogenicity observed with a third dose. Medically assisted adverse events, potentially immune-mediated medical conditions and serious adverse events “occurred infrequently after the booster dose and were balanced between the vaccine and placebo groups.” Nuvaxovid was approved as a dose booster in adults aged 18 and over also in Japan, Australia and New Zealand, and is currently under review in other markets, the company informs.