Novavax Inc said on Wednesday (May 4) it had filed an application with The Medicines and Healthcare products Regulatory Agency for the authorisation of its Covid-19 vaccine among adolescents aged 12 and older.
The medicines regulator had in February cleared the two-dose vaccine, Nuvaxovid, for use in adults amid a spike in cases fuelled by the Omicron variant of the coronavirus.
Novavax’s submission includes data from a late-stage trial in the United States, where the vaccine showed 80 per cent efficacy among adolescents when Delta was the dominant variant in the country.
The drugmaker in late January filed for emergency use authorisation of its Covid-19 shot for adults in the United States.
The U.S. Food and Drug Administration plans to hold several meetings of its outside panel of experts in June to discuss authorisation requests submitted by multiple Covid-19 vaccine manufacturers including Novavax.
