Moderna Inc said on Monday it has submitted an application to the European drugs regulator seeking conditional approval for its COVID-19 vaccine’s use in adolescents.
A similar request was done to Health Canada.
EMA had recommended granting a conditional marketing authorisation for COVID-19 Vaccine produced by Moderna to prevent Coronavirus disease (COVID-19) in people from 18 years of age. This is the second COVID-19 vaccine that EMA has recommended for authorisation in January 2021.
Soon after its approval, shortfalls in COVID-19 vaccine deliveries from U.S. drugmaker Moderna have spread across Europe, as Italy joined France and Switzerland in announcing the company’s shipments for February would miss expectations. Moderna told Reuters it had revised short-term delivery guidance for Europe and elsewhere outside the United States based on the “ramp-up trajectory” at its drug substance supplier, which is Swiss contract drug manufacturer Lonza .
However, a number of EU countries in March 2021 had opted not to renew their orders. The documents were released as the Hungarian Government sought to diffuse critiscm that it did not purchase as many Moderna doses as it could have, arguing it had done so because the doses would have arrived too late in 2021. Moreover, it insisted that it was not alone in taking such decision, listing 16 other countries that took the same route. According to the document, 16 countries opted out of the vaccine top-up, including: Poland, Romania, Belgium, Greece, the Czech Republic, Bulgaria, Slovakia, Ireland, Lithuania, Slovenia, Latvia, Estonia, Cyprus, Luxembourg and Malta.
Earlier last month, Moderna announced that its COVID-19 vaccine was shown to be effective in adolescents aged 12-17 and showed no new or major safety problems in a clinical trial, potentially setting the stage for a second vaccine for school-aged children to be authorised in July.