Published 21:04 IST, December 30th 2020
COVID-19 AstraZeneca vaccine's approval 'unlikely' in Jan due to insufficient data: EMA
Approval of AstraZeneca COVID-19 vaccine had been stalled as firm hadn’t presented enough data to warrant 'conditional marketing licence’, EMA said.
The European Medicines Agency (EMA) announced on December 29 that it is unlikely that the EU will approve AstraZeneca’s vaccine as there hasn’t been sufficient data provided by the pharmaceutical company. This comes as the EMA recently approved a conditional marketing authorization for the vaccine Comirnaty, manufactured by Pfizer and BioNtech. According to EMA’s release, the European Commission’s approval is subject to safeguards, controls, and obligations that the vaccines entail. In a statement to Belgian newspaper Het Nieuwsblad, the EMA's deputy executive director Noel Wathion said that AstraZeneca had not even filed an application and the European drug regulators haven’t got enough information about the potential vaccine.
In a statement, the EMA announced that it needed enough data about the quality of the drug, and once the data is turned in, the potential vaccine can formally apply for approval in the EU. For now, according to the watchdog, the approval of AstraZeneca had been stalled as the pharmaceutical firm hadn’t presented enough data to warrant 'conditional marketing licence’. “EU medicines regulatory network, EMA has been working around the clock to bring much needed COVID-19 vaccines to EU citizens as quickly as possible, while keeping the same rigorous standards of approval as for all vaccines,” the agency announced in a press release.
Moderna to be approved in January
EMA said, that the application for marketing authorization for the COVID-19 vaccine, developed by Moderna was ongoing and could be concluded at an extraordinary meeting of EMA’s human medicines committee (CHMP) on 6 January 2021. However, the agency cited a lack of safety data with the AstraZeneca vaccine. Earlier, the UK authorized AstraZeneca's COVID-19 vaccine Covishield after it received the recommendation from the Medicines and Healthcare Regulatory Agency (MHRA). AstraZeneca CEO, Pascal Soriot hailed the approval in a release, saying that “in 2020, teams across AstraZeneca have risen to the challenges COVID-19 has posed to global health.” The approval came as the UK inoculated close to 600,000 people in a mass vaccination campaign with the US’ Pfizer vaccine.
Updated 21:04 IST, December 30th 2020