(Reuters) – Europe’s drug regulator said on Tuesday it had started a real-time review of Spanish pharmaceutical firm Hipra’s COVID-19 vaccine candidate.
The decision by the human medicines committee of the European Medicines Agency (EMA) to begin the rolling review is based on early results from clinical studies, which compared the immune response to the vaccine with that seen with Pfizer/BioNTech’s Comirnaty, the regulator said.
The agency did not say when the review is expected to be completed.
Hipra is developing the protein-based vaccine as a booster for adults fully vaccinated with a different COVID-19 vaccine.
The decision to start the real-time review, so called because data is evaluated as it is made available, came nearly two months after the Spanish medicines agency authorised Hipra to carry out late-stage trials of the vaccine.
Hipra has forecast production capacity of 600 million doses this year and double that in 2023.
(Reporting by Mrinalika Roy in Bengaluru; Editing by Sriraj Kalluvila)
