Hipra Laboratories have received confirmation from the European Medicines Agency (EMA for its acronym in English) that the vaccine it develops against covid has passed the continuous review to which it has been subjected for months and, now, they are awaiting definitive marketing authorization.
From the company, its managers explain that they have taken this new step after a long process to demonstrate compliance with all health and safety measures. The forecast is that the final authorization will be obtained next week in a new meeting, although it is not ruled out that the term is extended a few more days.
The EMA, for the moment, has begun the evaluation of Hipra’s application to proceed with the commercialization of the vaccine and has announced the name of Bimervax. The continuous review began in March 2022 as a mandatory process to obtain validation, but the change in the pandemic situation has meant that the studies have been carried out without the urgency of the first moments and that the requests for information have been exhaustive. .
Hipra has had a contract with the European Commission since August that entitles the countries that comprise it to acquire up to a maximum of 250 million doses. This vaccine is adjuvanted recombinant protein and is kept at a refrigerated temperature between 2 and 8 degrees, which facilitates its storage and distribution. From the laboratories it has been explained that the technology used allows an important versatility for its adaptation to new variants of the virus.
Various hospitals, mainly Spanish, have participated in the entire testing process necessary to obtain this validation of the ongoing pre-market review.
