Hipra finalizes the ‘paperwork’ for the approval of its vaccine against covid-19

  • The director of R&D and records of the pharmaceutical company estimates that the injection will be approved during the last quarter

The first Spanish vaccine against covid-19 enters the ‘last big exam’ for final approval. As announced this Thursday by Elia Torroella, director of R&D and records of Hipra in a event organized by EL PERIÓDICOthe pharmacist is finishing collect all the information requested by the European Medicines Agency (EMA) for the definitive approval of this new injection against the coronavirus.

In the coming weeks, Hipra will deliver its final report. Thereafter, the European regulatory body is expected to deliver its verdict as soon as possible (which could result in a further delay of several weeks). “If all goes well, Hipra’s covid-19 vaccine will be approved during the last quarter of this year“, said the spokeswoman for the Girona pharmaceutical company.

As Torroella explained, the delay in approval of the first Spanish vaccine against covid-19 is mainly due to the change of requested requirements by regulatory bodies and health authorities for the evaluation of these drugs. “The pandemic situation has changed, so the requirements for this type of project have also changed,” argued the pharmacist during the avant-garde health conference organized by this newspaper.

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In the process of clinical trials, the Hipra vaccine has shown high rates of effectiveness against all variants detected to date of the coronavirus responsible for covid-19: from the one originating in Wuhan to the most widespread variations during the pandemic, as is the case with beta, delta and omicron. Recently, based on tests in volunteers, a high effectiveness against the subvariants BA.2, BA.4 and BA.5 of ómicron: the lineages that, today, are marking the course of the pandemic in practically the whole world.

According to Torroella in an interview with EL PERIÓDICO, the pharmaceutical company also is preparing to close a purchase agreement with Europe. “Many European countries are interested in buying the Hipra vaccine. We are also in talks with countries in Latin America, Southeast Asia and the Middle East,” explained the spokeswoman for the company from Girona in statements to this newspaper.

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