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EMA’s ongoing evaluation of Hipra’s COVID-19 vaccine begins

The European Medicines Agency (EMA) has started continuous evaluation of the vaccine against COVID-19 from Hipra, also known as PHH-1V. This vaccine recombinant protein adjuvanted It is proposed as a booster for adults who have already been fully vaccinated with a different COVID-19 vaccine.

The Committee for Medicinal Products for Human Use (CHMP) of the EMA will evaluate the vaccine through a rapid process (rolling review), whereby the data is evaluated as it is generated. This is the preliminary step for the pharmaceutical company to formally request the marketing authorization for the vaccine in the EU, which the EMA will communicate at the time.

The CHMP’s decision to initiate this review is based on preliminary results from manufacturing data, pre-clinical testing and adult clinical trials. Trials that have compared the immune response to the vaccine, measured by the level of antibodies against SARS-CoV-2, with that observed with the Comirnaty (BioNTech/Pfizer) mRNA vaccine, and indicate a better immune response generated by the Hipra vaccine against the Beta and Ómicron variants.

Approval of the Aemps to the phase III trial

The vaccine developed by the Spanish company Hipra received the approval of the Aemps to phase III clinical trial on February 1 as a booster dose for people with the complete regimen with a different vaccine, after the results obtained in previous trials that demonstrated a good safety profile and adequate efficacy.

Likewise, on March 11, the Aemps also authorized a second phase IIb clinical trial to see how it works against omicron in volunteers who have received two doses of Vaxzevria (AstraZeneca) and a Hipra booster, compared to those who have been vaccinated with two doses of Vaxzevria and Comirnaty.

In the previous phase IIb trial, authorized on November 15, the study was carried out with volunteers who had been administered Comirnaty. The first clinical trial was authorized on August 11 last year.

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