Catalonia's Hipra Covid-19 vaccine starts EMA marketing authorization review

Company faces last steps before jab reaches markets

The Hipra production facility in Amer, northern Catalonia
The Hipra production facility in Amer, northern Catalonia / Image from Hipra
Catalan News

Catalan News | @catalannews | Barcelona

March 22, 2023 03:06 PM

The European Medicines Agency (EMA) started reviewing a conditional marketing authorization application for Catalan company Hipra's Covid-19 vaccine, as announced on Wednesday.

After reviewing the data, EMA's human medicines committee (CHMP) will issue an opinion on whether to grant conditional marketing authorization, as sources from the EMA confirmed to Catalan News.

The European Commission will then make a legally binding decision, and if all these requests are greenlighted, the Catalan Covid-19 vaccine will start to be distributed across the different European markets.

The company has its headquarters in Amer, near Girona in northern Catalonia, and almost all the components of their jab against the pandemic have been manufactured in Europe. 

In August 2021, the first clinical trials on humans took place, and its production began in early 2022. In March that year, the EMA started the rolling review of the vaccine.

14 EU countries interested in buying it

The executive deputy president at Hipra, Carlos Montañés, told the press back in November that once the EMA allows the use of their jab, it will be commercialized immediately, adding that 14 EU member states have shown interest in buying doses. Each of them will cost less than €10.

The Covid-19 vaccine uses a recombinant protein different from the messenger RNA jab of Pfizer.

According to the company, doses can be stored at between 2°C and 8°C, so they do not need to be frozen, which "eases the logistics."

Hipra's officials also said that side effects are lower with their jab and the immunity is longer than with others.