EMA authorizes Catalan-developed Covid vaccine as booster dose

European medicines regulator recommends Hipra jab for over 16s who have already received mRNA vaccines

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 30, 2023 04:55 PM

March 31, 2023 02:43 PM

The European Medicines Agency (EMA) has approved the use of Hipra's Covid-19 vaccine, called Bimervax, as a booster shot. 

The regulatory organization recommends the jab for over 16s who have already received full doses of mRNA vaccines, such as those developed by Pfizer-BioNTech and Moderna.

The regulator's decision revealed on Thursday comes after verifying that the vaccine is "safe" and that there is sufficient "robust" data on its quality.

The European regulator believes that Bimevax is "at least as effective" as others when it comes to restoring the effects of the first dose in over 16s.

In their decision, they also say that pain where it is administered, headache, fatigue, and muscle pain are some of the most frequent side effects, although they are "light to moderate" and are gone within few days.

Delays in EMA approval

The final green light from the EMA has come exactly one year after the European regulator began evaluating the vaccine, later than the company expected, as it hoped to obtain authorization last November – indeed, later on Thursday, the pharma company leadership admitted that the delay has affected "negatively" to their plans, but said there is still market to sell it and they will be able to do it "within days."

Hipra believes they can produce 600 million doses per year and will meet the EU member states that signed a contract with the company showing interest in buying up to 250 million.

They are also willing to be granted approvals to commercialize the vaccine in Latin American countries, as well as in the Middle East and Southeastern Asia.

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.

EU Commission greenlights vaccine

Almost 24 hours after the EMA's approval, the European Commission authorized the marketing of the vaccine on Friday, as the health spokesperson Stefan de Keersmaecker told to the Catalan News Agency (ACN).

With this approval, the company can already start selling the vaccine in the EU market.

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.