Catalan pharmaceutical Hipra expects to join fourth round of covid vaccination in October

Company expects to receive European Medicines Agency approval in autumn

3 min
A researcher inside Hipra Pharmaceuticals, in an archive image

GironaOctober is the new date set by the Girona-based company Hipra to obtain authorisation for its vaccine against covid-19. The company's R&D director, Èlia Torroella, had said that they expected to receive the European Medicines Agency's (EMA) approval between June and July, but they have now been asked for more data. "The situation has been changing and different requirements have been made at different times, and in our case they have asked us to provide more information. We know what they want, we will provide it, and we are convinced that the vaccine will be part of vaccination plans in the autumn," Torroella emphasised, in reference to the Ministry of Health's plans to start administering the fourth dose to the over 60 and to healthcare personnel after the summer.

Torroella added that, so far, the data collected show that the new jab offers "superior" protection against all variants of coronavirus and has "fewer side effects" than other existing vaccines. "We have to wait for more months to pass, but we have confirmed that it has a longer duration and that, at least after six months, it offers clearly higher levels of protection," he stressed.

Hipra's vaccine is based on two recombinant proteins, one from the alpha variant and one from the beta variant, which are joined together in a single structure that generates an immune response against covid's Spike protein.

In parallel to the progress of clinical studies, Hipra is also in talks with the European Union to close a purchase contract. Torroella has indicated that they are at an "advanced stage" of negotiations, but that she cannot reveal either the number of doses nor the price to be paid because of contract confidentiality. In fact, despite the fact that vaccines have been purchased with public money, European authorities have not revealed how much money has been paid for each injection. "I can only say that it will be much cheaper than the mRNA vaccines," Torroella stated, in reference to Pfizer and Moderna vaccines.

Once the European Medicines Agency gives the Catalan vaccine the green light, the company will be able to sell the jab to other parts of the world. "We are in talks with countries in Latin America, the Middle East, Asia... There is a lot of interest because of the advantages it offers," Torroella said.

In fact, in order to guarantee that when they receive the EMA's authorisation they will have sufficient doses for all, since January Hipra has been producing vaccines and has also purchased all the necessary components to manufacture it, as well as containers and vials. "We have now produced over 100 million doses of the active substance. Our production capacity is enormous, we will have no problems," the director reiterated, who also said that they are working to offer a single-dose version as of 2023.

Next challenge: a sterilising vaccine

During the press event, other experts also participated and highlighted the advantages of Hipra's vaccine compared to others currently on the market. The secretary of the Spanish Society of Immunology, Carmen Cámara, pointed out that the vaccine is made with recombinant proteins – and not with mRNA like Pfizer's or Moderna's – and that this will allow the immune system to be stimulated in a different way.

"If we only use mRNA vaccines we are always calling up the same soldiers of the immune system and not the rest. The first and second time these soldiers work very well, but by the third time not so much because they are tired. And the fourth time they don't understand why the the rest of the soldiers are being called up, and they don't turn up," said Cámara, using a metaphor to argue that results improve if different kinds of vaccines are used. "[Using] Different vaccine models are not new, it was already done with Ebola and it gave fantastic results. And in the case of covid, a study showed that combining AstraZeneca and Pfizer gave a more powerful stimulus of both antibodies and cellular immunity," she stressed.

In addition, the professor of preventive medicine and public health, Ángel Gil de Miguel, pointed out that there are already other vaccines on the market, such as those for papilloma or hepatitis B, which are made from recombinant proteins – like Hipra's – and which, therefore, "are safer and have fewer side effects". Likewise, the fact that they can be stored at between 2°C and 8°C will greatly facilitate the logistics of distribution and administration

On the other hand, the main disadvantage of Hipra is that it is not a sterilising vaccine either, i.e. vaccinees can still become infected. However, according to Torroella, positive cases are all asymptomatic or mild and therefore it also protects against severe disease and death.