It has been a long time coming, but, finally, this Thursday Hipra has obtained the positive opinion from the European Medicines Agency (EMA) essential for the European Union to authorize the start of commercialization of its vaccine against covid-19, named Bimervax. According to the Catalan family company, in "a matter of hours" the European Commission will issue this authorization, which represents a historic milestone for the Catalan scientific and pharmaceutical sector and for Spain as a whole, as it is the first vaccine developed 100% in the European Union.
Bimervax is also the first bivalent adjuvanted recombinant protein vaccine authorized in the EU against this virus, which gives it a differential character compared to the vaccines mostly used until now, based on messenger RNA technology. According to Hipra, it is a vaccine for people over 16 years of age especially indicated as a booster dose and that can help increase vaccination rates, as it causes fewer reactions and offers a "superior" duration of immunity compared to the vaccines previously on the market.
"We have developed a vaccine that is very safe and, furthermore, it is less reactogenic than RNA vaccines, which represents a clear advantage for the population reluctant to vaccinate, tolerance is much better," assures Elia Torrella, executive vice president of Hipra and R&D director. According to the executive, Bimervax offers a very powerful "boost" as a fourth dose, provides protection against all existing variants of the virus and, furthermore, has the advantage that its logistics are very simple because it is "ready to use" ---it does not need to be reconstituted before use--- and because it does not require freezing: it must be stored refrigerated at a temperature between 2 and 8 degrees.
"For Hipra, today is a very exciting and long-awaited day," said Torrella, who emphasizes that the new vaccine is the result "of the company's knowledge" and also of its "enthusiasm, perseverance and optimism" with the project. Unlike other pharmaceutical companies, Hipra has shown total transparency regarding the price of the new vaccine: each dose will cost between 9.75 euros and 7 euros, depending on the volume of purchase made by each State.
And when can the first doses of Bimervax be injected? This is a decision that depends exclusively on the health authorities of the countries and the vaccination plans they activate, but Hipra assures that, in the best case, by the end of April they could deliver the vaccine to the warehouses that supply health centers.
"We have enough stock of finished product and raw material to be able to supply all the vaccines they ask for during these first months," assures Carles Fàbrega, Hipra's human health director. According to the executive, the production capacity of the Amer (Girona) plant is 600 million doses per year, although this figure could be expanded to 1,000 million if necessary.
The Girona-based company has already signed a pre-contract with 13 countries of the European Union that have the right ---though not the obligation--- to purchase up to 250 million doses. Of these 13 countries, a group of six ---including Spain--- had already communicated to the company their intention to make the first purchases once community authorization was obtained, so the first contracts could be formalized in the coming weeks. In parallel, Hipra is in negotiations with other non-EU countries, such as Malaysia and some states in Latin America, the Middle East, and Southeast Asia, but everything was on stand by awaiting the EMA's decision. "Now we will begin the registration phase in the rest of the countries of the world and we will also request WHO authorization," explained Fàbrega.
The company of the Nogareda family, which until now had focused solely on veterinary vaccines, has not wanted to reveal the amount of the investment it has made for the development of Bimervax, but assures that it is the "greatest economic and human effort" made to date. The bulk of the investment has been financed with its own resources, although Hipra has also received two public loans from the Center for Industrial Technological Development (CDTI) totaling 14.7 million euros, of which 10.82 million must be repaid.
Economic impact due to approval delay
The evaluation period for the vaccine by the European Medicines Agency has been longer than expected, as authorization has taken almost 12 months to arrive, compared to the express approvals of four months achieved by the first vaccines in the most acute phase of the pandemic. Hipra admits that this delay has had a negative economic impact because "it hinders market entry," in the sense that commercialization begins at a less opportune moment, as countries have high stocks of competitor vaccines and, furthermore, there is a widespread perception that the pandemic has already passed, which has led to a drastic drop in revaccination rates.
"Covid-19 is here to stay; there is a general scientific consensus that it will be necessary to continue vaccinating, especially certain population groups. It is very important to have more vaccines to keep covid under control, so there is clearly space in the market for a vaccine like Bimervax, we are very happy to have finally received approval," Torrella highlighted. Along the same lines, Fàbrega defends that the new Catalan vaccine "fits perfectly with the needs of the global population," although he declined to make sales forecasts for this first year.
Hipra also highlights another factor that states should consider when deciding whether or not to acquire their vaccine: "it is not good to vaccinate exclusively with a single technology", referring to the fact that currently the vaccines supplied are RNA and not recombinant protein. According to Torrella, the system they have used "facilitates the body's immune response" by introducing into the body a protein previously designed in a laboratory that generates antibodies, instead of the cells performing this step.
Furthermore, it is a bivalent vaccine, which means that instead of one, it contains two proteins to fight against two different variants, in this case Beta and Alpha of SARS-CoV-2. "It is a much more versatile vaccine, because it is a two-in-one", Torrella pointed out, after noting that if new variants appeared, the vaccine could be adapted in just four months. Bimervax technology is widely used and known in vaccine manufacturing, such as for hepatitis and influenza.
The board has thanked the entire team of Hipra professionals for the enormous effort made and, especially, all the volunteers who participated in the clinical trials that were necessary to obtain the EMA's approval.
According to Hipra, the EMA's positive opinion comes after concluding that "it has sufficient solid data on the quality, immunogenicity and safety of the vaccine." "In phase IIb and III studies, it has been shown that it is a safe, low-reactogenic vaccine with a broad capacity to neutralize the main variants of SARS-CoV-2, including the Omicron variants. In the comparative study versus the mRNA vaccine required by the EMA, it is shown that, 6 months after receiving the booster dose, people vaccinated with the Hipra vaccine present higher levels of neutralizing antibodies against all the variants studied, which suggests more lasting protection. In the same comparative study, it is shown to have less reactogenicity than the RNA vaccine," they add.