The Spanish pharmaceutical company Hipra's vaccine against Covid-19 is getting closer to delivery. In tests it has been found to offer a good response against the BA.2, BA.4 and BA.5 Omicron variants and also produces "longer-lasting" neutralising antibodies when combined with other formulations, the company said this week.
Trials found an increase in neutralising antibodies against the Omicron variants 14 days after subjects were given the Hipra's vaccine as a booster dose in people previously vaccinated with Pfizer or Moderna.
The Hipra data supports the plans of the Ministry of Health, which is considering using the Spanish vaccine as a second booster dose (the fourth jab for those vaccinated with messenger RNA) in the second half of September.
"The Hipra vaccine as a heterologous booster dose gives rise to a potent neutralising antibody response (more than tenfold) against all the variants studied (Wuhan, Beta, Delta and Omicron -BA.1)," the pharmaceutical company said.
These results, said the company from Amer (Gerona), "indicate that Hipra's vaccine generates a more sustained neutralising antibody response over time than Pfizer's messenger RNA vaccine, suggesting longer-lasting and more effective protection against circulating variants".
According to Hipra, their vaccine offers favourable prospects for safety and tolerability, as "no relevant adverse effects have been detected". The most common symptoms after the injection were pain at the site of inoculation, headache and fatigue, but the effects, said the company, "did not prevent the volunteers from going about their normal lives at any time" and disappeared in subsequent days.
The vaccine is in Phase IIb trials, prior to approval, but the company has announced that it will extend the studies with 200 new participants from ten hospitals in Spain to confirm efficacy as a second booster dose; half of them will have received two doses from Pfizer and the other half, three doses.
On 29 March, the European Medicines Agency (EMA) began evaluating Hipra's vaccine to certify its validity as a booster dose in adults who have been immunised with other vaccines. The EMA's Committee for Medicinal Products for Human Use (CHMP) initiated this process after reviewing preliminary results from laboratory studies and clinical studies in adults, which have been positive.
"Hipra's vaccine fits the current needs in Europe. With close to 50 per cent of the population still not having received a booster dose, and with the autumn vaccination campaigns in mind, it is positive news that European vaccines are available in alternative technologies to RNA vaccines," said the pharmaceutical company.
Hipra's formula uses two recombinant proteins with a similar structure, an alpha and a beta variant, which together form a single structure and an adjuvant that enhances the immune response.
The national Ministry of Health has recorded 41,683 new cases of coronavirus in the last three days, of which 23,226 have occurred in people over 60 years of age, bringing the total number of infections in Spain since the start of the pandemic to 13,132,159.
The cumulative incidence rate of Covid infections in Spain in the last 14 days in people over 60 years of age (the only group measured) is down from 1,158 cases per 100,000 inhabitants recorded last Friday to 1,018. There have been 382 Covid deaths reported in the last week, raising the official coronavirus death toll in Spain to 109,642.