covid vaccine
Covid-19 Vaccine

HIPRA, with 50 years of experience fighting communicable diseases through vaccine development, is a company committed to health, people, society and progress. This is why, in such an exceptional situation, HIPRA has decided to provide its know-how to tackle the pandemic. 

 

The HIPRA Covid-19 vaccine and its characteristics

 

The active component of the HIPRA Covid-19 VACCINE is an heterologous recombinant heterodimer protein that emulates the spike (S) protein and includes sequences of the new variants of the SARS-CoV-2 virus. The antigen, which is the active component of the vaccine, requires an adjuvant to amplify and enhance the immune response. In the HIPRA Covid-19 vaccine, the adjuvant is an oil-in-water emulsion, which has already demonstrated its efficacy and safety in many other vaccines.

This combination is capable of generating a strong immune response against the S protein of the SARS-CoV-2 virus, and consequently protecting against Covid-19.

The HIPRA vaccine is stored between 2 and 8º C, which facilitates its logistics and distribution. It is a ready-to-use vaccine administered via the intramuscular route.

HIPRA covid vaccine

Its mechanism of action

 

The HIPRA Covid-19 VACCINE is a heterologous recombinant protein vaccine, a technology widely used in biotechnology and for which there is widespread experience in vaccines extensively used in the population (flu, hepatitis A, papilloma, among others). The recombinant vaccine consists of synthetic (artificial) fragments of the virus causing the disease, the spike or S protein in the case of the SARS-CoV-2 virus causing Covid-19.

The vaccine is inoculated into the body triggering the immune response by producing antibodies and activating memory cells. When a vaccinated person is exposed to the virus, the generated antibodies will neutralize the virus, thereby preventing the development of the severe disease.

 

Phases and schedule

 

  • 2020 October: HIPRA Announces the development of a vaccine against COVID-19
  • 2021 Quarter 1: Start of preclinical trials
  • 2021 Quarter 3: Start of human clinical trials phase I/IIa
  • 2021 Quarter 4: Start of phase IIb & start of production
  • 2022 Quarter 1: Phase III trials
  • 2022 Quarter 2: Vaccine availability

The HIPRA Covid-19 VACCINE, like any other vaccine, undergoes rigorous clinical studies before being approved for use on humans by the regulatory authorities. These studies or clinical trials, classified by phases I, II, and III are used to determine the efficacy, safety, and tolerability of the vaccine. If the outcomes are satisfactory and unambiguous, agencies may authorize the use of the medicinal product and the laboratory may make it available to health services. 

 

The structure we have followed with our vaccine is as follows: 

Phase I/IIa*

The objective is to determine the appropriate dose and study the safety and immunogenicity of the vaccine.

*Study Reference NCT05007509

Phase IIb*

The objective is to determine the efficacy of the vaccine.

*Study Reference NCT05142553

Phase III

The objective is to assess the safety and tolerability of the vaccine.

Follow-up of vaccine efficacy and safety does not end with the vaccine approval, once marketed, further studies are conducted to confirm that in routine practice and with a longer-term perspective, health outcomes are as expected. In addition, pharmacovigilance continues to monitor the benefit/risk of the vaccine continuously.

Advances in the development of the HIPRA Covid-19 VACCINE are published here.

 

Productive Capacity

 

The HIPRA team is fully dedicated to research and the production of vaccines. The R&D, Production and Quality Assurance departments have extensive experience in this field.

We have the production capacity for 600 million doses in 2022 and we anticipate being able to double this figure by 2023.

Relevant aspects
conservation
Conservation

The vaccine may be stored between +2 and +8 ºC, which will facilitate its logistics and distribution.

availability
Availability

Production began in October 2021 and commercialization is expected by the end of 1st semester 2022.

versatility
Versatility

Offers protection against variants of concern (VOC).

The own project has received financial support from the CDTI (Spanish Centre for the Development of Industrial Technology).