EMA’s human medicines committee (CHMP) has started a rolling review of COVID-19 HIPRA vaccine. This protein-based vaccine is being developed by HIPRA as a booster vaccine for adults who have already been fully vaccinated with a different COVID-19 vaccine. The approval of this vaccine following the review is undoubtedly the steppingstone for the work of the RBDCOV Project, which is working on a new COVID-19 vaccine for children, adolescents and immunocompromised patients using a recombinant protein.
RBDCOV is a project that aims to test the efficacy, tolerability, and safety of the HIPRA’s vaccine against the different variants of COVID-19 by the consortium partners. This specific COVID-19 vaccine is an adjuvanted recombinant protein vaccine, based on a receptor biding domain (RBD) fusion heterodimer containing variants B.1.1.7 (alpha), and B.1.351 (beta) of SARS-CoV-2.
The step prior to marketing authorisation
The CHMP decision to initiate continuing review is based on preclinical development and preliminary results from clinical trials. Clinical trials have compared the immune response generated by the vaccine (as measured by the level of antibodies against SARS-CoV-2) with that observed with an mRNA vaccine (Comirnaty). Preliminary results show that the immune response is effective against SARS-CoV-2, including variants of concern such as Omicron.
The EMA, through the rolling review process, will evaluate existing and emerging data on HIPRA’s vaccine until marketing authorisation, following the usual EU standards for efficacy, safety, and quality. HIPRA expects to receive conditional marketing authorisation between the end of May and the beginning of June. The company is already prepared at the production level to have the vaccine available in a few days.
What is rolling review
A rolling review is a regulatory tool that the EMA uses to expedite the assessment of a promising medicine or vaccine during a public health emergency. Normally, all data on the efficacy, safety, and quality of a medicine or vaccine and all required documents must be ready at the start of the assessment in a formal marketing authorisation application. In the case of a continuing review, the EMA CHMP reviews data from ongoing studies as they become available and once sufficient data are available, the company can submit a formal application. This continuing review allows the marketing authorisation of the medicine to be obtained in a much shorter time than usual.
More about HIPRA vaccine
HIPRA’s vaccine works by preparing the body to defend itself against COVID-19. It contains two versions of part of the spike protein, or spike, which have been produced in the laboratory: one version corresponds to part of the alpha variant spike protein and the other corresponds to the beta variant spike protein. This protein is found on the surface of SARS-CoV-2 and is used by the virus to enter cells in the body. The vaccine also contains an adjuvant, a substance that helps boost immune responses to the vaccine.
When a person receives the vaccine, their immune system identifies the two vaccine proteins as foreign and produces natural defenses (antibodies and T-cells) against them. If the vaccinated person later comes into contact with SARS-CoV-2, the immune system will recognise the herringbone protein of the virus and be ready to attack it. Antibodies and immune cells can protect against COVID-19 by working together to kill the virus, prevent it from entering the body’s cells and destroy infected cells.
This vaccine is kept a temperature between 2°C and 8°C, facilitating storage and distribution. However, the technology used allows for great versatility in adapting it to new variants of the virus, if necessary in the future. The results obtained so far show that the vaccine produces neutralising antibodies against the current variants of concern and also efficacy in preventing the disease.
On 11 March, the Spanish Agency for Medicines and Health Products (AEMPS), which reports to the Ministry of Health, authorised a second phase IIb clinical trial of this vaccine. The aim of this research is to determine and compare the changes in immunogenicity against the omicron variant in volunteers who have received two doses of AstraZeneca’s vaccine and HIPRA’s vaccine as a booster dose (PHH-1V is its technical name), compared to those who have received two doses of BioNTech/Pfizer as a booster.
Know about RBDCOV project
The initiative is an innovative vaccine-focused research project that brings together the expertise of several European groups and companies in rational design of animal and human vaccine immunogens, vaccine manufacturing, distribution and commercialisation, cellular and humoral immune responses, clinical trials, regulatory issues, stakeholders’ involvement and patients’ perspective.
The purpose behind RBDCOV project is to offer a new tool to control the pandemic at short-medium and long term, and to manufacture and test the first recombinant protein-based vaccine to be authorised in Europe.
RBDCOV is going to generate robust data to demonstrate the safety and immunogenicity of this vaccine given as a booster vaccination to induce higher and more durable immune response, specially towards new and future viral variants, which will be bridged for the effectiveness in the prevention of COVID-19.