31st May 2023
Prime Minister Pedro Sánchez and Health Minister Carolina Darias on a visit to HIPRA in Amer (Girona) in April.
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EU Medicines Agency starts ‘rolling review’ of Spain’s Hipra Covid-19 vaccine

Latest: Coronavirus in Spain weekly figures (8 April)

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The European Medicines Agency (EMA) has begun a ‘rolling review’ [see below] of a Covid-19 booster vaccine made by Spanish pharmaceutical firm Hipra, saying early results showed it was effective against the Omicron strain.

‘Preliminary results suggest that the immune response with Covid-19 vaccine Hipra may be effective against SARS-CoV-2, including variants of concern such as Omicron,’ the Amsterdam-based EMA said in a statement.

The vaccine is stored at refrigerated temperature between 2 and 8 C, ‘making its storage and distribution easier’, Hipra said in its own statement. ‘The technology used allows great versatility to adapt it to new variants of the virus, if necessary, in the future,’ it added.

Going by the brand name PHH-1V, the Hipra dose will now be scrutinised by the EMA, before its maker can apply for full authorisation for use within the 27-member EU bloc. The EMA did not say how long the review would take.

It is being developed by Hipra as a booster vaccine for adults who have already been fully vaccinated with a different Covid-19 vaccine.

PHH-1V is a protein-based vaccine ‘that prepares the body to defend itself’ against Covid-19, the EMA said.

The vaccine contains two types of spike proteins, which SARS-CoV-2 — the virus that causes Covid-19 — uses to enter human cells.

When a person is administered the vaccine, their immune system will identify the two types of spike proteins as foreign and then produce natural defences — antibodies and T-cells — against them.

‘If, later on, the vaccinated person comes into contact with SARS-CoV-2, the immune system will recognise the spike protein on the virus and be prepared to attack it,’ the EMA said.

Covid-19 infections are again surging in parts of the world, blamed particularly on the spread of the highly transmissible BA.2 variant of Omicron.

The EU regulator has so far approved five Covid vaccines for use in the EU — Pfizer and Moderna, which use messenger RNA technology, AstraZeneca and Johnson & Johnson, which use viral vector technology, and Novavax, which is based on a spike protein produced in a laboratory.

A ‘rolling review’ is a regulatory tool that EMA uses to speed up the assessment of a promising medicine or vaccine during a public health emergency. Normally, all data on a medicine or vaccine’s effectiveness, safety and quality and all required documents must be ready at the start of the evaluation in a formal application for marketing authorisation. In the case of a rolling review, EMA’s human medicines committee (CHMP) reviews data as they become available and once enough data are available, the company can submit a formal application. The rolling review allows the marketing authorisation for the medicine to be obtained in a shorter time than usual.

Latest figures (with data collated up to Wednesday 23 March) show that Spain has administered 93,807,121 jabs of the Covid vaccine. 38,969,612 people have now been fully vaccinated, which is 82.2% of the total population (92.4% of the population aged over 12). A further 24,424,856 ‘booster’ jabs have also been administered. In a separate report, we publish the amount of vaccines administered for each region and its population in Spain, as well as the overall percentage of citizens vaccinated per age group: Covid-19 Vaccinations in Spain.

Prime Minister Pedro Sánchez and Health Minister Carolina Darias on a visit to HIPRA in Amer (Girona) in April.
Prime Minister Pedro Sánchez and Health Minister Carolina Darias on a visit to HIPRA in Amer (Girona) in April 2021. (Pool Moncloa / HIPRA)

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