EU watchdog starts review of Spain’s Hipra Covid-19 booster jab

The EU medicines watchdog on Tuesday began a rolling review of a Covid-19 booster vaccine made by Spanish pharmaceutical firm Hipra, saying early results showed it was effective against the Omicron strain.

EU watchdog starts review of Spain's Hipra Covid-19 booster jab
The EU regulator has so far approved five Covid vaccines for use in the EU. (Photo by CLEMENT MAHOUDEAU / AFP)

“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 European Medicines Agency (EMA) said in a statement.

Going by the brand name PHH-1V, the Hipra shot will now be scrutinised by the Amsterdam-based EMA, before its maker can apply for full authorisation for use within the 27-member 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.

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Spain to offer fourth Covid-19 vaccine dose to ‘entire population’

Spain’s Health Ministry on Thursday announced there will be a second Covid-19 booster shot offered to all age groups in the country, with the rollout likely to begin this autumn.

Spain to offer fourth Covid-19 vaccine dose to 'entire population'

Spain’s Health Minister Carolina Darias on Thursday announced that the country’s Public Health Commission, the body responsible for advising the ministry on Spain’s Covid vaccination strategy, has said there should be a fourth dose offered to all of Spain’s 47 million inhabitants. 

What hasn’t been fully decided yet is when the rollout will begin, although Darias did hint that it’s likely to take place during the autumn. 

“We’re waiting for the arrival of new vaccines adapted to Covid-19 variants by that date, as stated in the contracts we have signed with the pharmaceutical companies,” Darias said on La Sexta TV channel.

The decision also still requires full approval from the Public Health Commission. There’s unlikely to be a u-turn on the matter, although Spanish health authorities have at different stages of the pandemic taken some time to execute decisions they initially announced. 

Until now, only people over 80, those in care homes and people classified as vulnerable (cancer, HIV, transplant, dialysis patients) have been approved to have a second booster dose in Spain, which is milder than the initial two-shot vaccination given in 2021.

In April 2022, the European Medicines Agency (EMA) considered that at that time it was too early to speak of a fourth dose for all age groups, but they have given the go ahead to high-risk groups.

Around 50 percent of Spain’s population has had one Covid-19 booster dose (third dose), but the rates are lower among younger people.

Spain’s Public Health Commission is in favour of waiting to see how the country’s epidemiological situation evolves and for the new messenger RNA vaccines adapted to the new variants to be made available. 

These new serums are expected to be ready in October and the two pharmaceutical companies developing them, Pfizer and Moderna, have already submitted the results of their clinical trials to the European Medicines Agency.

Although for the past months Spain has only been counting Covid-19 infections in people aged 60 and over as well as serious cases, health authorities have recorded an increase in recent weeks. 

On Tuesday, they confirmed there were 36,133 new infections over the previous 7 days and 131 Covid deaths.

As part of its change of strategy towards the pandemic in recent months, the Spanish government has essentially treated Covid-19 like another endemic disease similar to the flu, deciding to remove quarantines for asymptomatic and mild cases, and after a long wait, relaxed indoor mask wearing rules.