THE HAGUE, March 29, 2022 (AFP) – 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.
“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.