Ana Macpherson
08/11/2021 17:15
Clarín.com
World
Updated 08/11/2021 5:15 PM
The Spanish Agency for Medicines and Health Products of Spain authorized this Wednesday
the first clinical trial of a Spanish vaccine
against coronavirus.
This is the product designed by the Catalan pharmacist Hipra, an expert in animal vaccines and based in Amer (Girona), which carries out this research together with the infection teams from the Hospital Clínic de Barcelona and the Josep Trueta de Girona.
The agency has given permission to
begin inoculation of the product in volunteers
.
The program for this part of the human trial aims to determine the appropriate doses and evaluate the safety and tolerability of PHH-1H, the proper name for Hipra's covid vaccine.
As reported by the AEMPS, this vaccine
uses two recombinant proteins
that correspond to the alpha variant (the British one) and the beta variant (the South African one).
They use both proteins in a single structure called a dimer and add an adjuvant to it that enhances the immune response.
The combination generates an immune response
against the famous protein S (Spike) of the covid coronavirus, which is what the virus uses to infect the cell.
“The project started with the Wuhan variant, but seeing how the British and in part the South African, the alpha and beta were taking their place, we thought it was ethically correct to change the plans and
rely on the new ones to advance further
, although would mean delaying the vaccine for a few months ”, explains Toni Maneu, head of Human Health at Hipra.
Government
By starting from these two proteins, the new candidate intends to
guarantee greater protection
against the new variants and the laboratory results show a good response to the delta, now hegemonic in Spain, especially in Catalonia.
"We hope to confirm," insists Maneu, who although happy about the authorization remains prudent.
The President of the Government, Pedro Sánchez at the premises of the Hipra pharmaceutical company.
Photo DPA
President Pedro Sánchez
visited the pharmaceutical multinational Hipra
, in Amer (Girona), last April Fernando Calvo / EFE This advantage will also be important commercially, because this Hipra vaccine with recombinant proteins follows the same model as those of Novavax and that of Sanofi / GSK, which are more advanced, but are based on the original variant protein.
The volunteers,
about 30 to start
, will receive the Hipra vaccine or one of the most widely used licensed vaccines, such as the one from Pfizer.
Randomly and masked, so that neither recipients nor those who run the trial in hospitals will know what each has received.
They will use low doses to start, which will increase as the observation of results allows it.
Two doses in 21 days for all volunteers.
When this phase is finished, 2b and 3 will begin, which will have two slopes.
“What Europe is asking of us is that we get a vaccine that can be applied
as a
booster
dose
with any other vaccine, because in a few months Europe will be massively vaccinated.
We will do another facet of the trial as the first vaccine, with the two complete doses, for countries that are very far from European coverage ”, explains Maneu.
Authorization
The European trial will need thousands of participants already vaccinated.
They hope that it can
start in October in 10 Spanish hospitals
and probably some in Portugal and Italy.
According to the plans of the company, with long experience in animal vaccines, everything could be ready so that in the first quarter of 2022
Hipra's covid vaccine was authorized in Europe.
"It is a company with
a long experience in producing new vaccines,
which is not a minor advantage", says the Minister of Health Josep Maria Argimon.
Not being able to deal directly with production and distribution instead complicated the expansion of the Oxford vaccine, which is produced by the Swedish laboratory AstraZeneca.
A nurse applies a vaccine in Spain.
Reuters photo
The two factories in Girona
foresee that they could start manufacturing this autumn, with preliminary results, so that the EMA authorization would reach them with some 50-70 million ready doses.
The plan is that in 2022 it will be possible to supply 600 to 900 million and in 2023, 1,200.
The price will depend on several factors, especially the agreement reached with the European Union, "if everything goes well and the results are confirmed", Maneu adds.
"But it is a less expensive vaccine than others
and with simpler logistics, because it can be kept between 2 and 8 degrees, in a normal refrigerator."
Another of the vaccines under investigation in Spain, the one developed by CSIC researcher Mariano Esteban,
stopped the start of its clinical phase with volunteers this August
, due to new requests from the Medicines Agency.
There are six other Spanish groups working on different types of vaccine against covid.
The vanguard
PB
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