Research First steps of the Hipra vaccine trial: "We are on the right track"
Live Coronavirus, Spain, today
The Minister of Science and Innovation, Diana Morant, said this Sunday that the Spanish vaccine against the coronavirus, developed by the
pharmaceutical company Hipra
, could be commercialized in early 2022 if clinical trials prosper.
This was stated this Sunday in an interview in El Periódico, after the pharmaceutical company announced on Friday the start of human trials of its coronavirus vaccine.
"The Hipra vaccine, which is currently the most advanced, has a good response to all variants and, in addition, it is kept at refrigerator temperature, which makes logistics much easier," said the minister.
The company announced this week the start of its first clinical trial, which has begun with its
inoculation to 6 of the 30 participants
included in the research and a registry of adverse effects of grade 1 or 2 "which is
normal in these cases
and indicates we are doing very well ", as explained by
Lorna Leal
, specialist of the Infectious Diseases Service of the
Hospital Clínic
, member of the AIDS and HIV infection group at
IDIBAPS
and Principal Investigator of the study.
The trial that is being carried out is
randomized
and
double-blind
with the participants being divided into two groups, randomly distributed, so that
25 will receive the Hipra vaccine while the remaining 5 will receive an RNA vaccine messenger
.
And the Pfizer vaccine has been chosen because it uses exactly the same administration schedule in two doses: a first on day 0 and a second on 21 days.
The vaccine is being tested in
healthy individuals
, with an age range
between 18 and 39 years old,
who as inclusion criteria in the trial should not have been vaccinated against covid-19 or have had the disease.
In this
phase I / IIa
of the trial, what is to be evaluated is the safety of the vaccine and its immunogenicity, that is, the cellular response it generates and the capacity to generate antibodies.
The first group of the trial
receives the lowest dose
, and from there
the doses
are
scaled
in the following groups, working with three levels of vaccine.
"Depending on the results, we will define the final dose to use," explained Leal.
An independent surveillance committee monitors the entire trial and precisely one of the objectives of the clinical trial is to determine the optimal dose of vaccine, which is why it is done with a small group of people.
Investment in Science
Morant has also revealed that
Spain has invested more than 100 million euros in research on Covid-19
only in the public sphere, from where 200 lines of research and 100 industrial training projects have been supported. On the other hand, Morant has pointed out that the Government works to "gather the maximum possible consensus so that the law of science goes forward." As explained by the minister,
Spain is below the European thresholds both in the number of scientists and in terms of salaries
.
"We are going to strengthen the infrastructures and research centers both economically and in terms of resources. All this will be done through tools that give stability to scientific careers. We will continue to advance in the law of science, which is also a Citizen clamor. Citizens demand that we increase investment in science and innovation and that we equal ourselves to European rates. That is the great objective, "he said.
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