10/19/2020 8:55 AM
Clarín.com
Politics
Updated 10/19/2020 8:55 AM
Hopeful but measured.
This is how the Buenos Aires Minister of Health, Fernán Quirós, showed himself during his usual press conference, noting that "between November and December" the results of the main phase 3 vaccines against the coronavirus will be known, a key step to combat the pandemic .
After the national minister, Ginés Gonzáles García, indicated that "in March we will be able to have the vaccine en masse," Quirós considered it "good news", but preferred prudence.
"The national Health Minister has been talking with the manufacturers and they have given him a certain guarantee that for the month of March there could be some local production of a certain magnitude, so it seems to me that it is good news," the official replied, before the consultation of journalists.
Anyway, he said it is necessary to wait for the results of the third phase: "Of course, for that to be effective,
the phase 3 studies will have to show that these vaccines are effective
in terms of decreasing acquisition or severity of the
disease.
disease".
Those results, he said, will arrive before the end of the year: "
Throughout November and December we will find out the results
of phase 3 studies of the main vaccines and from there we will see which of them are capable of producing and local access. It is important to wait for this information to see the path we are going to travel. "
On Sunday, González García had indicated that the vaccine could be in March, but explained: "Among the seven or eight that are in the first line, we are negotiating with five of those. There are three that are doing phase 3 trials in our country, and one will be manufactured here. But the exact date is not known by the manufacturers themselves, since they do not know when it will be approved, "he said.
However, Ginés clarified that the problem is not when, but how many, since after obtaining the vaccine, what the minister called "stage three, which is the logistics of a massive vaccination," will arrive.
What are the phases prior to launching a vaccine?
From the Argentine Chamber of Medicinal Specialties (CAEME), which brings together foreign laboratories in the country, they explain that "clinical pharmacological research (clinical studies) is an activity that encompasses four phases, which begins when a drug has already completed animal and in vitro tests have shown that its efficacy, safety and quality can be evaluated in people. "
The first stage, or phase 1, is carried out in a small group of people and seeks to evaluate the safety profile, that is, basically the adverse effects that a drug can have.
If it is shown to be safe, it goes to phase 2, which is done in a small group of patients, and although it continues to measure safety, here we already seek to verify its effectiveness and also what are the doses that work.
Then comes the litmus test for a drug: phase 3 that Quirós spoke about.
This stage of the trial also measures efficacy and doses, but
it is already done with a much larger population
(usually thousands of volunteers) and it is also sought to have a variety of population profiles, to evaluate the drug in different age groups and ethnic.
If this study has positive results - many of them published in scientific journals - the regulatory authorities advance with the approval so that it can be commercialized.
In these trials, volunteers are divided into two groups: one receives the drug and the other a placebo, a similar product but without therapeutic effect.
Neither the volunteers nor the doctors know what they are receiving (it is randomly assigned by computer) to ensure transparency of the study.
Once the product is on the market,
phase 4 continues
, which has to do with studies and monitoring of pharmacovigilance in the case of the report of new adverse effects or contraindications that had not been determined in the previous phases.
On education and kindergartens
In another section of the conference, the Buenos Aires minister was consulted about the
protests in the nursery schools
and the problems faced by parents with children of that age.
"We fully understand the economic situation of the gardens and the situation of the children, they are the dilemmas that must be managed every day. We are working with Minister Soledad Acuña on the protocols and ways to accelerate their return. As soon as we are in conditions we are going to advance rapidly, "analyzed Quirós.
Regarding the return to classes at the primary and secondary levels, Quirós was "proud."
And he added: "We are all proud and happy of the step we have taken. Of course we intend that as epidemiology improves, to take successive steps. It is an essential path, perhaps the most important, to advance in a prudent and careful in relinking the educational system with children ".
The return to the classroom at the Eduardo Latzina Technical School No. 35, in Villa Real.
Photo Mario Quinteros
In this regard, he concluded: "We continue working with groups that have not yet found a sufficient solution and we are working to see how to provide it."
With a strict protocol and small groups, the City resumed classes last week with educational accompaniment activities for 7th grade (primary) and 5th grade (secondary) students in public school playgrounds.
From the Buenos Aires Government they clarified that it is not a return to classes, but educational activities.
And that it will be progressive, starting with the schools that are already more prepared and continuing with the rest.
They estimate that in two or three weeks they will cover all the public schools in the City.
JPE
Look also
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Ginés González García: "In March we will be able to massively have the coronavirus vaccine"