Irene Hartmann
09/09/2021 17:22
Clarín.com
Society
Updated 09/09/2021 17:22
This Wednesday, in an interview on Miter radio, Fernando Polack, a respected pediatrician at the Infant Foundation and who led Pfizer's voluminous local phase 3 study against Covid, surprised by announcing that the investigation (also phase 3) of "an adult triple viral vaccine", which would conjugate
coronavirus, flu or influenza, and respiratory syncytial virus
(the main cause of bronchiolitis). In these lines, the specific details of that development.
Clarín was
able to speak with
Gonzalo Pérez Marc
, a pediatrician at the Infant Foundation, who outside of that institution has been working “in tandem with Polack” in the direction and coordination of several phase 3 studies in the Military Hospital environment.
The laboratories ask them;
they enroll, specify, follow, review and process the results, to summarize what is really a meticulous, complex and very well-guided research process.
The first thing that emerges from the talk is that
there is, in particular, no MMR vaccine to be tested
.
It is a project in a folder that Pérez Marc defined in a suggestive way: “It is a program that
we sense is going to happen
”.
Gonzalo Pérez Marc, the pediatrician who directs the first phase 3 study of an mRNA vaccine against respiratory syncytial virus.
But
there is news to tell and it is not minor
: in November
a phase 3 study will
begin (and they are already recruiting volunteers of more than 60 years through
www.vacunas60.com
) to overcome the most difficult challenge of this auspicious project "triple ": the
vaccine against
respiratory
syncytial
(or syncytial, it is the same) virus, also called by its acronym, RSV.
"At least there will be
3,000 people,
" said Pérez Marc, referring to the volunteers they hope to get, adding: "The idea is that they are over 60 healthy.
In other words, there are always risk factors at that age, but people without serious illnesses ”.
As is often the case in these cases, the doctor, for confidentiality reasons, could not reveal the name of the laboratory.
"They are the main
American laboratories
," he outlined before clarifying a clue that leads to a certain target: "The platform will be
messenger RNA
."
But, for the vaccine announced by Polack to materialize, an
mRNA flu vaccine
should also be approved
, a product that - apart from those known against Covid - does not exist.
For Pérez Marc, "phase 3 of such a vaccine will surely begin in the
first quarter of 2022
", since "several laboratories have studies against influenza A in phase 2," he said.
Adding the “Covid” leg of the mRNA platform (in phase 3 and with authorization for emergency use in most of the world), the doctor estimated that
the triple viral for adults could appear in two years
.
Studies in focus
Still,
getting a syncytial virus vaccine is a challenge in itself
.
Pérez Marc clarified that the one they will test will be
a single dose
and that it will not require the very low temperatures that other mRNA vaccines are known to require.
As for the study that will begin in November, it will not be the first of its kind to be carried out by this doctor.
Already in 2019 he coordinated the investigation of a Novavax vaccine (with funding from the Bill and Melinda Gates Foundation) against RSV, aimed at pregnant women, so that they could pass the antibodies to the fetuses through the placenta.
"In Argentina, the efficacy results were good, 68%, but the global study was below 40% and the vaccine was finally not approved," he recalled.
Now,
why give an RSV vaccine to older adults?
Children with nebulizers due to an epidemic of bronchiolitis.
Photo David Fernández
This
respiratory infection
is associated with children under two years of age, especially newborns, a population with a higher prevalence to develop bronchiolitis as a consequence of RSV.
In fact, these days there is an outbreak in Argentina and there is no vaccine or treatment to combat it (antibiotics do not work for viral diseases), beyond the monoclonal antibody palivizumab, which is used in very specific cases.
What is not very widespread is that
adults can also contract RSV
, although its symptoms are often mistaken for a cold or flu, terms that until the "Covid era" we used erratically.
“Today there is a revolution in vaccines aimed at older adults.
The population is aging, so the demand on the health system is greater.
The revolution aims precisely to
cover respiratory viruses that strongly affect risk groups
”, Pérez Marc stressed.
Taken
together, the
Covid-influenza-RSV triad
speaks of respiratory infections that "generate
similar damage
in these populations."
That is to say, those who are on the margins of life.
Childhood and old age
.
Special profile
Minutes before the talk with
Clarín
, Pérez Marc was skateboarding.
He went to the Military Hospital, where he spends a good part of the day: he coordinated with Polack ("
I run the studies, he participates in the overall design and organization
") the research with the Pfizer vaccine, which recruited 6,000 people, and that of the famous plant vaccine from the Medicago laboratory, which enrolled no less than 8,000 volunteers.
He also directs "another seven Covid and non-Covid clinical studies, for different types of treatments."
In Mendoza, they apply the Moderna vaccine to complete schemes against Covid to older adults.
Photo: Ignacio Blanco / Los Andes
You don't have to talk much with this 44-year-old doctor to understand his freshness, marked by a peculiar - and not so frequent in a doctor - eclecticism.
Far from just dealing with tedious pharmaceutical contracts and patient sheets bombarded by the fine print of "informed consent", Pérez Marc is a scholar who calls himself
restless about the "subjectivity of the patient
."
A postponed subjectivity.
Crushed, even.
He is a pediatrician, trained in Sports Medicine and
is in the last year of his degree in Philosophy from the UBA
.
In addition, he is doing a master's degree in Bioethics.
And he is close to finishing his doctorate in medicine.
The subject of his thesis is eloquent.
Right in the middle of a pandemic like this: "
The identity of the sick subject
."
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