The dengue vaccine from the Japanese laboratory Takeda
has been waiting for 17 months at ANMAT
.
In the last few hours, given the largest outbreak of dengue in Argentina in the last three years, the government let it be known that the approval of the drug would be imminent.
However, there were no further details.
Medical sources that follow the approval process closely said Tuesday, consulted by
Clarín
, that the approval would arrive
"before the end of the year
. "
The version also circulated that it could happen in August.
In any case, it would already
be too late
to deal with the wave of dengue that skyrocketed in March and would continue to rise at least until the end of May.
Takeda submitted the request for approval, at the same time, in much of the world.
Europe has already authorized it
and the United States would be close: in November the FDA gave priority to its review.
There is another vaccine against dengue, from the Sanofi laboratory, which was approved twice by ANMAT, the first in 2017 and the second in 2020. On the second occasion it was restricted only to those people who already had the disease
once
.
Despite the approval of the health agency, the drug
is not available in the country
.
The vaccine is called Dengvaxia and its use is indicated for people between the ages of 6 and 45 who
have already developed antibodies
to at least one strain of dengue.
Aedes aegypti mosquito larvae.
Each female lays about 700 eggs during her adult life, which lasts for a month.
Photo: Reuters
That universe in the City of Buenos Aires, for example, means around
12.5 percent of the population
, according to a seroprevalence study carried out in 2022 by Conicet researchers.
Those who have never been infected with the virus transmitted by the
Aedes aegypti mosquito
cannot use this vaccine
because, it has been found, they could be victims of a serious condition if they contract the disease again.
For this reason, although the drug had been approved in the first instance in the country in March 2017, then there was a change in the prospectus that narrowed the universe of possible vaccinated and that deserved a new approval from the ANMAT in June
2020
.
Those comings and goings would not have played in favor of the Sanofi vaccine.
To this was added that the final approval was given in
the middle of the pandemic
, when the concerns were focused on the Covid.
Tools against the dengue outbreak
Now there is a
new outbreak of dengue in Argentina
, with more than 16,000 confirmed cases and 14 deaths, so the possibility of having a vaccine against the disease is once again relevant.
A presentation of the quadrivalent dengue vaccine (against the four serotypes), approved by ANMAT but not available.
Photo: AFP
Brazil approved the Japanese vaccine a month ago, which is 80 percent
effective
and prevents
90 percent of hospitalizations
.
And the ANMAT, if the reports are true, would be finalizing the details to announce the same sooner rather than later.
There are
three key differences
between the Takeda and Sanofi vaccines:
1-
Takeda's is
two doses
with an interval of three months and Sanofi's is
three doses
with six-month intervals.
2-
The
age target
in the case of the Japanese is broader, since it extends up to 60 years, instead of 45.
3-
To receive it,
it is not a condition
to have had dengue at least once, with which the coverage is amplified.
In any pharmacy in the United States, the Dengvaxia vaccine (which requires a
serological study
to confirm that the person indeed had a previous infection) is offered for
$120
.
In the region it is only available in Paraguay.
Why is it not available in Argentina?
According to sources from the pharmaceutical industry, “there was no demand for vaccinations.
In addition, the supply process is not immediate, since
planning to provide it takes several months.
As long as there is demand, it can be available”, they explained.
Detail of a larva of the Aedes aegypti mosquito.
Photo: EFE
The World Health Organization recommended its massive use in areas where the seroprevalence of the virus is
greater than 70 percent and not less than 50
.
Argentina is far from that.
However, there is the option of using it in a personalized way.
The drug is approved in 30 countries.
It would be in the case of people who have already been infected with dengue once and who, in the event of a
second infection,
are at greater risk of suffering a serious condition, such as dengue hemorrhagic fever.
How many could it benefit?
How many people in the country could apply the Sanofi vaccine?
According to research by Conicet scientists led by Diego Flichman, published in the Journal of Clinical Virology in February 2022,
one in four
inhabitants of the Buenos Aires metropolitan area developed antibodies to dengue.
That is, at some time in his life he had the disease.
The work entitled "Epidemiology of dengue in Argentina: seroprevalence of antibodies in blood donors and circulating serotypes" was based on the analysis of
1,530 blood samples from 12 banks
in the center and north of the country.
The results of the study revealed the proportion of the population that has antibodies against dengue and, in addition,
which of the four serotypes of the virus circulated
during the last major outbreak of 2020. This last data is key to weighing the risk that exists suffer from the severe form of the disease.
Laboratory analysis for the detection of the dengue virus.
Photo: Reuters
The study concluded that 24.5% of the inhabitants of the AMBA over the age of 18 had dengue, and that in 2020, two serotypes circulated in this area: 42 percent were DEN-1 and 56 percent were DEN- 4.
It should be noted that this year
the largest currency in circulation is DEN-2
(in 10 jurisdictions) followed by DEN-1 (in seven jurisdictions).
Of all the dengue viruses, serotype 2 would be the one that most frequently produces
severe cases
, according to comparative research from the Center for Research in Tropical Diseases, of the Industrial University of Santander, in Colombia.
The historical prevalence of antibodies against dengue in the AMBA exceeds that of Corrientes (20.4%), Córdoba (12.7%), Tucumán (10.7%), Entre Ríos (7.7%), Santa Fe ( 7.3%), or Chaco (7.1%), among others.
Only Misiones (27.5%) and Santiago del Estero (27.0%) have higher prevalences.
The efficacy and safety of the Dengvaxia vaccine were evaluated by the ANMAT.
The report says that it "demonstrated, in studies carried out in populations with high seroprevalence, that it could
prevent two thirds of dengue cases
caused by the four serotypes."
It adds that "in efficacy studies conducted in 10 endemic countries in Latin America and Asia, it also
prevented 8 out of 10 hospitalizations
and
93% of severe cases
of dengue, such as the fatal hemorrhagic form of the disease, during the follow-up period." of 25 months”.
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