Pablo Sigal
05/05/2021 6:01 AM
Clarín.com
Society
Updated 05/05/2021 6:01 AM
Two days after the Pfizer laboratory presented the request for registration of its vaccine against Covid-19 at ANMAT,
the Belgian laboratory Janssen
, a subsidiary of the American corporation Johnson & Johnson, did so. Pfizer's process began on December 5, 2020 and Janssen's on December 7. The Pfizer vaccine was approved
in record time
(17 days), while the Janssen
vaccine is
still awaiting
approval
in Argentina.
Five months have
passed
since that presentation.
There is another fact that "sister" to these two vaccines: like Pfizer, Janssen
conducted part of its phase 3 trial in the country
.
The protocol was approved by the ANMAT on August 13.
The principal investigator was Mercedes Deluca, from the Stamboulian Center for Infectious Studies.
The Johnson & Johnson Vaccine
It was passed
in the United States, by the FDA, on February 27;
for the European Union, on March 11;
and by the World Health Organization, on March 12.
On April 13, it was suspended due to the appearance
of thrombosis
.
At the end of the month it was announced that these conditions were rare and immunizations were resumed.
The only country that decided to permanently eliminate it from its portfolio was Denmark.
Named
Ad26.COV2.S
, Janssen's vaccine is used in Austria, Belgium, the Czech Republic, France, Italy, Hungary, Latvia, Lithuania, Poland, the Netherlands, Spain, South Africa, and the United States.
It was the
fourth company
to initiate Phase 3 trials in the US, after Moderna, Pfizer and AstraZeneca.
The latter has not yet received authorization in that country.
The Janssen vaccine uses a
human adenovirus
as a vector for its immune architecture.
Its peculiarity is that, unlike the most popular vaccines that circulate on the market, such as Pfizer, Moderna, Sputnik V, AstraZeneca and Sinopharm, this one is applied in
a single dose
.
Janssen vaccine vials.
Photo: DPA
Phase 3 results based on
39,000 patients
were published April 21 in the New England Journal of Medicine.
The level of effectiveness is
somewhat below that
achieved by the other vaccines mentioned: in global trials it has reached an average immunity of
66.9 percent
within 28 days of its application.
At the same time, it showed an
85 percent
efficacy against severe disease, although a diminished power against the South African variant, which has not been detected in Argentina for now. Its single-dose format makes it attractive, especially for
distribution
logistics
. It is also the preferred by vaccine tourism, like the one favored by the United States.
Clarín has
been following the fate of the Janssen file in Argentina. ANMAT's response on March 12 had been that the health regulator continued to incorporate information requested from the laboratory, "sequentially", in order to make a decision. After almost two months without news, a new and concise official response to this medium arrived: "The company is still in the
process of adding information
."
Hermeticism prevails from the laboratory.
Nobody wants to explain why the approval process in Argentina has far exceeded the deadlines registered by the
main centers of reference in
the world.
The case also draws attention due to the contrast with the speed that other vaccines had to receive authorization in the country, or the recommendation to the Government to approve them.
The Ministry of Health has said more than once that Janssen is among the laboratories with which
a possible new purchase of doses
is being sought
, in a context in which the country is running out of few vaccines to continue with its national operation.
Presidential adviser Cecilia Nicolini stated a few days ago that these talks are advanced.
Perhaps in that negotiation, of which no concrete results are known for now, lies the
reason for the delay
in approving the vaccine, although a priori it seems a contradiction.
Pressure regulator
A source in the pharmaceutical industry, who has ties to Janssen and preferred anonymity, speculated that this delay could be linked to
"taking pressure off the government."
In other words, strictly technical matters would not be a stumbling block: "It has shown good efficacy and the problem of thrombi is not significant,"
the infectologist Eduardo López
explained to
Clarín
when consulted.
The interpretation, strictly political then, would be that if ANMAT
had already published
the authorization of the vaccine in Argentina, this would have generated an expectation that would probably be
difficult to be satisfied
in the short term. In fact, as this media learned, any commitment that Janssen would be willing to sign at this point in the pandemic would be for the
second half
of the year.
However, one piece of information could play
in
Argentina's
favor
: the rejection of part of the US population to be vaccinated.
It has been known that some governors of that country seek to attract "rebellious" citizens in the most heterodox way, with free beer and marijuana, for example, or directly with cash, in order to get them immunized.
There could be
an unemployed demand and usable
by other countries lacking doses.
Preparing a dose of vaccine with a Janssen vial.
Photo: ANSA
The need to
articulate
the authorization of the Janssen vaccine in Argentina with a possible purchase contract could be a
reasonable argument
.
In the case of the Pfizer vaccine, that timing did not work, as reflected in the chronology of events that took place towards the end of last year.
Just
a week
after Pfizer submitted the request for the registration of its drug to ANMAT, President Alberto Fernández announced the
agreement
with the Gamaleya Institute, of Russia, for 20 million doses.
The negotiating table with the American laboratory had entered the threshold of failure.
There, then, the paradox arose that the first vaccine authorized in the country (Pfizer)
had no chance
of landing in Ezeiza, while Sputnik V had a signed contract without still having the papers in order.
If Janssen seeks to
avoid this predicament
, it would not be strange that the bureaucratic and commercial authorities go hand in hand.
$
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