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Sinopharm vaccine: the Government says it is close to approving its use for those over 60

2021-03-24T21:25:39.695Z


The clinical evidence confirmed its safety and a formal process is lacking to advance with the authorization. How it impacts the vaccination plan.


Irene Hartmann

Paula galinsky

03/24/2021 18:10

  • Clarín.com

  • Society

Updated 03/24/2021 18:10

The approval of the ANMAT so that the

Sinopharm

vaccine

against the coronavirus can be used in people 

over 60 years of age

is about to be fulfilled,

a high official source

confirmed to

Clarín

, who explained that “the data has already been analyzed ... the only thing missing is the presentation formal.

They are administrative papers, not clinical evidence ”.

If everything goes as expected and in the face of the

three million doses

of this Chinese vaccine that the Government expects to receive (over the million that has already arrived), the news is a relief, considering the shortage of supplies to continue the immunization of those over 70, before it is too late to face the second wave of infections.

According to the information obtained, "Sinopharm has to complete what was requested", that is, a series of documents requested by the ANMAT, unavoidable to complete the regulatory formalities.

Undoubtedly, outside of the merely administrative, this documentation should include the information from

phase 3 of the trials

, which includes the safety and efficacy data of this drug in its use for people over 60.

The novelty, however, is that the ANMAT already had access to the central clinical data and, arguably, the vaccine is

"virtually" (but not officially) approved for older adults.

A young teacher from La Plata receives the injection against Covid from the Chinese laboratory Sinopharm, for now only approved in Argentina for children under 60 years of age.

/ Xinhua / Martín Zabala

Before the query about the

times and the reasons for the delay

, the consulted source assured that there is simply a "

delay

" due to apparently minor issues.

Among them, the “

translations

of the dossier”, he explained.

Not surprisingly, if one remembers that language barriers also delayed the delivery of papers to Argentina by the Gamaleya Center, producer of the Sputnik V vaccine.

Precisely, if a potential (and early) release of this Chinese drug for use in the most vulnerable population generates enthusiasm (the lethality in those over 60 is around 10% ...) it is due to the known difficulties in the production of vaccines, well below world demand. 

In Argentina, this delay has been translating into almost dropper arrivals of Sputnik doses, the only vaccine against Covid that today is applied to the segment over 70 years of age, not counting the 580,000 doses that arrived from the Indian version of the vaccine. from AstraZeneca (Covishield).

And not counting, it must be said, the small portion that should arrive this weekend from the AstraZeneca vaccine through the Covax fund.

The question is

when the Sinopharm vaccine will be approved in Argentina for people over 60

, some 7.4 million people.

The source consulted assured that "

when the documents arrive, the approval will be very fast

", since there will be no delays in evaluating the data.

Judging by what happened with the Russian vaccine, this approval process could take a day or two, once, of course, the translated dossiers reach the ANMAT.

Vaccination of teachers in the province of Río Negro with doses of Sinopharm.

/ Télam

Asked about this issue, from the Government of the city of Buenos Aires they were expectant of this approval, which would represent a turn in the Buenos Aires and national organization chart, today marked by the shortage of doses.

If the Sinopharm application is expanded, they will finish vaccinating those over 80 and start with those over 70, which in turn could be divided into two subgroups (over and under 75).

On the other hand, if it is not approved and more vaccines arrive from China, they may start with the immunization of those under 60 with comorbidities.

International evidence


From the Government they transmitted that "the evidence is already in other agencies and

the vaccine is already being used for older adults in other countries

."

Although these data are not publicly accessible, they clarified that "there is communication between the different drug regulatory agencies, which have a collaborative network."

Before learning of the prompt expansion of the use of this Chinese vaccine,

Clarín

had spoken with the infectologist doctor Eduardo López, head of the Department of Medicine at the Children's Hospital “Ricardo Gutiérrez” and one of the government's advisers on the pandemic.

In a talk in which he gave his opinion "in a personal capacity", López said that the Sinopharm vaccine should be approved in an emergency and "by analogy" with what other countries did, although the dissemination of phase 3 data on this segment of adults is lacking .

Images of the vaccination of people over 80 years old at Luna Park.

Photo Juano Tesone

“Sinopharm has already completed phase 3, in which they recruited people up to 85 years of age, and they are now in a follow-up stage.

The vaccine has already been approved in 36 countries

and some are using it for older adults, including China, the United Arab Emirates and Hungary, ”he explained.

Regarding the

overall

efficacy

after the second dose, the doctor explained that "it is

79% and protects almost 100% against serious disease

."

It also evaluated that as “there are no studies on the efficacy of applying a single dose or with an interval that exceeds one month, it is not advisable for people to receive the first dose and defer the next one, as is being evaluated with that of Covishield- AstraZeneca, based on the experience of the United Kingdom ”.

Regarding the

safety

of the Sinopharm vaccine, López provided reassurance: “

Less than 0.1%

of those vaccinated presented notable side effects such as fever;

and only 2 out of a million people suffered from severe symptoms such as allergies ”.

“We have to hurry to vaccinate the elderly because the situation may get worse: the Manaus variant is circulating communally in Brazil and we already saw that it reached Uruguay.

This mutation has high transmissibility and evades the immune system more easily ”, warned the doctor.

And then he concluded: “Winter is approaching and with low temperatures the chances of contagion increase.

People gather in closed and poorly ventilated environments and there are studies that show that the virus is more viable in the cold ”.

Source: clarin

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