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Who is crushing the Sputnik vaccine?

3 years ago babelfish

Who is crushing the Sputnik vaccine?

From Brazil to Italy. Where and how the Russian Sputnik vaccine finds opposition and progressive mistrust. Burioni's comment

Difficult days for the Sputnik Covid-19 vaccine. The drug developed by the Galameya Institute seems to have serious problems in Brazil: Anvisa, the country's health authority, said that the drug has "inherent risks" and "serious defects" in its composition.

Even Italy, which until now seemed particularly interested in the Russian antidote, is holding back. "It is useless to ask Aifa to intervene for Sputnik," said General Francesco Paolo Figliuolo, emergency commissioner.

Here are all the details.

WHAT SON SAID

Let's start with the statements of General Figliuolo. "Different types of vaccine perhaps were needed a few months ago", now that we have enough vaccine doses, "it is useless to ask Aifa somewhere to intervene for the purchase of Sputnik", said Figliuolo in recent days, visiting a vaccination center in Gemona.

SPUTNIK: DOSSIER OPEN

"Aifa intervenes on the basis of what Ema decides", recalled the extraordinary commissioner, also specifying that "the dossier on Sputnik is not yet complete" and that "there is no pharmacovigilance network".

RUSSIA POSTPONES INSPECTIONS

And not only: "The manufacturing company has postponed the inspection visit to the production sites".

"I am not a technician but citizens need to know this otherwise good information is not provided," added Figliuolo.

THE WORDS OF MARIO DRAGHI

These words represent a brake on what Mario Draghi said just a few weeks ago: “European coordination is the first way to look for vaccines. If the EU continues on Sputnik well, otherwise it will proceed in another way. European coordination must be sought with pragmatism, if it is not possible to maintain it, other ways can be seen ”.

WHAT HAPPENS IN BRAZIL

Meanwhile, there is no comforting news on the vaccine from Brazil.

In recent days, Brazil's National Agency for Health Surveillance (Anvisa) has rejected the request of some Brazilian states that had proposed to import and use Sputnik V.

SPUTNIK: COMPOSITION DEFECTS

The reason? The serum would have important manufacturing defects. Anvisa would have identified viral particles capable of replicating. And this would represent a serious health risk, with particular reference to immunosuppressed people.

THE SPUTNIK VACCINE V

Let's take a step back. The Sputnik V vaccine, like that of Astrazeneca and Janssen, is composed of adenoviruses. In the case of the Russian drug, Il Post specifies , the adenoviruses used are Ad26 for the first administration and Ad5 for the second.

Adenoviruses replicate naturally in the human body, but when used for vaccines, the ability to replicate must be neutralized. This, however, does not happen in the Sputnik vaccine, according to the Brazilian agency.

THE BRAZILIAN INVESTIGATIONS

Brazil, before ruling, sent Anvisa inspectors to Russia in early April to examine seven factories where the Sputnik vaccine is produced, but it only had access to three of the sites, and was denied access to it. Gamaleya Institute of Epidemiology and Microbiology in Moscow, according to the Brazilian online news portal G1.

INTRINSIC RISKS

And just taking into account the few data acquired during the inspections in person and the documents presented by Russia, Ana Carolina Marino, director general for health monitoring, said that the "inherent risks" of administering the vaccine were too great.

DEFECTS IN DEVELOPMENT

In particular, explains the Brazilian Agency, “according to GGMED, defects in product development have been identified in all phases of clinical studies (phases 1, 2 and 3). There is also an absence or insufficiency of data on quality control, safety and efficacy. One of the worrying information regarding the evaluation of the data available so far is that the cells in which the adenoviruses are produced for the development of the vaccine allow their replication ”.

ANVISA: RISK OF SERIOUS INFECTIONS WITH SPUTNIK

What are the risks? "This can lead to infections in humans and can cause harm and death, especially in people with low immunity and respiratory problems, among other health problems," explains Anvisa, adding that "This aspect deviates from the quality standards recommended by the 'World Health Organization (WHO) and the International Council for the Harmonization of Technical Requirements for Medicinal Products for Human Use (International Council for the Harmonization of Technical Requirements for Pharmaceuticals for Human Use – ICH), followed by the leading agencies regulation of the world, including Anvisa ".

ANVISA: INADEQUATE SPUTNIK STUDIES ON

The Brazilian Health Authority also denounces "inadequate characterization studies of the vaccine, including as regards the analysis of contaminating impurities and viruses during the production process, in addition to the lack of validation / qualification of quality control methods, among many others wait ".

THE JUDGMENT ON THE INSPECTIONS

Regarding the inspections, Anvisa underlines: "the lack of a technical approval report for the product has culminated in the need for a face-to-face inspection to allow the assessment of the production conditions of the companies involved in the production of the pharmaceutical-biological precursors and the vaccine. . During the visit, no production conditions were identified that demonstrate that the products are constantly manufactured and checked, so as to obtain a product with the quality required for the intended use ".

WHAT BURIONI SAYS

“Sputnik's problem appears to be serious. The vaccine should consist of a virus that is unable to replicate, while all the samples analyzed in Brazil contained viruses that were capable of replication. The unanimous rejection is not surprising ", comments the virologist Roberto Burioni on Twitter, also launching an assist to Walter Ricciardi, who replies:" and all the phenomena that wanted to bypass Ema and inoculate millions of them without adequate checks and controls? ".

PURPLE: EVEN SERIOUS CONSEQUENCES

Of the same opinion the immunologist Antonella Viola, who in the Corriere della Sera states: "If the adenovirus replicates it can cause infections that can be serious in immunocompromised subjects".

This is a machine translation from Italian language of a post published on Start Magazine at the URL https://www.startmag.it/sanita/chi-sta-stritolando-il-vaccino-sputnik/ on Thu, 29 Apr 2021 14:32:23 +0000.