why the WHO and the EMA do not approve it

“Fascination and controversy“Are the names chosen by the respected magazine Nature introduce a dedicated analysis of the coronavirus vaccine Sputnik V, which this 152-year-old English scientific publication asks: Why the World Health Organization (WHO) and the European Medicines Regulatory Authority (EMA) they haven’t approved it yet?

The subject is of capital relevance in Argentina (one of the 69 countries where it is approved), first of all because it was one of the first countries where the word “Sputnik” was even heard. In addition, it was the second nation (behind Belarus) where the vaccine began to be applied.

And it is the brand that walks the strongest here: on July 4th they almost arrived 11.3 million doses of the Russian vaccine, against nearly 9.6 for AstraZeneca and around 6.8 for Sinopharm.

When you think of “fascination“Two images come to mind:

1) The President of Russia, Vladimir Putin, announcing the launch of the first vaccine against Covid-19 of the world, even before large-scale studies in humans began.

2) The press release confirming the effectiveness of the 91.6% against symptomatic Covid infection.

“Controversial“On the other hand, remember those days at the end of 2020 and the beginning of 2021 when the chapter” Sputnik “ in Argentina, it was held in a worrying lack of data which raised various questions, beyond the authorities who reassured them by claiming to have reviewed the data, on the step the producing factories, that everything was “in order”.

But anyone who attended a press conference with authorities at the Gamaleya Center and the Russian Direct Investment Fund (RDIF) will understand the “controversy”. In these meetings sometimes a informal unusual for the scientific and pharmaceutical field.

Affirmations without too much detail, hyperbolic exclamations and almost no chance to ask make a style that clashes. Or maybe the announcements are made on Twitter, no proof.

Promises that have not been kept with phrases like “very soon we will publish everything in a major scientific journal“Were also common at one time.

However, the intermediate data of step 3 they finally appeared in February. And in April, a press release announced a very high efficiency: 96.7% with two doses.

These contrasts (which in Argentinian culture are dailies) make it surprising that a magazine like Nature dedicate the main note of your site, this Wednesday, to the controversial Russian vaccine. And to do it with an optimistic title: “Growing evidence suggests Sputnik COVID vaccine is safe and effective”.

As he explains Nature that WHO and EMA failed Sputnik’s approval months ago?

Arguments

Nature it does not take a position on the statements it disseminates: it attributes them to “the environment”.

“Some scientists say this and that “they explain. Due to the seriousness of the medium, it is assumed that these sketches are supported by qualified sources. unofficially.

Among the episodes that could have hindered the international approval of Sputnik, they mention, in the first place, when in September The Lancet released phase 1 and 2 vaccine data and a group of scientists came out to oppose the authors for the lack of data provided.

What really happened was that after the publication of this first article, almost 40 scientists British, American, Canadian, Italian, Swiss and Japanese institutions signed a letter detailing their observations: disorder and inconsistency in the presentation of data.

Then, beyond the fact that several countries have added the vaccine to their portfolio and even produce it (like Argentina), Nature recovers that in April, the National Agency for Public Health Surveillance (Anvisa) from Brazil rejected import of Sputnik, contesting its quality and effectiveness.

The measure, it is true, was canceled in June, but emergency use is only permitted in healthy adults. And Anvisa is one of the most respected agencies of its kind in the world.

The core

So far we have a behavior informal, which would sometimes lead to a inconsistency data and a mistrust of respected organizations, a product, perhaps, of the first.

Two other subjects he mentions Nature maybe explain more fully why the WHO did not give the green light to Sputnik, but yes, for example, to Sinopharm, even before they released interim Phase 3 data.

The first problem concerns the Sputnik production plants. “WHO has requested more data from the Gamaleya Institute and the agency’s inspections of Russian vaccine manufacturing and clinical trial facilities are ongoing,” he adds. Nature.

The problem is that although “so far nine sites have been inspected, WHO has noted concerns about one of the plants manufacturing “. This topic, as reported Bugle, it would already be being repaired by Russian developers.

The second belongs to the famous esaV, adverse reactions allegedly attributable to vaccination and immunization. The concern of the WHO and the European agency stems from the little vigilance Russian health authorities.

Do you think there is more neglect or concealment of data? No. The question depends on the Russian population’s lack of support for vaccination.

According to the newspaper The New York Times, as of June 30, only 23 million Russians, the 15% of the population, they had received at least one dose.

And a survey by the independent Levada Center reported this year that 60% of Russians do not want to be vaccinated, which complicates monitoring. And, even more, stop the pandemic there.

However, the time that WHO and EMA will take to give the Sputnik vaccine a “thumbs up” stay uncertain.

MG