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The acceleration of Covid-19 on Russian soil is exposing the weaknesses of the vaccine testing process, but it hasn’t stopped Russia from proceeding with an urgent request for authorization from the World Health Organization to initiate the inoculation of Sputnik V.
Cited hair portal sputniknews, Kirill Dmitriev, director general of the State Investment Fund, expressed “gratitude to the WHO for its active cooperation”.
“We hope that the pre-qualification process is successful at all stages”, He added.
Preparation of a dose of the Sputnik V | vaccine Photo: Tatyana Makeyeva – Reuters
In August, Russian President Vladimir Putin described Sputnik V as the world’s first registered coronavirus vaccine with the aim of ending the country’s pandemic.
Currently, according to the Russian authorities, the threshold of one and a half million infections has been exceeded and there are almost 27 thousand deaths.
As the number of cases associated with the second wave increases, the rush to produce an effective vaccine by several laboratories is creating an information and counter-information war.
Russia is accused by the international community of rushing vaccine approval before the third stage tests are completed, to withdraw political dividends.
Production of the Sputnik V vaccine is delayed and the doses administered in stages 1 and 2 do not attest to the efficacy and safety of the drug.
The results of phase 3 are essential to comply with the scientific protocol and, comparing the set of participants in competing pharmaceutical tests, increases the reserve on the safety and efficacy of Sputnik V.Alexander Gintsburg, head of the Gamaleya Institute, which develops the drug, acknowledged that the administration of the last two doses of the trial had covered only six thousand participants to date. Gintsburg says the vaccine is suitable for adults between 18 and 60, as no large-scale testing has been done in the remaining age groups.
The North American competitors have a substantially higher number of tests.
BioNTech-Pfizer, reveals the number of 35,771 people involved in the phase 3 clinical trial and Moderna’s lab speaks for 25,650 participants.
In view of the discrepancy in the protocols followed, Konstantin Chumakov, a virologist with the Global Virus Network, questions the Russian conclusions on clinical trial evidence.
The Russian lab replies that this waiting time was shortened at Sputnik because it was based on existing research for vaccines against Ebola and Middle East respiratory syndrome.
Chumakov recalls that none of the vaccines referred to by the Gamaleya Institute have been fully validated by international organizations and, in the case of Ebola, were only tested in Guinea after the outbreak of the epidemic.
Vaccine doses Sputnic V | Photo: Tatyana Makeyeva – Reuters
For this specialist, it cannot be called a vaccine produced by the Russian laboratory. “They are very good at developing prototypes (…) but I don’t think they have any experience in bringing products to market. They have not produced vaccines for over 30 years. “
After the test vaccine doses have been administered to the participants, Chumakov explains on CNN, it is necessary to “wait until they are infected and see if they will have a lower incidence or if they will have a more serious disease. There is simply nothing that can replace clinical trials. “
Accounting misunderstood
The production of 30 million vaccine doses by the end of 2020 was the intention of the Russian State Investment Fund which coordinates the strategic plan for the production of Sputnik V. This number has been reduced to 2.3 million by the Ministry of Industry and Commerce.
Agreements are underway with India, Brazil and Egypt to supply millions of doses.
Economic gains are in the sights of Putin, who promotes the production of the Russian vaccine as a good investment with the lobby of Russia, according to the news agency RIA Novosti.
Russian President Vladimir Putin, in videoconference with investors | Photo: Sputnik Photo Agency
This business represents a large volume of revenue, but it may be at risk because it depends on the license. In the rush to produce Sputnik V, the Russian lab will have bypassed the standards of scientific practice, which could delay international approval.
The need for standardized methods to compare vaccine efficacy is supported by researchers at the University of Oxford. “It is unlikely that we will have a single winning vaccine in the race against covid-19. Different technologies will bring different benefits that will be relevant in different situations,” said Susanne Hodgson, one of the scientists, quoted in a statement.
The authorities intend to apply the vaccine to the entire community, but the majority of the Russian population says they do not want Sputnik V until the WHO evaluation of the drug’s quality, safety and efficacy has been completed.
The name Sputnik was rescued by the first successful satellite launched in 1957 by the then Soviet Union.
In parallel with Sputnik V, Russia has started the production of two other vaccines: one at the Vector laboratories and the third at the Chumakov Institute.
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