European Medicines Agency begins data inspection of Sputnik V vaccine in Russia

The government of the European Union seeks in these hours clear proof of the effectiveness of the vaccine against COVID-19, Sputnik V. The comings and goings around the inoculant of Moscow is today a debate which goes beyond the scientific questions: it presents itself as an obstacle which divides the cohesion of community partners, not only in the area of ​​health, but which has also led to deep deviations from greater national autonomy.

The latest failure around the Russian vaccine was the recent decision of the Slovak health authorities, who recommended not to administer the doses received from this development, reporting erroneous, confusing, incomplete and inaccurate product information Arrived with the seal of the Gamaleya Institute.

In a report, the Slovak regulatory body argued that the material provided was not identical to that described in the medical journal The Lancet, which confirmed 91.6% efficacy for Sputnik V. On April 8, he reported that it was not identical to that provided to the European Medicines Agency (EMA), currently evaluating the possibility of authorize its application in the European Union.

Under pressure from the European drug regulator, even after the linking of two other authorized products, that of AstraZeneca / Oxford and Johnson & Johnson, with rare cases of thrombosis, the agency must carefully consider the strengths of the Russian vaccine to include it in its vaccination plan, but also guarantee quality and quantity with production on community land.

A delegation of EMA experts visited Russia on Saturday to examine data on the Russian vaccine Sputnik V, and to raise doubts, during a visit which should shed light, between political speculation and guarantees of scientific efficiency.

“This inspection seems to me and seems absolutely necessary“PPE MEP Nathalie Colin-Oesterlé, member of the European Parliament’s public health committee, told Franceinfo. The visit of the EMA expert delegation should “Will last one to two weeks», According to the parliamentarian.

In accordance with the doubts raised by the Slovak case, the MEP argued that “between the doses delivered and the doses used for clinical trials, there seems to be a lack of conformity”.

“The question that arises today concerns not only the components of these vaccines, but also the production capacities”, explains Colin-Oesterlé. According to information from the European press, the EMA dispatched inspectors to the sites to verify compliance with international standards and good practices, both in terms of clinical trials and in terms of manufacturing.

“We will not have a Sputnik V on the territory [si se aprueba] for four to six months, until it is approved, when the marketing authorization arrives, ”said Colin-Oesterlé. “In any case, it can only be a complement. It cannot replace what has been reserved, ”concluded the MEP.

Will you be able to overcome doubts?

For the EMA, inspecting a manufacturing site is a common and necessary step in the assessment of any drug application within the EU..

“The EMA has a legal obligation to verify that the manufacturers of medicines for which a marketing authorization is requested in the EU comply with good manufacturing practices (GMP)”, specifies the regulator.

The scope of the inspection was recalled by the director herself, Emer cooke, when announced the inspection of manufacturing sites in March. In addition officials arriving in Russia should check results at clinics that tested the vaccine to verify adherence to good practice clinics.

Despite the pressure, which increased after German Health Minister Jens Spahn’s claims about negotiations for Germany to have the Russian vaccine, the agency maintains the idea of ​​not publishing the results of its inspections until the entire assessment process for authorization has been completed.

Beyond all these steps, Hungary, Austria, the Czech Republic and Slovakia have decided to use the Russian vaccine without waiting for its validation by the European Medicines Authority, which cannot take place “before the end of June”, according to an official at the State Secretariat for European Affairs.

In the rest of the member countries, mistrust of the Russian vaccine is present. On March 17, five MEPs sent a letter to the EMA underlining these doubts., claiming that Russia has repeatedly demonstrated that it is “more than willing to participate professionally in the large-scale politicization and falsification of medical and scientific data when it serves its purposes“.

Parliamentarians recalled the many Olympic doping scandals in Russia, as well as the poisoning of opposition figure Alexei Navalny, as proof of this claim.

Recently, Europeans added to the discussion the demand for a reduction in military build-up in the region around eastern Ukraine, which includes Chancellor Angela Merkel’s request during a phone call to President Vladimir Putin a few hours ago. Here, open questions about the vaccine’s effectiveness and political tensions with Russia intersect again.

Peter Liese, spokesperson for conservative European People’s Party (EPP) health policy in the European Parliament, also called for a more detailed evaluation of the Russian vaccine.. “I can very well imagine that it works, that it offers good protection and has reasonable side effects. Yet this has not yet been proven, as it has never been fully inspected, ”he told DW in Germany.

No more confusion

Confusion also needs to be clarified in the scope of partner states to acquire vaccines outside of the block. Without permission from the regulatory agency, the European Commission (EC) said a few days ago that regions in the European Union (EU) can purchase coronavirus vaccines that are not part of the strategy community injection, like Sputnik V Russian, depending on the institutional framework of each member state.

The Brussels Community Government has spoken in this regard after learning that the Community of Madrid had entered into discussions with the suppliers of Sputnik V two months ago to reach a pre-purchase agreement. When the Madrid negotiations became known, dozens of independent contacts began to give rise to the agreements of the authority of the European Community. Another example is the Catalan autonomous government, which, apart from the negotiations of the federal executive headed by Pedro Sánchez, made contact with the Pfizer laboratory.

“If a vaccine is not in the EU vaccine portfolio, member states may decide to purchase it. Whether the regions can acquire it depends on the institutional structure of that Member State, ”said Health spokesperson Stefan De Keersmaecker.

Coming back to the scientific validation of the vaccine development of the Gamaleya Institute, lThe inspectors should check what information is available on the effectiveness of this injection if a single dose is applied, if it can be alternated with other vaccines for cases of thrombosis and finally its ability to stop the variants that predominate today. hui in Europe., all questions that currently do not have a clear answer in scientific publications describing the product promoted by Moscow.

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