Russian vaccine: the government asked the ANMAT for an “emergency authorization” to apply Sputnik V

he Ministry of Health presented to the National Administration of Drugs, Foods and Medical Technologies (ANMAT) an order for “Emergency authorization” Russian vaccine against the coronavirus, Sputnik V, with the aim of speeding up procedures so that they can begin to be applied as soon as the first doses arrive in the country.

The portfolio led by Ginés González García made the request this Friday, and the agency has 30 days to issue, a process similar to that implemented by governments such as the US and UK.

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The objective is to speed up the administrative procedures given the seriousness of the global epidemiological situation and to try to avoid the second hello cases of coronavirus.

ANMAT has the power to grant emergency authorization for vaccines or medicines in the event of exceptional health situations, such as that experienced with the COVID-19 pandemic.

“In an emergency or when sanitary conditions make it necessary to develop vaccines or for which the availability of safety and efficacy data is reduced, they may be authorized in accordance with the specific procedure established by this Administration in order to ‘assess risk / benefit for the availability of this vaccine within the framework of the strategy established by our country, ”maintains the organization.

Previously, on November 2, the HLB Pharma Group laboratory had submitted the documentation to ANMAT to register the vaccine and thus be able to produce it in its factory in the province of Buenos Aires in San Isidro.

The emergency authorization request formulated by the Ministry of Health was given a few days before the secretary for access to health, Carla Vizzotti, will lead an official mission to Russia to advance negotiations with the Moscow authorities and coordinate the logistical aspects for the shipment of Sputnik V doses.

With Vizzotti, Presidential Advisor Cecilia Nicolini and four ANMAT technicians traveled, which over the past week held meetings with Russian authorities and visited the facilities of the National Center for Epidemiology and Microbiology Nikolay Gamaleya and Generium .

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How are ANMAT Approval Protocols

Normally, all imported products require a long approval process, which may extend from six to eight months.

ANMAT requires a series of requirements from the company that manufactures a product, as well as documentation that certifies its biosafety, including the results of clinical trials. In the context of the health emergency, the steps that the Argentine organization theoretically establishes could be sped up.

“This situation is something special because it will not work normally, with which it cannot be supervised in a normal process, ”ANMAT explained to TN.com.ar.

One of the most important factors when approving a product is its origin. The agency is considering different types of health security classes when it comes to reliability. The countries listed in Annex 1 are those with high health surveillance.

The higher the food safety, the faster the process. In this case, Germany and the United States both belong to countries with high health surveillance. Another factor that works in its favor is the fact that the vaccine will also be marketed in the country of origin.

Another essential step is the presentation of the health protocols that have been carried out during the manufacturing and design process of the product, especially when it is a therapeutic novelty. Special permission can be provided to speed up the process as well.

Within ANMAT, there is a series of steps to follow, both technical and administrative, in which different departments must carry out the assessment. However, in this context, some specialists point out that instead of taking between 6 and 8 months, the approval could be carried out between 30 and 60 days.

In the usual processes, once the ANMAT has approved, the company (which must be registered in the country to market a product) initiates a first batch with checks before the official launch. As this would further delay the time to market, this step can be avoided. Something the body has already fixed in specific cases with products for rare diseases.