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The Government assured that ANMAT does not need to register the Moderna vaccine to start applying it

While waiting for the arrival of the first shipment of the 3,500,000 vaccines against the coronavirus that the United States donated to Argentina, the Government warned that it is not necessary for the National Administration of Medicines, Food and Medical Technology (ANMAT) to register the vaccine to be able to start to apply it in the country. It would be enough to authorize their entry.

“The vaccines, coming from Memphis, will arrive tonight on two flights to the Ezeiza International Airport. It should be noted that, being an exceptional donation, the vaccines do not require registration from the Argentine regulatory authority, and the authorization of ANMAT is sufficient for the entry and use by the State of the batches supplied by the Government. of the USA ”, the Ministry of Health of the Nation announced this Friday.

“According to the regulations and regulatory provisions, to be accepted, only the registration of the country of origin is considered, as long as that country is of high sanitary surveillance, as is the case of the Food and Drug Administration of the United States. (FDA), ”the statement added.

Following the official announcement by the Joe Biden administration, the Government formally accepted the donation made by the United States Department of Health and Human Services of 3,500,000 doses of the mRNA-1273 vaccine from Moderna laboratory.

This donation occurs after, after months of delay, the national government adapted the Vaccine Law 27,573 and moved forward with the suppression of “negligence” as an assumption of responsibility for the manufacturers of Covid-19 vaccines. The term negligence was considered by laboratory representatives as one of the obstacles to the supply of vaccines to the country.

The adaptation of the standard also made it possible for Argentina to sign -before the US donation- the first contract to receive 20 million doses from the Moderna laboratory from the first quarter of 2022.

The vaccine against the coronavirus of the American company demonstrated an efficacy of 94.1%, presented good results in the adolescent population and generated neutralizing titers against the new variants of the virus in immunized people. Although the multi-dose vials included in the packages should be stored between –25 ° C and –15 ° C, once thawed they can be kept refrigerated at 2 ° C to 8 ° C for 30 days.

On December 18, 2020, the FDA (United States regulatory entity) authorized the emergency use of Moderna vaccine in people over 18 years of age; it has since been approved for emergency use in more than 50 countries. On the other hand, the company has already requested an emergency authorization (or other conditional, interim or provisional authorization) for the use of its vaccine in adolescents at the FDA and before health agencies in various countries.

The FDA approval for minors would come soon, and the intention of the Alberto Fernández Government would be to use it for the vaccination of adolescents.

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