Why Moderna’s COVID-19 vaccines arrived in Argentina are authorized by a different mechanism than other doses

Last Saturday was the donation of 3.5 million doses of the messenger RNA vaccine developed by the company Moderna as part of a donation from the US Department of Health and Human Services to Argentina. The doses come from Memphis and arrived on two flights to Ezeiza International Airport. Unlike what has happened with other COVID-19 vaccines that are already applied in the country, since it is a donation, Moderna’s vaccine registration will not be required before the regulatory authority for medicines and vaccines, known by its acronym ANMAT. These vaccines are already cleared for emergency use by the US regulatory authority, the FDA.

According to the various regulations in force, which include laws, resolutions and provisions, the use of vaccines and other medical products must have the authorization of the national regulatory authority, which is the National Drug Administration. , food and medical technology.

In the case of Moderna’s vaccines, “as this is an exceptional donation, the vaccines do not require registration with the Argentinian regulatory authority, and the authorization of ANMAT is sufficient for the entry and use by the State of the lots, ”the ministry said. of the Health of the Nation, in charge of Carla Vizzotti. That is to say, registration is not compulsory before ANMAT, but they are authorized by ANMAT to apply in the country.

According to the regulations and regulatory provisions, only the registration of the country of origin of the vaccines is envisaged, “as long as this country has high health surveillance, as is the case with the Food and Drug Administration (FDA) the United States “. Moderna vaccine doses are expected to be applied to the population under the age of 18 to protect them from infection with the coronavirus.

Moderna’s vaccine donation was the largest the United States had made in Latin America. This was done after the national government agreed to adapt the Vaccine Law 27,573 which also allowed Argentina to sign the first purchase contract for messenger RNA vaccines in the first quarter of the year 2022.

Moderna’s phase III vaccine trials have shown great efficacy. It was found to be 94% effective. It causes the human immune system to produce strong antibodies that last for several months.

Since the start of the vaccination plan last December in Argentina, the Sputnik V vaccines, developed by the Gamaleya Institute in Russia, have been applied to the Argentine population; the Sinopharm vaccine from China; the vaccine developed by AstraZeneca and the University of Oxford, England; and Covishield, which is the same as AstraZeneca, but produced at the Serum Institute in India.

Different mechanisms for authorization or registration of vaccination have been used. One mechanism concerned companies that were already in the country. In these cases, an application for registration of a vaccine is made. The company must present information on development, production and quality control, as well as clinical studies, which support the quality, safety and efficacy required for its use in humans.

On December 22, ANMAT reported that it had authorized registration of Pfizer’s messenger RNA vaccine in the register of medicinal specialties. It was authorized for a period of one year from this provision, subject to sale under prescription. The purchase of these vaccines is still being negotiated between the Ministry of Health and the laboratory.

As, On December 30, ANMAT also took another step to allow registration of the AstraZeneca / Oxford vaccine. “It presents an acceptable benefit-risk ratio, making it possible to support the granting of the registration and the conditional authorization of the product for the requested indication. The same was granted for a period of one year from the date of this provision, subject to sale under prescription, ”said the public body in a press release.

Instead, with vaccines from Russia and China, other steps were taken. In the case of Sputnik V, there was first a resolution of December 24 from the Ministry of Health of the Nation, then the ANMAT made an analysis for the approval of its use. Regarding the Sinopharm vaccine, it was also authorized on the basis of a ministry resolution of February 22. In both cases, the authorization of emergency use of vaccines was framed within the framework of Law 27 573 and it is the Ministry of Health of the Nation which dictates the corresponding resolution which establishes their use, after the intervention of the competent bodies. . Articles 8 and 9 establish which bodies are to be involved in the process and how it is to be conducted.

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