Moderna vaccines arriving from the United States are still stored in a warehouse: what explanation have they given to the government

Six days have passed since the arrival of the 3,500,000 Moderna vaccines offered by the United States government. However, they remain in a repository awaiting application. The reason? The government is awaiting authorization to start with the vaccination of children under 18.

This has been stated at TN.com.ar Sources from the National Health Ministry and Buenos Aires, which on Monday opened the registration for the vaccination of adolescents between 13 and 17 years old with comorbidities. “We have decided to reserve these doses and we are awaiting news”, they agreed.

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Carla Vizzotti announced that at the last meeting of the Federal Health Council (COFESA), which brings together health ministers from 24 national jurisdictions, “we had the positive opinion of the European Union of the modern vaccine for adolescents between 12 and 17 years old. , and which is followed by an authorization “.

“We are also awaiting news from the Food and Drug Administration (FDA). In principle, the recommendation of the National Vaccination Commission (CoNaIn) and COFESA is to start vaccinating adolescents with risky conditions, and we agreed to precisely define these risk conditions on Tuesday, ”said the head of the national health portfolio.

A few hours before the landing of the 3,500,000 doses of Moderna, from Casa Rosada, they issued a statement in which they claimed that it was not necessary for the ANMAT (National Administration of Drugs, Food and medical technology) registers the vaccine to begin applying it.

“Being an exceptional donation, the vaccines do not require registration with the Argentinian regulatory authority,” they said. However, US clearance is awaited for use in the selected age group.

Last week, TN.com.ar He announced that the government of Buenos Aires also expects ANMAT’s authorization to apply Sinopharm to minors under the age of 18, something that China – the country that makes the vaccine – is already doing.

Moderna vaccine: use in minors and efficacy against the Delta variant

The Modern Covid-19 is an mRNA vaccine that encodes the Spike (S) protein and has Efficiency proven to more than 90%. It is applied in two doses with a 28 day interval, which can be extended up to 42 days. It requires temperatures between -50 and -15 degrees for storage and transport, but once thawed, it can be stored in the refrigerator for 30 days between 2 and 8 degrees.

The American company has submitted the tests and documentation required by the main regulatory authorities with the objective of obtaining an emergency authorization for its application in minors, a situation that could be defined soon, both at the FDA (Food and Drug Administration of the United States) and at the EMA (European Medicines Agency).

According to preliminary studies conducted in the United States, Moderna’s vaccine is highly effective against all variants of SARS-CoV-2. Included the Delta, considered 100% more contagious than the original virus and whose community circulation in Argentina is expected in August, as announced by the government.

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Vaccines law: changes by decree that opened the door to negotiations with American laboratories

The donation came after the government introduced by decree amendments to the Vaccine Law 27,573, which closed negotiations with Pfizer -principalmente- y Johnson & Johnson.

The adaptation of the regulations resulted in the deletion of the word “negligence” as assumption of responsibility of the constructors, and the creation of a fund of repairs to face possible compensations. And this accelerated the conclusion of a first contract: 20 million doses Moderna vaccine for the first quarter of 2022. This Thursday again, the Senate approved the DNU which changed the regulatory framework for the purchase of vaccines.