Without official release, ANMAT approved Janssen’s coronavirus vaccine

The same day the government announced that children aged 3 to 11 will be vaccinated with Sinopharm, the National Administration of Drugs, Food and Medical Technology (ANMAT) approved the Janssen vaccine. The measure was not disclosed by the Ministry of Health and was known on Tuesday.

The resolution of the drug control body, dated Friday, October 1, indicates that it is granted the “emergency case” single-dose vaccine from Janssen Pharmaceuticals (colloquially known as Johnson & Johnson’s).

The laboratory had made its first presentation to the regulatory body in December 2020, two days after the Pfizer laboratory, the first vaccine approved in the country. But its approval was delayed without much official explanation for ten months.

So far the government did not announce contracts with the laboratory American for the purchase of vaccines.

It was the most sought after vaccine by Argentines which – given the possibility that the United States would prevent the entry of the people vaccinated with Russian Sputnik V– they got a plane ticket to get to this country in the remaining time and access a dose of Johnson & Johnson like immune passport.

Official silence on approval surprise generated. A similar situation occurred with the vaccine Modern, which on Monday – to an extent that was not disclosed by the government either – received permission from the Department of Health to apply to people over 12 years of age.

The regulations, signed by Minister Carla Vizzotti, indicate that the National Administration of Drugs, Food and Medical Technology (ANMAT) evaluated the vaccine and obtained a “favorable outcome of the literature review”.

He also maintains that they were considered “acceptable for age groups over 12 years“Its” parameters of safety, immunogenicity and efficacy. “

In the file, the ANMAT provided in its first article: National administration of drugs, food and medical technology of the medicinal specialty of the trade name Janssen Covid-19 vaccine and the generic name Vacuna Contra Covid-19, which according to demand will be marketed in the Argentine Republic by Janssen Cilag Farmacéutica SA in accordance with the characteristic identification data of the product included in the registration certificate ”.

Sinopharm vaccine for boys

After some crosses between the Argentine Society of Pediatrics (SAP) and the Ministry of Health of the Nation, this Tuesday was Chinese Sinopharm vaccine approved for boys ages 3-11 which will begin to apply on October 12.

The announcement came after the entity claimed in a document specific data on the effectiveness of this vaccine in this population, following the recommendation of the National Administration of Drugs, Food and Medical Technology. (Anmat) to the government to apply it.

Various official voices were raised to criticize the SAP statement, and one of the most resounding was that of the governor of the province of Buenos Aires, Axel Kicillof, who declared that “there are no more doubts, nor anything to discuss “with reference to the ANMAT approval.

During a press conference, Minister Carla Vizzotti explained that as a first step, “priority children, those who are most at risk and who are most at risk, will be vaccinated. They have been waiting for this vaccine for more than 18 months in order to be able, even if a cautious presence is generated, approach schools“.

LM