Coronavirus: ANMAT also approved the Janssen vaccine | It is a single dose and achieves 94% effectiveness

As the coronavirus vaccination campaign progresses, this Friday the National Administration of Drugs, Food and Medical Technologies (Anmat) authorized the use of Janssen’s vaccine.

“To authorize the company Janssen Cilag Farmaceutica SA conditional registration for the purposes of its use in the Register of Medicinal Specialties (REM) and the National Administration of Medicines, Food and Medical Technology of the medicinal product under the trade name COVID-19 Vaccine Janssen ”, ordered the entity under the file number 1-47-2002-000686-20-3.

In addition, on behalf of the entity they indicated that “the new medicinal specialty presents a acceptable risk-benefit ratio, thereby supporting the granting of conditional registration and authorization for its use for the requested indication ”.

On the other hand, it has been established that “as a conditional authorization, the certificate will be valid for one year from the date of this provision ”.

Likewise, the text specifies that the company must “submit periodic safety reports every 6 months after the product has actually been marketed to the INAME (National Institute of Medicines)”.

He also specified that “any change in the safety or efficacy profile of the product must be certified in the corresponding modification of the prospectus”, and added that in the event of non-compliance with the obligations laid down, the ANMAT may ” suspend the marketing of the product approved by this provision, when justified by public health considerations ”.

Janssen’s vaccine

In March of this year, the World Health Organization (WHO) announced the emergency approval of the single-dose anticovid vaccine Janssen from the US pharmaceutical company Johnson & Johnson, after the approval received by those of Pfizer / BioNTech and AstraZeneca / Oxford.

Janssen’s vaccine is the first to be listed by WHO as a single-dose regimen that can be stored in a conventional refrigerator, which should facilitate vaccination logistics in all countries.

On the other hand, a month ago, the Johnson & Johnson company announced that its vaccine achieves 94 percent effectiveness when given in two doses and that those who receive the booster injection are better protected for longer.

According to information provided by the same company, the application of the single-dose vaccine generates up to 66% protection against severe and moderate coronavirus cases.

The same study – carried out by the company in the United States – also indicates that if the booster dose is applied six months after the first, it could be even more effective and generate twelve times higher antibodies four weeks after the second injection, regardless of the age of the vaccinated person.