Public Health Institute (ISP) approves emergency use of Johnson & Johnson’s Janssen COVID-19 vaccine through the COVAX mechanism
The single-dose Janssen vaccine has already been approved in Brazil, the United Kingdom, Canada, Colombia, the European Union, Mexico and the United States, for those 18 years and over.
Chile’s Public Health Institute (ISP) has approved the emergency use of a fifth COVID-19 vaccine: the Janssen Pharmaceuticals Companies of Johnson & Johnson vaccine. The vaccine has already been approved by the World Health Organization (WHO) and it will soon arrive in Chile, through the COVAX mechanism.
In order to be included on the WHO’s list for emergency use, COVID-19 vaccines must be evaluated for quality, safety and effectiveness. This is a prerequisite for the vaccine to be supplied through the WHO’s COVAX mechanism.
The single-dose Janssen vaccine has already been approved in Brazil, the United Kingdom, Canada, Colombia, the European Union, Mexico and the United States, for those 18 years and over.
The WHO’s COVAX mechanism operates as a platform to support the research, development and manufacture of a wide range of COVID-19 vaccine candidates. Its objective is to speed up the development and manufacture of vaccines and to guarantee fair and equal access to them throughout the world.
The objective of COVAX is to provide vaccines for at least 20% of the population of each country that participates in the mechanism, in order to protect those at higher risk and, ultimately, to save lives. Furthermore, the mechanism helps countries, such as those in Latin America, to access a portfolio of preapproved and safe vaccines in an equitable way.
The Acting Director of the Public Health Institute, Heriberto García, chaired the meeting, alongside experts from the National Drug Agency (Agencia Nacional de Medicamentos, ANAMED), who presented the COVAX mechanism evaluation criteria, as well as the characteristics of the Janssen vaccine in terms of its effectiveness against COVID-19 and its safety for use. Mr. García stated, “between December 2020 and April 2021, the ISP approved four vaccines for emergency use in Chile. The first was the Pfizer Laboratory’s vaccine, which was followed by Sinovac’s Coronavac vaccine and then AstraZeneca and Cansino. All of these vaccines were evaluated and submitted for expert opinion in Chile. In the case of the Janssen vaccine, our agencies approved a process that had already been carried out by the WHO, the world’s highest health authority, which is also the organization that certifies Drug Regulatory Agencies, like the ISP.”
Acting Director García further commented, “as well as approving the Janssen vaccine, which will become the fifth COVID-19 vaccine to be authorized for emergency use in Chile, this time through the COVAX mechanism, this will open up the possibility for us to recognize other vaccines that are already supported by this same mechanism in the future, such as Moderna and Sinopharm.”
Technical Data
The vaccine is a replication-incompetent recombinant adenovirus type 26 that acts as a vector to codify the virus’s Spike proteins. One 0.5 ml dose is administered in the deltoid muscle.
Regarding storage temperature and shelf-life: the vaccine has a shelf-life of two years when stored at -20°C; the vaccine has a shelf-life of three months when stored between 2 and 8°C.
In terms of effectiveness, the vaccine demonstrates 66.9% effectivity after 14 days in adults over 18 years of age, including those over 60. In severe and critical cases, effectiveness is 76.7% after 14 days of vaccination and 85.4% after 28 days.