Pfizer seeks approval to release vaccine for children 5 to 11 years in Brazil
RIO DE JANEIRO, BRAZIL – Pfizer announced on Wednesday that it would request approval for the use of the Comirnaty vaccine against Covid-19 in children aged 5 to 11 years in Brazil. The request will be sent to the national health regulatory agency (ANVISA) next month. The date, however, has not yet been set.
“The submission of the request to ANVISA for the approval of the use of the ComiRNAty vaccine, from Pfizer/BioNTech, for children between 5 and 11 years old should occur throughout November 2021,” the note says.
The request followstaht sent to the Food and Drug Administration (FDA) in the United States. A panel of the agency, formed by independent consultants, had already recommended using the immunization for this age group last Tuesday.
So far, there is no forecast for Brazil to start vaccinating children up to 11 years old against Covid-19. Health Minister, Marcelo Queiroga does not project the date and has passed the responsibility for a decision to ANVISA. The regulatory agency previously denied the use of Coronavac for the age group 3 to 11 years because of a lack of documentation.
According to ANVISA, these files have not yet been sent, and the result of the studies in this group should only be finalized in November. The agency says it has been following the issue with international authorities.
Currently, Pfizer’s vaccine can be used in adolescents 12 years old and older in Brazil. Moreover, it is the only one authorized by ANVISA for use in minors.
ISRAELI DOCTORS AND SCIENTISTS WARN
An independent Israeli group of physicians, lawyers, scientists, and researchers called the Professional Ethics Front yesterday advised the U.S. Food and Drug Administration (FDA) regarding the upcoming FDA discussion on administering COVID-19 vaccines to children aged 5-11, expressing “severe concerns” regarding the reliability and legality of official Israeli COVID vaccine data.
“We are aware that the state of Israel is perceived as ‘the world laboratory’ regarding the safety and efficacy of the Pfizer-BioNTech COVID-19 vaccine, as reflected by statements made by Dr. Albert Bourla, Dr. Anthony Fauci, and other senior figures in leading health authorities throughout the world,” the letter reads.
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