The Agency is considering the inclusion of Pfizer's vaccine indication for the immunization of children aged 5 to 11 years.
In an updated statement on the monitoring of adverse events linked to the use of the vaccine, Anvisa concludes that “the data do not indicate any change in the benefit–risk balance of the vaccine.”
The definitive registration request is different from authorization for emergency use, already granted to the consortium. For the latter, immunization is given to specific groups, whereas under definitive request the group in charge of the vaccine is allowed to vaccinate any individual in addition to selling the product.
The vaccine with its import authorized was produced in India by Serum Institute of India.
The calculation being made is the same as the one for the vaccine against influenza, with some 100 million doses countrywide.
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