Pfizer and Janssen can request emergency use


This week was marked by the beginning of the vaccination against COVID-19, after a long battle by the authorities for some of the main vaccines on the market to be approved on an emergency basis by Anvisa. At the moment, CoronaVac, an immunizer developed through a partnership between the Butantan Institute, an integral part of the state government of São Paulo, and the Chinese laboratory Sinovac, is being applied in São Paulo, Goiás, Maranhão and another ten Brazilian states.

The wait is now due to the vaccine developed by AstraZeneca in partnership with the University of Oxford and the Oswaldo Cruz Foundation (Fiocruz), which has also received approval for the emergency use of Anvisa, but awaits clearance from the Indian government to import the first doses later of a mismatch of information between the country and the Brazilian government.

Fortunately, Brazil should gain more options soon. Anvisa today issued the certification of good practices in the manufacture of medicines for laboratories Janssen, pharmaceutical division of the Johnson & Johnson group, and Pfizer, thus allowing their respective vaccines to be applied for the process of analysis of emergency use in the country.

Both vaccines already have phase 3 tests performed in Brazil, and while Pfizer already has documentation under analysis at Anvisa, sent in advance in order to speed up the registration of the immunizer, Janssen must complete the stage in February, with the order being able to formalized in March.

Applied in several countries around the world, the Pfizer vaccine uses the virus’s messenger RNA to allow the human body to replicate the Sars-CoV-2 Spike protein and then learn to fight it. Although it also uses genetic code to produce the Spike protein, the Janssen drug has deactivated adenovirus, the common cold virus, to generate the body’s immune response.


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