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Nov 27 (Reuters) – The National Health Surveillance Agency (Anvisa) said it received the request for continuous delivery of Covid-19 vaccines from Johnson & Johnson’s Janssen-Cilag laboratory on Friday.
“With the opening of the process, the laboratory also sent the first package referring to product quality data,” Anvisa said in a statement.
Last week Anvisa approved a normative instruction that will speed up the registration of vaccines against covid-19 in the country, authorizing laboratories that test drugs to present documents and technical data as they are generated, without having to wait for them to be opened. all the documents. the registration process.
Regulatory instruction applies only to vaccines that are being tested for covid-19.
This is the fourth laboratory to send data by continuous shipment for the covid-19 vaccine. The British AstraZeneca AZN.L, which develops an immunizer with the University of Oxford, the Chinese Sinovac SVA.O, which is testing CoronaVac, and the American Pfizer Inc PFE.N, which has a vaccine candidate in association with the BioNTech 22UAy German .F had already started the process.
Anvisa highlighted in its statement that “the continuous presentation is not yet the application for the registration of the vaccine.”
