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Anvisa (National Health Surveillance Agency) hopes to comply with the precautionary measure granted today by the Minister of the Supreme Court (Superior Federal Court) Ricardo Lewandowski, which allows states and municipalities to distribute a vaccine against covid-19 even without approval from the federal agency. The situation will occur if Anvisa does not respond within 72 hours to an authorization request and the immunizer in question is already approved by foreign health authorities.
According to Anvisa’s general manager, Rear Admiral Antônio Barra Torres, the agency is still awaiting notification of the STF’s decision, but will do “everything possible” to comply with what is established by the Minister of the Court.
“The determinations of the Supreme Federal Court are fulfilled,” Barra Torres said in an interview with CNN Brazil. “We have not yet had access to the official text of Minister Lewandowski’s decision, as soon as he reaches us with his determinations, we will do everything possible to fully comply with what is advocated there,” he added.
Barra Torres, however, admitted that the 72-hour deadline could be difficult to meet. Currently, Anvisa has a normal period for log analysis that can last up to 60 days. The time will go down if the producer of the immunizer goes through the continuous data submission process, as the Pfizer / BioNTech vaccine intends to do.
“It is clear that the deadlines can sometimes be difficult to meet due to the volume of information. But still we will not go out of the plan to try to meet that,” he said.
The CEO of Anvisa also said that it is “an immense responsibility” to certify the registration of a vaccine against covid-19 for a population of more than 210 million inhabitants.
“I always remember that these dossiers are very extensive. We are already clear about continuous shipping, we already have information for the process. But it remains an immense responsibility to attest to the quality, safety and efficacy of vaccines for a population as large as ours. “said Barra Torres.
The STF decision contemplates only vaccines that have already had a definitive registration approved by regulatory agencies in the United States, the European Union, Japan, and China. However, so far no immunizer against covid-19 has had this endorsement, since the Pfizer vaccine has been applied in the United States and the United Kingdom thanks to an emergency use authorization.
In Brazil, no vaccine requested emergency use and did not provide all the necessary documentation to have a definitive use record. In addition to Pfzier, the CoronaVac vaccine, which is developed and tested by the Butantan Institute in partnership with the Chinese laboratory Sinovac, also plans to apply for registration.
