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Anvisa (National Health Surveillance Agency) said today that requests for emergency use of vaccines against the new coronavirus that arrive at the agency will have their complete evaluation within ten days of the request. In a note, the agency also said that only vaccines with clinical trials conducted in Brazil will be able to receive emergency approval.
In the statement, Anvisa also noted that the simple emergency registration by agencies from other countries will not be enough to replicate the approval in Brazil.
Today, the São Paulo government announced that it will request the definitive and emergency registration of CoronaVac – produced by the Chinese laboratory Sinovac and by the Butantan Institute – at the same time and that it has the approval of the local agency in China to shorten the registration in Brazil.
Until now, there was no set deadline for evaluating requests for emergency use of vaccines, but the agency had already expected to demonstrate before the 60 days scheduled to evaluate the product’s registration against covid-19.
If all the necessary documents have been submitted to Anvisa by the vaccine manufacturers, Anvisa estimates a period of up to 10 (ten) days to complete the evaluation of the emergency use authorization, provided that they are vaccines from companies that have submitted data for Anvisa and have clinical trials in Brazil.
Anvisa
The agency said its servers are working full time, including in the weeks of Christmas and New Years, to evaluate procedures related to the vaccine.
“At this time of great urgency, we reaffirm our commitment to public health (sic) and rapid action to provide our population with a Covid 19 vaccine, in accordance with the parameters of quality, efficacy and safety.”
Registering abroad is not enough
Regarding the possible facilitation of the approval of vaccines already released in an emergency by regulatory bodies abroad, Anvisa said that there is no forecast for this to happen. According to the agency, each country has its peculiarities that must be taken into account when evaluating immunizers.
Part of the data, as well as the commitments and follow-up plans that must compose the request for emergency use refer exclusively to national realities and, therefore, the importance of the analysis of the vaccine to be used in Brazil, will be carried out by Anvisa.
Anvisa
The agency also said that it has agreements with “the main foreign regulatory authorities” and that there are procedures that allow some information already evaluated by other agencies to be analyzed more quickly by Anvisa. However, he stressed that none of the agreements provides for agencies to send vaccine data directly to Anvisa, leaving the laboratories to do this.
“Following the world scenario, it is possible to note that no regulatory authority, so far, has granted authorization for emergency use automatically, based on the evaluation of another country,” he said.
According to a law passed at the beginning of the pandemic, Anvisa has 72 hours to evaluate a request for the use of a vaccine based on the registration of a foreign agency. However, in the official note released today, the only term mentioned by Anvisa is ten days for the authorization of emergency use.
According to this law, Anvisa has a period of 72 hours to analyze the drugs against covid-19, as long as it is registered for permanent use by the US, European, Japanese or Chinese agency.
According to Anvisa, in the case of vaccinations carried out in the United Kingdom and the United States, for example, authorizations are for emergency vaccination and not for vaccine registration. Registration occurs when investigations are completed and health agencies allow commercial sale of vaccines in private clinics, with instructions and massive application.
Anvisa questions China’s standards
Specifically on CoronaVac, Anvisa, in its official note, questioned the standards adopted by the Chinese regulatory agency. The eastern country has already vaccinated its citizens on an emergency basis since June, but used partial efficacy data published by the Sinovac laboratory. The final vaccination report shouldn’t be ready until next week.
“The Chinese criteria for granting the emergency use authorization in China are not transparent and there is no information available on the criteria currently used by Chinese bodies for this decision making. To date, no other foreign regulatory authority has made a decision. similar in their countries. ” “, says Anvisa.
Without directly citing the government of São Paulo, the agency says that replicating the authorization granted by the Chinese agency could bring risks for Brazilians, although it has not reported which ones.
If the automatic replication of the foreign AUE (Authorization for Emergency Use) is authorized in Brazil, without the proper submission of data to Anvisa, weakening and delay in conducting the clinical study in Brazil is expected; in addition to exposing the Brazilian population to risks that will not be monitored by the company that developed the vaccine
Anvisa, with Chinese CoronaVac approval
No vaccine has requested authorization in Brazil
So far, no manufacturer has requested emergency approval of any vaccine for Anvisa. CoronaVac was predicted to request its order first, however due to a change in strategy, the immunizer will have its final requested registration next week.
There are four vaccines with phase 3 trials under way in Brazil: the one developed by AstraZeneca in association with the University of Oxford, the one by Sinovac in association with the Butantan Institute, the one by American Pfizer and BioNTech, and the Janssen-Cilag vaccine ( Johnson & Johnson).
* With information from Estadão Content
