Fiocruz investigator does not see sense in Anvisa’s demands



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The day after Pfizer confirmed that it renounced its intention to request the registration of emergency use of its covid-19 vaccine in Brazil, the infectious disease specialist and researcher at Fiocruz (Oswaldo Cruz Foundation), Júlio Croda, He said he didn’t see the point in the demands. carried out by Anvisa (National Health Surveillance Agency) to urgently evaluate the immunizer. Croda argued that other countries are already applying the Pfizer / BioNTech vaccine.

“It doesn’t make any sense, especially since we have two agencies that are even superior in terms of evaluation to Anvisa, the FDA [agência reguladora dos Estados Unidos] and the European agency, approving this, the UK agency as well ”, said the researcher in an interview with GloboNews.

“It does not make sense that this Pfizer vaccine is not approved by Anvisa and the requirements are higher than these other organisms,” reinforced the infectious diseases specialist at Fiocruz, the federal institution that will be responsible in Brazil for the production of the Oxford vaccine. The immunizer is developed by the AstraZeneca laboratory in association with the University of Oxford and is the main commitment of the Brazilian government for the national vaccination plan against covid-19.

Croda also criticized the statement made yesterday by President Jair Bolsonaro (without a party) that laboratories were the most interested in selling covid-19 vaccines to Brazil.

“No company has applied for the homologation in Brazil, so we are in this scenario, while Argentina, for example, a country that is next door, sends a plane to pick up Sputnik V in Russia.” [o país iniciou a vacinação contra a covid-19 hoje com o imunizante russo], the president argues that companies should look to the Ministry of Health to sell their vaccines. We will not have vaccines, there will be a great dispute in the world ”, he argued.

The researcher reinforced that the Brazilian government lacked planning to guarantee sufficient doses to start vaccination. The immunizer Pfizer, responsible for having already started campaigns in several countries around the world, will now try to register the definitive use in Anvisa, but Croda recalled that the laboratory should not have a large number of doses available for Brazil.

“The forecast, which is in the national plan itself [de vacinação], is 8.5 million doses. We cannot even finish phase 1 of our vaccination plan, “said the researcher, recalling the first phase of vaccination, aimed at priority groups and which has no start date yet.

“Unfortunately, Brazil made mistakes there in the past, it did not make any cooperation agreement with other companies. We will have a lack of vaccines for poor countries, for Africa, Asia and some countries in South America like Brazil. Our hopes for two vaccines” Croda added.

In addition to the Oxford vaccine, the federal government also provides in its national vaccination plan to be able to count on CoronaVac, the vaccine developed and tested by the Butantan Institute in alliance with the Chinese laboratory Sinovac. The immunizer, however, has been the subject of dispute between Bolsonaro and the governor of São Paulo, João Doria (PSDB), since Butantan is linked to the government of São Paulo.

Although you can only have two vaccines, both the AstraZeneca and CoronaVac immunizers have yet to apply for end-use approval at Anvisa. The Butantan vaccine, however, is theoretically ahead because it already has almost 10 million doses available in the country and the promise to release the results of clinical efficacy tests at the beginning of January, which will allow us to enter the process. register.

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