Anvisa says it received documents with test results of the Pfizer vaccine against Covid-19 | Vaccine

According to the agency, the documentation was included in the ongoing submission process. The US pharmaceutical Pfizer sent the first test data of BNT162b2, its candidate for the vaccine, on Wednesday (25).

“According to the provisions of Normative Instruction 77/2020, Anvisa has up to 20 days to analyze the documents, counted from the date of the protocol,” says the note.

Continuous submission is not yet the vaccine registration application. The process does not mean that the company requested the registration of the product in the country: at the current stage, the company seeks to streamline the process and prepare the future application.

• EFFICIENCY: Phase 3 testing indicates 95% effectiveness, says Pfizer
• SUPER COLD: Storage at -70 ° C is a challenge for buyers of BNT162b2

In Brazil, 2,900 volunteers participate in the tests and there is no closed agreement to supply the immunizer to the population, although the Ministry of Health includes Pfizer among the five manufacturers with which it is negotiating.

With the shipment of the first documents, the company began the so-called “continuous shipment process” planned by the federal agency to expedite the receipt of data from manufacturers that develop possible vaccines against the new coronavirus.

In continuous filing, companies will not need to have all the documents gathered to present them at once to Anvisa, as it normally happens.

“This is an important step for the immunizer to be available in Brazil. Pfizer will make available all the data necessary for the evaluation and will be in full collaboration with ANVISA so that this process runs smoothly and as quickly as possible, “said Márjori Dulcine, medical director of Pfizer Brazil, in a note.

• 4 of the 11 Covid vaccines in the final testing phase have already shown satisfactory rates of efficacy and safety; see comparison

Pfizer and the German laboratory BioNTech already announced that BNT162b2 had a 95% prevention of the disease, and there were no serious side effects, according to data from phase 3 studies. Despite this, the results have not yet been published. in a scientific journal.

According to the companies, “they plan to present the efficacy and safety data from the study for review by scientific journals, once the data analysis is complete.”

They said they had already submitted documents to “various regulatory agencies around the world, including the FDA (US), EMA (European Union) and MHRA (UK).”

Storage at -70 ° C is challenging

The Pfizer / BioNTech vaccine is based on mRNA technology. It contains a small genetic sequence developed in the laboratory that “teaches” the human body’s own cells to produce proteins similar to Sars-CoV-2, teaching the immune system to defend itself against the virus. Innovative, the “genetic vaccine” requires storage at a temperature below -70 ° C during transport.

Currently, the vaccines we are used to are stored between 2 ° C and 8 ° C. In the opinion of the experts, it would be impractical for Brazil to adapt structures for a wide use of BNT162b2.

Another important issue to evaluate in the possible acquisition is the cost. According to a report by Jornal Nacional, the estimate is that the dose will cost R $ 108.

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