SAO PAULO: Pfizer sent the results of the tests of their Covid-19 vaccine to the office of Brazilian health regulators, a mandatory move to authorise and register the vaccine, the US-based pharmaceutical said Wednesday.
“This is an important step for the vaccine to be available in Brazil,” Pfizer said in a Portuguese statement.
Brazil has the highest Covid-19 death rate in the world after the US with a population of 212 million. Since the pandemic started, more than six million novel cases of coronavirus have been reported.
The clinical outcomes of the BNT162b2 vaccine phase 3 trial, developed by Pfizer and the German pharmaceutical company BioNTech. It started in July and included 43,661 participants in 150 locations worldwide. There were 2,900 volunteers in Brazil, the firm said.
Representatives of Pfizer and the National Health Oversight Agency (Anvisa) of Brazil met on Wednesday to begin the outcome presentation process.
In order to streamline the process, Anvisa said that once they become usable, the laboratories producing the vaccines will present the findings.
Moreover, Pfizer stated that it plans to present phased vaccine-related statistics. It is including data showing its “95% efficiency rate seven days after taking the second dose, as shown in the Phase 2 clinical trial,” the statement read.
Pfizer’s Medical Director
Marjori Dulcine, Pfizer’s Medical Director in Brazil, said in the release, “Pfizer will make all the necessary data available for assessment and will collaborate with Anvisa. So that the process moves smoothly and as quickly as possible.”
In the European Union, Australia, Canada, Japan and the UK, the vaccine has been under assessment for weeks, the companies said earlier.
Brazil’s health ministry also agreed to buy 100 million doses of a different vaccine developed by AstraZeneca and Oxford University.
In addition, the health ministry said that over the past week officials have met with representatives of five pharmaceutical labs. Pfizer, Janssen, Bharat Biotech, Moderna and the Russian Direct Investment Fund (RDIF). “With the goal of diversifying actions” to help handle the Covid-19 pandemic.
The regional government of Sao Paulo – home to the country’s most populous city. It has signed an agreement with the Chinese laboratory SinoVac to purchase six million doses of the CoronaVac vaccine. After that, it also buy material to produce another 40 million doses locally.