SAO PAULO – Pfizer has given the office of Brazil’s health regulators results of the tests of its Covid-19 vaccine, a necessary step to approve and register the jab, said the US-based pharmaceutical yesterday.
“This is an important step so that the vaccine can be available in Brazil,” said Pfizer in a statement.
Brazil, with a population of 212 million, has the highest Covid-19 death rate in the world after the US. It has recorded more than six million coronavirus cases since the pandemic began.
The clinical results of the Phase 3 study of the BNT162b2 vaccine, developed by Pfizer and German pharmaceutical BioNTech, began in July, and involved 43,661 participants in 150 places around the world.
In Brazil, there were 2,900 volunteers, said the companies.
Representatives of Pfizer and Brazil’s National Health Oversight Agency (Anvisa) met yesterday to begin the process of presenting the results.
To streamline the process, Anvisa said the labs developing the vaccine can present the results as they become available.
Pfizer said it expects to present information related to the vaccine in stages, including data showing its “95% efficiency rate seven days after taking the second dose, as demonstrated in the Phase 2 clinical trial”.
“Pfizer will make available all of the necessary data for evaluation, and will collaborate with Anvisa so that the process moves smoothly and as quickly as possible,” said Marjori Dulcine, Pfizer’s medical director in Brazil, in the statement.
The vaccine has been under evaluation for weeks in the European Union, Australia, Canada, Japan and the UK, said the companies earlier.
Brazil’s Health Ministry also agreed to buy 100 million doses of a different vaccine developed by AstraZeneca and Oxford University.
The ministry said over the past week, officials have met representatives of five pharmaceutical labs – Pfizer, Janssen, Bharat Biotech, Moderna and the Russian Direct Investment Fund – “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 – has signed an agreement with Chinese laboratory SinoVac to purchase six million doses of the CoronaVac vaccine, and to buy material to produce another 40 million doses locally. – AFP, November 26, 2020
