Pfizer should start testing with pregnant women ‘soon’

Pfizer should start testing with pregnant women ‘soon’
Pfizer should start testing with pregnant women ‘soon’
The coordinator of Pfizer’s tests in Brazil, doctor Cristiano Zerbini, said today that the North American pharmaceutical company should start “soon” clinical studies in pregnant and immunodepressed people of the vaccine against the new coronavirus produced in partnership with the German biotechnology company BioNtech. According to Zerbini, the order for tests with pregnant women has already been Conep (National Research Ethics Commission) and Anvisa (National Health Surveillance Agency).

“We will wait for the ethical and regulatory agencies to allow the study to start. In immunosuppressed patients, we will still submit the protocols to the Brazilian authorities. But I have the impression that we will soon start these studies,” he said in an interview with CNN.

Zerbini he said the studies should last from one to three years, but said it was already possible to reap initial results, as is the case with the vaccine already in use around the world. The doctor cites regular reports, three and six months from the beginning of the tests, which are usually not produced by the laboratories.

“We don’t have to wait for all this (three years of testing) to get quicker answers. They will be given by the interim analyzes, which is what happened with all these vaccines that we are seeing now. There is no vaccine that is one year in duration. “, he emphasized.

Despite the fact that the Pfizer / BioNtech vaccine is the first and only one to have the definitive registration for application in Brazil, the country has not yet applied the immunizer. On the 19th, the federal government announced the purchase of 100 million doses, with the first batch of 13.5 million delivered by June.

Tests on children

Pfizer announced between yesterday and today that the vaccine produced by the pharmaceutical company is 100% effective in young people aged 12 to 15 years and has an efficiency of at least 91.3% after six months of application of the dose. Last Thursday (25), the laboratory announced that it has started clinical trials of the immunizer in children aged 6 months to 11 years in the United States.

“Pfizer is going to ask the FDA (Food and Drug Administration, a US agency that regulates food and medicines) for a license so that teenagers can also be vaccinated with the Biontec / Pfizer vaccine,” he warned Zerbin.

The doctor said that the immune system of young people is “more potent” than that of adults. He says, however, that the vaccine ration in children and adolescents tends to be more intense, despite being mild, such as local pain, fever and increased body temperature.

“The immune system of children and adolescents is very powerful. This immune protection sometimes decreases with age, so much so that in the study we did as an adult, it was necessary to evaluate the effectiveness in people over 60 years to see if it was really effective. and it was “, he stressed.

Variants

Regarding the effectiveness of Pfizer’s vaccine on the Brazilian variant, the doctor believes that it is effective, but warns of the need to wait for the results of studies.

“The Brazilian, British and South African variants are the most worrisome. The Brazilian was perhaps the youngest of all. Studies are still in progress,” he warned.

The Pfizer test coordinator in Brazil explained that the more cases of infected with covid-19 are confirmed, the more there is the possibility of new variants appearing.

“The variant occurs at random. When the virus is replicating, mutations occur, for the good and the bad of the virus. Mutations that make it more effective only occur because it has a chance of replicating itself. If we vaccinate a large amount of population, it can no longer replicate “, he defended.

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