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RIO – Pfizer will request from the National Sanitary Surveillance Agency (Anvisa) the emergency registration, in Brazil, of its covid-19 vaccine only the Food and Drug Administration (FDA, the US agency that deals with this type of procedure) gives the release in the United States. In a statement on Wednesday, the 18th, the pharmaceutical company said it had made a proposal to the Brazilian government and said it could “immunize millions of Brazilians” in the first half of 2021.
This Wednesday, the company reported what the immunizer was 95% effective in phase three of the tests, the most advanced for this type of product. The application for registration by the pharmacist will be submitted with the delivery of the final documentation of the phase 3 clinical trial. The forecast is that the product can already be applied in Brazilians from March of next year.
In a statement on Wednesday, the company said it had made “a proposal to the Brazilian government in line with the agreements closed in other countries, including Latin America, that would allow some million Brazilians to be vaccinated in the first half, subject to regulatory approval.” . da Saúde has claimed to analyze this and other immunizers in the final phase of testing.
Pfizer also explained that “it has developed a detailed logistics plan with tools to support the transport, storage and continuous monitoring of the temperature of the potential vaccine in an efficient manner.”
The result of a 95% effectiveness is considered excellent. The immunizer proved extremely safe. The most frequently reported side effects were very mild, such as pain or discomfort at the injection site. Problems such as fatigue and headaches were only registered in 3.8% of the cases and were temporary.
The emergency registration means that the vaccine will begin to be used without phase three being fully completed. Volunteers will be accompanied for two more years to establish the duration of the effectiveness of the immunizing agent. Scientists believe that, in a pandemic, this information becomes secondary.
Immunization also protects the elderly
Initially, the vaccine should be available to people in risk groups, such as health professionals and the elderly. “We were working with an estimated effectiveness of 70%; the result was exceptional, it means that out of every 100 vaccinated people, 95 are protected ”, said infectologist Edson Moreira, coordinator of the Pfizer study in Brazil. “No vaccine is 100% effective. I always like to remember the example of the smallpox vaccine, which is 80% efficient, but it managed to eradicate the disease worldwide ”.
In addition, as Moreira points out, the vaccine proved to be equally effective (94%) among people over 65, precisely those most vulnerable to the new coronavirus. “This is very good because, in general, the effectiveness of vaccines decreases with age, as the immune system ages and becomes less efficient,” he said. “It is extremely important that we can offer protection of this magnitude to people in this risk group.”
The clinical trial also showed that the vaccine is effective in protecting the population from both mild and moderate forms of the disease and severe forms.
The big challenge now concerns the storage and transportation of the vaccine, which requires temperatures of minus 70 degrees Celsius to remain stable. This can be a challenge for continental countries like Brazil.
“The alternative offered by the company is to transport the vaccines in special containers with dry ice, which would keep the vaccine viable for fifteen days. Furthermore, the product remains stable for another five days in a normal freezer ”, Moreira explained. “It is a challenge, but it is the kind of problem we were dying to face. Until recently, we didn’t have a vaccine, which was a bigger problem. “
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