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The American pharmaceutical company Pfizer today presented the results of the phase 3 tests of its vaccine against covid-19 in Anvisa (National Health Surveillance Agency), according to an update made on the agency’s website. The documents are now being analyzed by the agency.
“This is another step in the continuous sending of data to Anvisa for the registration of the vaccine in Brazil,” explained the Pfizer advisor, in contact with the report from the Twitter. “This has been going on since the end of November,” he added.
Until now, only Pfizer and AstraZeneca presented the results of phase 3 trials of their respective vaccines at Anvisa. No company, at least for now, has requested an emergency use.
With the results of phase 3 of the investigation, the idea is that there is a careful analysis of the studies by professionals in the area, without interests related to the company that developed the vaccine, in addition to the health agencies. The next step concerns the registration of the immunizer for emergency use.
Pfizer also applied for good manufacturing practice certification, and is under review, according to Anvisa.
Proposal to the federal government
Pfizer submitted to the federal government a proposal to commercialize the covid-19 vaccine that would allow vaccination in the first half of 2021 of millions of people in the country.
At that time, the Ministry of Health said that it should buy the immunizer from the US pharmaceutical company, since clinical trials point to “total efficacy and safety” of the supplies and after the registration of Anvisa.
The Bolsonaro government only announced in December the purchase of 70 million doses of the vaccine, after a long delay, questions and pressure from the governors.
“The company is working and understands the importance and complexity of the logistics behind this. The offer of the company is that the vaccine is delivered in these boxes at the vaccination points, which must be agreed and worked with the governments. That is the part that we still have to work with with the Ministry of Health and the Brazilian government, ”said Carlos. Murillo, President of Pfizer do Brasil.
Messenger RNA
Pfizer and BioNTech’s vaccine, called BNT162, is made with messenger RNA technology, which carries genetic information to the body to make a virus protein and activate our immune system to generate an antibody response against the pathogen.
The study involved some 43,000 volunteers. The effectiveness analysis was performed when the number of infected in the group of participants reached 170. When opening the blinding of the investigation (that is, verifying how many of the infected were in the vaccinated group and how many in the placebo group), the Researchers found that 162 infections occurred among those who did not take the immunizer, thus achieving 95% effectiveness.
Although modern and easy to produce, RNA vaccines are sensitive. They require cooling to -70ºC. Pfizer and BioNTech say that while they await authorization for emergency use, they are already taking care of the logistical preparations for the distribution of the product, including a special box that uses dry ice to keep the immunizer at the proper temperature for up to 15 days.
So far, only four countries have approved the Pfizer immunizer: the United Kingdom, the United States, Mexico, and Bahrain.
Published results of phase 3 trials of the world’s leading vaccines in development:
