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Sinovac says that the Chinese companies that coronavac bought Covidien 19 vaccines will arrive tomorrow as Turkey.
He also announced the first results of the phase 3 study in Turkey coronavac I am a volunteer.
Even before time …
Normally, to determine the safety and the percentage of efficacy of this vaccine, the number of patients in the vaccinated group and the placebo (liquid with the appearance of the vaccine) must reach at least 40 patients.
However, the Ministry of Health broke the code without waiting for 40 cases.
In other words, a scientific comparison was made determining who received the vaccine and who received a placebo.
Consequently, 1,322 subjects were evaluated, 752 in the vaccine arm and 570 in the placebo arm. Three of those vaccinated and 26 people on the placebo were found to contract the disease. The efficiency percentage was announced to be 91.25.
Meanwhile, CoronaVac Phase 3 results in Brazil and Indonesia have not been announced.
Brazil canceled the declaration twice without giving reasons.
Turkey is the only country reporting early results among the three countries where the vaccine is called …
How reliable are these results?
How scientific is it?
LIMITED QUANTITY HIGH ACTIVITY
In announcing the first results of CoronaVac with Health Minister Fahrettin Koca, Prof. Dr. Serhat Ünal accepts the criticism that the number of topics is small and limited.
However, Brazil notes that since it did not release the results of Phase 3, it was mandatory.
Ünal continues as follows:
“We made statistical calculations according to the rate of transmission of the disease and the protection values of the vaccine. We are based on having at least 40 patients in 12,400 volunteers. Meanwhile, the state intends to buy CoronaVac. The phase 1 and phase 2 studies of the vaccine were successful. Antibody positivity occurs in 97-98% of cases. But it was necessary to see Phase 3. They said that the study of 12,000 people in Brazil ended and the results will be released. The Ministry of Health awaited the results. These are such critical days … You got the vaccine. But Brazil did not explain. “
The Turkish Ministry of Health’s Agency for Pharmaceutical Products and Medical Devices explained that, by urgently requesting information from the Scientific Committee on December 23 from Unal, “we would not need early assessment.” They saw that nobody came from Brazil. They had to do it, ”he says.
Unal, noting that the effectiveness of the vaccine is 91.25 percent, adds “There is no doubt as to its effectiveness.” According to Ünal, the vaccine has been allowed to be imported for now.
The vaccines will be tested for 14 days between 10-14.
The use decision will also be announced, based on test results and, if released, data from Brazil and Indonesia.
NO OTHER OPTIONS?
Professor of Infectious Diseases and Clinical Microbiology, Koç University School of Medicine. Dr. Önder Ergönül, on the other hand, emphasizes that the number of subjects is insufficient and that additional data will be needed and continues as follows:
You might say, “This is our result.” But it is not correct to say ‘this is done’. We should ask the Chinese researchers to explain. We should ask about studies in Brazil and Indonesia. Not that way. What will you do if an error occurs? Wouldn’t people say ‘You cheated on us’ if there were side effects? “
Ergönül rightly asks: Have other options for Turkey been completely exhausted?
Can’t take vaccines with phase 3 completed? For example, the British AstraZeneca …
Why was Pfizer / BioNTech not resolved in time?
THE VACCINE MUST BE APPLIED AT THE END OF PHASE 3
COVID 19 Oversight Board of the Turkish Medical Association and Professor at the Department of Public Health of the Uludağ University School of Medicine Dr. Kayıhan Pala, on the other hand, arguing that the code was broken to import the vaccine, “I find it wrong. “It took at least 40 patients to show that the vaccine was safe and effective.”
Pala believes that the initial data is promising, but the number of subjects is insufficient to qualify the vaccine as effective and safe.
That I have to do?
According to Pala …
First, we need to finish the Phase 3 study in Turkey.
The results must be published in a scientific journal.
Data for Turkey should be considered in conjunction with those for Brazil and Indonesia.
Pala continues as follows:
“If the Ministry puts the vaccine into action without considering scientific measures, there may be doubts. However, we have to clear up all the questions. Approval of this vaccine before its phase 3 trial is published is not acceptable. When granting a license, a board of competent scientists must be formed. Their meetings must be open to the public. “
Pala said: “I wish we hadn’t closed the Refik Saydam Institute. “Today we would be making Phase 3 of our own vaccine,” he adds.
MANDATORY …
It seems that the Ministry of Health had completed Phase 3, the results of which were announced, it did not supply enough Pfizer / BioNTech vaccine in time, and the British AstraZeneca vaccine was not purchased, so the Turks were forced to turn to the Chinese CoronaVac.
While the work in Brazil and Indonesia is unknown …
While China is silent …
Based on data from 1,322 patients due to lack of choice, the vaccines were imported from China.
Turkey has become a vaccine laboratory, the customer.
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