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The COVID-19 candidate vaccine, which the US pharmaceutical company Pfizer is jointly developing with Bioentech, was found to show a 95% preventive effect on final phase 3 clinical results.
Pfizer said it plans to apply for emergency use approval from the Food and Drug Administration (FDA) within a few days.
According to Reuters and CNN on the 18th (local time), Pfizer announced that the final result of phase 3 clinical trials evaluating efficacy and primary side effects through an announcement of the day showed that its vaccine showed an efficacy of 95 % in the prevention of Corona 19. In particular, it was confirmed that 94% of people over 65 had a preventive effect.
Specifically, 170 of 43,661 participants in the phase 3 clinical trial were infected with Corona 19, of which 162 were counted in the placebo (dummy drug) prescription group and 8 in the vaccination group, and the efficacy of the vaccine it was measured at 95%. .
However, Pfizer did not disclose detailed data, such as the age of the eight people who received the vaccine. Furthermore, there is no specific explanation for the effects seen in the elderly.
Among those who received the vaccine, the only associated side effect was fatigue, and symptoms appeared in 3.8% of the participants after the second vaccination.
The results of the final Pfizer analysis were published approximately one week after the results of the interim analysis were published. On the 10th, Pfizer announced that as a result of an interim Phase 3 clinical analysis, its vaccine was more than 90% effective in preventing Corona 19.
Pfizer said it has obtained the data proving the safety of the vaccine required by the FDA and plans to apply for emergency use approval from the FDA within a few days.
The company explained: “The FDA requests at least 2 months of safety data for the urgent use of the vaccine in the development stage, and we have obtained all the safety data for 2 months.”
On the other hand, the phase 3 clinical trial of Pfizer’s COVID-19 vaccine is currently underway in 43,661 people in six countries, including the United States, since July. Of these, 41,135 people have completed the second vaccination.
Pfizer plans to continue collecting vaccine efficacy and safety data for Phase 3 clinical participants over the next two years.
Park Mira, Reporter for Money Today Broadcasting MTN
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