화이자, "코로나 백신 90% 이상 효과" VIDEO: Pfizer's coronavirus vaccine is more than 90% effective, early data suggests
Pfizer's coronavirus vaccine is more than 90% effective, early data suggests
By Yasemin Saplakoglu - Staff Writer 10 hours ago
These interim results evaluated 94 participants that developed COVID-19 in late-stage clinical trials.
Early data suggests that Pfizer's coronavirus vaccine is more than 90% effective in preventing an infection with the virus that causes COVID-19, the company announced on Monday (Nov. 9).
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화이자, "코로나 백신 90% 이상 효과" 화이자의 코로나바이러스 백신이 COVID-19를 유발하는 바이러스에 감염되는 것을 예방하는 데 90% 이상 효과가 있는 것으로 나타났다고 회사 측은 월요일(11월 9일) 발표했다. 화이저와 독일의 제약회사 바이오가 개발한 백신NTech는 7월 말 시작된 대규모 임상 3상 즉, 백신이 많은 사람들에게 안전하고 효과적이라는 것을 증명해야 하는 마지막 가장 중요한 시험 단계인 대규모 임상 실험에서 현재 시험 중이다.
초기 분석 결과 이들 94명 가운데 두 차례 백신을 접종받은 사람 중 28일 간격으로 발병한 사람은 10% 미만인 것으로 나타났다. 즉 위약을 받은 사람 가운데 90%가 넘는 경우가 대부분이었다. 하지만 이 90%의 효능은 보도자료를 통해 발표됐고, 업체들은 아직 실제 실험 자료를 내놓지 않고 있다. 이 데이터는 동료 검토 또는 의학 저널에 발표되지 않았다. "3단계 재판이 계속됨에 따라 이 비율은 달라질 수 있다"고 회사측은 성명서에서 말했다. 황기철 콘페이퍼 에디터 Ki Chul Hwang Conpaper editor curator |
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The vaccine, developed by Pfizer and German drug company BioNTech, is currently being tested in a large phase 3 clinical trial — the last and most critical stage of testing in which vaccines must prove to be safe and effective in a large group of people — that began in late July.
An external independent Data Monitoring Committee conducted an interim analysis of the trial by evaluating 94 participants who developed COVID-19 after receiving either the vaccine or the placebo — a control measure that has no impact on preventing the infection.
However, this 90% efficacy was announced in a press release, and the companies haven't yet released actual data on the trials. The data has not been peer-reviewed or published in a medical journal. As the phase 3 trial continues, this percentage may vary, the company said in the statement.
Though the results aren't yet conclusive, if the numbers hold up, they are much higher than expectations.
"This is really a spectacular number," Akiko Iwasaki, an immunologist at Yale University told The New York Times. "I wasn’t expecting it to be this high. I was preparing myself for something like 55 percent." Indeed, the Food and Drug Administration (FDA) has said that in order for a vaccine to be approved, it would have to be at least 50% effective.
If the number holds up, "that is huge," Dr. Ashish Jha, the dean of the School of Public Health at Brown University, told STAT News. "That is much better than I was expecting, and it will make a huge difference." However, he cautioned that researchers will need to see full results before making any conclusions.
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The phase 3 clinical trial has enrolled 43,538 participants to date across the U.S., Argentina, Turkey, Brazil, Germany and South Africa. Around 30% of U.S. participants and 42% of global participants have racially and ethnically diverse backgrounds, according to the statement.
Originally, the interim analysis was set to be conducted when 32 people had developed COVID-19, but after discussions with the FDA, that number was bumped up to at least 62 people, according to the statement. The trial will continue to enroll participants until the final analysis when 164 participants test positive for COVID-19, according to the statement.
The study will further evaluate whether the vaccine provides protection for those who have previously been infected with SARS-CoV-2 and if the vaccine reduces severity in vaccinated people who do develop COVID-19, according to the statement.
"Today is a great day for science and humanity," Dr. Albert Bourla, CEO and chairman of Pfizer, said in the statement. "We are reaching this critical milestone in our vaccine development program at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity and economies struggling to reopen."
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German company BioNTech and Pfizer announce 90% effictive coronavirus vaccine | COVID-19 Special kcontents
