■輝瑞研發的新冠疫苗在第三階段臨床試驗對感染新冠病毒的保護率超過90%。 資料圖片【原文】下文摘錄自香港《文匯報》11月10日︰
新冠肺炎疫情（COVID-19）肆虐全球，疫苗（vaccine）成為讓社會回復正常生活的最大希望。美國藥廠（pharmaceutical company）輝瑞（Pfizer）於11月9日宣布，公司與德國生物科技公司（biotechnology company）BioNTech合作研發的新冠疫苗，在第三階段臨床試驗（clinical trial）中，對感染新冠病毒的保護率超過90%，是首間公布疫苗實驗成功數據的藥廠。輝瑞表示本月稍後會向美國政府申請緊急使用（emergency use ）許可，美國總統當選人拜登（Joe Biden）隨即發聲明，形容輝瑞實驗成功的消息為公眾帶來希望，但同時強調抗疫路仍然漫長。
受疫苗利好消息刺激，加上拜登確定當選美國總統，市場憧憬美國外交及經貿政策有變，美股三大指數在11月9日全線爆升，道瓊斯工業指數（Dow Jones Industrial Average）早段升1,225點，報29,548點，升幅超過4%；標準普爾500指數（Standard & Poor's 500 Index）升120點，報3,629點；納斯達克綜合指數（Nasdaq Composite Index）亦升116點，報12,011點。輝瑞股價升超過7%。
輝瑞在美股開市前發聲明，公布與BioNTech合作研發的信使核糖核酸（messenger ribonucleic acid, mRNA）疫苗第三階段臨床試驗的初步結果。公司在美國及5個其他國家招募近4.4萬人參與實驗，並分成兩組，分別接種研發中的疫苗及安慰劑（placebo），在94名志願者報告確診新冠肺炎後，開始分析接種者與比對安慰劑組數據，計算出疫苗對超過90%接種者有效，遠超出食品及藥物管理局（Food and Drug Administration, FDA）批出緊急許可所要求的50%。
由於實驗未完結，輝瑞沒有公布94名確診志願者中，有多少人接種了疫苗，不過按照公司提供的數據推算，只有不多於8名確診志願者曾接種疫苗。
由於FDA要求試驗需要出現164名確診者，數據才龐大至足以證實疫苗有效，因此輝瑞會繼續試驗直至達到FDA要求。此外FDA亦要求藥廠追蹤實驗對象最少兩個月，才能確定疫苗是否會有副作用（side effect），輝瑞的實驗預料在本月稍後會達兩個月的門檻（threshold），不過公司指至今仍無人出現嚴重副作用。
輝瑞本月稍後即會向FDA申請使用許可，意味疫苗最快本月底或下月可正式上市，不過當局已表明需一段時間審批。為節省時間，輝瑞已經在確定疫苗是否有效前投入生產，預計在明年可生產達13億劑。輝瑞目前已經與多方簽訂疫苗供貨協議，包括美國、歐盟（European Union）、英國（United Kingdom）、加拿大（Canada）及日本（Japan）。
Pfizer's COVID-19 vaccine achieves 90% efficacy
【譯文】When the globe is hard hit by coronavirus pandemic, vaccines are expected to deliver hope to the society for a quick return to normal. The U.S. pharmaceutical company Pfizer announced on 9 November that the experimental COVID-19 vaccine jointly developed by the firm and the German biotechnology company BioNTech had achieved a vaccine efficacy rate of over 90% in the third phase of clinical trials, making the company the first in the world to release such preliminary trial data of successful vaccine. Pfizer said that it would apply for emergency use authorization from the U.S. government later this month, while the new President-elect Joe Biden immediately issued a statement describing that the news of the firm's successful experiment brought hope to the public, but there would be still a long way to go in fighting against the virus.
Stimulated by the good news of successful vaccines, added that Joe Biden had been elected the next U.S. president, the market was expecting changes in the U.S. diplomatic and economic and trade policies. Hence, an explosive surge was seen in all the three major U.S. stock indexes - the Dow Jones Industrial Average rose 1,225 points to 29,548 points, an increase of over 4%; the Standard & Poor's 500 Index rose 120 points to 3,629 points; the Nasdaq Composite Index also rose 116 points to 12,011 points. Pfizer stocks climbed more than 7% after releasing the news.
Pfizer issued a statement right before the opening of the U.S. stock market, announcing the preliminary results of the third phase of clinical trial of the messenger ribonucleic acid （mRNA） vaccine developed in cooperation with BioNTech. Nearly 44,000 people in the United States and 5 other countries were recruited by the firm to participate in the experiment, whom were being divided into two groups to receive the vaccine under development and the placebo.
After 94 volunteers were tested positive for COVID-19, the company started analyzing the data of the vaccine group versus the placebo group, and eventually found that the vaccine was more than 90% effective at preventing the virus, far exceeding the efficacy rate of 50% as requested by the U.S. Food and Drug Administration for a permit for emergency use.
As the experiment had not come to an end, Pfizer had not mentioned the number of people who had been vaccinated among the 94 confirmed cases of COVID-19. However, according to the data provided by the company, there should be no more than 8 volunteers of confirmed cases who had been vaccinated.
Since the FDA requested the trial to reach 164 confirmed cases of coronavirus infection for the purpose to obtain sufficient data to prove the efficacy of the vaccine, so Pfizer will continue the test until it meets the relevant requirements.
In addition, the authority also requested that the volunteers be monitored by the pharmaceutical firm for at least two months to observe if there would be any vaccine side effects. The company's experiment is expected to reach the two-month threshold later this month, but it claimed that no serious side effects had been detected so far.
Pfizer plans to apply for permission for emergency use from the FDA later this month, meaning that the vaccine could be officially launched by end of this month or early next month, but the authority had indicated that it would take some time for processing.
To save time, Pfizer has already started the production before fully confirming the efficacy of the vaccine, and expects to produce globally up to 1.3 billion doses next year. The company has already signed vaccine supply agreements with various parties, including the U.S., the European Union, the United Kingdom, Canada and Japan.■龐嘉儀
Q&A
1. 輝瑞公司於何時創立？
2. 該公司的總部位於哪裏？
3. 該公司於創立初期主要生產什麼產品？
4. 輝瑞研發的新冠疫苗據悉需要儲存於多少度的環境？
Answer
1. 1849年
2. 美國紐約（New York）
3. 化工產品
4. 攝氏零下70度