Drug-makers Pfizer and BioNTech said they are “within days” of seeking emergency use authorization for their COVID-19 vaccine from the U.S. Food and Drug Administration (FDA). Pfizer, an American company, and its German partner BioNTech said final results from the large Phase 3 study show the vaccine to be 95 percent effective against COVID-19. The drug-makers said there were 170 confirmed cases of COVID-19 in the study of 43,000 volunteers. Among the confirmed cases, eight received the experimental vaccine and 162 received a placebo, a shot with an inactive substance. The FDA only requires that a vaccine be at least 50 percent effective to be considered for emergency use. The agency also wants the drug-makers to present two months of safety data from the trials, which Pfizer said it had done.
Title: Pfizer ‘Within Days’ of Seeking Emergency Use for COVID-19 Vaccine
Content: <div id='article-page'><div id='article-content' data-media-url='//news-app-staging.s3.amazonaws.com' data-base-url='//news-app-staging.herokuapp.com' data-sound-name='https://news-app-production.s3.amazonaws.com/articles/4672/B.wav' data-capture-url='//staging.analytics.lingraphica.com/events/capture_news' data-article-title='Pfizer Within Days of Seeking Emergency Use for COVID-19 Vaccine' data-article-id='5199'><script src='//news-app-staging.herokuapp.com/javascripts/getscripts.js'></script><link rel='stylesheet' href='//news-app-staging.herokuapp.com/stylesheets/article.css' type='text/css' /><div class='article'><p><span data-start-time='0' data-end-time='17042'>Drug-makers Pfizer and BioNTech said they are “within days” of seeking emergency use authorization for their COVID-19 vaccine from the U.S. Food and Drug Administration (FDA).</span> <span data-start-time='17042' data-end-time='37438'>Pfizer, an American company, and its German partner BioNTech said final results from the large Phase 3 study show the vaccine to be 95 percent effective against COVID-19.</span> <span data-start-time='37438' data-end-time='50042'>The drug-makers said there were 170 confirmed cases of COVID-19 in the study of 43,000 volunteers.</span> <span data-start-time='50042' data-end-time='65313'>Among the confirmed cases, eight received the experimental vaccine and 162 received a placebo, a shot with an inactive substance.</span> <span data-start-time='65313' data-end-time='77813'>The FDA only requires that a vaccine be at least 50 percent effective to be considered for emergency use.</span> <span data-start-time='77813' data-end-time='91500'> The agency also wants the drug-makers to present two months of safety data from the trials, which Pfizer said it had done.</span> </p></div><div class='control-buttons-sticky' style='display:none;'><div class='control-buttons'><button title='Back' class='back' disabled='disabled'></button><button title='Play' class='play' disabled='disabled'></button><button title='Pause' class='pause' style='display:none;'></button><button title='Forward' class='forward' disabled='disabled'></button><button class='finished-reading' style='display:none;'>Done</button></div></div></div><div id='article-media'><div id='media-image'><img src='https://news-app-production.s3.amazonaws.com/articles/4672/B.jpg'/></div></div><div id='question-content' style='display:none;'><div class='vocabulary_question question-container' data-question-id=16303 data-hint-location='50042' style='display:none;'><div class='question' data-sound-name='https://news-app-production.s3.amazonaws.com/articles/4672/what_is_a_placebo.wav'>What is a placebo?</div><div class='choices' data-correct-choice='an inactive substance'><div class='choice' data-sound-name='https://news-app-production.s3.amazonaws.com/articles/4672/an_inactive_substance.wav'><span>an inactive substance</span></div><div class='choice' data-sound-name='https://news-app-production.s3.amazonaws.com/articles/4672/an_effective_vaccine.wav'><span>an effective vaccine</span></div><div class='choice' data-sound-name='https://news-app-production.s3.amazonaws.com/articles/4672/a_cure.wav'><span>a cure</span></div><div class='choice' data-sound-name='https://news-app-production.s3.amazonaws.com/articles/4672/a_place_setting.wav'><span>a place setting</span></div></div></div><div class='multiple_choice_question question-container' data-question-id=16304 data-hint-location='37438' style='display:none;'><div class='question' data-sound-name='https://news-app-production.s3.amazonaws.com/articles/4672/how_many_volunteers_were_involved_in_the_pfizer_vaccine_study.wav'>How many volunteers were involved in the Pfizer vaccine study?</div><div class='choices' data-correct-choice='43,000 '><div class='choice' data-sound-name='https://news-app-production.s3.amazonaws.com/articles/4672/43000_.wav'><span>43,000 </span></div><div class='choice' data-sound-name='https://news-app-production.s3.amazonaws.com/articles/4672/63000_.wav'><span>63,000 </span></div><div class='choice' data-sound-name='https://news-app-production.s3.amazonaws.com/articles/4672/3000_.wav'><span>3,000 </span></div><div class='choice' data-sound-name='https://news-app-production.s3.amazonaws.com/articles/4672/50000_.wav'><span>50,000 </span></div></div></div><div class='sentence_completion_question question-container' data-question-id=16305 data-hint-location='17042' style='display:none;'><div class='question' data-sound-name='https://news-app-production.s3.amazonaws.com/articles/4672/pfizer_partnered_with_a_biotechnology_company_in__blank_.wav'>Pfizer partnered with a biotechnology company in <span class='blank'>Germany</span>.</div><div class='choices' data-correct-choice='Germany'><div class='choice' data-sound-name='https://news-app-production.s3.amazonaws.com/articles/4672/germany.wav'><span>Germany</span></div><div class='choice' data-sound-name='https://news-app-production.s3.amazonaws.com/articles/4672/france.wav'><span>France</span></div><div class='choice' data-sound-name='https://news-app-production.s3.amazonaws.com/articles/4672/united_states.wav'><span>United States</span></div><div class='choice' data-sound-name='https://news-app-production.s3.amazonaws.com/articles/4672/england.wav'><span>England</span></div></div></div><div class='question-buttons'><button class='skip-button'></button><button class='hint-button'></button><button class='speak-button'></button></div></div></div>
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