{"id":94127,"date":"2020-10-20T14:50:37","date_gmt":"2020-10-20T11:50:37","guid":{"rendered":"https:\/\/en.buradabiliyorum.com\/modernas-covid-19-vaccine-could-be-ready-by-december\/"},"modified":"2020-10-20T14:50:37","modified_gmt":"2020-10-20T11:50:37","slug":"modernas-covid-19-vaccine-could-be-ready-by-december","status":"publish","type":"post","link":"https:\/\/buradabiliyorum.com\/en\/modernas-covid-19-vaccine-could-be-ready-by-december\/","title":{"rendered":"#Moderna’s COVID-19 vaccine could be ready by December"},"content":{"rendered":"

“#Moderna’s COVID-19 vaccine could be ready by December<\/strong>”
\n<\/p>\n

\n The feds could clear Moderna\u2019s experimental coronavirus vaccine for emergency use in December if the company\u2019s clinical research goes according to plan, CEO St\u00e9phane Bancel reportedly said.<\/p>\n

That timeline depends on the Massachusetts-based biotech firm getting positive results next month from its late-stage clinical trial of the vaccine, Bancel said during a Wall Street Journal conference<\/a> on Monday.<\/p>\n

Moderna will analyze how well the vaccine is working when 53 people in its Phase 3 study develop symptomatic cases of COVID-19, the Journal reported. That analysis is expected to take place in November, though the exact timing is tough to predict \u201cbecause it depends on the cases, the number of people getting sick,\u201d Bancel said.<\/p>\n

The company also expects to have enough data on the vaccine\u2019s safety in late November, Bancel said. The US Food and Drug Administration could decide whether to grant an emergency use authorization for the shot in December if Moderna submits an app<\/a>lication soon after reaching that safety milestone, according to the Journal.<\/p>\n

However, it\u2019s possible that the vaccine won\u2019t be deemed effective enough when the initial data is analyzed next month, the paper reported. Moderna would then reportedly conduct a second analysis when 106 people get sick with the coronavirus.<\/p>\n

But Bancel said that likely wouldn\u2019t happen until December, meaning the FDA couldn\u2019t grant emergency approval until late January or early February.<\/p>\n

Moderna\u2019s targeted timeline is similar to Pfizer\u2019s. The Manhattan-based drugmaker \u2014 which is developing a vaccine with the German firm BioNTech \u2014 said last week that it could seek emergency approval for its COVID-19 shot as soon as late November.<\/p>\n

AstraZeneca and Johnson & Johnson have also started Phase 3 clinical trials for their respective coronavirus vaccines, but both companies have had to pause their studies after participants got sick.<\/p>\n

Moderna shares jumped 3.6 percent in premarket trading Tuesday to $73.54 as of 7:18 a.m. after the Journal reported Bancel\u2019s comments.<\/p>\n

An FDA spokesperson said the agency could not comment on any firm\u2019s plans to seek an emergency use authorization or how long it would take to review such a submission.\n <\/p><\/div>\n

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Source<\/a><\/span><\/p>\n","protected":false},"excerpt":{"rendered":"

“#Moderna’s COVID-19 vaccine could be ready by December” The feds could clear Moderna\u2019s experimental coronavirus vaccine for emergency use in December if the company\u2019s clinical research goes according to plan, CEO St\u00e9phane Bancel reportedly said. That timeline depends on the Massachusetts-based biotech firm getting positive results next month from its late-stage clinical trial of the…<\/p>\n","protected":false},"author":1,"featured_media":94128,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"fifu_image_url":"https:\/\/nypost.com\/wp-content\/uploads\/sites\/2\/2020\/10\/201020-moderna.jpg?quality=90&strip=all&w=1200","fifu_image_alt":"","footnotes":""},"categories":[70897],"tags":[76409,1545,74873,73840,71041],"class_list":["post-94127","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","tag-10-20-20","tag-coronavirus","tag-fda","tag-pharmaceuticals","tag-vaccines"],"_links":{"self":[{"href":"https:\/\/buradabiliyorum.com\/en\/wp-json\/wp\/v2\/posts\/94127","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/buradabiliyorum.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/buradabiliyorum.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/buradabiliyorum.com\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/buradabiliyorum.com\/en\/wp-json\/wp\/v2\/comments?post=94127"}],"version-history":[{"count":0,"href":"https:\/\/buradabiliyorum.com\/en\/wp-json\/wp\/v2\/posts\/94127\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/buradabiliyorum.com\/en\/wp-json\/wp\/v2\/media\/94128"}],"wp:attachment":[{"href":"https:\/\/buradabiliyorum.com\/en\/wp-json\/wp\/v2\/media?parent=94127"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/buradabiliyorum.com\/en\/wp-json\/wp\/v2\/categories?post=94127"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/buradabiliyorum.com\/en\/wp-json\/wp\/v2\/tags?post=94127"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}