{"id":13846,"date":"2021-05-08T19:35:18","date_gmt":"2021-05-09T02:35:18","guid":{"rendered":"https:\/\/www.functionalps.com\/blog\/?p=13846"},"modified":"2021-05-08T19:38:15","modified_gmt":"2021-05-09T02:38:15","slug":"moderna-nears-its-first-ever-fda-authorization-for-its-covid-19-vaccine","status":"publish","type":"post","link":"https:\/\/www.functionalps.com\/blog\/2021\/05\/08\/moderna-nears-its-first-ever-fda-authorization-for-its-covid-19-vaccine\/","title":{"rendered":"Moderna nears its first-ever FDA authorization, for its COVID-19 vaccine"},"content":{"rendered":"\n

Source<\/a><\/p>\n\n\n\n

Published: Dec. 16, 2020 at 11:04 a.m. ET<\/p>\n\n\n\n

By\u00a0Jaimy Lee<\/a><\/p>\n\n\n\n

Wall Street analysts expect that the week will end with the FDA granting an emergency use authorization to the company\u2019s experimental vaccine.\u00a0<\/p>\n\n\n\n

If the Food and Drug Administration authorizes Moderna Inc.\u2019s COVID-19 vaccine candidate, it will be the second vaccine to be made available to Americans during the coronavirus pandemic \u2014 and the first-ever authorized product for the 10-year-old biotech.<\/p>\n\n\n\n

Shares of Moderna MRNA, +1.65%<\/a> were down 6.7% in trading on Wednesday morning, though Wall Street analysts largely expect that the week will end with the FDA granting an emergency use authorization to the company\u2019s experimental COVID-19 vaccine.<\/p>\n\n\n\n

The regulator on Tuesday called mRNA-1273 \u201chighly effective\u201d<\/a> in a report<\/a> published in advance of a FDA advisory committee meeting scheduled for Thursda<\/a>y that will allow a group of independent medical experts to discuss the risks and benefits of the still investigational vaccine. This is the final regulatory step before the FDA decides whether to authorize the vaccine.<\/p>\n\n\n\n

Moderna has said its coronavirus vaccine candidate has an efficacy rate of about 94%, based on data from clinical trials.<\/p>\n\n\n\n

Unlike Pfizer Inc.\u00a0PFE,\u00a0+1.00%<\/a>,\u00a0a traditional pharmaceutical company with a wide-ranging portfolio of commercialized medicines that last week\u00a0received emergency authorization<\/a>\u00a0from the FDA for the COVID-19 vaccine it developed with German biotech BioNTech\u00a0BNTX,\u00a0+9.35%<\/a>,\u00a0Moderna has never had one of its products make it as far along in the regulatory process as mRNA-1273.<\/strong><\/p>\n\n\n\n

The company, which has no FDA-approved or authorized products<\/strong>, has seen its market capitalization increase to about $54.3 billion in recent trading from just $6.6 billion at the end of 2019, according to FactSet data. In comparison, Pfizer\u2019s market cap was $211.1 billion.<\/p>\n\n\n\n

Moderna\u2019s stock tumbled to a low for the year at $17.78 on Jan. 7, five days before it announced plans to begin developing a vaccine aimed at preventing infection with what was then referred to as the novel coronavirus. At that time, the virus was still primarily infecting people in Wuhan, China.<\/p>\n\n\n\n

Since then, Moderna\u2019s stock had soared, closing at an all-time high of $169.86 on Dec. 8.<\/p>\n\n\n\n

In the last 11 months, the vaccine has moved through the three phases of clinical trials, and Moderna has announced multiple deals with governments around the world to acquires doses of its vaccine candidate. This includes about $1 billion to support clinical trials and manufacturing build-out from the National Institutes of Health and the planned purchase of 200 million doses<\/a> from the U.S. government.<\/p>\n\n\n\n

\u201cWhat has limited us in the past was capital,\u201d Moderna CEO St\u00e9phane Bancel\u00a0said this month at an investor conference, according to a FactSet transcript of the call. \u201cYou could see us sitting on a very substantial balance sheet at the end of 2021, which I think will be an equitable stepping stone for us to scale Moderna.\u201d<\/p>\n\n\n\n

The rapid rise in Moderna\u2019s value prompted Morgan Stanley analyst Matthew Harrison to downgrade the company on Wednesday to equal weight from overweight. Although Harrison sees \u201csignificant\u201d potential for Moderna over the long term, any near-term COVID-19 value has already been largely priced into the stock.<\/p>\n\n\n\n

The focus of the company\u2019s research and development pipeline is the same mRNA, or messenger ribonucleuc acid, technology it is using for the COVID-19 vaccine. It\u2019s been testing mRNA vaccines for cancers like melanoma and solid tumors, other infectious diseases like Zika, and some rare, inherited disorders like methylmalonic acidemia. None of the experimental vaccines have made it through mid-stage clinical trials except for its COVID-19 vaccine.<\/strong><\/p>\n\n\n\n

The FDA last week\u00a0authorized the BioNTech\/Pfizer vaccine<\/a>\u00a0one day after the advisory committee voted 17-4-1 that the benefits of their vaccine outweigh the risks. (The FDA isn\u2019t required to follow the advice of the committee but often does.) The \u201cno\u201d votes from four of the independent medical experts on the committee were attributed to concern about allowing the vaccine to be administered to teens who are at least 16 years old.<\/p>\n\n\n\n

The authorization made the BioNTech\/Pfizer vaccine the first to be authorized in the U.S. and also marked the first time that regulatory approval of any kind was granted to a mRNA product.<\/strong><\/p>\n\n\n\n

Because Moderna is seeking authorization for people who are at least 18 years old, some analysts expect a unanimous vote in favor of the FDA authorizing mRNA-1273. \u201cThis should not be an issue for Moderna given the trial and EUA request,\u201d Raymond James analyst Steven Seedhouse told investors on Wednesday.<\/p>\n\n\n\n

Moderna\u2019s stock has rallied 602.0% so far this year. The S&P 500 SPX, +0.74%<\/a> has gained 14.5% since the start of the year.<\/p>\n","protected":false},"excerpt":{"rendered":"

Source Published: Dec. 16, 2020 at 11:04 a.m. ET By\u00a0Jaimy Lee Wall Street analysts expect that the week will end with the FDA granting an emergency use authorization to the company\u2019s experimental vaccine.\u00a0 If the Food and Drug Administration authorizes Moderna Inc.\u2019s COVID-19 vaccine candidate, it will be the second vaccine to be made available […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-13846","post","type-post","status-publish","format-standard","hentry","category-general"],"_links":{"self":[{"href":"https:\/\/www.functionalps.com\/blog\/wp-json\/wp\/v2\/posts\/13846","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.functionalps.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.functionalps.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.functionalps.com\/blog\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.functionalps.com\/blog\/wp-json\/wp\/v2\/comments?post=13846"}],"version-history":[{"count":1,"href":"https:\/\/www.functionalps.com\/blog\/wp-json\/wp\/v2\/posts\/13846\/revisions"}],"predecessor-version":[{"id":13847,"href":"https:\/\/www.functionalps.com\/blog\/wp-json\/wp\/v2\/posts\/13846\/revisions\/13847"}],"wp:attachment":[{"href":"https:\/\/www.functionalps.com\/blog\/wp-json\/wp\/v2\/media?parent=13846"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.functionalps.com\/blog\/wp-json\/wp\/v2\/categories?post=13846"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.functionalps.com\/blog\/wp-json\/wp\/v2\/tags?post=13846"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}