NVAX Starts Late-Stage Study on COVID-19-Flu Combo & Flu Vaccines

Zacks12-11

Novavax NVAX announced that it has started dosing participants in the phase III study evaluating its experimental COVID-19-influenza combination (CIC) and stand-alone influenza vaccine candidates. The...

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Management will also assess the immunogenicity and safety of its standalone influenza vaccine.\nBoth experimental vaccines will utilize the company’s proprietary adjuvant technology, Matrix-M, to enhance the immune response. The study will focus on adults aged 65 and older.\nNovavax is in active discussions with the FDA for accelerated approval for both vaccines. Though more clarity on these discussions is expected in the second quarter of 2025, management has decided to enroll nearly 2,000 study participants in an initial cohort of the study.\nNVAX is also exploring strategic collaborations to finance the late-stage development and potential commercialization of both candidates.\nThis initiation is supported by data from a mid-stage study, which showed that both vaccines were well-tolerated and generated robust immune responses when compared with authorized comparators like Novavax’s own COVID-19 vaccine and influenza vaccines Fluzone HD and Fluad, marketed by Sanofi SNY and CSL Seqirus’ Fluad, respectively.\nNVAX Stock Performance\nYear to date, Novavax’s shares have soared 82.7% against the industry’s 7.3% decline.\nImage Source: Zacks Investment Research\nNVAX’s Recent Developments\nThe announcement was made just a month after the FDA lifted the clinical hold on the CIC and influenza vaccines. The agency had initially placed this hold in October after a study participant who took the CIC shot as part of a phase II study reported nerve damage.\nIn May, Novavax signed a multi-billion dollar deal with pharma giant Sanofifor its protein-based COVID-19 vaccine. Starting next year, Sanofi will market the company’s COVID-19 vaccine and use it to develop novel COVID-19-influenza combination vaccines. As part of this deal, NVAX received a payment of $570 million from SNY, including $70 million in equity investment. Novavax is also eligible to receive milestone payments of up to $700 million and royalties on sales of the COVID-19 vaccine from Sanofi.\nThe agreement permits both companies to develop their respective combined COVID-19-influenza combination vaccines and adjuvanted products at their own cost.\nOther Players Developing COVID-Flu Combination Shots\nApart from Novavax, pharma giants like Pfizer PFE and Moderna MRNA are also developing their respective COVID/flu combination vaccines using mRNA technology. Both peers are way ahead of NVAX as their candidates are in late-stage development.\nModerna is ahead of all its competitors in the COVID/flu combination space. In June, MRNA reported positive results from a late-stage study on mRNA-1083, its investigational mRNA-based combination vaccine against influenza and COVID-19, in older adults (50 years and above). This study met its primary endpoints, showing that mRNA-1083 elicited higher immune responses against influenza and COVID-19 than licensed standalone influenza and COVID-19 vaccines.\nBased on these results, MRNA intends to submit a regulatory filing seeking approval for mRNA-1083 before the end of this year, subject to ongoing discussions with the FDA. It aims to market the vaccine next year.\nPfizer suffered a major setback in this space a few months back when it reported data from a phase III study on its investigational mRNA-based COVID/flu combination vaccine. The study missed one of its two primary immunogenicity objectives. PFE is currently evaluating adjustments to its combination vaccine program to improve immune responses against influenza B and plans to discuss the next steps with health authorities. Pfizer is developing this vaccine in collaboration with BioNTech.\nA recent entrant into this space is Sanofi, which is also developing its own COVID/flu combination vaccines. Earlier today, SNY announced that the FDA has granted fast-track designation to two of its experimental combination vaccines for COVID-19 and influenza, each being evaluated in separate phase I/II studies. While the first combination pairs the Fluzone HD vaccine with Novavax’s COVID-19 vaccine, the second combines Sanofi’s Flubok influenza vaccine with the NVAX COVID-19 vaccine.\n\nNovavax, Inc. Price\n\nNovavax, Inc. price | Novavax, Inc. Quote\n\nNVAX’s Zacks Rank\nNovavax currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.\nWant the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report\nSanofi (SNY) : Free Stock Analysis Report\nPfizer Inc. (PFE) : Free Stock Analysis Report\nModerna, Inc. (MRNA) : Free Stock Analysis Report\nNovavax, Inc. (NVAX) : Free Stock Analysis Report\nTo read this article on Zacks.com click here.\nZacks Investment Research","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"dataReport","news_rank":0,"symbols":[],"gpt_button":0},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":true,"deviceId":"web-server-community-laohu8-v3","version":"4.29.3","shortVersion":"4.29.3","platform":"web","vendor":"web","appName":"ttm","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2490868314"}