Ultime notizie per Moderna (NASDAQ:MRNA) Azioni

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Moderna

Moderna is a commercial-stage biotech that was founded in 2010 and had its initial public offering in December 2018. The firm's mRNA technology was rapidly validated with its covid vaccine, which was authorized in the United States in December 2020. Moderna had 40 mRNA development candidates in clinical development as of September 2024. Programs span a wide range of therapeutic areas, including infectious disease, oncology, cardiovascular disease, and rare genetic diseases.

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<a href="https://asia.nikkei.com/Business/Pharmaceuticals/Moderna-cancels-Japan-mRNA-plant-plans-amid-weak-demand">https://asia.nikkei.com/Business/Pharmaceuticals/Moderna-cancels-Japan-mRNA-plant-plans-amid-weak-demand</a>

'Moderna cancels Japan mRNA plant plans amid weak demand'- Nikkei Asia

On Monday, the U.S. Food and Drug Administration (FDA) agreed to review GSK plc&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>) application to extend the indication of Arexvy (Respiratory Syncytial Virus Vaccine, Adjuvanted) to adults aged 18-49 <a href="https://www.benzinga.com/general/health-care" target="_blank" rel="noreferrer noopener">who are at increased risk</a>.
GSK's RSV vaccine is approved in the U.S. to prevent lower respiratory tract disease (LRTD) caused by RSV in adults aged 60 and older, as well as those aged 50-59 years at increased risk for LRTD caused by RSV.
RSV, a common contagious virus affecting the lungs and breathing passages, impacts an estimated 64 million people of all ages globally every year. More than 125 million adults in the U.S. are under 50. An estimated 21 million of these people have at least one diagnosed risk factor for severe RSV infection, such as chronic obstructive pulmonary disease, asthma, congestive heart failure, and coronary heart disease.
The regulatory submission is <a href="https://us.gsk.com/en-us/media/press-releases/fda-accepts-application-to-review-expanded-use-of-gsk-s-rsv-vaccine-arexvy/" target="_blank" rel="noreferrer noopener">supported</a> by a Phase 3b trial evaluating immune response and safety in adults aged 18-49 who are at increased risk compared to adults aged 60 and above.
The safety and reactogenicity data were consistent with those from the Phase 3 program, which supported the vaccine&#8217;s initial approval in the U.S.
A regulatory decision by the FDA on this submission is expected in the first half of 2026.
In June, the FDA expanded approval of Moderna Inc.'s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRNA#NASDAQ">MRNA</a>) respiratory syncytial virus vaccine to adults aged 18-59 at increased risk <a href="https://www.benzinga.com/news/health-care/25/06/45921359/fda-expands-modernas-rsv-vaccine-use-to-at-risk-adults-aged-18-59-amid-cdc-panel-shake-up" target="_blank" rel="noreferrer noopener">for disease</a>. That same month, the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) voted to recommend Merck &amp; Co Inc's (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MRK#NYSE">MRK</a>) Enflonsia (clesrovimab-cfor) as an option for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in infants younger than 8 months of age who are born during or entering their first RSV season.
With a <a target="_blank" href="https://www.cdc.gov/media/releases/2025/2025-cdcs-advisory-committee-on-immunization-concludes-meeting-with-joint-statement.html" rel="noreferrer noopener">five-to-two </a>majority, RFK Jr.'s newly constituted committee made its first ruling. This body was formed after RFK Jr. entirely replaced the previous 17-member panel <a target="_blank" href="https://www.benzinga.com/news/health-care/25/06/46136734/rfk-jrs-cdc-panel-recommends-mercks-rsv-shot-for-infants" rel="noreferrer noopener">with his selections</a>.
Also, in June, Sanofi SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) announced that it will begin shipping Beyfortus (nirsevimab) in early Q3 to ensure broad availability well ahead of the 2025-2026 respiratory syncytial virus (RSV) season, which typically starts in November and <a href="https://www.benzinga.com/news/health-care/25/06/45839621/beyfortus-output-tripled-as-sanofi-astrazeneca-scale-up-for-rsv-season" target="_blank" rel="noreferrer noopener">runs through March</a>.
In collaboration with its partner AstraZeneca plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>), Sanofi has tripled production capacity and doubled the number of manufacturing sites since the launch of Beyfortus in 2023.
Last week, GSK announced it has started shipping doses of its trivalent seasonal influenza vaccines to U.S. healthcare providers and pharmacies in preparation for the 2025-26 flu season.
This immediately follows FDA licensing and approval of the lot release. FLULAVAL and FLUARIX will be available in a 0.5mL, single-dose, pre-filled syringe and are indicated for people <a href="https://www.benzinga.com/pressreleases/25/07/b46342250/gsk-begins-shipping-influenza-vaccine-doses-for-the-2025-26-flu-season" target="_blank" rel="noreferrer noopener">six months and older</a>.
Price Action: GSK stock is down 1.36% at $37.77 at the last check on Tuesday.
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GSK Seeks FDA Nod To Broaden RSV Vaccine For Younger At-Risk Adults

These ten large-cap stocks were top performers last week. Are they a <a target="_blank" href="https://www.benzinga.com/trading-ideas" rel="noreferrer noopener">part of your portfolio</a>?
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<li>Venture Global, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/VG#NYSE">VG</a>) jumped 18.96% last week after landing a 20-year <a href="https://www.benzinga.com/pressreleases/25/07/b46314484/venture-global-and-sefe-announce-expansion-of-lng-partnership" target="_blank" rel="noreferrer noopener">LNG deal with Germany's SEFE</a>. For the quarter ended June, it exported 51 cargos (190.5 TBtu) from its Plaquemines facility, earning an average liquefaction fee of $7.09/MMBtu.</li>
<li>SoFi Technologies, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SOFI#NASDAQ">SOFI</a>) stock rose 14.29% this week after TD Cowen initiated coverage with a Hold rating and a <a href="https://www.benzinga.com/quote/SOFI/analyst-ratings" target="_blank" rel="noreferrer noopener">price forecast of $21</a>. The stock is also gaining from potential legislative changes that could significantly reroute student loan demand from federal <a href="https://www.benzinga.com/analyst-stock-ratings/analyst-color/25/07/46352055/how-trumps-student-loan-reform-could-funnel-billions-loans-sofi" target="_blank" rel="noreferrer noopener">programs to private lenders</a>.</li>
<li>Delta Air Lines, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/DAL#NYSE">DAL</a>) stock gained 11.91% this week after the company reported better-than-expected second-quarter <a href="https://www.benzinga.com/markets/earnings/25/07/46341383/delta-air-lines-ceo-confident-in-stronger-2025-as-demand-holds-steady" target="_blank" rel="noreferrer noopener">earnings per share and sales</a>. Multiple analysts also increased the <a href="https://www.benzinga.com/quote/dal/analyst-ratings" target="_blank" rel="noreferrer noopener">price forecast on the stock.</a></li>
<li>Unity Software Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/U#NYSE">U</a>) stock gained 9.17% after Wells Fargo maintained an Equal-Weight rating but raised its<a href="https://www.benzinga.com/quote/u/analyst-ratings" target="_blank" rel="noreferrer noopener"> price forecast from $19 to $24.</a></li>
<li>Moderna, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRNA#NASDAQ">MRNA</a>) stock increased 10.66% this week after the company received full FDA approval for its COVID-19 vaccine, Spikevax, for children aged 6 months through 11 years at increased <a href="https://www.benzinga.com/news/fda/25/07/46351929/fda-grants-complete-approval-to-modernas-covid-19-vaccine-for-children-as-young-as-6-months" target="_blank" rel="noreferrer noopener">risk for COVID-19 disease</a>. The company also announced it will sue RFK Jr over what they deem to be unlawful <a href="https://www.benzinga.com/news/health-care/25/07/46303191/medical-groups-sue-rfk-jr-for-assault-on-science-over-unlawful-covid-19-vaccine-rollbacks" target="_blank" rel="noreferrer noopener">COVID-19 vaccine rollbacks.</a></li>
<li>PTC Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PTC#NASDAQ">PTC</a>) stock increased 10.06% this week after Keybanc reiterated an Overweight rating, raising the <a href="https://www.benzinga.com/quote/PTC/analyst-ratings" target="_blank" rel="noreferrer noopener">price forecast from $185 to $192.</a> Also, media reports emerged claiming that Autodesk, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ADSK#NASDAQ">ADSK</a>)<a href="https://www.autodesk.com/" target="_blank" rel="noreferrer noopener"></a> is working with advisors as it weighs a potential acquisition of PTC in a deal that would <a href="https://www.benzinga.com/trading-ideas/movers/25/07/46333062/autodesk-stock-is-moving-lower-whats-happening">involve a mix of cash and stock.</a></li>
<li>Rocket Lab Corporation (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/RKLB#NASDAQ">RKLB</a>) stock rose 5.60% after selecting Bollinger Shipyards to help build its ocean landing platform <a href="https://www.benzinga.com/pressreleases/25/07/b46355743/rocket-lab-selects-bollinger-shipyards-to-support-modification-of-neutron-landing-platform" target="_blank" rel="noreferrer noopener">for the Neutron reusable rocket</a>.</li>
<li>Tapestry, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/TPR#NYSE">TPR</a>) stock gained 7.93% last week after Barclays reiterated an Overweight rating on the stock, increasing the <a href="https://www.benzinga.com/quote/TPR/analyst-ratings" target="_blank" rel="noreferrer noopener">price forecast from $98 to $105.</a></li>
<li>Southwest Airlines Company (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/LUV#NYSE">LUV</a>) stock increased 8.31% in the past week after Barclays maintained an Equal-Weight rating on the company, <a href="https://www.benzinga.com/quote/luv/analyst-ratings" target="_blank" rel="noreferrer noopener">raising the price forecast from $26 to $34.</a></li>
<li>Coinbase Global, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/COIN#NASDAQ">COIN</a>) stock upped 9.23% this week after Barclays maintained the stock with an Equal-Weight rating, <a href="https://www.benzinga.com/quote/COIN/analyst-ratings" target="_blank" rel="noreferrer noopener">raising the price forecast from $202 to $359</a></li>
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Delta Air, Moderna And Coinbase Are Among Top Large Cap Gainers Last Week (July 7-July 11): Are The Others In Your Portfolio?

Moderna's (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MRNA#NYSE">MRNA</a>) short percent of float has risen 3.2% since its last report. The company recently reported that it has 65.59 million shares sold short, which is 23.56% of all regular shares that are available for trading. Based on its trading volume, it would take traders 7.19 days to cover their short positions on average.
<h3>Why Short Interest Matters</h3>
Short interest is the number of shares that have been sold short but have not yet been covered or closed out. <a href="https://www.benzinga.com/money/how-to-short-a-stock?adType=benzinga-insights&amp;ad=short-interest&amp;campaign=wallstreetadvantage">Short selling</a> is when a trader sells shares of a company they do not own, with the hope that the price will fall. Traders make money from short selling if the price of the stock falls and they lose if it rises.
Short interest is important to track because it can act as an indicator of market sentiment towards a particular stock. An increase in short interest can signal that investors have become more bearish, while a decrease in short interest can signal they have become more bullish.
See Also: <a href="https://www.benzinga.com/short-interest?adType=benzinga-insights&amp;ad=short-interest&amp;campaign=wallstreetadvantage">List of the most shorted stocks</a>
<h3>Moderna Short Interest Graph (3 Months)</h3>
<img src="https://www.benzinga.com/files/images/story/2025/1752256833_0.png" alt="short_fig" />
As you can see from the chart above the percentage of shares that are sold short for Moderna has grown since its last report. This does not mean that the stock is going to fall in the near-term but traders should be aware that more shares are being shorted.
<h3>Comparing Moderna's Short Interest Against Its Peers</h3>
Peer comparison is a popular technique amongst analysts and investors for gauging how well a company is performing. A company's peer is another company that has similar characteristics to it, such as industry, size, age, and financial structure. You can find a company's peer group by reading its 10-K, proxy filing, or by doing your own similarity analysis.
According to <a href="https://www.benzinga.com/pro/">Benzinga Pro</a>, Moderna's peer group average for short interest as a percentage of float is 5.58%, which means the company has more short interest than most of its peers.
Did you know that increasing short interest can actually be bullish for a stock? <a href="https://www.benzinga.com/money/how-to-make-money-on-a-short-squeeze?adType=benzinga-insights&amp;ad=short-interest&amp;campaign=wallstreetadvantage">This post by Benzinga Money explains how you can profit from it.</a>
This article was generated by Benzinga's automated content engine and was reviewed by an editor.

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What's Driving the Market Sentiment Around Moderna?

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Moderna shares are trading higher after the company received full FDA approval for its COVID-19 vaccine, Spikevax, for children aged 6 months through 11 years at increased risk for COVID-19 disease

The U.S. Food and Drug Administration (FDA) has approved Moderna Inc.&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRNA#NASDAQ">MRNA</a>) supplemental Biologics License Application (sBLA) for Spikevax, the company&#8217;s COVID-19 vaccine, in children six months through 11 years of age who are at increased risk for COVID-19 disease.
The company&#8217;s COVID-19 vaccine, mRNA-1273, was previously available for pediatric populations under Emergency Use Authorization.
Also Read: <a target="_blank" href="https://www.benzinga.com/news/health-care/25/06/46168811/modernas-mrna-flu-vaccine-outperforms-standard-shots" rel="noreferrer noopener">Moderna&#8217;s mRNA Flu Vaccine Outperforms Standard Shots</a>
&#8220;COVID-19 continues to pose a significant potential threat to children, especially those with underlying medical conditions. Vaccination can be an important tool for protecting our youngest against severe disease and hospitalization,&#8221; said Stéphane Bancel, CEO of Moderna. &#8220;We appreciate the FDA&#8217;s diligent scientific review and approval of Spikevax for pediatric populations at increased risk for COVID-19 disease.&#8221;
Moderna<a target="_blank" href="https://investors.modernatx.com/news/news-details/2025/Moderna-Receives-Full-U-S--FDA-Approval-for-COVID-19-Vaccine-Spikevax-in-Children-Aged-6-Months-Through-11-Years-at-Increased-Risk-for-COVID-19-Disease/default.aspx" rel="noreferrer noopener"> expects</a> to have its updated Spikevax vaccine available for eligible populations in the U.S. for the 2025-2026 respiratory virus season.
Pfizer Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) and BioNTech SE (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BNTX#NASDAQ">BNTX</a>) have requested that London's Court of Appeal reverse a previous decision that found their COVID-19 vaccine to be in violation of a Moderna patent.
In July 2024, the High Court's ruling declared one of Moderna's mRNA technology patents invalid but upheld another, confirming that Pfizer and BioNTech's Comirnaty <a target="_blank" href="https://www.benzinga.com/general/biotech/24/07/39602190/london-high-court-ruling-fuels-pfizer-and-moderna-legal-dispute-over-covid-19-vaccine-patents" rel="noreferrer noopener">vaccine had infringed on it</a>.
Reuters reported that Pfizer and Moderna are trying to challenge a ruling that upheld a patent, after Judge Richard Meade allowed them to appeal his decision.
They argue that Moderna&#8217;s mRNA technology was simply a clear next step based on earlier research, so the patent shouldn&#8217;t be valid. However, Moderna believes the judge made the right decision and that the ruling should remain in place.
An alliance of medical and public health organizations filed a lawsuit on Monday against Secretary of Health and Human Services Robert F. Kennedy Jr.
The plaintiffs contend that Kennedy has launched an "assault on science, public health, and evidence-based medicine" through unilateral and arbitrary changes to COVID-19 vaccine recommendations for children <a href="https://www.benzinga.com/news/health-care/25/07/46303191/medical-groups-sue-rfk-jr-for-assault-on-science-over-unlawful-covid-19-vaccine-rollbacks" target="_blank" rel="noreferrer noopener">and pregnant individuals</a>.
According to a recent media report, Dr. Vinay Prasad, the U.S. Food and Drug Administration's (FDA) top vaccine official, overruled agency scientists to limit the approval of two COVID-19 vaccines, despite internal recommendations to clear <a href="https://www.benzinga.com/news/health-care/25/07/46250723/rfk-jr-influence-evident-as-vaccine-chief-overrules-scientists-limits-covid-19-vaccine-approval" target="_blank" rel="noreferrer noopener">them for broader use</a>.
FDA scientists had recommended full approval for updated COVID vaccines from Novavax Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVAX#NASDAQ">NVAX</a>) and Moderna for individuals aged 12 and older, citing favorable risk-benefit analyses.
But Prasad restricted the shots to those at higher risk, seniors and people with underlying health conditions, arguing that declining hospitalization and death rates from COVID-19 shifted <a target="_blank" href="https://www.benzinga.com/news/health-care/25/07/46250723/rfk-jr-influence-evident-as-vaccine-chief-overrules-scientists-limits-covid-19-vaccine-approval" rel="noreferrer noopener">the balance of risks and benefits</a>.
Price Action: MRNA stock is up 3.60% at $33.97 at the last check on Thursday.
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Biotech

BNTX

FDA Grants Complete Approval To Moderna's COVID-19 Vaccine For Children As Young As 6 Months

<a href="https://investors.modernatx.com/news/news-details/2025/Moderna-Receives-Full-U-S--FDA-Approval-for-COVID-19-Vaccine-Spikevax-in-Children-Aged-6-Months-Through-11-Years-at-Increased-Risk-for-COVID-19-Disease/default.aspx" title="https://investors.modernatx.com/news/news-details/2025/Moderna-Receives-Full-U-S--FDA-Approval-for-COVID-19-Vaccine-Spikevax-in-Children-Aged-6-Months-Through-11-Years-at-Increased-Risk-for-COVID-19-Disease/default.aspx">https://investors.modernatx.com/news/news-details/2025/Moderna-Receives-Full-U-S--FDA-Approval-for-COVID-19-Vaccine-Spikevax-in-Children-Aged-6-Months-Through-11-Years-at-Increased-Risk-for-COVID-19-Disease/default.aspx</a>

Moderna Receives Full FDA Approval for COVID-19 Vaccine, Spikevax, In Children Aged 6 Months Through 11 Years At Increased Risk For COVID-19 Disease

Moderna shares are trading higher after the company announced it will sue RFK Jr over what they deem to be unlawful COVID-19 vaccine rollbacks.

In a significant legal challenge that could reshape the future of <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">public health policy</a> in the United States, a powerful alliance of leading medical and public health organizations, including the American Academy of Pediatrics (AAP), the American College of Physicians (ACP), and the American Public Health Association (APHA), filed a lawsuit on Monday against Secretary of Health and Human Services Robert F. Kennedy Jr.
The plaintiffs contend that Secretary Kennedy has launched an &#8220;assault on science, public health, and evidence-based medicine&#8221; through unilateral and arbitrary changes to COVID-19 vaccine recommendations for children and pregnant individuals.
This unprecedented <a target="_blank" href="https://www.aap.org/en/news-room/news-releases/aap/2025/leading-medical-professional-societies-patients-sue-hhs-robert-f-kennedy-jr-for-unlawful-unilateral-vaccine-changes/?_gl=1&#x2A;12sk5li&#x2A;_ga&#x2A;NTIxOTQ2NTgyLjE3NTE5NzQ2MjA.&#x2A;_ga_FD9D3XZVQQ&#x2A;czE3NTE5NzQ2MTkkbzEkZzEkdDE3NTE5NzQ2MjYkajUzJGwwJGgw" rel="noreferrer noopener">legal action</a> seeks to halt what the coalition describes as an &#8220;existential threat to vaccination in America,&#8221; arguing that Kennedy&#8217;s directives, including the controversial dismissal of expert advisors from the CDC&#8217;s immunization committee, are endangering the nation&#8217;s long-standing, science-based vaccine infrastructure and, critically, the health of its most vulnerable populations.
Also Read: <a target="_blank" href="https://www.benzinga.com/news/25/07/46256464/lawmakers-investigate-whether-pfizer-delayed-covid-19-vaccine-results-for-political-reasons" rel="noreferrer noopener">Lawmakers Investigate Whether Pfizer Delayed COVID-19 Vaccine Results For Political Reasons</a>
<h2 class="wp-block-heading">Lawsuit Details And Allegations</h2>
The comprehensive lawsuit, filed in the U.S. District Court for the District of Massachusetts, names the U.S. Department of Health and Human Services (HHS) and Secretary Robert F. Kennedy Jr. as defendants. The plaintiffs, which also include the Infectious Diseases Society of America (IDSA), the Massachusetts Public Health Alliance (MPHA), the Society for Maternal-Fetal Medicine (SMFM), and a pregnant physician, assert that Kennedy acted &#8220;arbitrarily and capriciously&#8221; by altering COVID-19 vaccine recommendations for children and pregnant people without scientific basis.
This follows Secretary Kennedy&#8217;s public statement in May, where he <a target="_blank" href="https://www.benzinga.com/25/05/45624037/robert-f-kennedy-jr-says-cdc-drops-covid-vaccine-for-healthy-pregnant-women-kids" rel="noreferrer noopener">expressed pleasure at the removal</a> of the COVID-19 vaccine for healthy children and pregnant women from CDC recommended immunization schedules.
A critical aspect of the lawsuit&#8217;s complaint is Secretary Kennedy&#8217;s alleged unjust dismissal of 17 members of the Centers for Disease Control and Prevention&#8217;s (CDC) Advisory Committee on Immunization Practices (ACIP). These experts were reportedly replaced with individuals known for espousing anti-vaccine viewpoints.
Dr. Susan J. Kressly, President of the AAP, underscored the gravity of these actions, stating, &#8220;This wasn&#8217;t just sidelining science. It&#8217;s an attack on the very foundation of how we protect families and children&#8217;s health. And the consequences could be dangerous.&#8221;
The lawsuit further details a pattern of interference, including blocked CDC communications, delayed or canceled meetings of CDC and Food and Drug Administration (FDA) vaccine advisers, and the announcement of studies to investigate non-existent links between vaccines and autism.
<h2 class="wp-block-heading">Seeking Injunctions And Protecting Public Health</h2>
The plaintiffs are seeking both preliminary and permanent injunctions to reverse Secretary Kennedy&#8217;s rescissions of COVID-19 vaccine recommendations. They also request a declaratory judgment to legally pronounce these changes as unlawful. Richard H. Hughes IV, lead counsel for the plaintiffs and partner at Epstein Becker Green, voiced grave concerns, asserting, &#8220;This administration is an existential threat to vaccination in America, and those in charge are only just getting started. If left unchecked, Secretary Kennedy will accomplish his goal of ridding the United States of vaccines, which would unleash a wave of preventable harm on our nation&#8217;s children.&#8221;
The lawsuit alleges that the Directive is but one example of the Secretary&#8217;s agenda to dismantle the long-standing, Congressionally-authorized, science- and evidence-based vaccine infrastructure that has prevented the deaths of untold millions of Americans. The filing highlights that the Secretary&#8217;s dismantling of the vaccine infrastructure must end, and halting this effort begins with vacating the Directive.
<h2 class="wp-block-heading">FDA&#8217;s Internal Disagreements And Historical Legal Actions</h2>
Per a recent media report, Dr. Vinay Prasad, the U.S. Food and Drug Administration&#8217;s (FDA) top vaccine official, overruled agency scientists to limit approval of two COVID-19 vaccines, despite internal recommendations to clear <a target="_blank" href="https://www.benzinga.com/news/health-care/25/07/46250723/rfk-jr-influence-evident-as-vaccine-chief-overrules-scientists-limits-covid-19-vaccine-approval" rel="noreferrer noopener">them for broader use</a>.
FDA scientists had recommended full approval for updated COVID vaccines from Novavax Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVAX#NASDAQ">NVAX</a>) and Moderna Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRNA#NASDAQ">MRNA</a>) for individuals aged 12 and older, citing favorable risk-benefit analyses.
But Prasad restricted the shots to those at higher risk, seniors and people with underlying health conditions, arguing that declining hospitalization and death rates from COVID-19 shifted the balance of risks and benefits.
While distinct from the HHS lawsuit, this report underscores a broader climate of scrutiny and debate surrounding vaccine policy.
The AAP has a history of pursuing legal action against the federal government, regardless of political affiliation. Past instances include a 1983 lawsuit against HHS regarding life-sustaining treatment for infants and separate lawsuits against the FDA in 2016 and 2018 concerning graphic warnings on cigarettes and e-cigarette regulation, respectively.
Price Action: MRNA stock is trading higher by 11% to $33.18, and NVAX stock is up 6.61% at $7.05 at last check Tuesday.
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Photo by lev radin via Shutterstock

Government

Legal

Medical Groups Sue RFK Jr. For Assault On Science Over Unlawful COVID-19 Vaccine Rollbacks

U.S. stocks were mixed, with the Dow Jones index falling over 100 points on Tuesday.
Shares of Microchip Technology Incorporated (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MCHP#NASDAQ">MCHP</a>) rose sharply during <a href="https://www.benzinga.com/quote/MCHP">Tuesday's session</a>.
Mizuho analyst Vijay Rakesh maintained Microchip Technology with an Outperform rating and raised the price target from $78 to $85.
Microchip Technology shares jumped 4.1% to $74.36 on Tuesday.
Here are some other big stocks recording gains in today&#8217;s session.
<ul class="wp-block-list">
<li>Humacyte, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/HUMA#NASDAQ">HUMA</a>) shares jumped 27.4% to $2.7690. Humacyte announced Symvess has been awarded Electronic Catalog Listing approval from the US Defense Logistics Agency.</li>
<li>Wolfspeed, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/WOLF#NYSE">WOLF</a>) rose 18.2% to $2.7300 after nearly doubling on Monday. Wolfspeed shares have soared in recent sessions as investors anticipate a potential turnaround for the company after it filed for Chapter 11 bankruptcy last week.</li>
<li>SharpLink Gaming, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SBET#NASDAQ">SBET</a>) gained 16.4% to $14.75. SharpLink Gaming announced the acquisition of an additional 7,689 ETH for the week June 28 through July 4, 2025.</li>
<li>SoundHound AI, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SOUN#NASDAQ">SOUN</a>) jumped 16.4% to $13.28.</li>
<li>Bitmine Immersion Technologies, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BMNR#NYSE">BMNR</a>) shares rose 16% to $124.66.</li>
<li>QuantumScape Corporation (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/QS#NYSE">QS</a>) climbed 15.2% to $8.07.</li>
<li>Opendoor Technologies Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/OPEN#NASDAQ">OPEN</a>) gained 14% to $0.7153. Opendoor Technologies will report second quarter 2025 financial results for the period ended June 30, following the close of the market on Tuesday, Aug. 5.</li>
<li>Regencell Bioscience Holdings Limited (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/RGC#NASDAQ">RGC</a>) surged 13.2% to $20.87.</li>
<li>Anbio Biotechnology (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NNNN#NASDAQ">NNNN</a>) rose 13% to $44.45.</li>
<li>Recursion Pharmaceuticals, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/RXRX#NASDAQ">RXRX</a>) gained 12.8% to $5.57.</li>
<li>Moderna, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRNA#NASDAQ">MRNA</a>) rose 9.4% to $32.73.</li>
<li>Shinhan Financial Group Co., Ltd. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/SHG#NYSE">SHG</a>) gained 8.8% to $50.44.</li>
<li>Concentrix Corporation (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CNXC#NASDAQ">CNXC</a>) rose 7.7% to $61.05.</li>
<li>Albemarle Corporation (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/ALB#NYSE">ALB</a>) shares rose 7.6% to $70.47.</li>
<li>The Goodyear Tire &amp; Rubber Company (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GT#NASDAQ">GT</a>) gained 7.3% to $11.69.</li>
<li>Woori Financial Group Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/WF#NYSE">WF</a>) rose 7% to $54.09.</li>
<li>Intel Corporation (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/INTC#NASDAQ">INTC</a>) rose 5.7% to $23.26.</li>
<li>Dow Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/DOW#NYSE">DOW</a>) gained 5.7% to $29.05. Dow announced it will shut down three European plants, which may result in up to $790 million worth of asset write-downs.</li>
<li>Celanese Corporation (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/CE#NYSE">CE</a>) rose 4.7% to $60.79. Celanese announced that it will host a conference call to discuss its second quarter results on Tuesday, August 12.</li>
<li>Tesla, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TSLA#NASDAQ">TSLA</a>) gained 3.1% to $303.14. Tesla CEO Elon Musk recently announced plans to launch a new political party. Wedbush analyst Daniel Ives reiterated Tesla with an Outperform rating and maintained a $500 price target, while Mizuho analyst Vijay Rakesh maintained the stock with an Outperform rating and lowered the price target from $390 to $375.</li>
</ul>
Now Read This: 
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<li><a href="https://www.benzinga.com/news/25/07/46296955/meta-platforms-to-rally-around-9-here-are-10-top-analyst-forecasts-for-tuesday">Meta Platforms To Rally Around 9%? Here Are 10 Top Analyst Forecasts For Tuesday</a> </li>
</ul>
Photo via Shutterstock

BMNR

CNXC

HUMA

INTC

MCHP

NNNN

OPEN

RXRX

SBET

SOUN

TSLA

WOLF

Microchip Technology, Tesla, Humacyte And Other Big Stocks Moving Higher On Tuesday

Dr. Vinay Prasad, the U.S. Food and Drug Administration&#8217;s (FDA) top vaccine official, overruled agency scientists to limit approval of two COVID-19 vaccines, despite internal recommendations to clear <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">them for broader use</a>.
The decision reflects a growing pattern of vaccine restrictions under the leadership of the U.S. Health and Human Services Secretary Robert F. Kennedy Jr.
FDA scientists had recommended full approval for updated COVID vaccines from Novavax Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVAX#NASDAQ">NVAX</a>) and Moderna Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRNA#NASDAQ">MRNA</a>) for individuals aged 12 and older, citing favorable risk-benefit analyses.
Also Read: <a target="_blank" href="https://www.benzinga.com/news/health-care/25/06/45887132/novavaxs-experimental-covid-19-influenza-combo-shot-shows-immune-response-among-older-adults-in-" rel="noreferrer noopener">Novavax&#8217;s Experimental COVID-19-Influenza Combo Shot Shows Immune Response Among Older Adults In Phase 3 Trial</a>
However, citing federal documents released Wednesday, ABC News reported <a target="_blank" href="https://abcnews.go.com/Health/wireStory/fda-vaccine-official-restricted-covid-vaccine-approvals-advice-123431749" rel="noreferrer noopener">that</a> Prasad restricted the shots to those at higher risk, seniors and people with underlying health conditions, arguing that declining hospitalization and death rates from COVID-19 shifted the balance of risks and benefits.
In a five-page memo, Prasad wrote that &#8220;even rare vaccination-related harms, both known and unknown, now have a higher chance of outweighing potential benefits,&#8221; highlighting the need for more cautious vaccine policy.
The vaccines were eventually approved in May, but under the narrower eligibility <a target="_blank" href="https://www.benzinga.com/government/regulations/25/05/45537919/fda-limits-annual-covid-19-boosters-to-high-risk-americans-demands-new-trials-for-healthy-adults-in-policy-shift-under-rfk-jr" rel="noreferrer noopener">criteria dictated by Prasad</a>.
Novavax&#8217;s shot, Nuvaxovid, is the only protein-based COVID vaccine available in the U.S., while Moderna&#8217;s mNexspike is a lower-dose, updated version of its <a target="_blank" href="https://www.benzinga.com/news/fda/25/06/45719840/modernas-new-covid-vaccine-secures-fda-clearance-for-seniors-at-risk-individuals" rel="noreferrer noopener">original mRNA-based vaccine</a>.
Prasad also cited the risk of myocarditis, a rare heart inflammation, especially in younger people, as a key reason for restricting Moderna&#8217;s shot.
He directed the company to conduct further studies as a condition for approval. The FDA also added updated warning labels for Moderna and Pfizer Inc.&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) vaccines regarding myocarditis, though external researchers say such cases are typically mild and resolve quickly.
Top FDA leaders rarely intervene in the product review, making Prasad&#8217;s decision notable. He was appointed in May after Dr. Peter Marks resigned over policy disagreements with Kennedy.
In May, Kennedy, in a&nbsp;video&nbsp;posted to the social media platform X, announced that the COVID-19 vaccine will no longer be among the recommended vaccines for pregnant women and healthy children on the U.S. Centers for Disease Control and <a target="_blank" href="https://www.benzinga.com/25/05/45624037/robert-f-kennedy-jr-says-cdc-drops-covid-vaccine-for-healthy-pregnant-women-kids" rel="noreferrer noopener">Prevention&#8217;s immunization schedule</a>.
Price Action: At the last check on Thursday, Moderna (MRNA) stock saw an increase of 1.34%, trading at $30.69, while Novavax (NVAX) stock rose by 0.67% to $6.81. Pfizer (PFE) stock was also up at the last check.
Read Next:
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<li><a href="https://www.benzinga.com/news/contracts/25/07/46249640/astrazeneca-in-15b-talks-for-drug-that-could-upend-lung-cancer-treatment" target="_blank" rel="noreferrer noopener">AstraZeneca In $15B Talks For Drug That Could Upend Lung Cancer Treatment</a></li>
</ul>
Photo via Shutterstock

RFK Jr. Influence Evident As Vaccine Chief Overrules Scientists, Limits COVID-19 Vaccine Approval

<a href="https://www.nytimes.com/2025/07/02/health/fda-covid-vaccines.html" title="https://www.nytimes.com/2025/07/02/health/fda-covid-vaccines.html">https://www.nytimes.com/2025/07/02/health/fda-covid-vaccines.html</a>

'Top F.D.A. Official Overrode Scientists on Covid Shots; Records show that a top U.S. regulator rejected the recommendations of agency experts and limited the use of Covid vaccines.' - NY Times

This whale alert can help traders discover the next big trading opportunities.
Whales are entities with large sums of money and we track their transactions here at Benzinga on our options activity scanner.
Traders will search for circumstances when the market estimation of an option diverges heavily from its normal worth. High amounts of trading activity could push option prices to exaggerated or underestimated levels. 
Below are some instances of options activity happening in the Health Care sector: 
<table>
<thead>
<tr>
<th>Symbol</th>
<th>PUT/CALL</th>
<th>Trade Type</th>
<th>Sentiment</th>
<th>Exp. Date</th>
<th>Strike Price</th>
<th>Total Trade Price</th>
<th>Open Interest</th>
<th>Volume</th>
</tr>
</thead>
<tbody>
<tr>
<td>JNJ</td>
<td>CALL</td>
<td>TRADE</td>
<td>BEARISH</td>
<td>07/18/25</td>
<td>$157.50</td>
<td>$94.8K</td>
<td>1.5K</td>
<td>1.5K</td>
</tr>
<tr>
<td>MRNA</td>
<td>CALL</td>
<td>SWEEP</td>
<td>BEARISH</td>
<td>07/11/25</td>
<td>$30.00</td>
<td>$25.7K</td>
<td>980</td>
<td>1.0K</td>
</tr>
<tr>
<td>CNC</td>
<td>CALL</td>
<td>SWEEP</td>
<td>BULLISH</td>
<td>01/16/26</td>
<td>$35.00</td>
<td>$29.5K</td>
<td>10</td>
<td>899</td>
</tr>
<tr>
<td>UNH</td>
<td>PUT</td>
<td>TRADE</td>
<td>BEARISH</td>
<td>07/18/25</td>
<td>$307.50</td>
<td>$37.3K</td>
<td>1.1K</td>
<td>437</td>
</tr>
<tr>
<td>SRPT</td>
<td>PUT</td>
<td>TRADE</td>
<td>BEARISH</td>
<td>11/21/25</td>
<td>$20.00</td>
<td>$37.7K</td>
<td>1.0K</td>
<td>431</td>
</tr>
<tr>
<td>PRME</td>
<td>CALL</td>
<td>TRADE</td>
<td>BULLISH</td>
<td>10/17/25</td>
<td>$1.00</td>
<td>$27.5K</td>
<td>24</td>
<td>100</td>
</tr>
<tr>
<td>BMY</td>
<td>PUT</td>
<td>TRADE</td>
<td>BULLISH</td>
<td>12/17/27</td>
<td>$60.00</td>
<td>$161.0K</td>
<td>827</td>
<td>100</td>
</tr>
<tr>
<td>HIMS</td>
<td>CALL</td>
<td>TRADE</td>
<td>BEARISH</td>
<td>01/16/26</td>
<td>$1.00</td>
<td>$46.7K</td>
<td>14.6K</td>
<td>67</td>
</tr>
<tr>
<td>NVO</td>
<td>CALL</td>
<td>SWEEP</td>
<td>BULLISH</td>
<td>11/21/25</td>
<td>$75.00</td>
<td>$26.5K</td>
<td>387</td>
<td>61</td>
</tr>
<tr>
<td>ELV</td>
<td>CALL</td>
<td>SWEEP</td>
<td>BEARISH</td>
<td>09/19/25</td>
<td>$340.00</td>
<td>$90.7K</td>
<td>11</td>
<td>56</td>
</tr>
</tbody>
</table>

<h2>Explanation</h2>
These itemized elaborations have been created using the accompanying table. 
• Regarding JNJ (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/JNJ#NYSE">JNJ</a>), we observe a call option trade with bearish sentiment. It expires in 16 day(s) on July 18, 2025. Parties traded 465 contract(s) at a $157.50 strike. The total cost received by the writing party (or parties) was $94.8K, with a price of $204.0 per contract. There were 1504 open contracts at this strike prior to today, and today 1579 contract(s) were bought and sold. 
• For MRNA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRNA#NASDAQ">MRNA</a>), we notice a call option sweep that happens to be bearish, expiring in 9 day(s) on July 11, 2025. This event was a transfer of 211 contract(s) at a $30.00 strike. This particular call needed to be split into 8 different trades to become filled. The total cost received by the writing party (or parties) was $25.7K, with a price of $122.0 per contract. There were 980 open contracts at this strike prior to today, and today 1094 contract(s) were bought and sold. 
• Regarding CNC (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/CNC#NYSE">CNC</a>), we observe a call option sweep with bullish sentiment. It expires in 198 day(s) on January 16, 2026. Parties traded 50 contract(s) at a $35.00 strike. This particular call needed to be split into 9 different trades to become filled. The total cost received by the writing party (or parties) was $29.5K, with a price of $590.0 per contract. There were 10 open contracts at this strike prior to today, and today 899 contract(s) were bought and sold. 
• For UNH (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/UNH#NYSE">UNH</a>), we notice a put option trade that happens to be bearish, expiring in 16 day(s) on July 18, 2025. This event was a transfer of 65 contract(s) at a $307.50 strike. The total cost received by the writing party (or parties) was $37.3K, with a price of $575.0 per contract. There were 1172 open contracts at this strike prior to today, and today 437 contract(s) were bought and sold. 
• For SRPT (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SRPT#NASDAQ">SRPT</a>), we notice a put option trade that happens to be bearish, expiring in 142 day(s) on November 21, 2025. This event was a transfer of 65 contract(s) at a $20.00 strike. The total cost received by the writing party (or parties) was $37.7K, with a price of $580.0 per contract. There were 1022 open contracts at this strike prior to today, and today 431 contract(s) were bought and sold. 
• For PRME (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PRME#NASDAQ">PRME</a>), we notice a call option trade that happens to be bullish, expiring in 107 day(s) on October 17, 2025. This event was a transfer of 100 contract(s) at a $1.00 strike. The total cost received by the writing party (or parties) was $27.5K, with a price of $275.0 per contract. There were 24 open contracts at this strike prior to today, and today 100 contract(s) were bought and sold. 
• For BMY (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BMY#NYSE">BMY</a>), we notice a put option trade that happens to be bullish, expiring in 898 day(s) on December 17, 2027. This event was a transfer of 100 contract(s) at a $60.00 strike. The total cost received by the writing party (or parties) was $161.0K, with a price of $1610.0 per contract. There were 827 open contracts at this strike prior to today, and today 100 contract(s) were bought and sold. 
• Regarding HIMS (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/HIMS#NYSE">HIMS</a>), we observe a call option trade with bearish sentiment. It expires in 198 day(s) on January 16, 2026. Parties traded 10 contract(s) at a $1.00 strike. The total cost received by the writing party (or parties) was $46.7K, with a price of $4673.0 per contract. There were 14663 open contracts at this strike prior to today, and today 67 contract(s) were bought and sold. 
• Regarding NVO (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVO#NYSE">NVO</a>), we observe a call option sweep with bullish sentiment. It expires in 142 day(s) on November 21, 2025. Parties traded 45 contract(s) at a $75.00 strike. This particular call needed to be split into 4 different trades to become filled. The total cost received by the writing party (or parties) was $26.5K, with a price of $590.0 per contract. There were 387 open contracts at this strike prior to today, and today 61 contract(s) were bought and sold. 
• Regarding ELV (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/ELV#NYSE">ELV</a>), we observe a call option sweep with bearish sentiment. It expires in 79 day(s) on September 19, 2025. Parties traded 24 contract(s) at a $340.00 strike. This particular call needed to be split into 11 different trades to become filled. The total cost received by the writing party (or parties) was $90.7K, with a price of $3768.0 per contract. There were 11 open contracts at this strike prior to today, and today 56 contract(s) were bought and sold. 
Options Alert Terminology 
 - Call Contracts: The right to buy shares as indicated in the contract. 
 - Put Contracts: The right to sell shares as indicated in the contract. 
 - Expiration Date: When the contract expires. One must act on the contract by this date if one wants to use it. 
 - Premium/Option Price: The price of the contract. 
For more information, visit our <a href="https://pro.benzinga.com/blog/how-to-understand-option-alerts/">Guide to Understanding Options Alerts</a> or read <a href="https://www.benzinga.com/markets/options">more news on unusual options activity</a>. 
This article was generated by Benzinga's automated content engine and reviewed by an editor.

Options

streetTRACKS Dow Jones U.S. Large Cap Value Index Fund

Hims & Hers Health, Inc. Class A Common Stock

HIMS

PRME

SRPT

10 Health Care Stocks With Whale Alerts In Today's Session

Moderna shares are trading higher. The stock may be experiencing continued strength after the company, on Monday, reported results from its Phase 3 efficacy study evaluating its mRNA-1010 seasonal influenza vaccine in adults.

<a href="https://www.bloomberg.com/news/articles/2025-07-01/rfk-jr-vows-overhaul-of-lawsuit-sparing-vaccine-injury-program?embedded-checkout=true">https://www.bloomberg.com/news/articles/2025-07-01/rfk-jr-vows-overhaul-of-lawsuit-sparing-vaccine-injury-program?embedded-checkout=true</a>

'RFK Jr. Vows Overhaul of Lawsuit-Sparing Vaccine Injury Program'- Bloomberg

Moderna, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRNA#NASDAQ">MRNA</a>) on Monday revealed results from a Phase 3 efficacy study (P304) evaluating the relative vaccine efficacy (rVE) against influenza illness of mRNA-1010, the company&#8217;s seasonal influenza (flu) vaccine candidate, compared to a licensed standard-dose seasonal influenza vaccine in adults <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">aged 50 years and older</a>.
mRNA-1010 achieved the most stringent superiority criterion prespecified in the protocol, with an rVE of 26.6% in the overall study population. Additionally, strong rVE was observed for each influenza strain contained in the vaccine, including A/H1N1 (rVE=29.6%), A/H3N2 (rVE=22.2%), and the B/Victoria lineages (rVE=29.1%).
Subgroup analyses confirmed a consistently strong rVE point estimate across age groups, risk factors, and previous influenza vaccination status. In participants aged 65 years and older, mRNA-1010 demonstrated <a target="_blank" href="https://www.benzinga.com/pressreleases/25/06/ac46164898/moderna-announces-positive-phase-3-results-for-seasonal-influenza-vaccine" rel="noreferrer noopener">an rVE of 27.4%</a>.
Also Read: <a target="_blank" href="https://www.benzinga.com/news/health-care/25/06/45887132/novavaxs-experimental-covid-19-influenza-combo-shot-shows-immune-response-among-older-adults-in-phase-3-trial" rel="noreferrer noopener">Novavax&#8217;s Experimental COVID-19-Influenza Combo Shot Shows Immune Response Among Older Adults In Phase 3 Trial</a>
In a previous Phase 3 study, mRNA-1010 had demonstrated superior seroconversion rates and geometric mean titer ratios (GMR) against all strains included in the vaccine compared to both high-dose and standard-dose licensed seasonal influenza vaccine.
According to the CDC, seasonal flu-related hospitalizations and outpatient visits reached a 15-year high during the 2024-2025 season.
Over 600,000 Americans were hospitalized due to flu-related illness last year, leading to substantial direct and indirect costs and widespread disruption to daily life and work.
The trial enrolled 40,805 adults aged 50 years and older across 11 countries. Participants were randomly assigned to receive either a single dose of mRNA-1010 or a standard-dose licensed comparator, with a median follow-up of six months.
The safety and tolerability of mRNA-1010 were consistent with reported results from a previous Phase 3 study. The majority of solicited adverse reactions (SARs) were mild.
Injection site pain was the most common local SAR, and fatigue, headache, and myalgia were the most common systemic SARs reported.
There were no significant differences between the groups in the rates of unsolicited adverse events, serious adverse events, or adverse events of special interest.
Moderna plans to present these data at an upcoming medical conference and submit them for peer-reviewed publication. The company will engage with regulators on filing submissions for mRNA-1010.
Earlier this month, the U.S. Food and Drug Administration (FDA) expanded approval of Moderna&#8217;s respiratory syncytial virus vaccine to adults aged 18-59 at <a target="_blank" href="https://www.benzinga.com/news/health-care/25/06/45921359/fda-expands-modernas-rsv-vaccine-use-to-at-risk-adults-aged-18-59-amid-cdc-panel-shake-up" rel="noreferrer noopener">increased risk for disease</a>.
The mRNA-based shot showed significant immune responses in adults with underlying health conditions and maintained a favorable safety profile. The vaccine was previously limited to adults 60 and older, where it demonstrated 79% efficacy against RSV symptoms.
Price Action: MRNA stock is up 3.31% at $28.06 during the premarket session at last check Monday.
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Moderna's mRNA Flu Vaccine Outperforms Standard Shots

Moderna shares are trading higher after the company reported results from its Phase 3 efficacy study evaluating its mRNA-1010 seasonal influenza vaccine in adults.

mRNA-1010 demonstrated superior relative vaccine efficacy that was 26.6% (95% CI; 16.7%, 35.4%) higher than a licensed standard-dose seasonal influenza vaccine in adults aged 50 years and older
CAMBRIDGE, MA / <a href="https://www.accessnewswire.com/">ACCESS Newswire</a> / June 30, 2025 / Moderna, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRNA#NASDAQ">MRNA</a>) today announced positive results from a Phase 3 efficacy study (P304) evaluating the relative vaccine efficacy (rVE) against influenza illness of mRNA-1010, the Company's seasonal influenza (flu) vaccine candidate, compared to a licensed standard-dose seasonal influenza vaccine in adults aged 50 years and older. mRNA-1010 achieved the most stringent superiority criterion prespecified in the protocol, with an rVE of 26.6% (95% CI; 16.7%, 35.4%) in the overall study population. Additionally, strong rVE was observed for each influenza strain contained in the vaccine, including A/H1N1 (rVE=29.6%), A/H3N2 (rVE=22.2%), and the B/Victoria lineages (rVE=29.1%). Subgroup analyses confirmed a consistently strong rVE point estimate across age groups, risk factors and previous influenza vaccination status. In participants aged 65 years and older, mRNA-1010 demonstrated an rVE of 27.4%.
In a previous Phase 3 study, mRNA-1010 had already demonstrated superior seroconversion rates and geometric mean titer ratios (GMR) against all strains included in the vaccine compared to both high-dose and standard-dose licensed seasonal influenza vaccine. [1]
According to the CDC, seasonal flu-related hospitalizations and outpatient visits reached a 15-year high during the 2024-2025 season. [2] More than 600,000 Americans were hospitalized due to flu-related illness last year, leading to substantial direct and indirect costs, as well as widespread disruption to daily life and work. [3]
P304 (<a href="https://pr.report/bx98"> NCT06602024</a> ) is a Phase 3, randomized, observer-blind, active-controlled, case-driven, pivotal efficacy, immunogenicity and safety study. The trial enrolled 40,805 adults aged 50 years and older across 11 countries. Participants were randomly assigned to receive either a single dose of mRNA-1010 or a standard-dose licensed comparator, with a median follow-up of six months.
Safety and tolerability of mRNA-1010 were consistent with reported results from a previous Phase 3 study. [4] The majority of solicited adverse reactions (SARs) were mild. Injection site pain was the most common local SAR, and fatigue, headache and myalgia were the most common systemic SARs reported. There were no significant differences between the groups in the rates of unsolicited adverse events, serious adverse events, or adverse events of special interest.
Moderna plans to present these data at an upcoming medical conference and submit for peer-reviewed publication. The Company will engage with regulators on filing submissions for mRNA-1010.

Moderna Reports Results From Phase 3 Efficacy Study Evaluating rVE Against Influenza Illness Of mRNA-1010 Versus Licensed Standard-Dose Seasonal Influenza Vaccine In Adults

<a href="https://www.youtube.com/watch?v=z-16fImZoEc">https://www.youtube.com/watch?v=z-16fImZoEc</a>
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U.S. CDC Advisory Panel Votes 5-1 In Favor Of Children 18 Years & Younger Receiving Seasonal Flu Vaccine Only In Single Dose Forms That Are Free From Thimerosal; Of Pregnant Women Receiving Seasonal Flu Vaccine Only In Single Dose Forms That Are Free From Thimerosal; Of All Adults Receiving Seasonal Flu Shot Only In Single Dose Forms That Are Free From Thimerosal

U.S. CDC Vaccine Advisory Panel Votes 7-0 In Favor Of Adding Preventive RSV Therapies To Vaccines For Children Resolution

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