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NOVAVAX INC

Novavax

Novavax Inc is a biotechnology company that develops vaccines. The company works in the clinical stage of development with a focus on delivering novel products that prevent a broad range of diseases. It works together with its wholly owned Swedish subsidiary to produce vaccine candidates to respond to both known and emerging disease threats. The company believes its vaccine technology has the potential to be applied broadly to a wide variety of human infectious diseases. The company manages its business as one operating segment, the development and commercialization of vaccines. The company generates maximum revenue from the United States.

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Novavax Inc

Novavax, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVAX#NASDAQ">NVAX</a>) announced results Wednesday of the initial cohort of its COVID-19-Influenza Combination (CIC) and standalone trivalent hemagglutinin nanoparticle seasonal <a href="https://www.benzinga.com/general/health-care" target="_blank" rel="noreferrer noopener">influenza (tNIV) Phase 3 trial</a>.
The study showed that the CIC and flu vaccine candidates induced immune responses similar to those of licensed comparators Nuvaxovid&nbsp;and Sanofi SA&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) <a target="_blank" href="https://www.benzinga.com/pressreleases/25/06/n45879363/novavaxs-covid-19-influenza-combination-and-stand-alone-influenza-vaccine-candidates-showed-robust" rel="noreferrer noopener">Fluzone HD, respectively</a>.
Both standalone flu and CIC vaccine candidates induced robust immune responses to the vaccine strains (2.4-5.7-fold over baseline).
Also Read: <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">Robert F. Kennedy Jr. Says CDC Drops COVID Vaccine For &#8216;Healthy&#8217; Pregnant Women, Children</a>
&#8220;Both our combination and standalone flu vaccine candidates induced robust immune responses and were well tolerated,&#8221; said Ruxandra Draghia-Akli, executive vice president and head of Research and Development at Novavax.
&#8220;This&nbsp;data set adds to&nbsp;findings from our Phase 2 trial and will help inform discussions with potential partners.&#8221;
Both vaccine candidates were well tolerated and saw reactogenicity comparable to authorized comparators.
Nearly all (&gt;98%) solicited adverse events were mild or moderate in severity.&nbsp;
The cohort was designed to provide descriptive data on three flu strains&nbsp;(H1N1, H3N2, B) and SARS-CoV-2 (COVID-19) to inform a future registrational Phase 3 program.
The descriptive trial evaluated the safety and immunogenicity of the CIC and standalone flu vaccine candidates&nbsp;compared to Nuvaxovid and Fluzone HD in approximately 2,000 adults&nbsp;aged 65 and older.
This trial was not adequately powered to demonstrate statistical significance.
In May 2023, Novavax unveiled data for its COVID-influenza combination vaccine and&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/23/05/32287464/novavax-eases-uncertainty-announces-job-cuts-encouraging-data-from-covidflu-combo-shot" rel="noreferrer noopener">two other shots</a>.
Data from a Phase 2 trial in adults aged 50-80 showed that the combination shot produced an immune response comparable to its protein-based COVID vaccine and already approved influenza shots.
The study found that all three of Novavax&#8217;s vaccine candidates—the COVID/flu combination shot, a standalone flu shot, and a higher dose of its COVID shot—were safe and well-tolerated.
In May, Novavax received limited approval from the U.S. Food and Drug Administration (FDA) for its COVID-19 vaccine, Nuvaxovid. This marked a regulatory milestone and unlocking a $175 million milestone payment <a href="https://www.benzinga.com/25/05/45496095/novavax-scores-key-fda-win-shares-jump-19-as-sanofi-milestone-unlock" target="_blank" rel="noreferrer noopener">from partner Sanofi</a>.
Earlier in June, the FDA approved&nbsp;Moderna, Inc.'s&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRNA#NASDAQ">MRNA</a>) mNexspike&nbsp;(mRNA-1283), a new vaccine against COVID-19, for all adults 65 and older and individuals aged 12-64 years with at least one or more underlying risk factor as defined by the Centers for Disease&nbsp;<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">Control and Prevention (CDC)</a>.
Price Action: NVAX stock is up 0.56% at $7.24 at the last check on Wednesday.
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Photo: Shutterstock

Novavax's Experimental COVID-19-Influenza Combo Shot Shows Immune Response Among Older Adults In Phase 3 Trial

<ul>
<li>Both vaccine candidates induced robust immune responses across all antigens tested</li>
<li>No new safety signals were observed and both vaccine candidates were well tolerated consistent with past trials</li>
<li>Novavax continues to pursue partnering opportunities to advance further development of these programs</li>
</ul>
GAITHERSBURG, Md., June 11, 2025 /PRNewswire/ --&nbsp;Novavax, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVAX#NASDAQ">NVAX</a>) today announced results of the initial cohort of its COVID-19-Influenza Combination (CIC) and stand-alone&nbsp;trivalent hemagglutinin nanoparticle&nbsp;seasonal influenza (tNIV) Phase 3 trial that showed both the CIC and flu vaccine candidates induced immune responses similar to licensed comparators Nuvaxovid&#xAE; and Fluzone HD, respectively. This cohort was designed to provide descriptive data on three flu strains&nbsp;(H1N1, H3N2, B) and SARS-CoV-2 (COVID-19) to inform a future registrational Phase 3 program.
Both stand-alone flu and CIC vaccine candidates induced robust immune responses to the vaccine strains (2.4-5.7-fold over baseline). Both vaccine candidates were well tolerated and saw reactogenicity comparable to authorized comparators. Nearly all (&gt;98%) solicited adverse events were mild or moderate in severity.&nbsp;
This descriptive trial was designed to evaluate the safety and immunogenicity of the CIC and stand-alone flu vaccine candidates compared to Nuvaxovid and Fluzone HD in approximately 2,000 adults aged 65 and older. This trial was not adequately powered to demonstrate statistical significance. These results build on previous Phase 2 data.

Novavax Says Results Of Initial Cohort Of COVID-19-Influenza Combination And tNIV Phase 3 Trial Shows Both Vaccine Candidates Induced Immune Responses Similar To Licensed Comparators Nuvaxovid And Fluzone HD, Respectively

The American Pharmacists Association announced Monday it will withhold endorsement of the Centers for Disease Control and Prevention&#8217;s updated immunization schedule that removed COVID-19 vaccine recommendations for pregnant women and healthy children.
What Happened: The CDC modified its guidance last month, stating COVID-19 vaccines remain optional for healthy children when parents and physicians determine necessity, reported Reuters. Health Secretary Robert F. Kennedy Jr., who oversees the CDC, Food and Drug Administration and National Institutes of Health, announced the policy changes before official website updates.
&#8220;COVID-19 vaccination during pregnancy has been proven safe and effective. Additionally, this vaccine is not associated with any fertility issues in either women or men,&#8221; the pharmacists&#8217; association stated. The group emphasized that pregnancy represents a high-risk condition requiring COVID-19 vaccination recommendations.
Kennedy&#8217;s <a href="https://www.benzinga.com/government/regulations/25/05/45688464/rfk-jr-drops-covid-vaccine-recommendation-for-healthy-kids-but-experts-warn-of-major-risks">announcement bypassed the traditional CDC Advisory Committee</a> for Immunization Practices review processes. The policy shift follows FDA changes<a href="https://www.benzinga.com/news/25/05/45661031/robert-f-kennedy-jr-says-cdc-drops-covid-vaccine-for-healthy-pregnant-women-children"> limiting annual boosters to Americans over 65</a> and high-risk populations while requiring new clinical trials for healthy adults under 65.
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Why It Matters: The FDA recently advised vaccine manufacturers that fall 2025 formulations should target monovalent JN.1-lineage variants, preferentially using the LP.8.1 strain. Moderna Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRNA#NASDAQ">MRNA</a>) submitted its Spikevax 2025-2026 formula application targeting the LP.8.1 variant Friday.
Novavax Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVAX#NASDAQ">NVAX</a>) received limited FDA approval for its Nuvaxovid vaccine, authorized for individuals 65 and older and those 12 and up with underlying medical conditions. The approval triggered a $175 million milestone payment from partner Sanofi SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>).
The policy changes create uncertainty for vaccine manufacturers and healthcare investors as the <a 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">administration implements stricter clinical trial</a> requirements. Previous guidance under the Biden administration recommended additional COVID-19 boosters for healthy children despite limited clinical data supporting repeat booster strategies in pediatric populations.
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Disclaimer:&nbsp;This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.
Photo courtesy: JHVEPhoto / Shutterstock.com

American Pharmacists Association Withholds Endorsement Of CDC's Revised COVID-19 Vaccine Guidance

U.S. Health Secretary Robert F. Kennedy Jr. has championed &#8220;medical freedom&#8221; while simultaneously limiting access to COVID-19 vaccines and restricting food stamp purchases, creating what public health experts call a dichotomy in his approach to healthcare policy.
What Happened: Kennedy announced last week that the Centers for Disease Control and Prevention would remove COVID-19 vaccines from <a href="https://www.benzinga.com/news/25/05/45661031/robert-f-kennedy-jr-says-cdc-drops-covid-vaccine-for-healthy-pregnant-women-children">recommended </a>immunization schedules for healthy children and pregnant women.
The decision bypassed traditional advisory committee processes and shifted coverage from routine recommendations to shared clinical decision-making between doctors and patients.
&#8220;Regarding the vaccines, HHS is restoring the doctor-patient relationship,&#8221; HHS spokesperson Andrew Nixon said in a <a href="https://abcnews.go.com/Health/rfk-jr-promoted-freedom-choice-limiting-vaccines-food/story?id=122526364">statement</a> to ABC News. &#8220;We are encouraging those groups to consult with their health care provider to help them make an informed decision.&#8221;
Kennedy has also pushed to ban Supplemental Nutrition Assistance Program recipients from purchasing candy and soda with food stamps. Ten state governors have submitted waivers to the Agriculture Department requesting permission for such restrictions, according to Kennedy&#8217;s statements at a Make America Healthy Again event in May.
The Food and Drug Administration began <a href="https://www.benzinga.com/government/regulations/25/05/45399804/robert-kennedy-jr-cheers-fda-plan-to-ban-fluoride-supplements-for-children-calls-move-long-overdue">removing fluoride supplements for children </a>from the market, earning Kennedy&#8217;s praise as &#8220;long overdue.&#8221; The agency cited a lack of FDA approval and evidence that these products alter gut microbiomes.
Kennedy&#8217;s broader MAHA initiative has influenced restaurant chains to eliminate seed oils. Biglari Holdings Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BH#NYSE">BH</a>) subsidiary Steak &#8216;n Shake switched to beef tallow for French fries, while Sweetgreen Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/SG#NYSE">SG</a>), Bloomin&#8217; Brands Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BLMN#NASDAQ">BLMN</a>), and Restaurant Brands International Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/QSR#NYSE">QSR</a>) have initiated similar transitions.
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Why It Matters: Critics argue Kennedy&#8217;s policies contradict his &#8220;medical freedom&#8221; messaging by limiting choices. Removing COVID vaccines from CDC schedules restricts access while claiming to promote freedom.
&#8220;If you restrict access, you necessarily restrict choice,&#8221; Dr. Matthew Ferrari of Pennsylvania State University told ABC News. Public health experts warn Kennedy&#8217;s approach individualizes community health decisions. &#8220;We&#8217;re losing a lot of that underpinning, which has led to a lot of the gains in public health,&#8221; Dr. Craig Spencer of Brown University told ABC News.
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Disclaimer:&nbsp;This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.
Image Via Shutterstock

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RFK Jr. Champions 'Medical Freedom' While Curtailing Access, Say Public Health Experts

<a href="https://x.com/seckennedy/status/1930012848056365294?s=46&amp;t=dtUiyC3dUs5yGRgT9qYHWg">https://x.com/seckennedy/status/1930012848056365294?s=46&amp;t=dtUiyC3dUs5yGRgT9qYHWg</a>

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US Health Secretary Kennedy Posts On X "I want to address those of you who have anxieties about @US_FDA's limited approval of a new mRNA COVID vaccine for high-risk populations. Moderna has agreed to a true placebo-controlled trial of the new vaccine....."

The U.S. Food and Drug Administration (FDA) on Saturday approved Moderna, Inc.&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRNA#NASDAQ">MRNA</a>) mNexspike&nbsp;(mRNA-1283), a new vaccine against COVID-19, for all adults 65 and older and individuals aged 12-64 years with at least one or more underlying risk factor as defined by the Centers for Disease <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">Control and Prevention (CDC)</a>.
&#8220;The FDA approval of our third product, mNEXSPIKE&#8230;,&#8221; said Stéphane Bancel, Chief <a target="_blank" href="https://www.benzinga.com/pressreleases/25/05/ac45708511/moderna-receives-u-s-fda-approval-for-covid-19-vaccine-mnexspike" rel="noreferrer noopener">Executive Officer of Moderna</a>.
The FDA&#8217;s approval of mNEXSPIKE is based on results from a randomized, observer-blind, active-controlled Phase 3 trial, which enrolled approximately 11,400 participants aged 12 years and older.
Also Read: <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">Robert F. Kennedy Jr. Says CDC Drops COVID Vaccine For &#8216;Healthy&#8217; Pregnant Women, Children</a>
The primary efficacy objective was to demonstrate the non-inferior vaccine efficacy against COVID-19 starting 14 days after mNexspike compared to that after the comparator vaccine, mRNA-1273 (Spikevax), Moderna&#8217;s original COVID-19 vaccine.
Participants received either a 10 μg dose of mRNA-1283 or a 50 μg dose of mRNA-1273.
mRNA-1283 showed a 9.3% higher relative vaccine efficacy (rVE) compared to mRNA-1273 in individuals aged 12 years and older, and in a descriptive sub-group analysis, a 13.5% higher rVE in adults aged 65 and older.
In the Phase 3 trial, mRNA-1283 was found to have a similar safety profile to mRNA-1273, with fewer local reactions and comparable systemic reactions.
The most commonly solicited side effects were injection site pain, fatigue, headache and myalgia.
Moderna expects to have mNexspike available for eligible populations in the U.S. for the 2025-2026 respiratory virus season, alongside Spikevax and mRESVIA, the company&#8217;s approved respiratory syncytial virus (RSV) vaccine.
William Blair writes, &#8220;Approval of mRNA-1283 is an incremental win for Moderna, especially considering HHS Secretary Robert F. Kennedy Jr.&#8217;s negative public opinion on mRNA COVID-19 vaccines, and we continue to see autonomy and data-driven decisions at the FDA.&#8221;
&#8220;We do not see approval of mRNA-1283 as a massive boost to Moderna&#8217;s COVID-19 vaccine sales, which we believe are primarily driven by sentiment surrounding the vaccination market in general, but this is a critical step in the regulatory path for the combo flu/COVID vaccine product, mRNA-1083, which uses mRNA-1283 as the COVID-19 component of its formulation,&#8221; analyst Myles Minter writes.
Analyst Minter says Moderna is still facing challenges from new government policies, including <a target="_blank" href="https://www.benzinga.com/government/regulations/25/05/45663794/hhs-cancels-590m-moderna-bird-flu-vaccine-deal-casting-uncertainty-over-pandemic-preparedness-effort" rel="noreferrer noopener">losing about $700 million</a> in funding from the Department of Health and Human Services for its bird flu vaccine project.
In addition, William Blair writes that the company&#8217;s goal to break even by 2028 is overly optimistic since it would need to more than double its revenue—based on cash costs—to reach that target.
In May, the FDA approved Novavax, Inc.&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVAX#NASDAQ">NVAX</a>) Nuvaxovid for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adults 65 years and older and individuals 12 through 64 years who have at least one underlying condition that puts them at high risk for severe outcomes from COVID-19 (e.g. asthma, cancer, <a target="_blank" href="https://www.benzinga.com/pressreleases/25/05/n45489838/u-s-fda-approves-bla-for-novavaxs-covid-19-vaccine" rel="noreferrer noopener">diabetes, obesity, smoking)</a>.
Achievement of the U.S. license approval has triggered a&nbsp;$175 million&nbsp;milestone payment from Sanofi SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>).
Price Action: MRNA stock is up 4.82% at $27.84 during the premarket session at the last check on Monday.
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Moderna's New COVID Vaccine Secures FDA-Clearance For Seniors, At-Risk Individuals

<a href="https://www.washingtonpost.com/health/2025/05/30/covid-vaccines-children-pregnant-women/" title="https://www.washingtonpost.com/health/2025/05/30/covid-vaccines-children-pregnant-women/">https://www.washingtonpost.com/health/2025/05/30/covid-vaccines-children-pregnant-women/</a>

'Contradicting RFK Jr., CDC keeps recommending covid vaccine for kids' - Washington Post

The U.S. Health and Human Services Secretary Robert F. Kennedy Jr. announced that the Centers for Disease Control and Prevention will no longer recommend COVID-19 vaccines for healthy children and pregnant women, sparking criticism from public health experts who cite ongoing risks.
What Happened: Kennedy <a href="https://www.benzinga.com/news/25/05/45661031/robert-f-kennedy-jr-says-cdc-drops-covid-vaccine-for-healthy-pregnant-women-children">announced</a> the policy change in a video posted on X, joined by FDA Commissioner Dr. Marty Makary and NIH Director Jay Bhattacharya. &#8220;As of today, the Covid vaccine for healthy children and healthy pregnant women has been removed from the CDC recommended immunization schedule,&#8221; Kennedy stated. Makary said there is no evidence that healthy children &#8220;need&#8221; the vaccine.
The decision bypassed the traditional CDC Advisory Committee for Immunization Practices review process. Dr. Paul Offit, director of the Vaccine Education Center at Children&#8217;s Hospital of Philadelphia, said, &#8220;152 children died last year of COVID. 40% of those children were perfectly healthy,&#8221; challenging Kennedy&#8217;s rationale, <a href="https://abcnews.go.com/Health/healthy-children-vaccination-rfk-jr-cuts-covid-shot/story?id=122303993">reported</a> ABC News.
The policy follows FDA changes <a 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">limiting annual boosters to Americans</a> over 65 and high-risk groups while requiring new clinical trials for healthy adults under 65.
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Why It Matters: The announcement creates uncertainty for vaccine manufacturers and healthcare investors. Previous FDA policy shifts under the Trump administration have already <a href="https://www.benzinga.com/government/regulations/25/05/45488265/novavax-wins-limited-fda-nod-for-covid-shot-cleared-only-for-seniors-high-risk-groups-amid-safety-scrutiny">impacted vaccine approvals</a>, with Novavax Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVAX#NASDAQ">NVAX</a>) receiving only limited approval for seniors and high-risk groups after regulatory delays.
Dr. Gregory Poland from the Atria Research Institute noted that over one million U.S. children may have experienced long COVID, with vaccination reducing emergency room visits and hospitalizations by approximately 40%.
Image via Shutterstock
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RFK Jr. Drops COVID Vaccine Recommendation For Healthy Kids, But Experts Warn Of Major Risks

The President Donald Trump administration terminated a <a href="https://www.benzinga.com/25/02/43999106/trumps-officials-to-re-consider-modernas-590-million-bird-flu-vaccine-funding-hhs-cites-biden-administrations-failed-oversight">nearly $600 million contract</a> to Moderna Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRNA#NASDAQ">MRNA</a>) for developing an mRNA-based bird flu vaccine, ending a key former President Joe Biden-era pandemic preparedness initiative.
What Happened: Health and Human Services officials canceled Moderna&#8217;s $590 million contract for bird flu vaccine development, the company announced on Wednesday.
Moderna CEO Stéphane Bancel stated: &#8220;While the termination of funding from HHS adds uncertainty, we are pleased by the robust immune response and safety profile observed in this interim analysis of the Phase 1/2 study of our H5 avian flu vaccine and we will explore alternative paths forward for the program.&#8221;
The company reported that clinical testing in approximately 300 adults showed participants achieved nearly 98% immunity within three weeks of the second vaccine dose, with the treatment being generally well-tolerated.
Trump administration officials had previously indicated they were reviewing all contracts from the prior administration. Robert F. Kennedy Jr.-led HHS criticized the review as necessary due to <a href="https://www.benzinga.com/25/02/43999106/trumps-officials-to-re-consider-modernas-590-million-bird-flu-vaccine-funding-hhs-cites-biden-administrations-failed-oversight">&#8220;four years of the Biden administration&#8217;s </a>failed oversight&#8221; of mRNA vaccine expenditures.
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Why It Matters: The contract termination threatens pandemic preparedness as H5N1 continues spreading. The Biomedical Advanced Research and Development Authority awarded the January funds to create defenses against strains circulating in livestock and birds. This followed an earlier $176 million bird flu vaccine development award granted in July.
 The CDC has confirmed <a href="https://www.benzinga.com/general/biotech/25/01/43046294/bird-flu-raising-red-flags-among-health-officials-cdc-urges-faster-testing?utm_source=chatgpt.com">67 human bird flu cases since 2024</a>, with the first U.S. death reported in Louisiana, highlighting the ongoing public health threat.
Other vaccine manufacturers are also developing bird flu vaccines, including Novavax Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVAX#NASDAQ">NVAX</a>) and CureVac N.V. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CVAC#NASDAQ">CVAC</a>), both with vaccines in clinical trials.
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Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.
Photo by pedro7merino via Shutterstock

Government

Politics

Trump Administration Terminates $590 Million Moderna Bird Flu Vaccine Deal, Dismantling Biden-Era Pandemic Preparedness Effort

Management

Novavax Eliminates Position Of COO And Terminates John Trizzino; Trizzino To Continue To Provide Consulting Services

<a href="https://nypost.com/2025/05/27/us-news/new-covid-19-strain-from-china-that-saw-massive-hospitalizations-spike-spreads-to-us/" title="https://nypost.com/2025/05/27/us-news/new-covid-19-strain-from-china-that-saw-massive-hospitalizations-spike-spreads-to-us/">https://nypost.com/2025/05/27/us-news/new-covid-19-strain-from-china-that-saw-massive-hospitalizations-spike-spreads-to-us/</a>

Global

'New COVID strain from China that led to massive spike in hospitalizations has spread to the US — including NYC' - NY Post

The U.S. Health and Human Services Secretary Robert F. Kennedy Jr. announced Tuesday that the COVID-19 vaccine will no longer be among the recommended vaccines for pregnant women and healthy children on the US Centers for Disease Control and Prevention&#8217;s <a href="https://www.benzinga.com/general/health-care" target="_blank" rel="noreferrer noopener">immunization schedule</a>.
Kennedy announced the change in a&nbsp;video&nbsp;<a target="_blank" href="https://x.com/seckennedy/status/1927368440811008138?s=46&amp;t=dtUiyC3dUs5yGRgT9qYHWg" rel="noreferrer noopener">posted</a> to the social media platform X.
&#8220;As of today, the Covid vaccine for healthy children and healthy pregnant women has been removed from the CDC recommended immunization schedule,&#8221; Kennedy said. &#8220;Last year, the Biden administration urged healthy children to get yet another COVID shot, despite the lack of any clinical data to support the repeat booster strategy in children.&#8221;
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/25/05/45254051/vinay-prasads-appointment-to-fdas-cber-triggers-questions-over-future-of-cell-and-gene-therapy-regulation" rel="noreferrer noopener">Vinay Prasad&#8217;s Appointment To FDA&#8217;s CBER Triggers Questions Over Future Of Cell And Gene Therapy Regulation</a>
He was joined by the U.S. Food and Drug Administration Commissioner Dr. Marty Makary and National Institutes of Health Director Dr. Jay Bhattacharya.
As of Tuesday morning, the immunization schedule posted online had not yet been changed.
In 2021, Kennedy <a target="_blank" href="https://www.regulationsa.gov/document/FDA-2021-P-0460-0001" rel="noreferrer noopener">filed</a> a citizen petition&nbsp;requesting the FDA to revoke Emergency Use Authorizations for existing COVID-19 vaccines and refrain from approving and licensing them.
The update follows the FDA&#8217;s changes to COVID-19 vaccine requirements, limiting annual booster approvals to older and high-risk Americans while implementing stricter clinical trial <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">requirements for healthy adults</a>.
The FDA will now require new clinical trials for approval of annual COVID-19 boosters for healthy Americans under age 65, effectively restricting their availability to older adults and those at risk of severe illness, according to FDA Commissioner&nbsp;Marty Makary&nbsp;and top U.S. vaccines regulator&nbsp;Vinay Prasad&nbsp;in the New England Journal of Medicine, reported Reuters.
Last week, the FDA&#8217;s Vaccines and Related Biological Products Advisory Committee (VRBPAC) <a target="_blank" href="https://www.fda.gov/vaccines-blood-biologics/industry-biologics/covid-19-vaccines-2025-2026-formula-use-united-states-beginning-fall-2025" rel="noreferrer noopener">voted</a> to recommend a monovalent JN.1-lineage vaccine composition.
Based on the totality of the evidence, the FDA has advised the manufacturers of the approved COVID-19 vaccines that to more closely match currently circulating SARS-CoV-2 viruses, the COVID-19 vaccines for use in the United States beginning in fall 2025 should be monovalent JN.1-lineage-based COVID-19 vaccines (2025-2026 Formula), preferentially using the LP.8.1 strain.&nbsp;
On Friday, Moderna Inc.&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRNA#NASDAQ">MRNA</a>) submitted an application to the FDA to review its Spikevax 2025-2026 formula, targeting the SARS-<a target="_blank" href="https://www.benzinga.com/pressreleases/25/05/ac45595488/moderna-files-fda-application-for-the-lp-8-1-targeting-covid-19-vaccine" rel="noreferrer noopener">CoV-2 variant LP.8.1</a>.
Also, Novavax Inc.&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVAX#NASDAQ">NVAX</a>) received limited FDA approval for its COVID-19 vaccine, Nuvaxovid, marking a regulatory milestone and unlocking a&nbsp;$175 million milestone payment&nbsp;from partner&nbsp;Sanofi SA&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>)
The approval came after a six-week delay as regulators <a target="_blank" href="https://www.benzinga.com/25/05/45295534/novavax-reports-q1-profit-as-revenue-surges-to-over-600-million-and-lower-costs-raises-2025-forecasts" rel="noreferrer noopener">sought additional data</a>.
The vaccine is now authorized for people aged 65 and older and for individuals 12 and up with underlying medical conditions that increase the <a target="_blank" href="https://www.benzinga.com/25/05/45496095/novavax-scores-key-fda-win-shares-jump-19-as-sanofi-milestone-unlock" rel="noreferrer noopener">risk of severe COVID-19</a>.
Price Action: MRNA stock is down 2.86% at $27.01 at the last check Tuesday.
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Photo: Shutterstock

Robert F. Kennedy Jr. Says CDC Drops COVID Vaccine For 'Healthy' Pregnant Women, Children

<a href="https://x.com/seckennedy/status/1927368440811008138?s=46&amp;t=dtUiyC3dUs5yGRgT9qYHWg">https://x.com/seckennedy/status/1927368440811008138?s=46&amp;t=dtUiyC3dUs5yGRgT9qYHWg</a>

US Health Secretary Kennedy Posts On X "Today, the COVID vaccine for healthy children and healthy pregnant women has been removed from @CDCgov recommended immunization schedule. Bottom line: it's common sense and it's good science. We are now one step closer to realizing @POTUS's promise to Make America Healthy Again."

<a href="https://endpts.com/fda-vaccine-advisors-update-covid-strain-guidance-following-new-framework/#:~:text=Committee%20members%20voted%20unanimously%20to,was%20the%20KP.2%20strain" title="https://endpts.com/fda-vaccine-advisors-update-covid-strain-guidance-following-new-framework/#:~:text=Committee%20members%20voted%20unanimously%20to,was%20the%20KP.2%20strain">https://endpts.com/fda-vaccine-advisors-update-covid-strain-guidance-following-new-framework/#:~:text=Committee%20members%20voted%20unanimously%20to,was%20the%20KP.2%20strain</a>.

'All FDA Committee Members Voted Unanimously To Recommend A Monovalent JN.1-lineage Covid-19 Vaccine For The Upcoming Season, The Same Recommendation Made Last Year; The FDA Ultimately Told Vaccine Manufacturers That The Preferred Strain Within That Lineage Was The KP.2 Strain' - STAT News

<a href="https://www.wsj.com/politics/policy/rfk-jr-maha-commission-report-5c13696d">https://www.wsj.com/politics/policy/rfk-jr-maha-commission-report-5c13696d</a>

'What's Inside RFK Jr.'s MAHA Report'- Wall Street Journal

Novavax's (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVAX#NYSE">NVAX</a>) short percent of float has fallen 17.46% since its last report. The company recently reported that it has 42.33 million shares sold short, which is 26.23% of all regular shares that are available for trading. Based on its trading volume, it would take traders 6.4 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>Novavax Short Interest Graph (3 Months)</h3>
<img src="https://www.benzinga.com/files/images/story/2025/1747843220_0.png" alt="short_fig" />
As you can see from the chart above the percentage of shares that are sold short for Novavax has declined since its last report. This does not mean that the stock is going to rise in the near-term but traders should be aware that less shares are being shorted.
<h3>Comparing Novavax'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>, Novavax's peer group average for short interest as a percentage of float is 16.62%, 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.

Short Sellers

Short Ideas

What's Driving the Market Sentiment Around Novavax?

The U.S. Food and Drug Administration has announced significant changes to COVID-19 vaccine requirements, limiting annual booster approvals to older and high-risk Americans while implementing stricter clinical trial requirements for healthy adults.
What Happened: The FDA will now require new clinical trials for approval of annual COVID-19 boosters for healthy Americans under age 65, effectively restricting their availability to older adults and those at risk of severe illness, according to FDA Commissioner Marty Makary and top U.S. vaccines regulator Vinay Prasad in the New England Journal of Medicine, reported Reuters.
&#8220;At-risk Americans can be reassured that they will be covered by such approvals. At the same time, we want more evidence at the U.S. Food and Drug Administration,&#8221; Prasad told FDA scientists during a live-streamed presentation on Tuesday. &#8220;We want to know more about what these products are doing, especially as we enter the seventh, eighth and ninth dose.&#8221;
See Also: <a href="https://www.benzinga.com/markets/25/05/45537306/google-unveils-total-reimagining-of-search-with-chatbot-style-feature-to-compete-with-openai">Google Unveils &#8216;Total Reimagining Of Search&#8217; With Chatbot-Style Feature To Compete With OpenAI</a> Why It Matters: This policy shift represents a significant departure from previous U.S. vaccination strategy, with Makary and Prasad noting that America has been more aggressive than other high-income nations in recommending yearly shots for healthy adults.
The decision comes amid shifting political priorities at the FDA under Health Secretary Robert F. Kennedy Jr., who has been remaking the U.S. health system to align with President Donald Trump&#8216;s goal of dramatically <a href="https://www.benzinga.com/government/regulations/25/05/45488265/novavax-wins-limited-fda-nod-for-covid-shot-cleared-only-for-seniors-high-risk-groups-amid-safety-scrutiny">shrinking the federal government</a>. 
This follows a pattern of increased scrutiny of vaccines, as evidenced by the FDA&#8217;s recent limited approval of Novavax Inc.&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVAX#NASDAQ">NVAX</a>) COVID-19 vaccine only for <a href="https://www.benzinga.com/government/regulations/25/05/45488265/novavax-wins-limited-fda-nod-for-covid-shot-cleared-only-for-seniors-high-risk-groups-amid-safety-scrutiny">people 65 and older and those 12</a> and up with underlying health conditions.
Despite the policy change, investors appeared reassured that vaccine policies for older and high-risk Americans remain unchanged. Shares of COVID-19 vaccine makers rose following the announcement, with Moderna (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRNA#NASDAQ">MRNA</a>) up 6.06%, Pfizer (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) rising 2.22%, BioNTech&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BNTX#NASDAQ">BNTX</a>) U.S. ADRs up 4.1%, and Novavax gaining 1.5%.
Image Via Shutterstock 
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Disclaimer:&nbsp;This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.

FDA Limits Annual COVID-19 Boosters To High-Risk Americans, Demands New Trials For Healthy Adults In Policy Shift Under RFK Jr.

<a href="https://x.com/US_FDA/status/1924871996216951112">https://x.com/US_FDA/status/1924871996216951112</a>
&nbsp;

Macro Economic Events

Economics

PCVX

FDA's Vinayak Prasad Says No High-Quality Evidence For Benefit Of Vaccinating People Around Immunocompromised People With Covid Shots; I Don't Envision Randomized Trials Every Year For Covid Vaccines But Rather When There's Major Antigenic Shift

WIIM

Shares of vaccine stocks are trading higher following a report indicating FDA advisers will consider if COVID-19 vaccines should target the LP.8.1 subvariant for 2025-2026.

<a href="https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-advisers-consider-if-new-covid-shots-should-target-lp81-subvariant-2025-05-20/" title="https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-advisers-consider-if-new-covid-shots-should-target-lp81-subvariant-2025-05-20/">https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-advisers-consider-if-new-covid-shots-should-target-lp81-subvariant-2025-05-20/</a>

'US FDA Advisers To Consider If New COVID Shots Should Target LP.8.1 Subvariant' - Reuters News

Press Releases

Novavax Announces Changes to Board of Directors

SHIELD-Utah Study Shows Novavax's COVID-19 Vaccine Induces Lower Reactogenicity Symptoms Compared to mRNA

Novavax Appoints Charles Newton to Board of Directors

Novavax to Report First Quarter 2025 Financial Results on May 8, 2025

Novavax Announces Significantly Improved Terms for Collaboration and License Agreement with Takeda for Nuvaxovid® in Japan

Novavax to Participate in BofA Securities 2025 Health Care Conference

Earnings

Novavax Reports First Quarter 2025 Financial Results and Operational Highlights

U.S. FDA Approves BLA for Novavax's COVID-19 Vaccine

Novavax to Participate in Upcoming Investor Conferences

Novavax's COVID-19-Influenza Combination and Stand-alone Influenza Vaccine Candidates Showed Robust Immune Responses and Were Well Tolerated in Initial Cohort of a Phase 3 Trial

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