Booster Epidemiological Evaluation of Health, Illness and Vaccine Efficacy Study: Randomized Trial to Compare the Clinical Efficacy of Novavax vs. mRNA COVID-19 2023-2024 Updated Vaccines Among Adults 18-49 and 50+ Years in the United States

The purpose of this research study is to find out how well two different 2023-2024 updated COVID-19 vaccines protect people from COVID-19 (the disease caused by the SARS-CoV-2 virus), and to determine if getting a 2023-2024 updated vaccine provides better protection from COVID-19 than not getting a vaccine.
If the participant chooses to get a 2023-2024 updated COVID-19 vaccine as part of this study, they will have a 50/50 chance of receiving either the Novavax or Pfizer mRNA vaccine.
If the participant decides not to get a 2023-2024 updated COVID-19 vaccine, the participant can still participate in other study activities.
STUDY ACTIVITIES:
* An online enrollment survey
* An in-person enrollment visit
* Weekly online surveys for 20 weeks
* Weekly COVID-19 tests for 20 weeks
* Additional online surveys if you have COVID-19 symptoms or tested positive for COVID-19.
* Additional COVID-19 tests if you have COVID-19 symptoms or tested positive.
* Online survey questions in the middle and at the end of the study

开始日期2023-11-22

申办/合作机构

University of Utah

[+2]

NCT05925127

/ Completed临床2/3期

A Phase 2/3, Randomized, Double-Blind Study to Evaluate the Safety and Immunogenicity of Different Booster Dose Levels of Monovalent SARS-CoV-2 rS Vaccines in Adults ≥ 50 Years Previously Vaccinated With COVID-19 mRNA Vaccines

This is a Phase 2/3, randomized, double-blind study to evaluate the safety and immunogenicity of different booster dose levels of the monovalent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) recombinant (r) spike (S) protein nanoparticle (SARS-CoV-2 rS) vaccines with Matrix-M™ adjuvant (NVX-CoV2373 [prototype Wuhan vaccine with Matrix-M adjuvant] or NVX-CoV2601 [Omicron XBB.1.5 subvariant vaccine with Matrix-M adjuvant]).

开始日期2023-10-16

申办/合作机构

Novavax, Inc.

NCT05875701

/ Completed临床3期

A Phase 3 Study to Evaluate the Immunogenicity and Safety of Novavax COVID-19 Vaccine(s) as Second or Subsequent Booster After mRNA Vaccines in Individuals 18 to 49 Years of Age

This is an open-label Phase 3 study evaluating the immunogenicity and safety of Novavax vaccine(s) with Matrix-M™ adjuvant (ancestral strain NVX-CoV2373 and an alternative strain and/or multivalent Novavax vaccine) as booster doses following a series of primary and booster doses of authorized/approved mRNA vaccines followed by a single booster dose of NVX-CoV2373 in the Novavax 2019nCoV-307 study (NCT05463068).

开始日期2023-03-28

申办/合作机构

Novavax, Inc.

100 项与 SARS-CoV-2 Spike Protein Vaccine(Recombinant)(Novavax, Inc.) 相关的临床结果

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100 项与 SARS-CoV-2 Spike Protein Vaccine(Recombinant)(Novavax, Inc.) 相关的转化医学

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100 项与 SARS-CoV-2 Spike Protein Vaccine(Recombinant)(Novavax, Inc.) 相关的专利（医药）

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174

项与 SARS-CoV-2 Spike Protein Vaccine(Recombinant)(Novavax, Inc.) 相关的文献（医药）

2025-05-01·LANCET INFECTIOUS DISEASES

Immunogenicity and safety of a monovalent omicron XBB.1.5 SARS-CoV-2 recombinant spike protein vaccine as a heterologous booster dose in US adults: interim analysis of a single-arm phase 2/3 study

Article

作者: Surowitz, Ronald ; Julien, Craig ; Wadsworth, Larkin ; Cai, Zhaohui ; Kouassi, Alex ; Ylisastigui, Pedro ; Yenal, Kem ; Noveck, Robert ; Kalkeri, Raj ; Hammershaimb, E Adrianne ; Tapia, Milagritos ; Jacobs, Michael ; Smith, Katherine ; Seger, William ; McDonald, Jara ; Akinsola, Adebayo ; Vrbicky, Keith ; Fanning, Sue ; Noriega, Fernando ; Alves, Katia ; Davis, Matthew ; Studdard, Harry ; Gorgos, Linda ; Mallory, Raburn M ; Plested, Joyce S ; Nelson, Joy ; Uribe, Eduardo ; McClelland, R Scott ; Zhu, MingZhu ; Kotloff, Karen ; Murillo, Abel ; Smith, William ; Alleman, Brandon ; Adelglass, Jeffrey ; Hollister, Ripley ; McClelland, R. Scott ; Bell, Codey ; Kaba, Muneer ; Pickrell, Paul ; Slechta, Stacy ; Freeman, George ; Lockwood, Robert ; Ferrera, David ; Chu, Laurence ; Cloney-Clark, Shane

BACKGROUND:

Authorities globally recommended a monovalent omicron XBB.1.5-based COVID-19 vaccine for the 2023-24 season. The Novavax COVID-19 vaccine, NVX-CoV2601, contains XBB.1.5 recombinant spike protein, based on an authorised prototype vaccine (NVX-CoV2373) technology. We aimed to determine whether a single dose of NVX-CoV2601 versus NVX-CoV2373 (from a previous study [2019nCoV-311 part 2]) produced superior neutralising antibody (nAb) responses, and non-inferior seroresponse rates to XBB.1.5, after three or more previous mRNA-based COVID-19 vaccinations.

METHODS:

In part 1 of this single-arm, phase 2/3 study (2019nCoV-313), participants aged 18 years or older who had been previously vaccinated with three or more doses of mRNA-1273 (Moderna) or BNT162b2 (Pfizer-BioNTech) were enrolled across 30 US centres (research groups and universities) located across 20 states. Participants received one intramuscular injection of NVX-CoV2601 (5 μg XBB.1.5 spike plus 50 μg Matrix-M adjuvant). Coprimary endpoints were superiority of baseline-adjusted nAb geometric mean XBB.1.5 titres (adjusted GMTs), with superiority declared when the lower bound of the 95% CI for the GMT ratio (GMTR) was greater than 1, and non-inferiority of seroresponse rates, with non-inferiority declared when the lower bound of the 95% CI for the seroresponse rate difference was greater than -10%, on day 28; comparisons were made for NVX-CoV2601 administered in this study versus NVX-CoV2373 administered in part 2 (group G) of the 2019nCoV-311 study. Coprimary endpoints were assessed in the per-protocol immunogenicity set (ie, all participants who received study vaccine, underwent 28 days of follow-up, had day 0 and day 28 samples available, and had no major protocol deviations). Safety was a secondary endpoint and included assessments of solicited treatment-emergent adverse events up to 7 days and unsolicited treatment-emergent adverse events up to 28 days after vaccination in the safety analysis set (ie, all participants who received study vaccine). Here we report the prespecified interim analysis of immunogenicity and safety up to day 28. This study is registered with ClinicalTrials.gov, NCT05975060, and is now complete.

FINDINGS:

Between Sept 7 and Sept 8, 2023, 380 individuals were screened, of whom 332 were enrolled and received study vaccine. At the 28-day interim analysis database lock (Jan 17, 2023), the per-protocol analysis sets included 309 (93%) of 332 NVX-CoV2601 recipients and 227 (90%) of 252 NVX-CoV2373 recipients. Mean age of NVX-CoV2601 recipients was 52·1 years (SD 16·1); 192 (62%) of 309 were female and 117 (38%) were male. Mean age of NVX-CoV2373 recipients was 42·2 years (13·4); 128 (56%) of 227 were female and 99 (44%) were male. At day 28, the baseline-adjusted nAb GMT for NVX-CoV2601 was 905·9 (95% CI 807·1-1016·8) and for NVX-CoV2373 was 156·6 (137·0-179·0); the between-group adjusted GMTR was 5·8 (95% CI 4·9-6·9). In the per-protocol immunogenicity set, seroresponse rates were 64% (196 of 305) among recipients of NVX-CoV2601 and 7% (16 of 227) among recipients of NVX-CoV2373, with a seroresponse rate difference of 57% (95% CI 51-63). In the NVX-CoV2601 group, within 7 days, solicited local treatment-emergent adverse events were reported in 189 (57%) of 332 participants (including one [<1%] grade 3 or worse event; tenderness) and solicited systemic treatment-emergent adverse events were reported in 158 (48%) participants (including four [1%] participants with one or more grade 3 events; malaise [n=3], headache [n=2], fatigue [n=1], and muscle pain [n=1]). The most common solicited treatment-emergent adverse events were tenderness (171 [52%]) and pain (98 [30%]) at the injection site, fatigue (97 [29%]), and muscle pain (97 [29%]). Up to day 28, unsolicited adverse events considered related to study vaccination in the NVX-CoV2601 group occurred in five (2%) participants (one for each of asthma, axillary pain, diarrhoea, hypertension [which was medically attended], and presyncope). No serious adverse events due to study product, adverse events of special interest, or deaths due to study product occurred, and no study discontinuations due to treatment-emergent adverse events occurred.

INTERPRETATION:

The coprimary endpoints were met, and NVX-CoV2601 was well tolerated. These interim data support NVX-CoV2601 use per guidance for XBB.1.5-directed COVID-19 vaccines and demonstrate the adaptability of this vaccine platform for updated SARS-CoV-2 spike proteins.

FUNDING:

Novavax.

2025-04-01·Lancet Microbe

Vaccine efficacy of NVX-CoV2373 against SARS-CoV-2 infection in adolescents in the USA: an ancillary study to a phase 3, observer-blinded, randomised, placebo-controlled trial

Article

作者: McArthur, Monica A. ; Kotloff, Karen L. ; Ackerman, Ronald ; Repaka, Rekha ; Brown, Elizabeth R. ; Deming, Meagan E. ; Cohen, Stuart H. ; Turley, Christine B. ; Gay, Cynthia ; Steil, Kenneth ; Formentini, Elizabeth ; Jeanfreau, Robert ; Robb, Merlin L. ; Deming, Meagan E ; Mason, Robin ; Seger, William ; Chu, Laurence ; McArthur, Monica A ; Daly, Wendy ; Musante, David ; Rapaka, Rekha R ; Shaw, Marian E. ; Gorman, Richard ; Wolff, Peter ; Miller, Vicki E. ; Etokhana, Kenneth ; Maguire, Rebecca ; Hachigian, Greg ; Neuzil, Kathleen M. ; Schrag, Stephanie J. ; Robb, Merlin L ; Sexter, Joanna ; Neuzil, Kathleen M ; Barranco-Santana, Elizabeth ; Schrag, Stephanie J ; Musante, David B ; Brown, Elizabeth R ; Waters, Michael ; Humphrys, Mike ; Arvay, Melissa ; Essink, Brandon ; Adelglass, Jeffrey ; Ravel, Jacques ; Kotloff, Karen L

BACKGROUND:

Although existing COVID-19 vaccines are known to be highly effective against severe disease and death, data are needed to assess their ability to reduce SARS-CoV-2 infection. We aimed to estimate the efficacy of the NVX-CoV2373 protein subunit vaccine against SARS-CoV-2 infection, regardless of symptoms, among adolescents.

METHODS:

We performed an ancillary observational study (SNIFF) to the phase 3, observer-blinded, randomised, placebo-controlled PREVENT-19 trial that assessed vaccine efficacy against symptomatic COVID-19 in the USA. Participants in the PREVENT-19 trial included healthy adolescents aged 12-17 years and with no history of laboratory-confirmed SARS-CoV-2 infection. They were randomly assigned (2:1) to receive either the NVX-CoV2373 (Novavax, Gaithersburg, MD, USA) vaccine (immediate NVX-CoV2373 group) or placebo (delayed NVX-CoV2373 group) on days 0 and 21 (initial series). After 2 months, in a crossover series, participants received two doses, 21 days apart, of the intervention that they did not receive in their initial series. Participants at 47 of the PREVENT-19 sites were invited to participate in the SNIFF study and self-collect nasal swabs at home twice weekly for SARS-CoV-2 testing to assess vaccine efficacy against SARS-CoV-2 infection. This primary outcome was defined as the first identification of SARS-CoV-2 detected by RT-PCR, regardless of symptoms, with onset within 4 weeks after the second dose of the initial vaccination series until the second dose of the crossover series. Secondary outcomes were vaccine efficacy against asymptomatic and minimally symptomatic SARS-CoV-2 infection, durability of vaccine efficacy against SARS-CoV-2 infection, and durability of vaccine efficacy against asymptomatic and minimally symptomatic infections. Outcomes were analysed in the modified intention-to-treat population, which included all participants without previous SARS-CoV-2 infection and was restricted to participants enrolled within 4 weeks of the second dose of the primary (primary analysis population) or crossover (post-crossover analysis population) series. This study is registered with ClinicalTrials.gov (NCT04611802).

FINDINGS:

Between June 1 and Dec 17, 2021, 1196 (53·2%) of the 2247 adolescent participants recruited in the PREVENT-19 trial enrolled in the SNIFF study. The primary analysis population included 471 participants in the immediate NVX-CoV2373 group and 220 in the delayed NVX-CoV2373 group. Incidence of SARS-CoV-2 infection was 14·9 cases per 100 person-years (95% CI 7·9-25·5) in the immediate group and 54·2 cases per 100 person-years (33·6-82·9) in the delayed group; vaccine efficacy was 73·5% (95% CI 47·1-86·7; p=0·0002). Incidence of minimally symptomatic or asymptomatic SARS-CoV-2 infection was 10·3 cases per 100 person-years (95% CI 4·7-19·6) in the immediate group and 36·1 cases per 100 person-years (19·8-60·7) in the delayed group; vaccine efficacy was 72·8% (95% CI 37·1-88·2; p=0·0023). After the second crossover dose, incidence of SARS-CoV-2 was 14·6 cases per 100 person-years (95% CI 8·6-23·0) in the immediate group (receiving placebo at crossover) and 9·1 cases per 100 person-years (3·0-21·3) in the delayed group, with a durability ratio of 160·3 (95% CI 59·5-431·6; p=0·35). Almost all infections after crossover were minimally symptomatic or asymptomatic, with a durability ratio of 151·4 (55·9-410·4; p=0·41).

INTERPRETATION:

Among adolescents participating in the PREVENT-19 trial during the delta (B.1.617.2) variant wave of the COVID-19 pandemic, the NVX-CoV2373 vaccine was highly efficacious against SARS-CoV-2 infection regardless of symptoms, indicating its potential to reduce the reservoir of infections that contribute to community transmission.

FUNDING:

US Department of Health and Human Services, Administration for Strategic Preparedness and Response, Biomedical Advanced Research and Development Authority, National Institute of Allergy and Infectious Diseases, and National Institutes of Health.

2025-03-01·JOURNAL OF INFECTION

The immunogenicity, reactogenicity, and safety of a bivalent mRNA or protein COVID-19 vaccine given as a fourth dose

Article

作者: Rudel, Anna ; Higgins, Rachel A ; Hart, John ; Ong, Darren Suryawijaya ; Do, Lien Anh Ha ; Neal, Eleanor ; Mazarakis, Nadia ; Toh, Zheng Quan ; Mahanty, Siddhartha ; Bright, Kathryn ; Justice, Fran ; Nguyen, Cattram ; Subbarao, Kanta ; Luu, Skyy ; Licciardi, Paul V ; Quah, Leanne ; Dassanayake, Shashini ; Watts, Emma ; Mulholland, Kim ; von Mollendorf, Claire ; Moore, Kerryn A ; Ng, Yan Yung

OBJECTIVES:

We conducted a randomised controlled trial (RCT) to compare immunogenicity, reactogenicity and safety one month after a fourth COVID-19 mRNA or protein vaccine dose.

METHODS:

This RCT recruited healthy adults in Melbourne, Australia, who had previously received three COVID-19 vaccine doses at least six months prior and had no SARS-CoV-2 infection in the last three months. The participants were randomised (1:1) to receive the bivalent mRNA vaccine (mRNA-1273.214/mRNA-1273.222, hereafter Moderna) or protein vaccine (NVX-CoV-2373, hereafter Novavax) as a fourth dose. A self-selected control group who elected not to receive an additional dose were also included. The co-primary endpoints compared immunogenicity at 28 days post-vaccination measured as binding antibodies (IgG against Ancestral and Omicron subvariants; BA.1, BA.4/5 and JN.1) between the two vaccine groups, and reactogenicity within one-week post-vaccination.

CLINICALTRIALS:

gov Identifier: NCT05543356.

RESULTS:

Between Feb 28 and Oct 4, 2023, 496 participants were enrolled into the study. Participants were randomised into either the bivalent mRNA Moderna (n=177) or protein Novavax (n=176) vaccine groups, with n=143 allocated to the control group. The geometric mean ratio (GMR) of anti-Spike binding IgG antibody levels were higher for the Moderna vaccine compared to the Novavax vaccine at 28 days post-vaccination for all variants tested, including Ancestral (GMR: 2.11, 95% CI: 1.88 - 2.37), BA.1 (GMR: 2.32, 95% CI 2.04 - 2.63), BA.4/5 (GMR: 2.32, 95% CI: 2.04 - 2.65), and JN.1 (GMR: 2.40, 95% CI: 2.14 - 2.70). The frequency of any local and systemic reactions (grades 1-4) was higher for the Moderna vaccine (159/177; 89.8%) compared to the Novavax vaccine (130/176; 73.9%). Serious reactions (grade 3-4) between the groups were similar (11/177; 6.2%, versus 9/176; 5.1%, respectively).

CONCLUSION:

At day 28 post-vaccination, higher immunogenicity was observed following Moderna vaccination compared to Novavax vaccination when given as a fourth dose in healthy adults for Ancestral and Omicron subvariants, including JN.1. However, local and systemic reactogenicity was higher in the Moderna vaccine group compared with the Novavax vaccine group. These results may have important implications for ongoing booster strategies.

587

项与 SARS-CoV-2 Spike Protein Vaccine(Recombinant)(Novavax, Inc.) 相关的新闻（医药）

2025-05-15

·BioSpace

FDA Delays Decision Date on Biohaven’s Spinocerebellar Ataxia Application

iStock, Andrii Yalanskyi The FDA also changed its tune and is now planning to convene an advisory committee to discuss Biohaven’s application. The FDA has pushed back by three months its decision date for Biohaven ’s investigational glutamate modulator troriluzole for the treatment of spinocerebellar ataxia, the biotech announced Wednesday evening. Biohaven, whose stock slumped more than 12% in premarket trading Thursday, now expects to receive the verdict in the fourth quarter. In a note to investors early on Thursday, analysts at William Blair called the delay “surprising,” especially given the “proximity to the completed mid-cycle review.” On Monday, Biohaven also said that it had not received communication from the FDA regarding its application for troriluzole and continued to expect the regulatory decision to come in the third quarter. In its press announcement on Wednesday, Biohaven said that the regulatory delay was to give the FDA enough time to review additional data that the company submitted in response to a request from the agency. As per William Blair based on communication with Biohaven management, the FDA’s questions “were part of the routine review process,” which the company has responded to “in a timely manner.” The company also revealed that the FDA now intends to convene an advisory committee to discuss the application for troriluzole, though that meeting has not been scheduled yet. William Blair analysts said they are “not surprised by the AdCom expectation given troriluzole would represent the first FDA-approved therapy for the treatment of SCA [spinocerebellar ataxia].” Troriluzole works by modulating the neurotransmitter glutamate, a key excitatory signal. The drug candidate increases the uptake of glutamate from the synapse, in turn lowering the concentration of the neurotransmitter in the synaptic space, according to Biohaven’s website . The overall effect of troriluzole is to prevent the overexcitation of neurons. In September 2024, Biohaven unveiled topline pivotal data for troriluzole, demonstrating that the drug slowed disease progression by 50% to 70% versus untreated comparators. The troriluzole delay comes amid delays at the FDA. Last week, for instance, the regulator failed to meet its target decision date for GSK’s Nucala, which the pharma is pushing into chronic obstructive pulmonary disease. Last month, the FDA also ran into delays for Stealth BioTherapeutics ’ Barth Syndrome application and Novavax ’s COVID-19 vaccine. William Blair addressed this possibility directly in its note. “There will be investor debate over whether this is a sign of FDA delays as a result of layoffs and restructuring at the agency,” the analysts wrote, however noting that the FDA has had a history of extending reviews in the neuroscience space. In January 2023, for example, argenx’s supplemental application for Vyvgart Hytrulo in myasthenia gravis also ran into a regulatory delay , William Blair said. Despite the delay, “we remain optimistic that the FDA will show more regulatory flexibility” toward troriluzole “given the rare-disease nature of SCA, lack of treatment options for the disease, and troriluzole’s risk/benefit,” the analysts added.

疫苗上市批准临床3期

2025-05-13

·佰傲谷BioValley

都2025年了，COVID-19疫苗还能卖出超过10亿美元

都已经2025年了，COVID-19疫苗还能卖出超过10亿美元。可能是对海外的环境情势不了解，小编真心的想问，到底是谁还在购买/使用COVID-19疫苗？不降反升的COVID-19疫苗销售额Novavax/Nuvaxovid：同比增长641%Novavax的Nuvaxovid，是拿到美国FDA监管授权的第四款COVID-19疫苗。由于获批时间（于2022年7月获批）上落后，Nuvaxovid的销售数据在2022年和2023年远远低于两款COVID-19 mRNA疫苗。但是奇怪的是，在2025年第一季度，Nuvaxovid居然成为了全球销售额最高的COVID-19疫苗。根据Novavax发布的2025年第一季度（2025Q1）业绩报告，Nuvaxovid在2025Q1的销售额达到6.01亿美元，同比2024Q1销售额（8200万美元）增长641%。Novavax表示，第一季度产品销售额的增长主要是由于两项预购协议（APA）终止后确认的6.03亿美元。不过，值得注意的是，Nuvaxovid还未获得FDA的完全批准。此前FDA未在原定的PDUFA日期（2025年4月1日）给予Nuvaxovid完全批准，并要求Novavax完成额外的临床试验，这使得Nuvaxovid的监管前景扑朔。辉瑞/Comirnaty：同比增长62%辉瑞的Comirnaty，是首款获得美国FDA批准的COVID-19 mRNA疫苗，也是全球（除中国）应用最广泛的COVID-19疫苗。辉瑞发布的2025年第一季度业绩报告显示，Comirnaty在2025Q1的收入达到5.65亿美元，同比增长62%。根据披露，主要原因是由于美国市场的份额增长和国际市场的合同交付增加。Moderna/Spikevax：同比下降49.7%Moderna的Spikevax，是一款比肩Comirnaty的COVID-19疫苗，也在当年创造了销售神话，Spikevax在2021年和2022年连续保持全球畅销药物前五之列，销售总额超过300亿美元。根据Moderna的2025Q1财报，Spikevax在2025Q1的销售额为8400万美元，其中包括2900万美元的美国销售额和5500万美元的国际销售额。Moderna在1月份参加了招标机会，以竞争欧盟的COVID疫苗业务。这几款COVID-19疫苗中，唯有Spikevax的25Q1销售额同比下降，比较符合小编的预期。可能是新冠疫苗最后的余晖了不过，这可能是COVID-19疫苗最后的余晖了。首先，先前和各公司签订的COVID-19疫苗合同，要么结束，要么终止，违约费就是最后一笔收入。其次，在特朗普政府班子的“疫苗新政”，以及“反疫苗活动家”小罗伯特·肯尼迪（Robert F. Kennedy Jr.）上任卫生与公众服务部（HHS）部长，美国未来的疫苗市场可能发生变动，进而萎缩。在3月份，美国联邦卫生官员本周表示，随着新冠疫苗的结束，他们正在追回分配给各州和地方公共卫生部门以及其他卫生组织的114亿美元资金。这意味着，美国政府将对COVID-19疫苗持消极态度。同时，“反疫苗活动家”小罗伯特·肯尼迪（Robert F. Kennedy Jr.）于2025年2月13日通过参议院听证，正式上任美国卫生与公众服务部（HHS）部长。这位“反疫苗”卫生部长上台后，先是阻碍了ACIP（美国预防接种咨询委员会）和疫苗与相关生物制品咨询委员会（VRBPAC）的进行，后又推出新疫苗审批政策，要求所有新疫苗在获批前都要进行安慰剂对照试验，进一步提高了疫苗监管的门槛。在这些由美国特朗普政府主导的政策下，美国未来的疫苗领域和市场可能会陷入低迷。小结但是这也说不准，毕竟特朗普是出了名的反复无常。或许，未来特朗普又出台利好疫苗发展的政策，大力推广新冠疫苗呢？参考资料：1.https://ir.novavax.com/press-releases/2025-05-08-Novavax-Reports-First-Quarter-2025-Financial-Results-and-Operational-Highlights2.https://s28.q4cdn.com/781576035/files/doc_financials/2025/q1/Q1-2025-PFE-Earnings-Release-FINAL.pdf3.https://investors.modernatx.com/news/news-details/2025/Moderna-Reports-First-Quarter-2025-Financial-Results-and-Provides-Business-Updates/default.aspx4.https://www.biospace.com/business/novavax-sales-jump-600-yoy-as-covid-19-vaccine-still-in-limbo-at-fda本周好文推荐如需转载请联系佰傲谷并在醒目位置注明出处········

疫苗财报信使RNA紧急使用授权

2025-05-09

·PRNewswire

April Recap: 15 Top Health Press Releases

A roundup of the most newsworthy healthcare press releases from PR Newswire, including Eli Lilly's GLP-1 medication study results and business updates from Crunch Fitness and Regulus Therapeutics. NEW YORK, May 9, 2025 /PRNewswire/ -- With thousands of press releases published each month, it can be difficult to keep up with everything on PR Newswire. To help healthcare journalists and consumers stay on top of the month's most popular releases and newsworthy trends, here's a recap of some of the past month's most read- and engaged-with stories. The list below includes the headline (with a link to the full text) and an excerpt from each story. Click on the press release headlines to access accompanying multimedia assets that are available for download. Continue Reading PR Newswire Monthly Health Press Release Roundup, April 2025. Photos provided by Ro, Garmin International, Inc. and Visit Myrtle Beach. Lilly's oral GLP-1, orforglipron, demonstrated statistically significant efficacy results and a safety profile consistent with injectable GLP-1 medicines in successful Phase 3 trial "As a convenient once-daily pill, orforglipron may provide a new option and, if approved, could be readily manufactured and launched at scale for use by people around the world," said David A. Ricks, Lilly chair and CEO. The Elizabeth Taylor AIDS Foundation Issues Emergency Grant Cycle to Address Forthcoming Gap Funding Providing financial resources to organizations in need, the initiative will be aimed at ensuring that critical, wrap-around health services for HIV treatment & prevention and programs focused on Transgender communities can continue to operate into the near future. Crunch Fitness Announces Strategic Investment from Leonard Green & Partners Under the terms of the agreement, LGP will acquire a majority interest in Crunch Fitness from TPG Growth, the middle market and growth equity platform of global alternative asset management firm TPG, and Crunch's minority shareholders. Novo Nordisk warns consumers about counterfeit Ozempic® (semaglutide) injection 1 mg in the US Novo Nordisk has become aware of several hundred units of Ozempic® (semaglutide) injection 1 mg distributed outside the Novo Nordisk authorized supply chain in the US. The US Food and Drug Administration (FDA) has also updated its website with information about these counterfeit versions of Ozempic. IMDELLTRA® Demonstrated Superior Overall Survival in Small Cell Lung Cancer IMDELLTRA demonstrated statistically significant and clinically meaningful improvement in overall survival (OS) compared to local standard-of-care (SOC) chemotherapy. Jay Bradner, M.D., executive vice president, Research and Development, at Amgen, commented on the "overwhelming clinical benefit" stating the results "affirm IMDELLTRA as standard of care." Infant Immunization Week: Protecting Our Youngest Against Measles and More As National Infant Immunization Week arrives, Fidelis Care, along with other health experts and The Centers for Disease Control and Prevention (CDC), urge parents to ensure their children receive timely vaccinations, including the measles-mumps-rubella (MMR) vaccine, to safeguard their health and prevent the spread of infectious diseases. Johnson & Johnson MedTech Announces Completion of First Cases with OTTAVA™ Robotic Surgical System OTTAVA is designed as a multi-specialty soft-tissue surgery robot, supporting a broad range of procedures across patient anatomy and surgical specialties, including the most complex surgeries that require a multi-quadrant approach. H.I.G. Capital Completes Acquisition of GetixHealth GetixHealth provides leading revenue cycle management (RCM) solutions to healthcare providers, featuring a comprehensive suite of services that includes patient responsibility management, eligibility and enrollment, third-party claims resolution, patient access, and insurance billing. SHIELD-Utah Study Shows Novavax's COVID-19 Vaccine Induces Lower Reactogenicity Symptoms Compared to mRNA Preliminary data showed Novavax's non-mRNA JN.1 COVID-19 vaccine induced lower frequency and severity of short-term side effects and impact on daily life compared with Pfizer-BioNTech mRNA vaccine. Breakthrough Prize Announces 2025 Laureates in Life Sciences, Fundamental Physics, and Mathematics "This year's Breakthrough Prize laureates have made amazing strides – including treatments for major diseases affecting millions of people worldwide – showing once again the transformative power of curiosity-driven basic science," said Priscilla Chan and Mark Zuckerberg. Ginkgo Bioworks Teams Up with Partners on ARPA-H Project to Stabilize Pharmaceutical Supply Chains - Using Amber Waves of Grain Ginkgo Bioworks and partners were awarded a $29 million contract by ARPA-H to develop distributed manufacturing of essential medicines using wheat germ cell-free expression systems. Kaiser Permanente Debuts Largest Hospital-based Renewable Microgrid in U.S. With 2MW of solar generation and 9MWh of battery storage, the system supports California's clean energy transition, reduces emissions, and saves money while boosting backup generation with renewable power. The Revival of the Ice Bucket Challenge Supports and Highlights the Critical Need for Mental Health Awareness and Discussions: The new viral sensation Takes Over Instagram Quickly Raising Thousands to Benefit the Work of Active Minds More than a decade after the original Ice Bucket Challenge captured global attention in support of the fight against ALS, The University of South Carolina's MIND club (Mental Illness Needs Discussion) has launched a bold, reimagined Ice Bucket Challenge focused on mental health. As part of their campaign, participants are encouraged to donate to Active Minds, the nation's leading nonprofit organization mobilizing youth and young adults to transform mental health norms. Meet vívoactive 6, the latest health and fitness smartwatch from Garmin vívoactive 6 includes Garmin's suite of popular fitness, wellness and smart features, plus an even brighter AMOLED display and up to 11 days of battery life. Regulus Therapeutics Enters into Agreement to be Acquired by Novartis AG Novartis will acquire Regulus for $7.00 per share in cash, with the potential to receive an additional $7.00 per share in cash through a contingent value right, for a total equity value of up to approximately $1.7 billion For more news like this, check out all of the latest health-related releases from PR Newswire. Trending Topics Among the health news that was distributed in April, the PR Newswire team was able to spot several larger stories that highlight the trends shaping the industry. GLP-1 Accessibility: GLP-1 medications maintained their position as healthcare's dominant topic, with April announcements focusing on expanding legitimate access while combating counterfeit products. Novo Nordisk secured two significant victories: successfully blocking unauthorized compounded versions of Wegovy® and Ozempic® while simultaneously expanding patient access through strategic telehealth partnerships. Manufacturing capacity grew with SHL Medical's new $220 million U.S. facility for autoinjectors, while innovation accelerated with Galmed's sublingual semaglutide formulation and Lilly's successful Phase 3 trial results for its oral GLP-1 medication. Consumer-focused initiatives included Ro's partnership with Charles Barkley as a GLP-1 celebrity ambassador and sPiLLRx's launch of an anonymous community platform for medication users, highlighting how companies are anticipating diverse consumer needs while working to maintain medication accessibility. National Autism Awareness Month: April brought significant attention to autism awareness and acceptance, with a notable focus on research findings and innovative support services. New CDC data, shared by The Autism Community in Action, revealed an increase in autism rates, now affecting 1 in 31 U.S. children. Organizations responded with expanded services, such as Goldfish Swim School's new adaptive lesson program and Myrtle Beach's enhanced sensory-friendly initiatives. Healthcare innovations were also prominent, with Acclaim Autism implementing Appian AI technology to reduce patient intake time by 83%, allowing children to receive care months sooner while maintaining HIPAA compliance. National Infant Immunization Week: As measles outbreaks continued to concern health officials, National Infant Immunization Week (April 21-28) generated substantial attention for the importance of childhood vaccinations. HealthTrackRx emerged as a key player, identifying over 10% of nationwide measles cases in their first week of testing. The company also partnered with the CDC to launch a rapid PCR test for H5N1, demonstrating the growing integration between private diagnostic companies and public health infrastructure to address multiple concurrent health threats. Health insurers joined the conversation with Fidelis Care urging parents to maintain vaccination schedules, emphasizing prevention as a cornerstone of pediatric health. Advocacy also expanded globally through Education Cannot Wait's campaign highlighting vaccination as an essential component of international education standards for children in crisis regions. Looking ahead: PR Newswire anticipates significant wire activity in May around Mental Health Awareness Month, National Nurses Week (May 6-12) and Skin Cancer Awareness Month. Early May announcements are expected to recognize National Women's Health Month, likely with maternal health innovations around Mother's Day. Aging and caregiving themes will also likely dominate coverage as organizations prepare for Older Americans Month with activities and resources. Do you have a health press release to distribute? Sign up with PR Newswire to share your story with the audiences who matter most. 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临床结果临床3期疫苗并购

100 项与 SARS-CoV-2 Spike Protein Vaccine(Recombinant)(Novavax, Inc.) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB15810

研发状态

批准上市

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适应症	国家/地区	公司	日期
新型冠状病毒感染	欧盟	Novavax CZ as	2021-12-20
新型冠状病毒感染	冰岛	Novavax CZ as	2021-12-20
新型冠状病毒感染	列支敦士登	Novavax CZ as	2021-12-20
新型冠状病毒感染	挪威	Novavax CZ as	2021-12-20

未上市

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适应症	最高研发状态	国家/地区	公司	日期
SARS-CoV-2 败血症	临床3期	美国	Novavax, Inc.	2023-10-16
严重急性呼吸综合征	临床3期	英国	Novavax, Inc.	2020-09-28
流感病毒感染	临床2期	澳大利亚	Novavax, Inc.	2022-12-30
流感病毒感染	临床2期	新西兰	Novavax, Inc.	2022-12-30

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05299359 (CTgov)	临床3期	新型冠状病毒感染	150	TAK-019 (Main Part: Day 15 of This Study: TAK-019)	獵淵夢餘觸憲構積繭蓋(蓋醖艱淵顧遞積構構簾) = 齋鹹構築淵範製鏇遞襯齋築顧夢壓鬱鏇膚壓膚 (製廠膚簾鏇衊鏇鹹觸製, 顧憲範網齋鏇餘壓鑰範 ~ 遞鬱鹹鑰壓積齋簾鹽鹹)	-	2023-07-28
				TAK-019 (Day 15 of This Study)	-
NCT04712110 (CTgov)	临床1/2期	新型冠状病毒感染	200	Placebo (Placebo)	範膚衊鏇鹹構蓋鏇範憲 = 鏇膚簾窪糧醖膚築蓋壓衊範築鹽醖鹹衊遞鑰廠 (壓簾襯齋鏇選願淵遞醖, 繭壓壓鏇獵淵繭壓鹹顧 ~ 願鹹壓憲窪獵餘糧襯積) 更多	-	2023-06-06
				TAK-019 (TAK-019)	鑰醖鑰積壓壓艱獵憲積(築蓋獵餘獵糧艱糧醖憲) = 醖齋鬱獵獵鏇願蓋窪願衊觸廠顧窪窪艱製壓鏇 (鹽範膚獵膚艱膚淵簾鬱, 艱獵顧鹹觸蓋製製蓋顧 ~ 願廠艱鹽衊獵遞選窪獵) 更多
NCT04611802 (PREVENT-19, Pubmed \| Vaccine)	临床3期	新型冠状病毒感染 \| 严重急性呼吸综合征	-	NVX-CoV2373 vaccine	淵艱製夢鑰淵淵遞蓋鹹(餘製遞顧蓋餘築願襯願) = 醖選獵壓獵遞獵鹽蓋網淵糧簾觸顧糧網觸壓夢 (願觸網廠齋選網窪鹽蓋 )	积极	2023-05-22
				Placebo	鹽憲艱鏇餘衊糧構遞襯(觸廠觸糧鏇願範膚艱鹹) = 顧襯壓鹽窪齋鹹齋鏇積襯膚鏇醖鏇網憲鑰夢選 (築築遞糧築積獵淵齋壓, 83.1 ~ 100)
NCT04611802 (PREVENT-19, Pubmed)	临床3期	新型冠状病毒感染	2,232	NVX-CoV2373	簾顧夢遞憲鹽積餘襯醖(構鬱範齋鑰廠醖膚簾築) = 願艱衊襯窪範鬱餘選鏇選積製憲糧糧鏇構積壓 (壓餘衊鹹選窪築衊遞積, 1.31 ~ 6.46) 更多	积极	2023-04-03
				Placebo	簾顧夢遞憲鹽積餘襯醖(構鬱範齋鑰廠醖膚簾築) = 網糧鑰壓構顧壓壓鏇憲選積製憲糧糧鏇構積壓 (壓餘衊鹹選窪築衊遞積, 8.42 ~ 23.93)
Biospace 人工标引	临床1/2期	新型冠状病毒感染 \| 流感病毒感染	642	NVX-CoV2373	繭壓衊襯膚餘鹹淵鹽鬱(艱廠繭範鹹鹽蓋蓋鹹齋) = Serious adverse events were rare, and none were assessed as being related to the vaccine. 衊襯獵夢範製鑰遞簾膚 (網築鬱選壓遞鬱顧餘憲 )	积极	2022-10-13
NCT04611802 (PREVENT-19, Pubmed) 人工标引	临床3期	新型冠状病毒感染	2,247	NVX-CoV2373	願膚齋積憲憲觸餘夢顧(襯繭選網夢繭餘憲選鏇) = largely mild-to-moderate, transient, and more frequent in NVX-CoV2373 recipients and after the second dose. 壓觸衊鹽願構艱夢鏇網 (齋襯憲範蓋鏇憲糧糧淵 ) 更多	积极	2022-09-21
				Placebo
NCT04583995 (Pubmed) 人工标引	临床3期	新型冠状病毒感染	15,187	NVX-CoV2373	簾簾膚選蓋艱鏇齋襯憲(膚積窪憲顧廠網艱窪網) = 築淵鹹夢簾積餘積選憲窪齋構構憲鬱壓廠夢範 (製蓋淵鹹製製衊鏇製醖 ) 更多	积极	2021-09-23
				Placebo	簾簾膚選蓋艱鏇齋襯憲(膚積窪憲顧廠網艱窪網) = 膚築獵窪憲網艱壓繭襯窪齋構構憲鬱壓廠夢範 (製蓋淵鹹製製衊鏇製醖 ) 更多
NCT04611802 (PREVENT-19, Corporate Publications) 人工标引	临床3期	新型冠状病毒感染	-	NVX-CoV2373	遞艱構遞膚鏇網獵蓋糧(獵網蓋齋齋壓築膚淵獵) = 鏇獵蓋鹽網蓋衊願窪艱築選餘簾鹽夢積齋淵選 (遞觸糧淵構鏇齋構簾齋, 82.9 ~ 94.6) 更多	积极	2021-06-14
				Placebo	-
NCT04533399 (Pubmed \| Br Dent J \| N Engl J Med) 人工标引	临床2期	新型冠状病毒感染	4,387	NVX-CoV2373	淵壓淵餘壓築艱鏇觸醖(構衊窪齋糧鹽鏇夢齋窪) = 選簾衊繭顧繭鹽鏇夢窪壓蓋蓋獵鹹窪願選選簾 (築廠鏇鏇衊鹽選蓋廠廠 ) 更多	积极	2021-05-20
				Placebo	淵壓淵餘壓築艱鏇觸醖(構衊窪齋糧鹽鏇夢齋窪) = 鑰膚窪築網襯鹽選選積壓蓋蓋獵鹹窪願選選簾 (築廠鏇鏇衊鹽選蓋廠廠 )