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Project NextGen

U.S. Project NextGen For Vaccines and Therapeutics 2024

Project NextGen is a $5 billion multi-government agency initiative to develop the next generation of vaccines and therapeutics. The U.S. government (Biomedical Advanced Research and Development Authority (BARDA) announced it would collaborate with the U.S. National Institutes of Health's NIAID across the federal government and the private sector to advance the pipeline of new, innovative vaccines and therapeutics from labs to clinical trials to potential FDA authorization, approval, and commercial availability for people nationwide.

In 2023, vaccines targeting more robust, broader, or longer-lasting immune responses were identified. Intranasal vaccines have the potential to stop viruses at the site of infection, and self-amplifying mRNA and additional antigens may generate a more robust immune response than current vaccine technologies.

The BARDA awards support vaccine candidates for clinical evaluation:

$8.5 million to CastleVax for a vector-based intranasal vaccine candidate.

$10 million to Codagenix for a live-attenuated intranasal vaccine candidate (phase 3).

$10 million to Gritstone Bio for a self-amplifying mRNA vaccine candidate.

$9.27 million to Vaxart's Phase 2b clinical study evaluating oral pill XBB COVID-19 vaccine candidate.

Project NextGen will provide an initial $10 million and up to $389 million to support Codagenix's Phase 2b clinical study of CoviLiv™.

The $749,000 BARDA contract supports proof-of-concept studies for on-demand manufacturing and release processes that use HDT Bio's LION™ formulation for RNA vaccine production. LION is a proprietary nanoemulsion tailored for RNA-based vaccines and therapeutics production. It is designed to enable facile formulation and faster manufacturing compared to the characteristics of standard lipid nanoparticles used in existing products.

Project NextGen News

October 2, 2024 - Emergex Vaccines Holding Limited announced that the U.S. NIAID has selected the company for inclusion in its Project NextGen. Emergex's CoronaTcP candidate has demonstrated in a completed Phase I clinical trial in Switzerland to have a favorable safety profile and to successfully induce epitope-specific CD8+ memory subsets.

July 23, 2024 - BARDA will provide $25 million in Project NextGen funding to Walgreens to conduct a decentralized clinical trial. The agreement is BARDA's first with a major retail pharmacy to use this clinical trial approach.

July 1, 2024 - The U.S. NIH announced the investigational vaccine, MPV/S-2P, uses murine pneumonia virus (MPV) as a vector to deliver a version of the SARS-CoV-2 spike protein (S-2P) stabilized in its prefusion conformation. MPV has aan affinity for epithelial cells that line the respiratory tract and may be effective in delivering vaccines to the places where natural coronavirus infections begin.

March 14, 2024 - The Imperial College London is leading an international consortium on a $57 million project to develop advanced virus-blocking coronavirus vaccines.

January 19, 2024 - Dr. Michael Finney, Vaxart's Interim CEO, said, "We believe our oral pill vaccine platform may ultimately hold the promise of revolutionizing how we fight pandemics and vaccinate against several infectious diseases."

January 4, 2023 - ATCC announced a five-year, $87 million award from the BARDA to support the development of next-generation medical countermeasures to protect Americans from public health security threats such as coronaviruses.

November 2, 2023 - NIH/NIAID Project NextGen selected Tonix Pharmaceuticals' TNX-1800 for Inclusion in vaccine studies.

October 13, 2023—The U.S. Department of Health and Human Services announced the selection of initial next-generation vaccine candidates and more than $500 million in awards for Project NextGen, which is kick-starting planning for Phase 2b clinical trials and technologies that advance innovative next-generation vaccine and therapeutics platforms.

October 10, 2023 - Ocugen, Inc. announced that the NIAID will conduct a trial comparing the administration of Ocugen's mucosal vaccine candidate, OCU500, via two different mucosal routes: inhalation into the lungs and as a nasal spray. With funding from Project NextGen, NIAID will cover the total cost of the clinical trials, including operations and related analysis.

August 10, 2023 - The Institute for Progress filed the following comment in response to BARDA's Request For Information on ways Project NextGen could ensure future COVID-19 vaccine technologies bolster preparedness against future variants.

September 26, 2023 - The U.K. Health Security Agency agreed to an advance purchase agreement with CSL Seqirus to be on standby to produce over 100 million influenza pandemic vaccines if or when needed in the U.S.

September 22, 2023 - The U.S. CDC announced the recipients of 13 funding awards to establish a first-of-its-kind national network, the Outbreak Analytics and Disease Modeling Network (OADMN). The awards, totaling $262.5 million in funding over five years, will support state and local decision-makers in developing and implementing new tools to detect, respond to, and mitigate public health emergencies more effectively.

September 13, 2023 - ICON plc announced it is partnering with BARDA, contract number 75A50120D00017, to execute a clinical trial to evaluate the effectiveness of next-generation COVID-19 vaccine candidates.

March 15, 2021 - The Military Health System and Defense Health Agency granted the $72 million CDMRP PRMRP Technology/Therapeutic Development Award, a product-driven award mechanism intended to provide support for the translation of promising preclinical findings into products for clinical applications, including prevention, detection, diagnosis, treatment, or quality of life, in at least one of the Congressionally directed FY21 PRMRP Topic Areas.

Disease X information is posted at Precision Vax.

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Robert Carlson, MD

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Wednesday, October 2, 2024 - 09:55

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Project NextGen is a U.S. government initiative to develop the next generation of vaccines and therapeutics.

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The journal Nature Biotechnology volume recently confirmed that Japanese regulators are proceeding to launch a second-generation COVID-19 vaccine that uses self-amplifying messenger RNA (sa-mRNA), the first vaccine of this kind to get full approval.

According to the News in Brief article posted on January 17, 2024, the innovative sa-mRNA ARCT-154 vaccine enables host cells in the body to make copies of the mRNA that encodes viral replicase genes and immunogenic genes.

Co-developed by Arcturus Therapeutics and CSL, ARCT-154 uses a lower concentration than conventional mRNA vaccines to achieve similar or better antigen expression, meaning they could be safer and manufactured on a large scale.

The vaccine's approval by Japan's Ministry of Health was announced in November 2023.

Japan has administered 434,119,370 COVID-19 vaccine doses throughout the pandemic as of January 16, 2024.

Arcturus and CSL have also filed an MAA for European regulatory approval of ARCT-154.

Vaccine Treats:

COVID-19

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Respiratory Syncytial Virus (RSV)

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Tokyo

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Novavax COVID-19 Vaccine

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The U.S. Centers for Disease Control and Prevention (CDC) today published a COCA Now email alert confirming that in most of the continental United States, the ABRYSVO™ respiratory syncytial virus (RSV) vaccine should be given to pregnant women from September through January 31, regardless of year-to-year circulation, when infants would be born during increased RSV activity,

As of late January 2024, numerous indicators show RSV infection decreasing in the U.S.

Jurisdictions that have different RSV seasonality from most of the continental United States, such as Alaska, southern Florida, Guam, Hawaii, Puerto Rico, the U.S.-affiliated Pacific Islands, and the U.S. Virgin Islands, may consider RSV vaccination of pregnant women after January 31.

The CDC and its Advisory Committee on Immunization Practices recommend the RSV vaccination during 32–36 weeks gestation.

The CDC recently reported among women who were pregnant and ≥32 weeks gestation since September 22, 2023, the overall coverage with the RSV vaccine was 14.4% as of January 13, 2024.

Infants born to unvaccinated mothers should receive Beyfortus™ (nirsevimab). This single-dose, long-acting monoclonal antibody provides immediate, passive immunity protection to the infant against RSV-associated lower respiratory tract disease.

As of 2024, Beyfortus availability has increased in the U.S.

COCA Now emails will be sent as soon as possible after the CDC publishes new content, ensuring clinicians are updated.

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ABRYSVO RSVpreF RSV Vaccine

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A recent population-based observational study conducted in Scotland highlights the positive impact of human papillomavirus (HPV) vaccination in young women and the benefits of early vaccination.

Published by the Journal of the National Cancer Institute on January 22, 2024, this study reported no cases of invasive cervical cancer were recorded in women immunized at 12 or 13 years of age, irrespective of the number of doses.

Women vaccinated between 14 to 22 years of age and given three doses of the bivalent HPV vaccine showed a significant reduction in incidence compared with all unvaccinated women (3.2/100 000 [95% confidence interval (CI) = 2.1 to 4.6] vs 8.4 [95% CI = 7.2 to 9.6]).

Data for women born between January 1988 and June 5, 1996, were extracted from the Scottish cervical cancer screening system in July 2020 and linked to cancer registry, immunization, and deprivation data.

According to the U.S. CDC, HPV is the most common sexually transmitted infection in the U.S. People get HPV by having vaginal, anal, or oral sex with someone who has the virus. A study in the U.S. recently discovered that within two years of a new relationship, about 40% of unvaccinated women contract HPV.

As of January 25, 2024, 140 countries have introduced an HPV vaccine into immunization programs.

There are various approved HPV vaccines and numerous vaccine candidates conducting clinical research.

Vaccine Treats:

HPV Cancers

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by Katharina

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Scotland

Vaccine:

Cervavac HPV Vaccine

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According to a Clinician Outreach and Communication Activity COCA Now message published today, the U.S. Centers for Disease Control and Prevention (CDC) was notified of 23 measles cases between December 2023 and January 23, 2024.

On January 24, 2024, this COCA Now email stated these cases include seven direct importations of measles by international travelers and two outbreaks with more than five cases each.

Specifically, most of the recent measles cases were among children and adolescents who had not received a measles-containing vaccine, even if they were age-eligible.

The increased number of measles importations in the U.S. reflects a rise in global measles outbreaks.

Over the past year, the CDC says Yemen (23,066) and India (13,997) have reported the most measles cases.

In the U.S., the Philadelphia Department of Public Health recently reported a measles cluster among unvaccinated residents. Nine measles cases have been confirmed in Philadelphia locations in 2024.

The Georgia Department of Public Health confirmed a measles case in an unvaccinated Atlanta resident.

The Virginia Department of Health was notified of a confirmed case of measles in a person who traveled through Northern Virginia airports.

In greater Kansas City, Missouri, a resident at the Kansas City International Airport and North Kansas City Hospital was infected with the measles virus.

And in Washington, six measles cases were confirmed in January 2024.

In the U.S., various measles vaccines, such as GSK's Priorix, are generally available at local pharmacies.

COCA Now emails will be sent as soon as possible after the CDC publishes new content, ensuring clinicians are updated.

Vaccine Treats:

Measles

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US CDC measles case trends 2023

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Vaccine:

Priorix Vaccine

Pregnant Women Prefer RSV Passive Immunization Protection for Infants

28 percent of new infants got RSV protection from Beyfortus Nirsevimab in 2023

January 25, 2024

Fact checked by Robert Carlson, MD

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Novavax, Inc. today announced that the United Kingdom's (U.K.) Medicines and Healthcare products Regulatory Agency (MHRA) granted marketing authorization for Nuvaxovid XBB.1.5 dispersion for injection, COVID-19 Vaccine (recombinant, adjuvanted) for active immunization to prevent COVID-19 in individuals aged 12 and older.

Recent data indicate Novavax's vaccine can stimulate both arms of the immune system and induce a broad response against circulating variants.

"Today's MHRA authorization is recognition of the role our vaccine can have in protecting the British public against COVID-19 this year," said John C. Jacobs, President and Chief Executive Officer, Novavax, in a press release on January 24, 2024.

"We are in ongoing conversations with additional U.K. partners to identify potential opportunities to offer our protein-based non-mRNA COVID-19 vaccine to all eligible individuals who want one."

"We believe this is critical to supporting long-term, broad uptake of a seasonal COVID-19 vaccine in the U.K."

In clinical trials, the most common adverse reactions associated with Novavax's prototype COVID-19 vaccine (NVX-CoV2373) included headache, nausea or vomiting, muscle pain, joint pain, injection site tenderness, injection site pain, fatigue, and malaise.

If people are concerned about an adverse event, it should be reported on a Yellow Card. Reporting forms and information can be found at https://coronavirus-yellowcard.mhra.gov.uk/.

The U.K. authorization was based on non-clinical data showing that Novavax's updated COVID-19 vaccine induced functional immune responses for XBB.1.5, XBB.1.16, and XBB.2.3 variants.

Additional non-clinical data demonstrated that Novavax's vaccine-induced neutralizing antibody responses to subvariants JN.1, BA.2.86, EG.5.1, FL.1.5.1, and XBB.1.16.6, as well as CD4+ polyfunctional cellular (T-cell) responses against EG.5.1 and XBB.1.16.6.

In 2023, the U.S. Food and Drug Administration amended its authorization for Novavax COVID-19 Vaccine, Adjuvanted for use in individuals 12 and older, to include the 2023-2024 formula.

Novavax COVID-19 vaccine brands include Nuvaxovid, NVX-CoV2601, CovoVax, NVX-CoV2373, and TAK-019, Trademark filing #90813423.

Vaccine Treats:

COVID-19

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by Gerd Altmann

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Gaithersburg

Vaccine:

Novavax COVID-19 Vaccine

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According to the U.S. Centers for Disease Control and Prevention (CDC) COVIDVaxView data, about 11% (CI 10.1 to 11.8) of children under the age of 18 are up to date with their COVID-19 vaccinations.

From a state perspective, as of January 23, 2024, Massachusetts has reached about a third of children with COVID-19 vaccinations.

Furthermore, Louisana was the lowest-ranked state, with only 3.1% (CI 1.2 to 5.0) of children up to date.

The CDC says up to date with the updated 2023-24 COVID-19 vaccine is defined as receipt of at least one vaccination since September 14, 2023, for children ≥5 years; for children <5 years, up-to-date status was defined based on the current recommendations that also take into account number of doses and brand of vaccine.

Up-to-date status was determined by survey questions on the month and year of the most recent COVID vaccine, and for children <5 years, the total number of COVID vaccinations received and brand of the most recent COVID vaccine.

Each week, estimates for prior weeks are recalculated by the CDC using the additional interviews conducted that week.

Vaccine Treats:

COVID-19

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US CDC COVIDVaxView data Jan. 23, 2024

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Vaccine:

Novavax COVID-19 Vaccine

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The Ministry of Health of the Republic of Liberia today announced the arrival of 112,000 doses of the Mosquirix™ (RTS,S) malaria vaccine.

GSK's Mosquirix vaccine has been piloted in Africa since 2019 and has been shown to be safe and effective, reducing severe malaria by 30% and malaria deaths by 13%.

With two malaria vaccines now approved for use in Africa, Liberia's fight against this preventable mosquito-borne disease may save thousands of children's lives. Malaria vaccinations are scheduled to launch in April 2024.

"The arrival of this life-saving vaccine is a game changer in our fight against malaria," said Adolphus Clarke, Director of the Expanded Programme on Immunization at the Ministry of Health of Liberia, in a press release on January 23, 2024.

"We are committed to ensuring that every child in Liberia has access to this vaccine and is protected from this deadly disease."

According to the World Health Organization, eleven countries saw an estimated 249 million malaria cases and 426,000 deaths in 2022.

In the United States, about ten locally acquired malaria cases were reported in 2023.

However, malaria vaccines are not available in the U.S. as of January 2024.

Vaccine Treats:

Malaria

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WHO malaria vaccine shipments 2024

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