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The Access to Advanced Health Institute (AAHI) today announced that it has received an $18 million award from the National Institutes of Health (NIH) to develop a temperature stable, single-dose, RNA chikungunya vaccine candidate.
The NIH award disclosed on August 3, 2023, supports the development, preclinical testing, and human clinical evaluation of a vaccine that meets an increasingly urgent need for a reliable, abundant supply.
Chikungunya is a viral disease transmitted to humans through the bites of mosquitoes infected with the chikungunya virus (CHIKV), says the U.S. CDC.
Chikungunya outbreaks are significant causes of morbidity and mortality in Asia, Africa, and Latin America, for which no vaccine is currently approved.
From 2006–2021, 4,590 chikungunya cases in travelers were reported in the U.S.
Several vaccine candidates are conducting late-stage clinical trials, such as Valneva SE's VLA1553, a monovalent, single-dose, live-attenuated vaccine candidate.
AAHI's approach to an RNA vaccine against chikungunya differs from the RNA vaccines the U.S. FDA currently approves to prevent other diseases.
“This project will demonstrate the use of RNA vaccine technology to avoid some of the classic manufacturing challenges in the large-scale manufacture of live-attenuated vaccines,” said Emily Voigt, Ph.D., Principal Scientist, AAHI RNA Platform Lead, and Co-Principal Investigator for the award, in a press release.
Unlike other RNA vaccines, this candidate will generate a live "attenuated" virus that could induce strong and long-lasting immune protection against this mosquito-borne disease.
The new 5-year project builds upon work supported by the NIH (R43AI127053) for AAHI's proof-of-concept ground-laying work, which demonstrated that a liquid presentation of this live-attenuated chikungunya RNA vaccine candidate elicited strong immune responses in animals after a single dose, protecting them from mortality and joint swelling after being challenged with the virus (Voigt et al. 2021).
AAHI is a nonprofit biotech research institute located in Seattle, Washington, that combines the high-quality science of an academic research organization with the product development capabilities of a biotech company to help combat some of the world's deadliest diseases, including infectious diseases
The U.S. CDC's Advisory Committee on Immunization Practices (ACIP) is meeting today to review Respiratory Syncytial Virus (RSV) Maternal/Pediatric vaccine and a long-acting monoclonal antibody.
On August 3, 2023, Dr. Grace Lee is leading the ACIP meeting agenda, which includes, but is not limited to, the following presentations:
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Introduction - Dr. S Long
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EtR summary for nirsevimab - Dr. J Jones
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Nirsevimab implementation considerations - Dr. G Peacock
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Clinical considerations for nirsevimab & Workgroup considerations / proposed recommendations - Dr. J Jones
At around 2 pm ET today, the ACIP is scheduled to vote on two recommendations.
Previously, the U.S. Food and Drug Administration approved Beyfortus (nirsevimab-alip) for the prevention of RSV lower respiratory tract disease in neonates and infants born during or entering their first RSV season and in children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.
In the U.S., the RSV season generally starts in Florida in the fall. As of August 3, 2023, there have not been any RSV outbreaks reported this year.
The ACIP unanimously recommends routine use of Beyfortus™ to protect all infants below 8 months of age. The committee also voted unanimously to include Beyfortus in the Vaccines for Children program, supporting equitable access for all eligible infants.
Bavarian Nordic A/S today announced that the U.S. Biomedical Advanced Research and Development Authority (BARDA) placed a new order valued at USD 120 million, primarily covering the manufacturing of new bulk product for the Company's JYNNEOS® smallpox/mpox vaccine.
The bulk product, representing USD 96 million of the contract value, will be manufactured and invoiced in 2023 and will only partly restore the inventory used to manufacture vaccines in response to the global mpox outbreak that began in May 2022.
Nearly 5.5 million JYNNEOS doses have been manufactured for the U.S. government throughout 2022 and 2023, and replenishment of the bulk inventory is necessary to fulfill the Company's long-term commitment to deliver a freeze-dried version of the vaccine for U.S. smallpox preparedness.
In addition, Bavarian Nordic will manufacture and supply additional liquid-frozen vaccine doses in 2023, valued at USD 3 million.
The agreement includes additional services totaling USD 21 million, of which the majority will be received in 2024 and 2025.
Paul Chaplin, President & CEO of Bavarian Nordic, said in a press release on August 3, 2023, "The U.S. government's foresight enabled us last year to rapidly respond to the global mpox outbreak by converting the readily available bulk product into final vaccine dose."
"Together with our U.S. manufacturing partner, we have completed manufacturing all doses ordered by the U.S. government during the mpox outbreak."
"However, maintaining the readiness to respond to future health crises is essential, and this new contract will enable us to deliver on the contract for a freeze-dried version of the vaccine, awarded to us by the U.S. government back in 2017, which aims to strengthen the nation's preparedness against smallpox."
Since 2003, Bavarian Nordic has worked with the U.S. government on the development, manufacturing, and supply of a non-replicating smallpox vaccine. The JYNNEOS (MVA-BN, IMVANEX®) vaccine has been deployed globally since 2022.
In 2023, mpox outbreaks have been reported Africa, the Americas, Chicago, China, Denver, France, Japan, London, New York, Portugal, South Korea, and Spain. Furthermore, mpox breakthrough cases in vaccinated people have been confirmed in 2023.
Merck today announced that the U.S. Food and Drug Administration (FDA) approved an expanded indication for the ERVEBO® vaccine, which is now indicated for preventing disease caused by Zaire ebolavirus in individuals 12 months of age and older.
ERVEBO was previously approved for use in individuals 18 and older.
This Ebolavirus vaccine does not protect against other species of Ebolavirus (Sudan) or Marburgvirus.
As of March 2023, over 500,000 doses of ERVEBO had been delivered to a stockpile administered by the International Coordinating Group on Vaccine Provision.
"Ebola virus disease is contagious and potentially deadly in children and adults. We're proud of the approval of ERVEBO for the prevention of disease caused by Zaire ebolavirus in children as young as 12 months old, which is another milestone in our continued commitment to help address the global health threat caused by Zaire ebolavirus," said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories, in a press release on August 3, 2023.
The vaccine's effectiveness when administered concurrently with antiviral medication, immune globulin, and/or blood or plasma transfusions is unknown, and the duration of protection conferred by ERVEBO is unknown.
ERVEBO includes a contraindication for individuals with a history of a severe allergic reaction (e.g., anaphylaxis) to any vaccine component, including rice protein.
The initial Ebola virus disease case first appeared in 1976 in Africa. Since then, numerous outbreaks of Zaire and Sudan have been confirmed.
As of August 3, 2023, the FDA and European Medicines Agency have approved other ebola prevention and treatment products.
The Janssen Pharmaceutical Companies of Johnson & Johnson recently announced the submission of a supplemental New Drug Application to the U.S. Food and Drug Administration (FDA) seeking to expand the indication of EDURANT® to include the treatment of human immunodeficiency virus type 1 (HIV-1) infection in children weighing 10 kg or more.
As of July 28, 2023, a parallel Marketing Authorization application was submitted to the European Medicines Agency to support a type II variation and line extension for expanded pediatric use in Europe.
If the new applications are approved, EDURANT could be administered to younger pediatric patients via standard 25 mg tablets or new 2.5 mg tablets for oral dispersion that were developed to aid administration and weight-adjusted dosing for children.
“We’ve been working to fight HIV for decades and are proud to have helped bring forward nine medicines for people living with HIV,” said Penny Heaton, M.D., Global Therapeutic Area Head, Infectious Diseases and Vaccines, Janssen Research & Development, LLC, in a related press release.
“These filings are the latest example of our longstanding work to make different treatment options available to meet the diverse needs of people living with HIV.”
EDURANT is not a preventive vaccine but is an HIV-1 specific, nonnucleoside reverse transcriptase inhibitor indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-naïve patients 12 years of age and older and weighing at least 35 kg with HIV-1 RNA less than or equal to 100,000 copies/mL.
As of August 2, 2023, the FDA has not approved an HIV vaccine.
The U.S. CDC Advisory Committee on Immunization Practices (ACIP) is meeting on August 3, 2023, regarding the proposed recommendation for Beyfortus™ (Nirsevimab-alip), the first approved extended half-life monoclonal antibody (mAB) offering passive immunization to prevent lower respiratory tract infections (LRTI) caused by the respiratory syncytial virus (RSV).
This ACIP meeting draft agenda, from 11:00 am – 3:30 pm EDT, includes presentations on Feasibility/implementation plans for monitoring the safety and effectiveness of this RSV prevention drug and second-season clinical considerations.
The webcast link for this open-to-the-public digital meeting is here.
John Farley, M.D., M.P.H., director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research, commented on July 17, 2023, “Today’s approval (Beyfortus) addresses the great need for products to help reduce the impact of RSV disease on children, families, and the health care system.”
The FDA previously approved the Synagis® (Palivizumab) RSV mAb in 1998.
RSV is a virus that causes acute respiratory infection in individuals of all age groups. While most infants and young children experience mild, cold-like symptoms, some infants, especially with their first infection. RSV is transmitted from person to person through close contact with someone who is infected.
In most parts of the U.S., RSV circulation is seasonal, typically starting in Florida during the fall and peaking in the winter.
Merck today announced positive topline results from two Phase 3 trials evaluating V116, the company's investigational 21-valent pneumococcal conjugate vaccine in vaccine-naïve and previously vaccinated individuals.
In both studies, V116 had a safety profile comparable to the comparator in the studies.
Results from the STRIDE-3 clinical trial demonstrated statistically significant immune responses compared to PCV20 (pneumococcal 20-valent conjugate vaccine) in vaccine-naïve adults for serotypes common to both vaccines as assessed by serotype-specific opsonophagocytic activity (OPA) 30 days post-vaccination.
Positive immune responses were also observed for serotypes unique to V116.
Additionally, results from STRIDE-6 demonstrated that V116 was immunogenic for all 21 pneumococcal serotypes in the vaccine among adults who previously received a pneumococcal vaccine at least one year before the study.
If approved, V116 would be the first pneumococcal conjugate vaccine designed for adults, says Merck.
Dr. Eliav Barr, senior vice president, head of global clinical development, and chief medical officer of Merck Research Laboratories, said in a press release on July 27, 2023, "These results support the potential for V116 to become an important new preventative option for adults, regardless of prior pneumococcal vaccination status, by expanding coverage to include eight serotypes not currently included in any licensed vaccine."
According to pre-pandemic 2019 U.S. CDC data, the 21 serotypes covered by V116 are responsible for 85% of invasive pneumococcal disease in individuals 65 and older.
V116 includes eight serotypes not currently covered by approved pneumococcal vaccines.
Serotypes unique to V116 include 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B, which were responsible for approximately 30% of invasive pneumococcal disease in individuals 65 and older, based on pre-pandemic 2019 U.S. CDC data.
GSK plc today announced Shingrix®, a vaccine against herpes zoster (shingles), had achieved a U.S. cumulative immunization rate that grew from 30% at the end of 2022 and has now reached 32% at the end of Q1'23.
And sales increased in the second quarter of 2023, reaching 880 million pounds (about $1.1 billion).
However, U.S. sales declined 10% in the quarter, impacted by unfavorable wholesaler and distributor inventory movements plus lower non-retail demand partly offset by strong retail growth and pricing.
On October 20, 2017, the U.S. FDA authorized Shingrix.
Furthermore, Shingrix is now available in 33 countries, with recent additions in India and Japan.
Emma Walmsley, Chief Executive Officer, GSK said in a press release on July 26, 2023, "We have made a strong start to 2023, with excellent performance across Vaccines, Specialty and General Medicines."
"We are very focused on our upcoming launches, including our potential RSV older adult vaccine, and on continuing to strengthen our pipeline – both organically with several positive late-stage read-outs already this year, and through targeted business development."
In the U.S., the CDC says an estimated 1 million people get shingles yearly. If you've ever had chickenpox, you can get shingles. Even children can get shingles. Your risk of shingles increases as you get older.
GSK says people should not receive Shingrix if they are allergic to its ingredients or have had an allergic reaction to a previous dose of Shingrix.
