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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.
MenFive®, the first conjugate vaccine to protect against the five predominant causes of meningococcal meningitis in Africa, has been prequalified by the World Health Organization (WHO).
Developed through a 13-year collaboration between Serum Institute of India Pvt. Ltd. (SIIPL) and PATH, MenFive® protects against meningococcal serogroups A, C, W, Y, and X and is designed to eliminate annual meningitis outbreaks and epidemics in the African meningitis belt.
It is also the only vaccine preventing meningitis caused by meningococcal group X, a pathogen increasingly implicated in African meningitis outbreaks.
Adar Poonawalla, CEO of Serum Institute of India, said in a media release on July 12, 2023, "As the first conjugate vaccine to safeguard against the five predominant causes of this deadly disease, MenFive® offers hope for a future free from annual outbreaks and epidemics in the African meningitis belt."
WHO prequalification ensures a vaccine meets strict international quality, safety, and efficacy standards, was supported by extensive clinical studies in The Gambia, India, and Mali that demonstrated a high level of safety and immunogenicity.
Importantly, prequalification allows MenFive® to be procured by United Nations agencies and Gavi, The Vaccine Alliance.
Meningitis is the inflammation of the tissues surrounding the brain and spinal cord. It is usually caused by infection.
Meningococcal meningitis is a bacterial infection that sets in rapidly and can kill within hours. It can cause severe brain damage and sepsis, leading to limb amputation, and is fatal if untreated in 50% of cases, says the WHO.
Anyone can contract meningococcal meningitis, but children under age five—especially infants—are likely to suffer the most severe effects.
In the United States, two types of meningococcal vaccines are licensed by the Food and Drug Administration: Meningococcal conjugate (MenACWY) vaccines and Serogroup B meningococcal (MenB) vaccines.
In the United States, community outbreaks of the respiratory syncytial virus (RSV) typically occur during late fall, winter, and early spring.
However, recent data indicates the state of Florida has been the location where RSV cases are initially reported each year.
As of July 22, 2023, the Florida Department of Health segmented reported RSV activity had been identified in a few counties, and the southeast area was in-season, but no community outbreaks.
The U.S. Centers for Disease Control and Prevention say RSV can be contagious for 3 to 8 days in an infected person and is spread by coughs or sneezes. And healthcare providers should consider RSV in patients with respiratory illness.
Infants and children with RSV infection may have rhinorrhea and decreased appetite before other symptoms appear. Additionally, some infants and people with weakened immune systems can spread RSV after not showing signs for up to one month.
As of July 18, 2023, laboratories reported to the CDC the total number of RSV tests performed and those tests that were positive.
From a prevention perspective, the U.S. FDA has recently approved RSV vaccines and a second antibody therapy for children.
Moderna, Inc., a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, and Merck today announced the initiation of the pivotal Phase 3 randomized V940-001 clinical trial evaluating V940 (mRNA-4157), an investigational individualized neoantigen therapy (INT), in combination with KEYTRUDA, Merck's anti-PD-1 therapy, as an adjuvant treatment in patients with resected high-risk (Stage IIB-IV) melanoma.
INTs are designed to train and activate the immune system so that a patient can generate an antitumor response specific to their tumor mutation signature.
V940-001 is the first Phase 3 study of a planned comprehensive clinical development program initiated following the positive primary analysis of the Phase 2b KEYNOTE-942/mRNA-4157-P201 trial.
Global recruitment in V940-001 has begun, and the first patients are now enrolling in Australia.
"The initiation of the V940-001 Phase 3 trial is an exciting and important milestone for us as we work with our colleagues at Merck and the melanoma patient community to investigate how individualized neoantigen therapy may potentially transform the treatment of the most serious form of skin cancer," said Kyle Holen, M.D., Moderna's Senior Vice President and Head of Development, Therapeutics and Oncology, in a press release on July 26, 2023.
Melanoma, the most serious form of skin cancer, is characterized by the uncontrolled growth of pigment-producing cells.
Nearly 325,000 new cases were diagnosed worldwide in 2020.
In the U.S., skin cancer is one of the most common types of cancer diagnosed, and melanoma accounts for a large majority of skin cancer deaths. It is estimated there will be nearly 100,000 new cases of melanoma diagnosed and almost 8,000 deaths resulting from the disease in the U.S. in 2023.
Press Trust of India (PTI) today reported the Bacillus Calmette Guerin (BCG) vaccine manufactured by the Serum Institute of India will soon be exported to Canada for immunotherapy to treat bladder cancer.
BCG is a live freeze-dried preparation derived from an attenuated strain of Mycobacterium bovis.
As part of the therapy, the vaccine is administered into the bladder through a catheter, where it stays in the lining of the bladder for a specific duration affecting the cells and fighting cancer without impacting other body parts.
The product is for intravesical instillation and is available in 40 mg and 80 mg presentations, reported PTI PLB on July 25, 2023.
When cancer starts in the bladder, it is called bladder cancer, says the U.S. Centers for Disease Control and Prevention (CDC). Smoking is the most important risk factor for bladder cancer.
Since the 1970s, the BCG vaccines have been administered as an immunotherapeutic treatment for bladder cancer patients. And BCG has been the standard therapy for treating high-risk nonmuscle-invasive bladder cancer patients to avoid the recurrence and progression of the disease.
Using a catheter, BCG is given in a solution placed directly into the bladder. Intravesical treatments flush the bladder with drugs that kill cancer cells that remain after surgery.
According to the National Cancer Institute, this lowers the chance of cancer returning.
The 100 years old BCG vaccine is primarily used to prevent tuberculosis disease worldwide.
The journal NPJ Vaccines recently reported that researchers have developed and characterized a novel dual-target single-shot vaccine candidate that protects against Ebola (EBOV) and Yellow Fever (YFV) infection.
Announced on July 11, 2023, the YF-EBO pre-clinical vaccine candidate could help communities combat simultaneous EBOV and YFV epidemics, such as in Africa.
While there are approved vaccines for Ebola (Ervebo®) and Yellow fever (Stamaril®) in 2023, a single combo vaccine could enhance vaccination campaigns.
EBOV is a member of the Filoviridae family that causes severe and acute systemic disease in humans, known as Ebola virus disease, with mortality rates up to 80%.
YFV is a mosquito-borne flavivirus causing severe hemorrhagic disease in humans.
Yellow fever is endemic in Central and South America, as well as sub-Saharan Africa, where EVD surges.
Despite the availability of a very efficient live-attenuated yellow fever vaccine (Stamaril), annually, an estimated 51,000–380,000 severe cases of YF still occur, resulting in 19,000–180,000 deaths.
The re-emergence of YF outbreaks can be mainly attributed to low vaccine coverage due to supply issues.
Therefore, alike for EVD, a second-generation YFV vaccine with a sustainable supply could deliver measurable benefits during dual outbreaks.
Future studies must address whether this observed cross-reactive humoral immunity is sufficient to also provide cross-protection against heterologous challenge, ideally in step-up models using original filoviruses under BSL4 conditions, wrote these researchers.
The World Health Organization (WHO) today announced a case of Middle East Respiratory Syndrome Coronavirus (MERS-CoV) cases was confirmed in Abu Dhabi, the United Arab Emirates (UAE).
According to the WHO's Disease Outbreak News on July 24, 2023, this MERS-CoV case had no history of direct or indirect contact with camels, goats, or sheep.
Prior to this WHO notification, the last MERS-CoV infection reported from the UAE was in November 2021.
Since July 2012, the UAE has confirmed 94 MERS-CoV cases and 12 related fatalities.
The WHO expects that additional cases of MERS-CoV infection will be reported from the Middle East.
MERS-CoV cases have reached 2,605 globally, including 936 associated deaths as of July 2023.
These are MERS vaccine candidates in development, but the WHO has not approved any.
Bavarian Nordic A/S recently announced that its Phase 3 clinical trial of MVA-BN® RSV, a respiratory syncytial virus (RSV) vaccine candidate for adults ≥60 years of age, did not meet all the primary endpoints of preventing lower respiratory tract disease (LRTD) from RSV.
Based on this outcome, Bavarian Nordic will discontinue its RSV program, including its partnership with Nuance Pharma to develop and launch the vaccine for selected Asian markets.
“We are disappointed that our RSV vaccine candidate was not successful in this pivotal trial,” said Paul Chaplin, President and Chief Executive Officer of Bavarian Nordic, in a press release on July 22, 2023.
The final study results showed that the vaccine candidate had a 59% efficacy in preventing at least two pre-defined LRTD symptoms meeting one of the efficacy criteria of the study.
However, when measuring more severe LRTD based on at least three pre-defined symptoms, the vaccine candidate only demonstrated a 42.9% efficacy and missed the co-primary endpoint of the study.
As of July 24, 2023, there are two approved RSV vaccines in the U.S. and several late-stage vaccine candidates conducting research.
With 117 confirmed cases of circulating variant polioviruses and 107 detections in sampled wastewater in the WHO African Region as of July 2023, the Africa Regional Certification Commission (ARCC) recently urged partners to address gaps in polio immunity urgently.
The ARCC, which held its 31st meeting in early July 2023, called for accelerated implementation of supplementary immunization activities.
"We are looking forward to implementing the additional ARCC recommendations to guide how we can deliver on the promise of the polio-free Democratic Republic of the Congo and Africa," said Dr. Serge Emmanuel Holenn, Deputy Minister of Health of the Democratic Republic of the Congo.
In this response, @WHOAFRO Tweeted on July 24, 2023, that the Republic of Madagascar recently launched a polio vaccination campaign to reach over 18 million people.
Madagascar has reported 13 cVDPV1 cases in 2023. Last year, there were 16 cVDPV1 cases.
And 8 circulating vaccine-derived poliovirus type 1 (cVDPV1) positive environmental samples were reported in Analamanga in July 2023.
Countries with cVDPV1 have the risk of international spread. Therefore, they are subject to WHO temporary recommendations.
The World Health Organization (WHO) says polio is a vaccine-preventable disease.
As of July 2023, 670 million doses of the nOPV2 vaccine had been administered, primarily in Africa. On March 28, 2023, the WHO's SAGE recommended that it be the preferred polio vaccine for response to cVDPV2 outbreaks wherever possible.
The nOPV2 vaccine is not authorized by the Food and Drug Administration. Therefore, it is not available in the U.S.
The ARCC is an independent body established in 1998 to oversee the certification status of the African region as free from indigenous wild poliovirus.
Updated: On July 25, 2023, the WHO confirmed the priority regions (Analamanga, Vakinankaratra, Alaotra Mangoro, and Atsimo Andrefana) and those under 15 in the 19 other regions.
