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The U.S. Centers for Disease Control and Prevention (CDC) published a Morbidity and Mortality Weekly Report that confirmed Guillain-Barré syndrome (GBS) was identified as a potential safety concern following respiratory syncytial virus (RSV) vaccination.
On May 30, 2024, the CDC wrote that 'Findings are consistent with those from trials; reports of GBS (5.0 and 1.5 reports per million doses of Abrysvo and Arexvy vaccine administered, respectively) were more common than expected background rates.
Two deaths among RSV vaccine recipients who had been diagnosed with GBS were reported.
The CDC, the U.S. FDA, and the Centers for Medicare & Medicaid Services are conducting population-based surveillance assessments of RSV vaccine safety and risks for GBS. Findings from these studies will help guide the development of Advisory Committee on Immunization Practices recommendations.
About 10 million older adults have been vaccinated against RSV since August 2023.
As of June 3, 2024, three approved RSV vaccines for adults and one monoclonal antibody for infants are available in the U.S.
According to the Global Polio Eradication Initiative (GPEI), five counties reported new cases involving vaccine-derived poliovirus types.
The GPEI's latest weekly update confirmed Angola reported its second circulating vaccine-derived poliovirus type 2 (cVDPV2) case of 2024, and Chad, the Democratic Republic of the Congo (DRC), Niger, and Nigeria also reported cVDPV2 cases as of May 29, 2024
Additionally, the DRC reported two more cases of circulating vaccine-derived poliovirus type 1.
The World Health Organization (WHO) confirmed in April 2024 that the spread of the poliovirus remained a Public Health Emergency of International Concern and recommended its extension through July 2024 to reduce the risk of the international spread of poliovirus outbreaks.
In May 2024, the U.S. Centers for Disease Control and Prevention (CDC) issued an updated Global Polio Alert - Level 2, Practice Enhanced Precautions Travel Health Notice regarding polio outbreaks and poliovirus detections in 34 countries.
The African country Angola recently reported two cases of Acute Flaccid Paralysis (AFP). These AFP cases are the first in Angola since the 2019-2020 polio outbreak, which recorded 124 cases.
Furthermore, 36 potential AFP cases are awaiting classification, which may or may not be related to the polio virus.
As of June 2024, both the WHO and CDC recommend polio vaccinations and booster doses for under-immunized people visiting outbreak areas.
In the U.S., IPV vaccines have been offered since 2000, and over 1 billion nOPV2 vaccine doses have been offered in African countries.
Valneva SE today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending authorization of Valneva's IXCHIQ® single-dose vaccine for the prevention of disease caused by the chikungunya virus in adults.
The European Commission will review the CHMP recommendation, and a decision on the marketing authorization application (MAA) of IXCHIQ in the European Union (EU), Norway, Liechtenstein, and Iceland is expected in the third quarter of 2024.
It will become the first chikungunya vaccine available in the EU under the International Reliance Procedure to address this unmet medical need if approved.
The U.S. Food and Drug Administration approved IXCHIQ in 2023. In February 2024, the U.S. Centers for Disease Control and Prevention (CDC) vaccine committee voted to recommend using IXCHIQ.
Valneva is also preparing an MAA for submission to the U.K. Medicines and Healthcare products Regulatory Agency.
Two additional MAAs are under review by Health Canada and the Brazilian Health Regulatory Agency, with potential approvals in 2024.
Dr. Richard Hatchett, Chief Executive Officer of the Coalition for Epidemic Preparedness Innovations, commented in a press release on May 31, 2024, "Over one billion people live in areas where Chikungunya is endemic, and recent large outbreaks underline the urgent need for safe and effective vaccines against this debilitating disease."
Chikungunya is a mosquito-borne viral disease caused by the chikungunya virus, which is transmitted by Aedes mosquitoes. Infection leads to symptomatic disease in up to 97% of humans four to seven days after the mosquito bite.
According to the U.S. CDC, chikungunya outbreaks have accelerated in 2024.
For example, the CDC recently issued a Level 2 Travel Health Advisory for the Maldives. Local authorities reported elevated chikungunya activity in multiple areas in the Maldives in May 2024.
The Coalition for Epidemic Preparedness Innovations (CEPI) and Bavarian Nordic A/S today announced a partnership to advance the development of Bavarian Nordic's Modified Vaccinia Ankara (MVA-BN®) vaccine (JYNNEOS®, IMVAMUNE®, IMVANEX®) for children in Africa.
On May 30, 3034, CEPI stated it awarded $6.5 million to support a Phase 2 clinical study evaluating the immunogenicity and safety of MVA-BN in children from 2 to less than 12 years of age compared to adults for the prevention of smallpox, mpox, and related orthopoxvirus infections.
This phase 2 clinical trial will be conducted in one or more African countries and is planned to be initiated later in 2024. Notably, the study will also generate evidence on the vaccine in endemic African populations and could potentially support regulatory approval of MVA-BN in endemic countries.
The new trial follows the publication of a continental plan by Africa CDC and African Ministries of Health to strengthen mpox preparedness and response efforts, as well as the World Health Organization's framework for enhancing the prevention and control of mpox.
"We now understand that children suffer disproportionately from mpox, a concerning and neglected disease that has spread rapidly in recent years," said Dr. Richard Hatchett, CEO of CEPI, in a press release.
"To address the risk children face in DR Congo (Clade I) and other areas where the disease is endemic, CEPI is supporting this important trial which will provide key mpox vaccine safety and immunogenicity data in children."
Over 6,500 mpox cases and 345 deaths have been reported in DR Congo in 2024, with children accounting for the majority of infections and deaths. Mpox was initially identified in the DR Congo in 1970.
In 2024, Mpox cases were also confirmed in the Congo, Cameroon, Central African Republic, and Liberia.
The mpox strain behind the current outbreak in Africa, known as Clade I, is estimated to be fatal in around 8-12% of cases. In the U.S., Clade II has been detected since May 2022.
MVA-BN or JYNNEOS is a non-replicating smallpox-mpox vaccine approved in the U.S., and is available at certain clinics and pharmacies in 2024.
CSL Seqirus today announced it was selected by the U.S. Biomedical Advanced Research and Development Authority (BARDA) to complete the fill-and-finish process of the pre-pandemic vaccine for the U.S. government as part of the National Pre-Pandemic Influenza Vaccine Stockpile program.
Under the terms of the agreement revealed on May 30, 2024, CSL Seqirus will deliver approximately 4.8 million doses of a pre-pandemic vaccine well-matched to the H5 of the currently circulating H5N1 strain.
This acquisition of a pre-pandemic vaccine will increase BARDA's vaccine stockpile to support the U.S. government's pre-pandemic response. It is the fourth award CSL Seqirus has received from BARDA in response to sustained highly pathogenic avian influenza activity.
"The U.S. CDC maintains the risk to public health as low. We are closely monitoring the situation because we are acutely aware of the threat that influenza virus strains like H5N1 can pose and take seriously our role in preparedness efforts alongside our government and public health partners," said Marc Lacey, CSL Seqirus, Global Executive Director for Pandemic, in a press release.
"This agreement, building upon prior agreements with BARDA, will help support the U.S. government's ability to respond swiftly if the current avian flu situation changes."
On April 1, 2024, the U.S. Food and Drug Administration (FDA) Dr. Peter Marks informed the media that the U.S. stockpile of avian flu-specific vaccines would work well if deployed.
As of May 2024, FDA-approved avian influenza vaccines are not commercially available in the U.S. The FDA says annual flu shots are unlikely to protect people during avian influenza (bird flu, cow flu) outbreaks.
In Europe, the European Commission (EC) signed a framework contract on July 28, 2022, for the joint procurement of GSK's Adjupanrix, a pandemic influenza vaccine. That contact enables EC Member States to purchase up to 85 million vaccine doses during an influenza pandemic.
BARDA is part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services.
CSL Seqirus is a business of Australia-based CSL.
The Coalition for Epidemic Preparedness Innovations (CEPI) and BioNTech SE today announced they are expanding their strategic partnership to contribute to building a sustainable and resilient end-to-end African vaccine ecosystem.
CEPI is committing up to $145 million to support BioNTech's establishment of mRNA vaccine R&D, clinical, and commercial-scale manufacturing capabilities at the Company's facility in Rwanda.
BioNTech and CEPI intend to work jointly to rapidly respond to outbreaks on the African continent caused by known viral threats or an as-yet-unknown pathogen with epidemic or pandemic potential.
Under the terms of the agreement, BioNTech intends to provide affordable access to its prophylactic vaccines, such as those against malaria, mpox, and tuberculosis, manufactured at the Kigali facility.
"Africa still has to import 99% of all the vaccines it needs to protect its people from potentially deadly diseases, meaning many are left waiting far too long to get the life-saving doses they need. This must change ...... said Dr. Richard Hatchett, CEO of CEPI, in a press release on May 30, 2024.
BioNTech and CEPI first announced their strategic partnership in September 2023.
NanoViricides, Inc. today elaborated on its development of a first-in-class, broad-spectrum antiviral agent that could revolutionize the treatment of viral infections, including RSV, Influenza, and other viruses.
Over 90% of human pathogenic viruses are known to use one or more "landing sites" in the Sulfated Proteoglycans ("SPG") family. NanoViricides says a successful host-mimetic nanoviricide drug using SPG as the key feature to attracting viruses could theoretically attack most, if not all, such viruses.
NV-387 is designed to mimic SPG and attack the virus as a cell-mimicking decoy.
For example, in a recent RSV study, extended orally administered NV-387 was compared with a high dose of ribavirin. Two doses were given on the first day of dosing, followed by one daily dose for the next nine days (11 doses). NV-387 given by this dosing regimen led to complete survival of the mice beyond the 21-day study period, with no signs of pathology apparent on the last day of observation.
"An antiviral agent with an extra-ordinary broad spectrum of antiviral activity, coupled with strong safety, is a 'holy grail' of antiviral medicines," said Anil R. Diwan, Ph.D., President and Executive Chairman of the Company, in a press release on May 29, 2024
"Our host-mimetic, direct-acting, nanoviricide™ platform technology capable of destroying virus particles has made this possible, we believe. NV-387 is now ready for Phase II studies towards the goal of regulatory approvals worldwide."
He further commented, "If and when approved, NV-387 could be as revolutionary an antiviral agent as penicillin was as an anti-bacterial agent."
