Vaccine Breaking News

Vaccine breaking news brought to you by Precision Vaccinations

Mar 1, 2024 • 10:21 am CST
from Pixabay

CytoDyn Inc., a biotechnology company developing leronlimab, a CCR5 antagonist, announced that the U.S. Food and Drug Administration (FDA) has lifted its clinical hold on leronlimab.

According to a press release on February 29, 2024, the Company is now free to proceed with its proposed HIV clinical trial exploring leronlimab and its effects on chronic inflammation.

The FDA placed a partial clinical hold on the Company's HIV program on March 30, 2022.

CytoDyn's CEO, Dr. Jacob Lalezari, commented, "CytoDyn is grateful for the FDA's guidance on our (HIV) protocol, and we are excited to open a new chapter in the development of leronlimab as a therapy that provides clinical benefit by modulating chronic inflammation."

Leronlimab is a humanized monoclonal antibody that is a once-a-week subcutaneous injection that can also be administered intravenously.

However, it is not a traditional HIV vaccine candidate.

It is a competitive rather than allosteric inhibitor of the CCR5 receptor. This mechanism of action of binding competitively to the CCR5 receptor differentiates leronlimab from all other CCR5 antagonists.

The CCR5 receptor is a protein located on the surface of various cells, including white blood cells, stellate cells that produce scar tissue in the liver, and cells that undergo malignant transformation. It is the predominant co-receptor needed for certain strains of HIV to infect healthy T-cells.

The CCR5 receptor serves as a receptor for chemical attractants called chemokines. Chemokines are the key orchestrators of leukocyte trafficking by attracting immune cells to the sites of inflammation.

For HIV, leronlimab is a viral-entry inhibitor, protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. 

Dr. Lalezari plans to host a webcast on Tuesday, March 5, 2024, to provide a Company update. The update will include discussing the Company's clinical trial goals and expectations, upcoming publications, and overall development strategy.

Mar 1, 2024 • 3:23 am CST
from Pixabay

The global measles outbreak continued to impact people in England during late February 2024. Over the past decade, the uptake levels of childhood vaccines offered in England have been falling across all vaccines, including measles.

Data show more than 3.4 million children in England are either unprotected or not fully protected and at risk of catching completely preventable diseases.

 

According to the UK Health Security Agency, 69 additional laboratory-confirmed measles cases have been confirmed in England since one week ago.

As of March 1, 2024, the total number of measles cases confirmed since October 2023 is now 650.

Sixty-three percent (410 of 650) of these measles cases have been in the West Midlands, 15% in London, and 7% in Yorkshire and The Humber. The remaining cases were reported in other regions of England.

To change the trajectory of this measles outbreak, the UKHSA is launching a Childhood Immunisations national marketing campaign on March 4, 2024.

Professor Dame Jenny Harries, Chief Executive of UKHSA, said in a media release, "We need an urgent reversal of the decline in the uptake of childhood vaccinations to protect our communities. Through this campaign, we particularly appeal to parents to check their children's vaccination status and book appointments if their children have missed any immunizations."

"The ongoing measles outbreak we are seeing is a reminder of the very present threat."

"Unless uptake improves, we will start to see the diseases vaccines protect against re-emerging and causing more serious illness."

The UKHSA is co-ordinating its national marketing campaign with an operational measles, mumps, and rubella (MMR) catch-up campaign to counter this decline.

Areas with low uptake will be a focus for support and parents of children aged six to 11 years will be contacted directly and urged to make an appointment with their child's GP practice for any missed MMR vaccines.

In 2023, two million texts, emails, and letters were sent to parents and carers of 1-5-year-olds who were unvaccinated, and thanks to those efforts, 165,000 doses of MMR vaccine were delivered.

Feb 29, 2024 • 1:32 pm CST
by Alfonso Cerezo

A new survey published in the journal Vaccine revealed about 68% of parents in high- and emerging-incidence states would vaccinate their children against Lyme disease.

With Lyme disease vaccines approaching approval, there appears to be significant consumer demand in some U.S. states. 

Announced on February 28, 2024, this survey found addressing safety concerns important, and a healthcare provider recommendation could also encourage those unsure or unwilling to be vaccinated.

Given the slight preference for monoclonal antibody passive immunization over-vaccination, particularly in rural areas, access to both may increase Lyme disease prevention.

Initially developed by Valneva SE, the VLA15 Lyme disease vaccine candidate development program was granted Fast Track designation by the U.S. Food and Drug Administration in 2017.

The journal The Lancet Infectious Diseases published results from a Jully 2023 study that concluded Valneva's novel multivalent Lyme vaccine candidate was safe and immunogenic. 

VLA15 is currently in advanced phase 3 clinical study.

Feb 29, 2024 • 10:58 am CST
NCPA 2024

The U.S. Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) voted to recommend that individuals aged 65 and older receive an additional dose of 2023-2024 Formula COVID-19 vaccine four months after receiving the last dose.

According to a Novavax Inc. press release on February 28, 2024, while today's recommendation focuses on protection for older adults at increased risk of COVID-19, information shared at this ACIP meeting also reinforces the ongoing benefit of vaccination for all eligible.

Data from clinical trials continue to show broad long-lived neutralization responses to currently circulating forward-drift variants, including JN.1 and JN.4, for Novavax's protein-based non-mRNA COVID-19 vaccine while maintaining a favorable side effect profile.

Peer-reviewed real-world effectiveness data that shows the immune responses seen in our trials translate into COVID-19 prevention in the real world is being published.

Those interested in a non-mRNA protein-based vaccine should ask their pharmacists about the Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) (NVX-CoV2601) at major retail pharmacies nationwide, including, but not limited to, Albertsons, CVS Pharmacy and Rite Aid.

Vaccine doses can also be located at us.novavaxcovidvaccine.com or vaccines.gov.

Novavax's Nuvaxovid™ XBB.1.5 is one of 13 COVID-19 vaccines the World Health Organization listed as of early 2024.

Feb 28, 2024 • 5:09 am CST
US CDC Feb. 2024

The Advisory Committee on Immunization Practices (ACIP) is scheduled to review this draft agenda today at 8 AM EST. This two-day ACIP meeting includes digital access; no registration is required to watch the webcasts.

On the agenda, vaccines to be discussed include COVID-19, Chikyngyna, Influenza, Polio and others.

As previously announced, the ACIP has undergone significant member changes in 2024.

The ACIP develops recommendations for U.S. immunizations, including ages when vaccines should be given, number of doses, time between doses, and precautions and contraindications.

Recent ACIP meeting recommendations are available at this link.

These recommendations are subject to the approval of the U.S. Centers for Disease Control and Prevention director, Dr. Mandy Krauthamer Cohen.

Feb 28, 2024 • 4:00 am CST
WHO 2024

The World Health Organization (WHO) has recently updated its guidelines on infection prevention and control for Ebola disease ten years after the West African Ebola outbreak.

During outbreaks, Ebola infections have relatively high case fatality rates, averaging about 50%.

Therefore, it is crucial to have evidence-based, up-to-date infection prevention and control guidelines to ensure a safe, systematic, and standardized approach during outbreaks, said the WHO in a media release on February 27, 2024.

The complete guidelines are available on the WHO website (WHO/WPE/CRS/HCR/2023.1) and the web-based MAGICapp platform.

Since 2019, various Zaire Ebolavirus vaccines have been approved by the U.S. Food and Drug Administration, European Medicines Agency, and the WHO. These Ebola vaccines are not commercially available in 2024.

Feb 27, 2024 • 4:52 pm CST
US CDC Republic of Peru map 2024

The global outbreak of dengue disease has significantly impacted the Republic of Peru in early 2024. Compared to last year, dengue cases have increased about 90%.

As of February 26, 2024, Peru's Ministry of Health (Minsa) declared a dengue emergency for 20 of the country's 25 regions for the next three months.

Lima, the capital of Peru with about 11 million residents, lies in one of the impacted regions.

However, local media has not reported dengue cases in the tourist hot spot of Machu Picchu.

César Vásquez Sánchez, Minsa's Director, explained that this health emergency declaration will allow more budget to be transferred in the following weeks to confront this disease in the regions better. 

Vásquez Sánchez explained there have been 31,364 accumulated cases of Dengue have been reported throughout Peru and 32 related deaths this year.

"As the World Health Organization had already announced a few months ago, 2024 would be a catastrophic year for Latin America regarding dengue fever. The unusual heat wave and the absence of winter have generated a perfect panorama for the spread of Dengue," he mentioned.

While the U.S. Centers for Disease Control and Prevention (CDC) issued a Travel Health Notice regarding dengue outbreaks in the Americas on February 9, 2024, it did not include Peru.

The CDC says Dengue is a disease caused by a virus spread through mosquito bites. It can become severe within a few hours. Severe Dengue is a medical emergency, usually requiring hospitalization.

Feb 27, 2024 • 11:13 am CST
by Luis Tenorio

Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) today announced it awarded $2.2 million to LimmaTech Biologics AG to advance the development of its novel vaccine candidate targeted to prevent Neisseria gonorrhea (NG) infections.

The CARB-X award supports the development of LimmaTech's vaccine candidate that incorporates multiple antigens commonly found in NG bacteria. The goal is to develop a cost-effective vaccine that elicits a robust immune response against different NG bacterial strains.

"Gonorrhea is becoming increasingly resistant to treatment, which reinforces the pressing need for a highly effective and safe vaccine that can protect against this serious and pervasive pathogen," said Dr. Franz-Werner Haas, CEO of LimmaTech, in a press release on February 27, 2024.

"We believe our proprietary vaccine technology offers advantages in efficacy, production scalability, and simplicity to include multiple antigens that can effectively address bacterial infectious disease threats."

The WHO Global Health Sector Strategy on Sexually Transmitted Infections has set goals for reducing gonorrhea incidence by vaccination by 90%.

As of February 2024, no gonorrhea vaccine candidate has been approved by the U.S. Food and Drug Administration or European Medicines Agency.

However, the U.K.'s Joint Committee on Vaccination and Immunisation agreed in 2023 that a targeted program should be initiated using the 4CMenB (Bexsero®) vaccine for the prevention of gonorrhea in those who are at most significant risk of infection.

LimmaTech is a Swiss clinical-stage biotech company that has built a robust pipeline of innovative vaccines to provide solutions against increasingly dangerous infections, including Staphylococcus aureus and Shigella.

Feb 27, 2024 • 5:18 am CST
by Gerd Altmann

Takeda and Biological E. Limited today announced a strategic partnership to accelerate access to QDENGA® (Dengue Tetravalent Vaccine [Live, Attenuated]) multi-dose vials (MDVs).

MDVs offer economic and logistical advantages for National Immunization Programs by minimizing packaging and storage expenses and reducing medical and environmental waste.

These doses will ultimately be made available for government procurement in dengue-endemic countries by 2030 to support National Immunization Programs.

"Takeda's long-term goal for our dengue program has been to make QDENGA broadly available to those at risk who may benefit from immunization. Within the last year, we've successfully launched in private markets, are now launching in some public programs, and working with partners to support a broader public health impact," said Gary Dubin, M.D., president of the Global Vaccine Business Unit at Takeda.

According to the press release on February 27, 2024, BE will ramp up to a manufacturing capacity of up to 50 million doses a year, accelerating Takeda's efforts to manufacture 100 million doses annually within the decade.

The partnership will build upon existing manufacturing capacity for the vaccine at Takeda's facility in Singen, Germany, and Takeda's long-term collaboration with IDT Biologika GmbH.

Dengue fever is among the most common mosquito-borne viral diseases worldwide. Dengue is endemic in more than 100 countries and causes an estimated 390 million infections yearly.

The Americas, Southeast Asia, and Western Pacific regions are the most seriously affected, with Asia alone representing ~70% of the global disease burden.

In 2024, the state of Florida reported two cases of locally acquired dengue from two counties. In 2023, positive samples from 186 humans were reported from five counties.

QDENGA is currently available in the private market in countries in Europe, Indonesia, and Thailand and in private and some public programs in Argentina and Brazil.

As of late February 2024, QDENGA is not approved by the U.S. FDA.

Feb 26, 2024 • 1:00 pm CST
by Michelle Raponi

In 2024, an unusual number of measles outbreaks have already been confirmed in the United States. 

The Centers for Disease Control and Prevention (CDC) reported 35 measles cases recently. Recent measles cases have been reported in Indiana and New Orleans.

In 2024, there has been an alarming increase in the number of measles cases in the United States. The Centers for Disease Control and Prevention (CDC) has recently reported 35 confirmed measles cases.

And in Florida, a media statement issued by the Florida Department of Health on February 23, 2024, confirmed six measles cases in Broward County and a travel-related case in Central Florida (Polk County).

This area of Florida is home to about 2 million people and is adjacent to various entertainment parks and convention centers.

The Florida Department of Health in Broward County confirmed on February 20, 2024, that students at Manatee Bay Elementary School in Weston were infected, and about 200 classmates did not attend class last week.

Suspected measles cases are required to be reported immediately to county health departments or the Department's Bureau of Epidemiology to ensure prompt response and public health efforts. If a measles infection is suspected, please call your local county health department or the Department's Bureau of Epidemiology at 850-245-4401.

These cases relate to the global measles outbreak, generally impacting unvaccinated children and international travelers.

Last year, the CDC published a global Watch-Level 1, Practice Usual Precautions, Travel Health Notice identifying measles outbreaks in 47 countries.

In 2023, over 500,000 suspected measles cases were reported in 169 destinations.

Feb 26, 2024 • 12:08 pm CST
by Dean Moriarty

The U.S. Centers for Disease Control and Prevention (CDC) has confirmed Gonorrhea can be cured with the proper treatment for several years.

However, in 2024, the bacteria causing Gonorrhea is recognized by the World Health Organisation as a priority pathogen, for which resistance to existing treatments is rising.

According to industry news, an innovative product may offer better options than the CDC's recommended therapy (ceftriaxone).

GSK plc announced on February 26, 2024, that they had obtained positive headline results from the pivotal EAGLE-1 phase III trial for gepotidacin.

The clinical trial met its primary efficacy endpoint, with gepotidacin (oral, two doses of 3,000mg) demonstrating non-inferiority to intramuscular (IM) ceftriaxone (500mg) plus oral azithromycin (1,000mg), which is a leading combination treatment regimen for Gonorrhea.

Gepotidacin is a potential first-in-class oral antibiotic that has a novel mechanism of action for treating uncomplicated urogenital Gonorrhea in adolescents and adults.

In a press release, Chris Corsico, Senior Vice President, Development at GSK, said, "With rising incidence rates and concern around growing resistance to existing treatments, Gonorrhea threatens public health globally."

"These positive headline results demonstrate the potential for gepotidacin to provide a novel oral treatment option in the face of rising resistance and for patients who cannot take other treatments due to allergies or intolerance."

Detailed results from the EAGLE-1 trial will be presented at an upcoming scientific meeting and shared with global health authorities.

Gonorrhoea is a sexually transmitted infection caused by bacteria called Neisseria gonorrhoeae. It has been estimated that there are 82 million new cases globally each year.

Recently, repurposed vaccines have shown effectiveness against Gonorrhoea, while vaccine candidates conduct late-stage studies.

Feb 26, 2024 • 9:32 am CST
US FDA VRBPAC meeting schedule

The US Food and Drug Administration (FDA) announced in a post on X that on May 16, 2024, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) will hold a public discussion to recommend the selection of strain(s) to be included in the 2024-2025 formula for COVID-19 vaccines.

On February 26, 2024, the FDA confirmed that changes to the vaccine composition may be necessary based on the currently circulating strains of the virus that causes COVID-19.

After receiving any recommendations from the VRBPAC regarding the 2024-2025 formula update, the FDA plans to take appropriate regulatory actions on updated COVID-19 vaccines so that manufacturers can make them available by September 2024.

The FDA expects that the composition of COVID-19 vaccines may need to be updated annually, as is done for seasonal influenza vaccines.

Background material and the link to the online teleconference and/or video conference meeting will be available on the Advisory Committee calendar no later than two business days before the VRBPAC meeting.

Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Eastern Time. 

Contact Information: Sussan Paydar or Prabhakara Atreya, Center for Biologics Evaluation and Research, FDA, 202-657-8533 or [email protected].

Feb 26, 2024 • 8:53 am CST
by Candelario Gomez Lopez

It has been reported by local media that the new Pfizer COVID-19 vaccine is now available at some pharmacy chains in Mexico.

According to Mexico News Daily, certain branches of Farmacias del Ahorro, Farmacias Benavides, Farmacias San Pablo, and Farmacias Guadalajara, among others, offer nurse-administered vaccinations.

As of February 20, 2024, Pfizer's updated Comirnaty Omicron XBB 1.5 vaccine costs between $49.78 to $58.65.

The Mexican health regulatory agency authorized the sale of Pfizer's vaccine in December 2023.

Feb 25, 2024 • 12:03 pm CST
by Ben Menting

In 2024, there have been several reports of avian influenza virus infections in birds, mammals, and humans. As a result, government agencies are taking measures to prepare for potential pandemics.

On February 23, 2024, the Human Medicines Committee of the European Medicines Agency (EMA) issued its recommendations for avian influenza vaccines.

The committee adopted positive opinions for two vaccines intended for active immunization against the H5N1 subtype of influenza A virus, also called bird flu.

One of them, Celldemic (zoonotic influenza vaccine (H5N1)(surface antigen, inactivated, adjuvanted, prepared in cell cultures)), is intended for immunization during outbreaks of influenza coming from animals, including when public health authorities anticipate a possible pandemic.

The other, Incellipan (pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted, prepared in cell cultures)), is a pandemic preparedness vaccine intended for use only if a flu pandemic has been officially declared.

In the event of a pandemic, once the virus strain causing the pandemic is identified, the manufacturer can include this strain in the authorized pandemic preparedness vaccine and apply for the vaccine to be authorized as a 'final' pandemic vaccine.

Because the vaccine's quality, safety, and efficacy have already been assessed with other potential pandemic strains, the authorization of the final pandemic vaccine can be accelerated, wrote the EMA.

According to the U.S. Centers for Disease Control and Prevention, about 20 million H5N1 and 12 million H7N9 vaccines were available in the National Strategic Stockpile in 2023.

The U.S. FDA authorized the Audenz™ (Influenza A(H5N1) Monovalent Vaccine, Adjuvanted) cell-based vaccine on January 31, 2020.

Feb 24, 2024 • 5:18 pm CST
US CDC Travel Alert 2024

While the global dengue outbreak continues in 2024, many parts of the Americas are at risk. A trendy vacation destination in Central America reports a significant surge in dengue cases this year.

According to the Costa Rica Ministry of Health, there have been 4,787 confirmed cases of dengue during the first six reporting periods of this year.

As of February 23, 2024, Costa Rica's Central North region concentrates the highest accumulated notification of dengue cases this year with 1,228 cases, followed by the Central Pacific with 832 and the Central South with 762 cases.

During 2023, there were over 24,914 dengue cases, an increase from the 7,485 dengue patients in 2022.

To alert international travelers of this mosquito-transmitted health risk, Costa Rica was included in the U.S. CDC's Level 1 - Practice Usual Precautions, dengue notice on February 09, 2024.

The Ministry of Health has called on the population to constantly clean and empty the containers in which water is stored for domestic use. Likewise, residents are urged to collaborate with our officials when they visit your homes for fumigation, presenting proper identification.

The Vector Control Program team recently carried out 16,645 fumigations in the towns of La Carpio, Pavas, and Alajuela.

As of 2024, the Dengvaxia® vaccine was sold in private pharmacies in Costa Rica. The price is around $130. 

However, the second-generation QDENGA® dengue vaccine is not offered in Costa Rica.