Vaccine News

Invivyd, Inc. today announced that PEMGARDA™ (pemivibart, VYD222), a half-life extended monoclonal antibody (mAb), has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the pre-exposure prevention of COVID-19 in adults and adolescents (12 years of age and older weighing at least 40 kg) who have moderate-to-severe immune compromise due to certain medical conditions or receipt of certain immunosuppressive medications or treatments and are unlikely to mount an adequate immune response to COVID-19 vaccination.

PEMGARDA recipients should not be infected with or have had a known recent exposure to an individual infected with the SARS-CoV-2 coronavirus.

VYD222 was engineered from adintrevimab, Invivyd's investigational mAb that has a robust safety data package and demonstrated clinically meaningful results in global Phase 2/3 clinical trials for preventing and treating COVID-19. 

Dave Hering, CEO of Invivyd, commented in a press release on March 22, 2024, "PEMGARDA is the first authorized mAb from our proprietary platform approach. We are committed to ongoing process improvement while working with global regulatory agencies to increase the speed and efficiency of new mAb candidate development even further."

"Additionally, we plan to explore the protective clinical benefits of mAb prophylaxis for symptomatic COVID-19 disease in future studies."

As previously disclosed in December 2023, a potential early signal of clinical protection from symptomatic COVID-19 confirmed by RT-PCR was observed. Invivyd is now providing an update on the clinical cases of confirmed symptomatic COVID-19 through Day 90.

Beyond today's update, additional cases of COVID-19 have occurred in Cohorts A and B post-Day 90. These data are planned to be analyzed at Day 180 and presented when available.

The FDA says SARS-COV-2-targeting mAbs are laboratory-produced antibodies that can help the immune system attack SARS-COV-2.

These mAbs block entry of SARS-CoV-2 into human cells, thus neutralizing the virus. SARS-CoV-2 can mutate over time, resulting in genetic variation in the population of circulating viral strains.

Some virus variants can cause resistance to one or more of the mAb therapies authorized to treat COVID-19.

The Walgreens Flu Index® recently published information regarding flu activity compiled using retail prescription data for antiviral medications used to treat influenza across Walgreens locations nationwide.   

As of March 16, 2024, Walgreens listed the Top Designated Markets with Flu Activity were:

1. Ft. Smith-Fayetteville-Springdale-Rogers, Ark.
2. Omaha, Neb.
3. Oklahoma City, Okla.
4. El Paso, Texas (Las Cruces, N.M.)
5. Little Rock-Pine Bluff, Ark.

Seperately the U.S. CDC reported five influenza-associated pediatric deaths during the 2023-2024 flu season during Week # 11. This data increases the flu season total to 121 pediatric deaths.

Last flu season, 184 influenza-associated pediatric deaths were reported.

As of March 24, 2024, various types of flu vaccines remain available at most community pharmacies. About 158 million flu vaccines had been distributed this season.

Note: The Walgreens Flu Index is not intended to illustrate levels or severity of flu activity but rather to illustrate which populations are experiencing the highest incidence of flu.

As World Tuberculosis Day approaches on March 24, everyone should focus on preventing this disease to reduce its impact on society.

According to GlobalData, an analytics company, various TB vaccines are in late-stage development and hold promise in containing the disease burden.

GlobalData reported today that there are currently 11 TB vaccine candidates in the late stages of development.

For example, the M72/AS01E vaccine candidate could be the first licensed TB vaccine in decades.

While the 100-year-old Bacillus Calmette-Guérin (BCG) vaccine is up to 80% effective at preventing TB infection in young children, it provides reduced protection against pulmonary TB.

This means there is a significant need for improved prophylactic vaccines.

Currently, there are about 16 approved TB vaccines in use worldwide.

Anaelle Tannen, Infectious Disease Analyst at GlobalData, commented in a press release on March 22, 2024, "Progress in this area has the potential to save countless lives as well as reduce the health and socio-economic burden associated with this disease."

Tannen added, "Prevention and early diagnosis are key to stopping the ongoing spread of the disease. The BCG vaccine is currently the only prophylactic on the market. It is given to babies in countries where TB is common."

"In areas where TB is less common, it is only given to those at high risk, including those that are more likely to be exposed to the bacterium."

TB remains a global pandemic, with 1.8 billion people estimated to be infected with the bacteria, according to the World Health Organization (WHO). India leads most countries in reporting TB cases and deaths.

The disease exists in both a latent and active form; the latent type does not express symptoms and is not transmissible unless it develops into the active type.

The lifetime risk for latently infected persons is about 5-10%.

Antibiotics are typically administered for at least six months, and ensuring the course is completed is vital to prevent antibiotic resistance, says the WHO.

In the United States, the TICE® BCG vaccine is available at most health departments but not retail pharmacies.

A clinical-stage intranasal vaccine company developing parainfluenza virus 5 (PIV5)-vectored vaccines that harness the full breadth of the immune system to protect against serious infectious diseases today announced preliminary data from the first two cohorts of a Phase 1/2a clinical trial studying BLB201, a vaccine candidate against severe respiratory syncytial virus (RSV) disease.

On March 21, 2024, Blue Lake Biotechnology, Inc., stated the data show that BLB201 is immunogenic and well tolerated, with no significant safety events reported to date following a single intranasal dose in RSV seropositive children 18-59 months of age.

The ongoing trial is currently enrolling both RSV seropositive and RSV seronegative children as young as eight months of age.

No vaccine-related severe safety signals have been reported among the initial 10 participants ages 18-59 months who received the BLB201 study vaccine in this Phase 1/2a study (NCT05655182).

In the five participants who received the higher dose of 10⁷ PFU of BLB201, prominent increases in RSV neutralizing antibody (nAb) responses were observed at four weeks post-vaccination, with 80% having a 3.6- to 57-fold rise in nABs over baseline.

RSV-specific mucosal IgA antibody and cellular immune responses were also observed.

“Given the challenges of developing an RSV vaccine for children, it is highly encouraging that BLB201, our intranasal RSV vaccine candidate, has been well tolerated in this age group so far,” said Biao He, Ph.D., founder and CEO of Blue Lake Biotechnology, in a press release.

“It is also very exciting to see RSV-specific immune responses to our vaccine in children who have previously been exposed to RSV. We are eager to generate more data in younger children, including infants who have not had prior exposure to RSV, and to develop a highly effective and safe vaccine to protect this vulnerable population from RSV.” 

As of March 2024, approved antibody drugs and a maternal RSV vaccine can provide passive immunity against RSV in infants. However, no RSV vaccine has been approved for generating prophylactic immunity in infants and children.

Despite extensive efforts, the Federal Republic of Nigeria continues to confront an expanding Lassa fever outbreak in 2024, reporting new cases and deaths.

Throughout 2024, Nigeria's Centre for Disease Control and Prevention (NCDC) confirmed 682 cases and 128 deaths, which is a Lassa fever case fatality rate of 18.8%, far exceeding the rate recorded in 2023.

The report identified 62% of confirmed cases originating from Ondo, Edo, and Bauchi states.

The NCDC wrote in 2023 that annual outbreaks of Lassa fever also involved infection and death of healthcare workers. This loss of life is not just a statistic but a significant loss of a loved family member, a spouse, a parent, and often a seasoned healthcare worker and team member. This exacerbates the challenge of insufficient human resources for health in the country.'

As of March 2024, the U.S. Food and Drug Administration and the European Medicines Agency had not approved a Lassa fever virus vaccine candidate.

However, four vaccine candidates (INO-4500, MV-LASV, rVSV∆G-LASV-GPC, and EBS-LASV) have entered the clinical clinical stage.

Without an available vaccine, the U.S. CDC says the risk of Lassa virus infection is associated with peridomestic rodent exposure, where inappropriate food storage increases the risk.

The CDC says people should practice safe food precautions and avoid handling, cooking, or eating raw or undercooked meat or animal products.

A corporate venture firm focused on investing in companies developing innovative solutions and ideas today announced its participation in an extension of the Series C financing round for Nouscom, a clinical-stage immuno-oncology company.

Nouscom raised approximately $82 million in its oversubscribed Series C round, which was first announced in November 2023.

Angelini Ventures joins a syndicate of top-tier international healthcare investors by participating in Nouscom’s financing.

This new financing will enable Nouscom, based in Basel, Switzerland. to continue advancing and expanding its wholly-owned clinical pipeline to achieve multiple clinical value catalysts, including:

• Readout from its ongoing randomized Phase 2 clinical trial for NOUS-209, an off-the-shelf cancer vaccine for treating Mismatch Repair/Microsatellite Instable Metastatic Colorectal Cancer.
• Phase 1b study completion and progression of NOUS-209 monotherapy in Lynch Syndrome carriers investigating the potential to intercept, prevent, or delay cancer in high-risk individuals.
• Completion of the Phase 1b study for NOUS-PEV, a personalized cancer immunotherapy, in combination with a checkpoint inhibitor in patients with advanced melanoma and entry into randomized Phase 2 trials in indications with high unmet medical needs.

Dr. Marina Udier, Chief Executive Officer at Nouscom, commented in a press release on March 21, 2024: “We are delighted to have extended our successful Series C financing round and excited to have Angelini Ventures on board. Their support strengthens our commitment to innovation and accelerates our journey towards delivering next-generation treatments for cancer patients.”

Millions of people's health is at risk by the mosquito-transmitted, vaccine-preventable chikungunya virus (CHIKV), but most Americans are unaware of its global impact.

In-person information about a newly approved chikungunya virus (CHIKV) vaccine will be shared at the Walter E. Washington Convention Center in Washington, D.C., from April 1-4, 2024.

Valneva SE, a France-based specialty vaccine company, today announced it will present its single-shot chikungunya vaccine for adults, IXCHIQ®, and participate in a panel discussion on efforts to eradicate chikungunya outbreaks at the 24th World Vaccine Congress.

XCHIQ®, the world's first and only chikungunya vaccine approved in the U.S., was recently recommended by the CDC's Advisory Committee on Immunization Practices for international travelers to at-risk areas.

As of March 21, 2024, CHIKV was identified in nearly 115 countries, primarily in the Region of the Americas. As of December 2023, approximately 460,000 CHIKV cases and 360 related deaths have been reported worldwide.

On the evening of April 2, Valneva will attend the Vaccine Industry Excellence Awards ceremony, where the vaccine is a finalist for the Best Prophylactic Vaccine award for IXCHIQ®.

And on April 3, Valneva's Chief Medical Officer, Dr. Juan Carlos Jaramillo, will participate in the "Vaccine Development and Efforts towards Eradicating Chikungunya" panel discussion.

For further details, contact Laetitia Bachelot-Fontaine, VP, Global Communications and European Investor Relations, at [email protected]