Vaccine News

Icosavax, Inc. today announced it had entered into a definitive agreement under which AstraZeneca would purchase the company Phase 2 study of IVX-A12, a combination virus-like particle (VLP) vaccine candidate targeting both respiratory syncytial virus (RSV) and human metapneumovirus (hMPV).

There are currently no treatments or preventative therapies for hMPV. Adults with hMPV infection may have viral pneumonia, worsening asthma, or COPD symptoms. And there are no combination vaccines for RSV.

Announced on December 11, 2023, Iskra Reic, Executive Vice President, Vaccines & Immune Therapies, AstraZeneca, commented in a press release, "This VLP vaccine technology has the potential to transform prevention against severe infectious diseases, including RSV and hMPV."

"With the addition of Icosavax's Phase III-ready lead asset to our late-stage pipeline, we will have a differentiated, advanced investigational vaccine and a platform for further development of combination vaccines against respiratory viruses."

"This aligns with our strategy to deliver a portfolio of therapies to address high unmet needs in infectious diseases and our ambition to protect the most vulnerable patients who have a high risk of severe outcomes."

Separately, Icosavax announced positive topline interim results from its Phase 2 clinical trial of IVX-A12 against RSV and hMPV in older adults.

IVX-A12 induced robust immune responses against both RSV and hMPV at Day 28 across both formulations with and without adjuvant.

"We're delighted to announce positive topline interim data from our Phase 2 trial of IVX-A12, our potential first-in-class combination vaccine candidate against RSV and hMPV," said Adam Simpson, Chief Executive Officer of Icosavax, in a press release.

"We believe that IVX-A12 has the potential to address a significant unmet need and, as the furthest advanced RSV and hMPV combination vaccine in the clinic, to build on an emerging, large market opportunity."

The ongoing Phase 2 clinical trial of IVX-A12 is a randomized, observer-blinded, placebo-controlled, multicenter trial designed to evaluate the safety and immunogenicity of a single dose of RSV and hMPV combination VLP vaccine IVX-A12, with and without CSL Seqirus' proprietary adjuvant MF59®.

Regarding the proposed acquisition, the upfront cash portion of the consideration represents an equity value of approximately $838 million, a 43% premium over Icosavax's closing market price on December 11, 2023, and a 73% premium to Icosavax's volume-weighted average price for the preceding 60 trading days.

Combined, the upfront and maximum potential contingent value payments represent, if achieved, an equity value of approximately $1.1 billion, a 91% premium over Icosavax's closing market price on December 11, 2023, and a 130% premium to Icosavax's volume-weighted average price for the preceding 60 trading days.

Merck and Moderna, Inc. today announced the initiation of a pivotal Phase 3 randomized clinical trial (INTerpath-002) evaluating V940 (mRNA-4157), an investigational individualized neoantigen therapy, in combination with KEYTRUDA®, Merck’s anti-PD-1 therapy, as adjuvant treatment in patients with completely resected (R0) Stage II, IIIA or IIIB (with nodal involvement) non-small cell lung cancer.

Global recruitment of the INTerpath-002 has begun, and the first patients enrolled in Australia.

“As lung cancer is the leading cause of cancer death worldwide, there is a need for continued scientific advancements to help fight this disease at earlier stages when patients have the best chance for better outcomes,” said Dr. Marjorie Green, senior vice president and head of late-stage oncology, global clinical development, Merck Research Laboratories, in a press release on December 11, 2023.

“By combining KEYTRUDA with V940 (mRNA-4157), a promising new modality, we are researching innovative new approaches for earlier stage non-small cell lung cancer.”

As previously announced, in addition to INTerpath-002, the combination of V940 (mRNA-4157) plus KEYTRUDA is being investigated in INTerpath-001, a global, randomized, double-blind, placebo- and active-comparator-controlled Phase 3 trial evaluating patients with resected high-risk (Stage IIB-IV) melanoma.

INTerpath-001 is actively screening in 14 countries, representing 38 sites.

The companies confirmed they plan to expand the comprehensive clinical development program for V940 (mRNA-4157) to additional tumor types.

The Africa Centres for Disease Control and Prevention (Africa CDC) recently welcomed the announcement from The Global Vaccine Alliance (GAVI) Board for the establishment of the African Vaccine Manufacturing Accelerator (AVMA).

The AVMA is a financing mechanism to create a sustainable vaccine manufacturing industry in Africa. It will make up to $1 billion in funds available to support vaccine manufacturing in Africa.

Dr. Jean Kaseya, Africa CDC Director General, commented in a press release on December 8, 2023, "Today is a significant moment for Africa. The targeted USD 1 Billion from GAVI to African Manufacturers is a game changer for the continent and advances our efforts towards vaccine self-reliance."

"The African Union has set a target for the continent to produce 60% of the vaccines needed by 2040, and the AVMA is indeed an accelerator towards that ambition."

"GAVI has been an incredible partner in this; we will continue to advance together on this journey of self-reliance. Together, we are united with a mission for vaccine equity."

The launch of AVMA is an important message from our partners that Africa will no longer be solely a recipient of vaccines but an active member and contributor to the global vaccine ecosystem.

The collaboration has seen several vaccine manufacturing projects taking shape, and others are in the works to guarantee self-reliance in Africa should any health emergency or outbreak hit the continent.

In addition, Africa CDC remains committed to collaborating with all partners and stakeholders in the vaccine ecosystem to facilitate the full operationalization of AVMA and expedite the attainment of health security, as envisaged in Agenda 2063.

Since most respiratory syncytial virus (RSV) activity in the United States is initially recorded in the state of Florida, watching for the bending of the curve offers insights regarding future cases. 

As of December 8, 2023, the U.S. Centers for Disease Control and Prevention (CDC) updated its RSV detection graphs to display the 5-week moving average. RSV infections typically occur during late fall, winter, and early spring.

There are variations in the timing of RSV outbreaks between regions and communities in the same region.

For Florida, the two charts indicate RSV's peak was in late November 2023.

Separately, the Florida Department of Health reported that as of December 2, 2023, RSV activity was decreasing in hospital admissions, positivity tests, and ER visits.

But, there was an RSV outbreak in Pinellas County.

From a prevention perspective, both RSV vaccines are available at most clinics and pharmacies in Florida. However, the CDC recently confirmed the percentage of seniors receiving an RSV vaccine was just 15.9%.

Unfortunately, the RSV antibody passive immunization for infants, Beyfortus™, remains in limited supply. 

Virtually all children get an RSV infection by the time they are two years old. Most of the time, RSV will cause a mild, cold-like illness. RSV antibodies can help protect children from severe disease from an RSV infection.

RSV can be dangerous for infants and young children. Each year, thousands are hospitalized due to RSV infection, says the CDC.

The U.S. Centers for Disease Control and Prevention (CDC) today announced very few seniors have received an approved vaccine that protects against Respiratory syncytial virus (RSV).

This common respiratory virus can become severe and require hospitalization.

As of December 8, 2023, the CDC confirmed the percentage of adults 60+ reporting receiving an RSV vaccine was 15.9%.

This CDC data indicates an uptake gap compared to a recent survey.

A recent poll by the University of Michigan's Institute for Healthcare Policy and Innovation revealed that 21% of seniors want an RSV vaccination in 2023. 

Unlike previous RSV seasons, there are two RSV vaccines endorsed by government agencies, which are as follows:

AREXVY™ RSV vaccine is approved for adults aged 60 and above.

ABRYSVO™ RSVpreF RSV bivalent vaccine is from Pfizer Inc.

The U.S. Food and Drug Administration, the U.K.'s Medicines and Healthcare products Regulatory Agency, and the European Commission recommend adults 60 years and older and pregnant women receive a single dose of an RSV vaccine based on discussions with healthcare providers and under certain conditions. 

Dr. Mandy Cohen, Director of the CDC, commented during a media interview on December 8, 2023, "What we know is that several viruses are circulating, but we also have tools to protect ourselves."

"And we're hoping more can do that before the Christmas holiday."

In the U.S., RSV vaccines are generally available at clinics and pharmacies.

The U.S. Centers for Disease Control and Prevention (CDC) today announced seasonal flu activity continues to increase in most parts of the country, with the southeast and south-central areas of the country reporting the highest levels of activity.

As of December 8, 2023, outpatient respiratory illness is above baseline nationally for the fifth week and is at or above baseline in all 10 HHS Regions. 

Furthermore, the National Center for Health Statistics (NCHS) Mortality Surveillance data available on December 7, 2023, indicates that 0.2% of the deaths (48) that occurred during Week #48 were due to influenza.

Last week, in #47, there were 61 flu-related deaths and 2,373 pneumonia-related deaths.

Specifically, there were four influenza-associated pediatric deaths reported during Week #48, bringing the 2023-2024 season total to 12 pediatric deaths.

Last flu season, about 182 children died from influenza.

From a prevention perspective, the CDC recently confirmed that over 151 million flu shots had already been distributed in the U.S.

These influenza vaccines are generally available at clinics and pharmacies, 

The U.S. Centers for Disease Control and Prevention (CDC) today announced a Health Alert Network (HAN) Health Advisory about the occurrence, geographic spread, and sexually associated human-to-human transmission of Clade I Monkeypox virus (MPXV) in the Democratic Republic of the Congo (DRC).

Since January 2023, the DRC has reported 12,569 suspected mpox cases and 581 related deaths from 22 regions.

The new HAN says cases of Clade I MPXV have not been reported in the United States as of December 7, 2023. The global outbreak of Clade II MPXV was initially reported in May 2022.

However, clinicians should be aware of the possibility of Clade I MPXV in travelers who have been in DRC. 

Third-party data indicate that the number of tourists arriving in the DRC was about 460,880 in 2021.

The CDC recently issued a Travel Health Notice (Level 2 - Practice Enhanced Precautions) for people traveling to DRC. Furthermore, there are no direct commercial passenger flights from DRC to the U.S. as of December 2023.

U.S. FDA-approved vaccines (JYNNEOS, ACAM2000) are expected to be effective for both Clade I and II MPXV infections.

Vaccination or prior MPXV infection should provide antibodies that will provide cross-protection to other orthopoxviruses, including Clade I MPXV, says the CDC.

However, clinical verification is under review.

The CDC recommends clinicians encourage vaccination for eligible patients.

Eligible patients who have only received one dose of Bavarian Nordic JYNNEOS® (MVA-BN®, IMVAMUNE®) vaccine, which is based on a live, attenuated vaccinia virus, should receive the second dose as soon as possible, regardless of the time that has elapsed since the first dose.

Mpox vaccines have limited availability in the U.S.

Furthermore, clinicians should notify their state health department if they have a patient with mpox-like symptoms and should submit lesion specimens for clade-specific testing for these patients.