Vaccine News

Led by researchers at NYU Grossman School of Medicine, a recent study showed no significant difference in the strength of the immune response (IgG antibodies) between most of those who received their vaccine injections in small doses between layers of the skin.

In some cases, the IgG antibodies were detected more than six months after the second and final JYNNEOS® vaccination.

Because of limited space between skin layers, intradermal injections can only accommodate small doses, while larger doses generally require subcutaneous injections.

The smaller doses, about one-fifth of the usual full dose and spread out by as long as three months, were authorized by the U.S. FDA and CDC in August 2022.

About 155,000 New Yorkers have been vaccinated, mainly using smaller doses.

"Our study shows that smaller vaccine doses of mpox vaccine administered in two doses spread out over weeks to months were similar to the full (subcutaneous) FDA-approved dose," said study co-lead investigator and infectious disease specialist Angelica Cifuentes Kottkamp, MD, in a press release on December 14, 2023,

"Implementing the smaller dose was a good emergency measure in the face of immediate shortages of the vaccine," said Dr. Kottkamp, an assistant professor in the Department of Medicine at NYU Langone Health.

Additionally, the New England Journal of Medicine published a Correspondence that revealed people fully vaccinated with two smaller JYNNEOS doses had an immune response four times stronger than those who did not complete the vaccination series and had only one dose.

This study's finding is significant since The Lancet Infectious Diseases reported on December 7, 2023, that 12% of JYNNEOS vaccinated individuals were non-antibody responders.

Bavarian Nordic codeveloped JYNNEOS with the U.S. Government to ensure adult populations, including people with weakened immune systems, could be protected from smallpox.

On February 22, 2023, the U.S. CDC issued Interim Clinical Considerations confirming that mpox vaccination should continue to be offered to people with the highest potential for exposure to mpox. The U.K. and Europe have issued similar notices in 2023.

The U.S. government today announced that Sanofi and AstraZeneca will make available 230,000 additional doses of a new passive immunization that prevents lower respiratory tract infections in infants caused by the respiratory syncytial virus (RSV).

Announcement on December 14, 2023, the additional doses of Beyfortus™ (Nirsevimab-alip) are scheduled for delivery in January 2024.

Beyfortus, an extended half-life monoclonal antibody, was approved by the U.S. FDA in July 2023.

This new allocation is in addition to the 77,000 Beyfortus doses released to the U.S. in November 2023.

Sanofi had previously confirmed that demand for this product, especially for the 100 mg doses, had been higher than anticipated.

In clinical trials, a single injection reduced the chances of severe RSV infection by 74.5%.

RSV disease can be prevented either by giving antibody products to infants and young children or by giving their mothers RSV vaccine during pregnancy, says the U.S. CDC.

According to a Johns Hopkins news article published in July 2023, monoclonal antibodies work by providing immediate and short-term protection, whereas vaccines “boost your immunity in the future.

David Dowdy, MD, professor in Epidemiology, explained that your immune system can’t “learn” anything from an antibody. The drug is “basically to protect during a time of life when people are most vulnerable.”

The protection that Beyfortus provides is called “passive immunity” because it does not come from the person’s immune system.

Before 2023, there were no immunizing tools to protect older adults from illness and death due to respiratory syncytial virus (RSV). This year, the U.S. Food and Drug Administration approved two RSV vaccines for older adults.

According to an Original Article published today by the New England Journal of Medicine, an mRNA-based vaccine was found to be very effective at protecting healthy adults. 

In this ModernaTX, Inc. sponsored ongoing, randomized, double-blind, placebo-controlled, phase 2/3 clinical trial, participants were randomly assigned, in a 1:1 ratio, adults 60 years of age or older to receive one dose of mRNA-1345 (50 μg) or placebo.

The two primary efficacy endpoints were preventing RSV-associated lower respiratory tract disease with at least two signs or symptoms and at least three signs or symptoms. A key secondary efficacy endpoint was the prevention of RSV-associated acute respiratory disease. Safety was also assessed.

Overall, 17,793 participants were assigned to receive the mRNA-1345 vaccine candidate. The median follow-up was 112 days (range, 1 to 379).

The primary analyses were conducted when at least 50% of the anticipated cases of RSV-associated lower respiratory tract disease had occurred.

Vaccine efficacy was 83.7% (95.88% confidence interval [CI], 66.0 to 92.2) against RSV-associated lower respiratory tract disease with at least two signs or symptoms and 82.4% (96.36% CI, 34.8 to 95.3) against the disease with at least three signs or symptoms. Vaccine efficacy was 68.4% (95% CI, 50.9 to 79.7) against RSV-associated acute respiratory disease.

Protection was observed against both RSV subtypes (A and B) and was generally consistent across subgroups defined according to age and coexisting conditions.

Participants in the mRNA-1345 group had a higher incidence than those in the placebo group of solicited local adverse reactions (58.7% vs. 16.2%) and systemic adverse reactions (47.7% vs. 32.9%). Most of these reactions were mild to moderate in severity and were transient.

However. serious adverse events occurred in 2.8% of the participants in each trial group.

In summary, these researchers wrote, 'This phase 2–3 efficacy trial showed that a single 50-μg dose of the mRNA-1345 vaccine in adults 60 or older was efficacious against a spectrum of RSV-confirmed respiratory disease.'

The U.S. CDC's COVIDVaxView COVID-19 Vaccination Dashboard was updated today, reflecting current trends in children's, adults, and pregnant women's vaccination rates.

As of December 13, 2023, the CDC confirmed:

As of December 2, 2023, 7.7% (95% Confidence Interval: 6.5%-8.9%) of children (six months to 17 years) were reported to be up to date with the 2023-24 COVID-19 vaccine. An additional 18.6% (15.9%-21.3%) of children had a parent who said they planned to get their child vaccinated.

And 17.2% (95% Confidence Interval: 16.3%-18.1%) of adults reported receiving an updated 2023-24 COVID-19 vaccine since September 14, 2023. An additional 14.6% (13.4%-15.9%) said they plan to get vaccinated.

Furthermore, 9.6% of pregnant women had received the updated 2023-24 COVID-19 vaccine. Vaccination coverage was highest among non-Hispanic Asian (16.5%) pregnant women and lowest among non-Hispanic Black (3%) women.

Additional COVID-19 vaccination data by demographic characteristics at the national level and overall estimates by jurisdiction are available at this CDC link.

Eisai Co., Ltd. and Biogen Inc. today announced that humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody LEQEMBI® Intravenous Infusion (200 mg, 500mg, lecanemab) is scheduled to launch in Japan on December 20, 2023.

LEQEMBI received manufacturing and marketing approval for the indication of slowing progression of mild cognitive impairment and mild dementia due to Alzheimer's disease (AD) in Japan on September 25, 2023.

The pending launch in Japan marks the second country to have LEQEMBI on the market, following the U.S. Food and Drug Administration (FDA) approval in July 2023.

In the U.S., treatment with LEQEMBI should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials, says the FDA.

"The availability of LEQEMBI opens a new era in the treatment of AD, potentially giving patients and their families additional valuable time together and further positions Japan as a leader in caring for an elderly population," said Christopher A. Viehbacher, President and Chief Executive Officer of Biogen, in a press release on December 13, 2023.

"We will work alongside Eisai to engage the medical community and support the patient journey, especially early diagnosis, as mounting evidence suggests early intervention may provide a greater impact on disease progression."

As national influenza rates increased post-Thanksgiving, according to the Walgreens Flu Index®'s latest report, the state of Texas is leading the nation in influenza activity.

As of December 9, 2023, the Index identified the leading cities using retail prescription data for antiviral medications used to treat influenza across Walgreens locations nationwide.

1. Lafayette, La.
2. Harlingen-Weslaco-Brownsville-McAllen, Texas
3. Baton Rouge, La.
4. Beaumont-Port Arthur, Texas
5. Montgomery-Selma, Ala.
6. El Paso, Texas (Las Cruces, N.M.)
7. Houston, Texas

Anita Patel, PharmD, Vice President of Pharmacy Service Development at Walgreens, commented in a press release on December 7, 2023, ".... practicing good respiratory etiquette are all important steps to protect yourself and your loved ones this winter, especially if you are feeling sick or planning to travel and gather for the holidays."

Testing is the best way to know for sure if you have a specific respiratory virus so you can take appropriate precautions and get the proper relief or treatment immediately.

Once you know your test results, your pharmacist can help you determine the best next steps and get the appropriate treatment as soon as possible, whether that's a prescription medicine or over-the-counter essentials to manage your symptoms, says Walgreens.

Furthermore, the U.S. CDC recommends getting an annual flu shot before gathering with friends and family this holiday season.

As of December 2, 2023, over 152 million flu vaccines (nasal, cell-based, egg-based) have been distributed in the U.S. and are available at most clinics and pharmacies.

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 influenza.

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.