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Vaccine mega-trials: Rare behemoths in the vaccine trial landscape

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Abstract

The vast majority of vaccines are prophylactic in nature. As a result, the demonstration of their efficacy paradoxically requires the infectious disease to occur among non-diseased study participants randomized between investigational vaccine and appropriate control groups. The statistics of vaccine efficacy (VE) calculation are nearly entirely and solely based on the number of observed incident disease cases during follow-up. For certain diseases, the sample sizes needed to achieve the required number of observations may reach 5,000 subjects or many more, requiring vaccine mega-trials to be conducted. In this article, the author provides an overview of mega vaccine trials conducted over the last 20 years.

Introduction

Prophylactic vaccines generally are intended for healthy or medically stable populations. Administration to hundreds of thousands or even millions of people in a few yea…

Five pharmaceuticals featured on Time’s list of top inventions alongside other medical breakthroughs

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Time magazine’s most recent roundup of 200 inventions included an array of product types, spanning household gadgets and AI applications. Five distinct pharmaceuticals also made the list, not counting a shipping container for biologics and a vaccine for bees. Among the notable pharmaceutical advances on the list are a novel postpartum depression drug, a novel Alzheimer’s therapy, the first FDA-approved RSV vaccine, a blockbuster drug for diabetes and obesity that has driven record-breaking sales for Novo Nordisk. Outside of pharmaceuticals, other medical products that made Time’s list include advanced prosthetic limbs and portable diagnostic devices. Read on to see which pharmaceutical products won the attention of one of the most influential magazines in the U.S.

Zurzuvae, a new PPD treatment option

Zuranolone molecule image from PubChem

HHS awards more than $1 billion to advance next-gen COVID-19 vaccines and therapeutics

The U.S. Department of Health and Human Services (HHS) has awarded $1.4 billion to support vaccine clinical trials to test new, more effective and longer-lasting COVID-19 vaccines. In all, Project NextGen is a $5 billion initiative from Biomedical Advanced Research and Development Authority (BARDA) and the National Institute of Allergy and Infectious Diseases (NIAID).

The aim of the program is to identify and address strengths and weaknesses of current COVID-19 therapies and vaccines, as well as the back the development of next-gen COVID-19 vaccines and therapies

The latest funding announcement announced allots $1 billion for vaccine clinical trials, $326 million for a new monoclonal antibody and another $100 million to spark innovation of novel vaccine and therapeutic technologies.

Towards next-gen COVID-19 vaccines and therapies

Regeneron alone received $326 million under the program, dubbed Project NextGen. The funding for the Tarrytown, New York–bas…

Legal dispute precede Pfizer’s latest FDA nod for RSV vaccine

Amid a backdrop of recent RSV vaccine approvals, GSK and Pfizer find themselves locked in a legal spat over alleged patent infringements. Both Big Pharma giants now possess the FDA’s blessing for their respective respiratory syncytial virus (RSV) vaccines. Pfizer’s recent win came with the second approval for its Abrysvo vaccine, which the company now highlights as the first FDA-approved maternal vaccine to guard infants against RSV.

In early May, GSK’s Arexvy became the first to win FDA’s blessing to protect individuals aged 60 and above from RSV complications. By the end of the month, Pfizer had won approval for Abrysvo in the same age group.

Yet, behind the scenes of these approvals, legal clouds gather. GSK has taken its grievances to a federal court in Delaware, alleging that Pfizer infringed on four of its patents related to its Arexvy vaccine. In a Reuters-posted filing, GSK claims it began work on its RSVPreF antigen in the early 2000s. In th…

Moderna leans on RSV vaccine, AI and a diversified pipeline to regain competitive edge

Moderna surged to prominence thanks to its rapid development of a competitive COVID-19 vaccine. Since the early days of the pandemic, however, the company has struggled to maintain its momentum. Year-to-date, its stock is down close to 40%, trading around $110 per share.

Adapting to COVID-19 variants

The company hopes that its development of vaccines for the XBB.1.5 COVID-19 variant will help bolster financial performance. “We are now awaiting approval to start for our updated COVID-19 vaccine applications to regulators globally,” Moderna CEO Stéphane Bancel said.

Developing a robust pipeline

Moderna CEO Stéphane Bancel has stressed in the past that Moderna is more than a COVID-19 company. “Our commercial team is also preparing for the 2024 launch of our next respiratory commercial product,” Bancel said. This product in question, a vaccine for respiratory syncytial virus (RSV) could potentially compete against products from GSK and Pfizer, among others.

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Codagenix taps synthetic biology and machine learning in vaccine development

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In the quest to outsmart viral foes such as SARS-CoV-2, RSV and influenza, Codagenix, a clinical-stage biotech firm based in Farmingdale, New York, has engaged a unique arsenal: the intersection of synthetic biology and machine learning. Their weapon of choice is a blend of live-attenuated virus design and codon deoptimization technology. Their process involves introducing mutations or ‘bad codons’ into the virus to slow its replication rate in the human host, thus converting it from a deadly pathogen into a live attenuated vaccine.

A machine learning-aided algorithm meticulously guides this process, ensuring the modifications are safe and effective. “We recode the DNA of a virus to slow down the rate of translation in the human host cell,” said J. Robert Coleman, the co-founder and CEO of Codagenix.

All viruses use the body to replicate t…

An overview of the RSV vaccine candidate landscape in early 2023

[RSV image from NIAID]

Respiratory syncytial virus (RSV) remains a prominent global health concern. Each year, the virus is to blame for 2.1 million outpatient visits for children under 5 years old, according to CDC. Other vulnerable populations, including older adults and immunocompromised individuals, are also at risk.

Nevertheless, RSV has long been a research focus. Scientists first identified RSV in 1956. A year later, the pediatrician and virologist Robert M. Chanock linked RSV to respiratory infections in children. Attempts to develop a vaccine for the virus soon followed.

Despite numerous attempts beginning in the 1960s, an FDA-approved RSV vaccine has remained elusive until recently. Out front is GSK’s (NYSE:GSK) RSV vaccine for adults aged 60 and older, which has won the backing of an FDA advisory panel. Close behind is Pfizer’s (NYSE:PFE) single-dose vaccine for the same a…