Why vaccination is important and the safest way to protect yourself

GSK Trails After Pfizer In 5-in-1 Meningococcal Vaccine Race

The FDA has started a review of GSK's five-in-one meningococcal vaccine, cueing up a decision in mid-February next year, as it tries to chase down a rival candidate from Pfizer cleared last year.

The new vaccine is a combination of GSK's already-approved vaccines Bexsero and Menveo and is designed to protect against meningitis and blood poisoning caused by the A, B, C, W, and Y serogroups (MenABCWY) of the bacteria Neisseria meningitidis.

MenABCWY covers five of the six serogroups that cause most disease worldwide, with the B, C, and Y strains responsible for most cases of invasive meningococcal disease (IMD) encountered in the US.

GSK is currently the market leader in the meningococcal vaccine market, racking up sales of £1.26 billion (almost $1.6 billion) last year across the Bexsero and Menveo brands, but is having to play catch-up to Pfizer in the MenABCWY combination category after the FDA cleared the latter's Penbraya in October.

Penbraya also combines elements from Pfizer's meningococcal vaccines Trumenba and Nimenrix, which together made around $300 million in 2023, and started shipping in the US earlier this year.

Also active in the category is Sanofi, which sells MenACWY vaccines Menactra and MenQuadfi, lacking coverage of the B serogroup considered the most common cause of meningococcal disease in the US. Sanofi is working on a MenABCWY shot codenamed SP0230, which is currently in mid-stage clinical development.

The companies see potential for their new vaccines in simplifying immunisation schedules and reducing the number of injections needed – four across two products before Penbraya's launch – as well as potentially enhancing uptake and reducing costs.

They argue that the current need to use multiple meningococcal vaccines to provide coverage across all meningococcal strains has resulted in confusion among consumers and doctors, leading to poor compliance and restricting sales.

In the US, while meningococcal vaccine recommendations for all five serogroups have been in place since 2015, annual immunisation rates for IMD have remained low overall.

With the FDA review now underway, GSK is hoping for a positive verdict for its shot by the action date of 14th February.

"IMD is an unpredictable but serious illness that can cause life-threatening complications," said GSK in a statement. "Despite treatment, among those who contract IMD one in six will die, sometimes in as little as 24 hours. One in five survivors may suffer long-term consequences such as brain damage, amputations, hearing loss, and nervous system problems."

What To Know About Personalized MRNA Cancer Vaccines After Promising Trials From Moderna And Merck

Topline

Cancer vaccines are finally showing promise as Moderna and Merck touted promising data on an experimental skin cancer vaccine and the U.K. Announced plans for a "landmark" scheme to test the technology across the country this week, after decades of research that could bring a new era of personalized medicine.

Moderna is one of the companies researching how mRNA technology can be used to treat cancer.

© 2024 Bloomberg Finance LP Key Facts

Merck and Moderna released "extremely impressive" positive data from a mid-stage trial of the world's first personalized mRNA cancer vaccine for melanoma, the deadliest form of skin cancer, which when used alongside Merck's blockbuster immunotherapy, Keytruda, halved the risk of patients dying or the cancer returning.

The trial, the longest study into the new technology so far, is one of a growing number of collaborations testing how mRNA vaccines — the technology underpinning COVID-19 in shots from Pfizer, BioNTech and Moderna — can be turned against different types of cancer.

mRNA, short for messenger ribonucleic acid, is a kind of informational molecule that carries instructions for cells on how to make proteins, including antigens that can stimulate the immune system.

While mRNA shots for viruses like COVID-19 are designed to prevent disease by instructing cells to produce a harmless viral protein that trains the immune system to recognize and defend against the virus in the future, mRNA cancer vaccines are therapeutic and are for people who already have cancer.

Each vaccine is developed using samples of their cancer and personalized to an individual patient using genetic sequencing and artificial intelligence, priming the immune system to recognize unique mutations or features of the cancer cells and attack them if any are remaining or resurface after treatments like surgery, boosting chances of recovery and remaining cancer free in the future.

Get Forbes Breaking News Text Alerts: We're launching text message alerts so you'll always know the biggest stories shaping the day's headlines. Text "Alerts" to (201) 335-0739 or sign up here.

News Peg

While mRNA cancer vaccines are starting to show promise and experts hint a paradigm shift for cancer treatment is on the horizon, it is still early days for the therapy. The treatments have a long way to go until entering mainstream clinical practice. Until approval, the vaccine treatments are considered experimental and will primarily be available as part of clinical trials, for which patients around the world, including the U.S., are already being recruited. In late May, England announced a first-of-its kind scheme aimed at streamlining the often difficult recruitment process for trials. The country's National Health Service will act as a matchmaker setting up thousands of patients with different clinical trials for specific cancer shots as part of the scheme, which is called the Cancer Vaccine Launch Pad. Victoria Kunene, a clinician leading the trial at Queen Elizabeth Hospital Birmingham, told the BBC she believes the vaccines mark a "new era," adding that she hopes they become "the standard of care" one day.

What To Watch For

Merck and Moderna said they started late stage clinical trials for both their melanoma vaccine and a lung cancer vaccine, both of which are "actively enrolling" participants. The firms have also started mid-to-late stage trials of squamous cell carcinoma, another type of skin cancer, as well as a type of kidney cancer and urothelial carcinoma, which makes up most bladder cancers.

Crucial Quote

Late last year, Moderna CEO Stéphane Bancel told AFP of the melanoma vaccine: "We think that in some countries the product could be launched under accelerated approval by 2025," describing the vaccines as "immunotherapy 2.0."

Key Background

The early successes of Moderna's cancer vaccine has helped shore up confidence in the company and its future. While Moderna flourished during the pandemic, its coronavirus shots remain its only product on the market. This will soon change following the recent approval of its RSV shot, its second ever, but Moderna has struggled to maintain its profile amid an influx of mRNA competitors and dwindling demand for Covid jabs. Though it maintains a robust pipeline of traditional vaccines in development that use its mRNA technology — such as for Lyme disease, flu and norovirus — the company has bet big on its personalized cancer treatments and is clear it plans to be at the forefront of this new frontier of medicine.

Further Reading ForbesCancer Vaccine Trials-Using Same mRNA Tech Behind Covid Shots-Could Launch In U.K. This SeptemberBy 'Medicine is going personalised': Moderna's UK boss on the coming vaccine revolutionMedicine, Technology and the End of CancerThe doctor behind the next big thing in cancer treatmentCNNThousands to trial personalised cancer vaccines

F.D.A. Advisers Recommend A New Covid Vaccine Formula For The Fall

A committee of advisers to the Food and Drug Administration voted on Wednesday to update the formula for the Covid vaccine ahead of an anticipated fall immunization campaign, now an annual step to try to offer better protection against versions of the virus in circulation.

The unanimous vote by the 16 advisers recommends a formula aimed at combating the variant JN.1, which dominated infections in the United States in February, or a version of it. In recent weeks, JN.1 has been overtaken by descendants known as KP.2 and KP.3.

In the coming weeks, the F.D.A. Is expected to formally recommend a variant target for vaccine makers for the next round of shots in the late summer or early fall. Any decision involves some educated guesswork, given that any new vaccine formula won't be available until months after a variant becomes dominant.

"It's becoming clear that the ideal timing for a vaccine composition decision remains elusive," said Jerry Weir, an official with the F.D.A.'s vaccine division.

Dr. Peter Marks, who oversees that division, urged the committee to consider encouraging the mRNA vaccine makers to focus on the latest versions of the virus in broader circulation.

"We always say we shouldn't be chasing strains, but we're paying an incredibly high premium for mRNA vaccines to be able to have the freshest vaccines," he said, referring to the technology used by Moderna and Pfizer. He compared the choice of a vaccine to selecting fresher milk at the grocery store.

We are having trouble retrieving the article content.

Please enable JavaScript in your browser settings.

Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.

Thank you for your patience while we verify access.

Already a subscriber? Log in.

Want all of The Times? Subscribe.

---