Vaccine News

According to an updated Travel Health Advisory, there are now 34 destinations that may have circulating poliovirus.

As of May 3, 2024, the Global Polio Eradication Initiative confirmed various countries reported WPV1, cVDPV2, and cVDPV1 polio cases this year.

On April 26, 2024, the U.S. Centers for Disease Control and Prevention (CDC) reissued its Level 2 - Practice Enhanced Precautions notice regarding recent polio outbreaks.

The CDC says that adults who previously completed the full, routine polio vaccine series may receive a single, lifetime booster dose of polio vaccine before traveling to any destination listed. And to ensure that anyone who is unvaccinated or incompletely vaccinated completes the routine polio vaccine series before departing abroad.

In the U.S., polio vaccination services are generally available at health clinics and community pharmacies.

Previously, the World Health Organization (WHO) confirmed during the 38th meeting of the IHR Emergency Committee for Polio that the spread of the poliovirus remained a Public Health Emergency of International Concern and recommended its extension for a further three months to July 2024 to reduce the risk of the international spread of poliovirus.

Unfortunately, the U.S. is included in the WHO April 2024 notice.

Moderna, Inc. today reported financial results and provided business updates for the first quarter of 2024.

On May 2, 2024, the Company reported $167 million in Spikevax® (COVID-19 vaccine) sales in the first quarter of 2024, compared to $1.9 billion in the same period in 2023, a decrease of 91%.

This sales decline aligns with the anticipated transition to a seasonal COVID-19 vaccine market.

"As we anticipate the launches of our Spikevax 2024-2025 formula and RSV vaccine, we are exercising financial discipline and have intensified our focus on building and utilizing AI technologies to further streamline operations and enhance productivity," said Stéphane Bancel, Chief Executive Officer of Moderna, in a press release.

"With ten late-stage programs and additional new programs advancing toward pivotal studies, we continue to expect numerous product milestones this year across our vaccines and therapeutics portfolio."

"This is the start of a banner year for our vaccine platform as we continue to advance mRNA medicines for patients. This is just the beginning."

A recent announcement of positive interim results from the NEXTCove Phase 3 trial showed that Moderna's next-generation COVID-19 vaccine (mRNA-1283) elicited a higher immune response against both the Omicron BA.4/BA.5 and original virus strains of SARS-CoV-2 compared to Moderna's licensed COVID-19 vaccine (mRNA-1273.222).

The next-generation vaccine is designed to be refrigerator-stable and paves the way for a combination vaccine against influenza and COVID-19 (mRNA-1083). The Company is engaging with regulators on the next steps.

And Moderna's Phase 3 trial of its combination vaccine against seasonal flu and COVID-19 (mRNA-1083) is fully enrolled. The Company anticipates data from the study in 2024.

According to a post on X by @DrPatSoonShiong, the initial 1,000 doses of ANKTIVA® (N-803) shipped on May 1, 2024.

On April 22, 2024, ImmunityBio Inc. announced that the U.S. Food and Drug Administration (FDA) had approved ANKTIVA plus BCG vaccine therapy for treating certain patients with BCG-unresponsive bladder cancer.

The company says Anktiva is the backbone of ImmunityBio's Quantum Oncotherapeutics immunotherapy-based vaccine approach for treating multiple tumor types.

"We hypothesized that activation and proliferation of natural killer cells through IL-15 stimulation could rescue T cells after checkpoint failure, regardless of tumor type or location. As with non-muscle invasive bladder cancer, we believe that ANKTIVA enhanced the NK and T cell activity critical for targeting and killing cancer cells which have entered the phase of tumor evasion and resistance," said Patrick Soon-Shiong, M.D., Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio, in a press release on April 25, 2024.

In 2024, Anktiva is expected to cost $35,800 per dose. ImmunityBio's Patient Assistance Program is expected to ensure access to ImmunityBio's innovative cancer treatment for those in financial support.

Recce Pharmaceuticals Ltd. today announced an Independent Safety Committee approved an increase in dosing to 4,000mg over a fast infusion of 30 minutes in a Phase I/II clinical trial evaluating its lead candidate, RECCE® 327 (R327).

The Company says it identified 30 minutes as the optimum infusion time and increased to a higher concentration per regulatory expectations to investigate R327’s high concentration potential.

“We’re thrilled the independent safety committee has unanimously clearly an increased R327 dose to 4,000mg, over a 30-minute fast IV infusion,” said James Graham, Chief Executive Officer of Recce Pharmaceuticals, in a press release on April 30, 2024.

“The ability to administer high concentrations of a broad-spectrum anti-infective underscores the potential of a novel treatment for millions of patients worldwide with urinary tract infections (UTI) or urosepsis each year.”

Dosing has successfully achieved Minimum Inhibitory Concentration activity among existing clinical samples. The Company has now dosed 3,000mg at multiple infusion times: 15, 20, 30, 45 minutes, and 1 hour.

In accordance with the study protocol, the efficacy of R327 via IV administration will be made available at the completion of the ACTRN12623000448640 trial.

Recce’s New Class of Synthetic Anti-Infectives have a universal mechanism of action with the ability to overcome hyper-cellular mutation of bacteria and viruses. RECCE® 327 is not a preventive vaccine and is not approved for use in humans in any country.

The investigational recurrent UTI vaccine MV140 is available in Australia and various countries in 2024.

Repertoire® Immune Medicines announced today that it has entered a multi-year strategic collaboration with Bristol Myers Squibb to develop tolerizing vaccines for up to three autoimmune diseases.

Repertoire is developing tolerizing vaccines as a new class of programmable medicines for patients with autoimmune diseases.

These vaccines have the potential to re-establish immune homeostasis, leading to durable disease remission in the absence of generalized immune suppression, thereby overcoming the limitations of today's medicines and transforming the lives of patients who have been diagnosed with an autoimmune disease.

The collaboration aims to develop efficacious, selective, and durable treatments for patients suffering from autoimmune disease by resetting the immune system.

Repertoire will lead all activities through to development candidate nomination, while BMS will lead clinical development, regulatory affairs, and commercialization of the tolerizing vaccines under an exclusive worldwide license.

Repertoire will utilize its T cell receptor (TCR)-epitope discovery platform, DECODE, and its proprietary lipid nanoparticle delivery technology to discover and develop the tolerizing vaccine development candidates.

In addition, it will deploy DECODE to monitor immune responses to the tolerizing vaccines in patients during clinical development to provide key insights into the pharmacodynamic effect of the vaccines.

"This agreement is a recognition of the transformative power of Repertoire's DECODE platform to discover and develop programmable T cell targeted immune medicines," said Torben Straight Nissen, Ph.D., CEO of Repertoire and Executive Partner of Flagship Pioneering, in a press release on April 29, 2024.

"We are excited to collaborate with Bristol Myers Squibb to combine their leadership in immunology with our unique ability to discover key disease-associated epitopes in patients with autoimmune diseases. This collaboration enables us to serve patients suffering from autoimmune diseases by translating our DECODE discoveries into potentially transformative medicines that address the underlying cause of their disease." 

Under the terms of the agreement, Repertoire will receive an upfront payment of $65 million and up to $1.8 billion for achieving development, regulatory, and commercial milestones in addition to receiving tiered royalties.

With the creation of efficacious cancer prevention vaccines to target human papillomavirus (HPV) in the first decade of this century, the World Health Organization (WHO) set an ambitious target to lower cervical cancer incidence and mortality by 30% by 2030.

While the WHO targets are aspirational, no country has yet verified that it has reached them.

A presentation by Professor Suzanne Garland at this year's ESCMID Global Congress revealed that even though the evidence is clear and continues to build that HPV vaccination is reducing cervical cancer incidence and mortality and HPV-related disease, there are high variations in coverage globally.

Prof Garland reviewed the WHO Dashboard data, which shows that of 194 reporting countries, 137 (71%) have HPV in their national vaccination programs.

The WHO database shows that the average full vaccine coverage is 44% globally.

Specifically, it shows that Canada, Ireland, Sweden, Spain, and Portugal have full vaccination coverage above 70%, while the USA and Germany trail behind at 50-70%.

Of the HPV national programs reporting to the end of 2023, 42% are for both sexes, while 58% are for girls only.

Globally, 21% of girls have received at least one dose of HPV vaccine by age 15, which has steadily increased from 4% in 2010.

Prof Garland concluded in a press release on April 27, 2024, "Vaccination is a critical component of the global strategy to eliminate cervical cancer as a public health problem."

"There is strong and growing evidence on effectiveness against cervical cancer, with rates falling steadily as vaccination takes effect."

"Scaling up vaccine access and coverage globally is critical to reduce inequities between and within countries."

In the United States, several states are reaching a broad number of boys and girls, while others are lagging.

For example, Texas's HPV vaccination rate for children ages 13–17 is below the national average, ranking 48th out of 50 states and the District of Columbia in 2021. 

In 2021, 51.5% of Texas teens completed the HPV vaccine series.

As of April 29, 2024, HPV vaccines are available at clinics and pharmacies in the U.S.

The Global Polio Eradication Initiative (GPEI) today announced the Kingdom of Saudi Arabia has pledged $500 million over the next five years to support the elimination of polio.

The GPEI stated on April 28, 2024, that these funds will yearly protect more than 370 million children with polio vaccines.

It will also facilitate the delivery of other life-saving interventions, such as nutritional supplements and bed nets, to underserved communities and strengthen health systems to better prepare countries for emerging health threats.

“For decades, polio inflicted lifelong suffering on children and families. Today, we take another step toward finally eradicating it, thanks to the generous contributions of the Kingdom of Saudi Arabia. When we invest in eradicating polio, we make immunization and health systems more resilient, we equip nations to better respond to public health challenges, and most importantly, we ensure that more children can live healthy lives,” said Bill Gates in a press release.

The announcement builds on a long history of support from Saudi Arabia and regional partners to the global polio eradication effort as well as across the Eastern Mediterranean – the last region where wild polio is endemic.

For more than two decades, Saudi Arabia has not only financially supported the GPEI but has also advocated for polio eradication and access to other life-saving vaccines in the Eastern Mediterranean and beyond.

Unfortunately, the GPEI also reported several polio detections this past week.

• Afghanistan: 10 WPV1-positive environmental samples
• Pakistan: two WPV1-positive environmental samples
• Angola: one cVDPV2-positive environmental sample
• Nigeria: two cVDPV2 cases
• Somalia: one cVDPV2 case
• South Sudan: three cVDPV2 cases
• Yemen: one cVDPV2 case and eight positive environmental samples
• Zimbabwe: one cVDPV2-positive environmental sample

To better address the evolving risk of type 2 variant poliovirus (cVDPV2), the next-generation novel oral polio vaccine type 2 (nOPV2) is being deployed in countries affected by these outbreaks.