Vaccine News

GSK plc today presented preliminary positive results from the phase III trial evaluating the immunological vaccine effectiveness and safety of its MenABCWY combination vaccine candidate.

On Mau 12, 2023, the vaccine candidate demonstrated non-inferiority in primary endpoints for five  Neisseria meningitidis serogroups (A, B, C, W, and Y) compared to two doses of Bexsero® (meningococcal group B vaccine) and one dose of Menveo (meningococcal group A, C, W-135, and Y conjugate vaccine) in 10–25-year-olds.

In addition, the vaccine candidate was generally well tolerated, with a safety profile consistent with Bexsero and Menveo.

In a separate confirmatory arm of this phase III trial, the MenABCWY vaccine candidate showed immunological effectiveness against a panel of 110 diverse meningococcal serogroup B (MenB) invasive strains, which account for 95% of strains circulating in the US.

Professor Terry Nolan, principal investigator for the phase III trial and Head of the Vaccine and Immunisation Research Group at the Peter Doherty Institute for Infection and Immunity at the University of Melbourne and Murdoch Children's Research Institute, said in a press release, "Meningococcal vaccination can help save lives, and these results are significant in moving one step closer to protection against five meningococcal serogroups with a single vaccine."

"The potential for a simplified immunization schedule could improve accessibility for the target population susceptible to meningococcal disease."

Five Neisseria meningitidis serogroups (A, B, C, W, and Y) account for nearly all invasive meningococcal disease (IMD) cases worldwide.

Meningitis B is the most common serogroup in the US, accounting for more than half of meningococcal disease cases among 16–20-year-olds. 

Currently, immunization coverage rates for Men B are estimated at approximately 31% of adolescents in the US.

GSK stated it is working closely with regulatory agencies to review the complete phase III data set, including the supplemental Biologics License Application for Bexsero, to confirm full licensure under the Accelerated Approval pathway. Detailed results will be submitted for publication in a peer-reviewed scientific journal later in 2023.

Precision Vaccinations publishes meningococcal vaccine news.

The first participant recently received a dose of a Zika virus vaccine candidate in a phase 1 clinical trial conducted by the University of Liverpool at the Clinical Research Facility within the Royal Liverpool University Hospital.

This study is essential since Zika remains an ongoing threat, with thousands of cases of the mosquito-borne virus reported annually, in countries such as Brazil, Belize, Guatemala, Paraguay, and Bolivia.

And in 2023, Puerto Rico reported 21 probable Zika cases.

And pregnant women continue at the highest risk for the infection as the virus can cause severe fetal congenital disabilities, such as microcephaly, a condition where a baby's head is much smaller than expected.

It's hoped that the vaccine, designed to be suitable for use during pregnancy, wrote these researchers on May 2, 2023.

“Zika should not be forgotten, especially since climate change contributes to the spread of the Aedes mosquitoes to countries without immunity. Vaccines like ours will enable us to be better prepared for the next Zika outbreak,” commented Dr. Krishanthi Subramaniam in a press release on April 27, 2023.

The vaccine originates from a 2016 Zika Rapid Response grant awarded to Dr. Tom Blanchard and colleagues at the University of Manchester in collaboration with the UK Health Security Agency.

Dr, Blanchard has since developed several iterations to enhance the vaccine's effectiveness and manufacturing scale-up.

Liverpool researchers have been driving this project forward since 2017. The team has used an approach to develop a vaccine based on studies to understand immunity to Zika and other related viruses.

As of May 11, 2023, there are no U.S. FDA-approved Zika vaccines.

The Republic of Costa Rica Ministry of Health continues to monitor work on dengue cases in different areas such as Sarapiquí and Río Cuarto.

As of May 9, 2023, epidemiological week #16, a total of 1,179 cases of dengue were reported, with the Huetar Caribe and Central Sur regions presenting the most cases.

Given the previous declaration of a dengue outbreak by the North Central Region, a total of seven officers were displaced to work in the town of Santa Rita and Río Cuarto to assist with fumigation efforts.

Costa Rica was included in the U.S. CDC's recent dengue outbreak travel advisory for the Americas.

Almost half of the world's population, about 4 billion people, live in areas with a risk of dengue. Moreover, dengue is often a leading cause of illness in high-risk areas, says the U.S. CDC.

Dengue is caused by one of four related viruses. For this reason, people can be infected with dengue multiple times in their life.

Approximately 1 in 20 patients with dengue virus disease progress to develop a severe, life-threatening disease called severe dengue.

Dengue vaccines are approved and available in certain countries as of May 11, 2023.

Additional Costa Rica disease outbreak news is posted by Vax-Before-Travel.

The U.S. Centers for Disease Control and Prevention (CDC) has scheduled for today at 2 pm ET a Clinician Outreach and Communication Activity (COCA) call with updated recommendations for COVID-19 vaccine use.

During this COCA Call on May 11, 2023, presenters will discuss updated COVID-19 vaccine recommendations by age group and for those with immunocompromise.

Sara Oliver, MD, MSPH, and Evelyn Twentyman, MD, MPH, will also highlight optional COVID-19 vaccine doses for specific populations.

With a simplified schedule, the CDC recommends that everyone stay up to date with recommended COVID-19 vaccines to better protect themselves from severe illness.

Most people in the United States have not yet received an updated (bivalent) mRNA COVID-19 vaccine, with less than 17% uptake.

The Webinar Link: https://www.zoomgov.com/j/1619378091; ID: 161 937 8091; Passcode: 499465.

The Kingdom of Lesotho recently confirmed a measles outbreak in the capital city of Maseru, which has a population of over 300,000.

In response, through the Maseru District Health Management Team, the Ministry of Health launched a measles vaccination campaign in mid-April 2023. 

Measles is a severe disease that can be prevented with safe and effective vaccines.

Lesotho is located in the country of South Africa, which has been reporting measles outbreaks in 2023.

South Africa's National Institute for Communicable Diseases reported in April the percentage of samples testing positive for measles remained at 27%.

Unfortunately, the Mountain Kingdom's 2022 measles vaccination campaign turnout was about 33% in 2022.

Before 2019, Lesotho had gone about ten years without a measles outbreak.

Measles outbreak news and alerts are posted by Vax-Before-Travel.

Sinovac Biotech Ltd. today announced it would provide its CoronaVac® vaccine to self-paying groups in Hong Kong and confirmed a donation plan.

Additionally, the company will collaborate with local charity groups to provide donations, giving more children in Hong Kong access to free its inactivated original strains COVID-19 vaccine.

On March 31, 2023, the Government of the Hong Kong Special Administrative Region announced that beginning April 20, 2023, high-risk groups would be able to receive free doses of COVID-19 vaccines.

Whereas low-risk groups, including children, can only receive their vaccines via the private market through self-pay.

"SINOVAC's ongoing fight against COVID-19 is based on our mission to 'supply vaccines to eliminate human diseases,'" said Yin Weidong, Chairman, President, and CEO of SINOVAC, in a press release on May 10, 2023.

"From developing the COVID-19 vaccine to obtaining market approvals, from the first CoronaVac® shipment landing in Hong Kong 800 days ago to the rollout of a massive public vaccination program, SINOVAC and Hong Kong have taken steps together to emerge from the shadows of the pandemic."

CoronaVac® is the first COVID-19 vaccine to be used in children from as young as three years old, under the World Health Organization's Emergency Use List.

As of March 2023, CoronaVac® has been authorized for use in more than 60 countries, regions, and international organizations. But not in the U.S.

The cumulative global vaccine supply exceeds 2.9 billion doses.

Novavax, Inc. today announced that its COVID-Influenza Combination (CIC), stand-alone influenza, and high-dose COVID vaccine candidates all showed a reassuring preliminary safety profile and comparable reactogenicity to individual Novavax influenza and COVID vaccine candidates or authorized influenza vaccine comparators.

Additionally, all three vaccines demonstrated preliminary robust immune responses.

In all groups, no adverse events (AE) of special interest, no potentially immune-mediated medical conditions, and no treatment-related serious AEs.

"The reactogenicity results support our previous observations that this technology is well suited for combination vaccines because large amounts of antigen can be incorporated without impacting tolerability," said Filip Dubovsky, President, Research and Development, Novavax, in a press release on May 9, 2023.

"The immune responses we observed were robust, and the data we have shared today significantly increase the probability of Phase 3 success."

Furthermore, the highest dose stand-alone COVID vaccine candidate achieved statistically significant anti-S IgG and neutralization responses, approximately 30% higher than Novavax's prototype COVID vaccine while maintaining comparable safety and reactogenicity to the currently authorized dose level of Nuvaxovid™.

Various CIC vaccine candidates are in late-stage development as of May 9, 2023.