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Meissa Vaccines announced positive safety and immunogenicity data for MV-012-968, the company's intranasal live attenuated Respiratory syncytial virus (RSV) vaccine candidate.
Meissa is developing MV-012-968 as a needle-free, adjuvant-free vaccine to protect infants and toddlers from the respiratory syncytial virus (RSV).
The company says RSV is the leading cause of infant hospitalization in the United States and is considered a "missing" pediatric vaccine.
The clinical study in RSV-naïve (seronegative) participants between the ages of six and 36 months enrolled 79 participants at multiple sites in the U.S. to evaluate the safety and immunogenicity of MV-012-968 (NCT04909021).
At the highest dose tested, no serious adverse events related to vaccination were reported with no evidence of any lower respiratory tract symptoms, no Grade 2 or 3 fever observed, and low level, transient vaccine shedding detected.
All RSV-naïve infants and toddlers demonstrated a vaccine response to two doses of 107 PFU.
Serum-neutralizing antibody responses to MV-012-968 were robust and comparable to those seen with previous live attenuated RSV vaccine candidates demonstrating high efficacy against medically-attended RSV disease.
Moreover, MV-012-968 demonstrated significantly greater tolerability to date than these previous candidates.
"With this outstanding safety and robust serum antibody response, we believe Meissa's live attenuated vaccine has the potential to be a best-in-class solution to protect infants and toddlers from RSV, and we are now preparing to advance MV-012-968 into a Phase 2/3 clinical trial next year (2024)," said Martin Moore, Ph.D., co-founder and Chief Scientific Officer, Meissa Vaccines, in a press release on August 8, 2023.
"These data also demonstrate the power of our AttenBlock platform to generate live attenuated vaccines with outstanding safety and immunogenicity – something that we've not seen with other platforms."
As of August 10, 2023, the U.S. FDA has approved RSV vaccines for seniors and antibody therapies for infants.
The World Health Organization (WHO) published Influenza Update N° 451 that stated virus detections remained low, with activity in many countries in the southern hemisphere now decreasing after having peaked in recent weeks.
And no exceptional flu outbreaks were confirmed over the past two weeks.
On August 7, 2023, the WHO reported that influenza activity decreased in Oceania, Central America, and temperate South America, with influenza A viruses predominant.
Furthermore, in the temperate zones of the northern hemisphere, influenza activity was reported at low levels or below the seasonal threshold in most reporting countries.
And in the Caribbean countries, influenza activity remained low overall.
As of August 10, 2023, over 100 million flu shots are available at most health clinics and pharmacies in the U.S.
SK bioscience recently announced that it secured 6.5 million shares of common stock through a private placement investment in Novavax, a global company advancing protein-based vaccines with its novel Matrix-M™ adjuvant.
Concurrent with the equity investment announcement, SK bioscience and Novavax have extended their current license agreement, adding Novavax's updated COVID-19 vaccine ((Nuvaxovid, CovoVax, NVX-CoV2373)
The agreement serves as a strategic shift of partnership from the pandemic period to the endemic phase, in which SK bioscience will obtain exclusive rights to Novavax's COVID-19 variant vaccine in South Korea and non-exclusive rights in Thailand and Vietnam to supply and commercialize the vaccine.
Jaeyong Ahn, CEO of SK bioscience said in a press release on August 8, 2023, "We believe that the strategic equity investment and the continuous cooperation between SK bioscience and Novavax, which are among the few companies that focused on developing COVID-19 vaccines during the pandemic, will create a powerful synergy."
Through the enhanced partnership, SK bioscience will explore potential future collaborations with Novavax such as utilizing Novavax's adjuvant, Matrix-M. Novavax also develops COVID-Influenza combination, stand-alone influenza, and high-dose COVID-19 vaccine candidates.
Taiwan's Centers for Disease Control (TCDC) today reported seven new mpox cases. The patients develop symptoms like fever, swollen lymph nodes, and blistering rash between July 24 and August 1, 2023.
As of August 7, 2023, a total of 266 mpox cases (250 local cases and 16 imported cases) have been diagnosed.
The TCDC stated that according to the research, mpox vaccination (Jynneos) could effectively reduce the risk of infection.
In July, Taiwan expanded its mpox immunization drive at 125 medical institutions, especially those who have been "infected with sexually transmitted diseases.
According to statistics from the TCDC, as of August 7, 2023, a total of 77,809 Mpox vaccination services have been completed, including 447 post-exposure prophylaxis vaccinations and 77,362 pre-exposure prophylaxis vaccinations.
About 25,803 people have completed two vaccinations, and 19,510 people received only one dose.
As influenza and respiratory syncytial virus (RSV) seasons approach the U.S., health leaders focus on pregnant women's vaccination needs.
The Centers for Disease Control and Prevention (CDC) will conduct a Clinician Outreach and Communication Activity (COCA) webinar on August 10, 2023, to share updated clinical vaccination guidance for pregnant women.
The CDC and the American College of Obstetrics and Gynecology emphasize the importance of vaccinations for pregnant women and recommend vaccinations against pertussis, flu, and COVID-19 to protect themselves and their babies during the first few months of life.
The CDC says there have been recent declines in vaccination coverage for Tdap (tetanus, diphtheria, and pertussis) and flu shots and low uptake of COVID-19 vaccines among pregnant women.
During Thursday's COCA Call, presenters (Naima T. Joseph MD, MPH, Tara C. Jatlaoui, MD, MPH) will give a comprehensive overview of the timing and promotion of vaccines people should receive during pregnancy and provide an update on RSV vaccine candidates for pregnant women.
This one-hour webinar is scheduled for Thursday, August 10, 2023, 2:00 PM – 3:00 PM ET, at Webinar Link:
https://www.zoomgov.com/j/1604412918; ID: 160 441 2918; Passcode: 650748. Note: Zoom recently modified its privacy policies.
Updated August 10, 2023 - presentation slides.
Dallas County Health and Human Services (DCHHS) today reported the first West Nile Virus (WNV) death in Dallas County, Texas, for the 2023 season.
The patient was a female resident in the City of Irving diagnosed with West Nile Neuroinvasive Disease.
This is the second WNV human death reported in Texas this year.
For 2023, a total of one hundred and sixty-seven mosquito traps have tested positive for WNV.
Over the last five years, Texas has had 485 WNV cases and 65 related deaths.
“It’s very sad to report the first West Nile Virus death this season,” said Dr. Philip Huang, Director of DCHHS, in a press release on August 9, 2023.
“This again reminds us how important it is to protect against mosquito bites that can carry multiple diseases like WNV. Mosquito activity remains high in Dallas County.”
DCHHS says most people exposed to WNV don’t get sick, but about 20% develop symptoms like headache, fever, muscle and joint aches, nausea, and fatigue. In a small proportion, less than 1%, the virus affects the nervous system, leading to the more severe West Nile neuroinvasive disease that can cause neck stiffness, disorientation, tremors, convulsions, paralysis, and even death.
Aedes albopictus and Aedes aegypti mosquitoes, which transmit WNV, are currently circulating in Texas and remain active in much of Texas into November and December.
As of August 9, 2023, no U.S. FDA-approved WNV vaccines are available.
The World Health Organization (WHO) today reported a steady increase in the proportion of SARS-CoV-2 coronavirus variant EG.5 reported, and based on its characteristics, EG.5 may spread globally & cause a surge in COVID-19 cases.
However, as of August 9, 2023, while EG.5 has shown increased prevalence, growth advantage, and immune escape properties, there have been no reported changes in COVID-19 severity to date.
Based on the available evidence, the public health risk posed by EG.5 is evaluated as low globally, aligning with the risk associated with XBB.1.16 and the other currently circulating variants of interest.
During epidemiological week #29 (17 to July 23, 2023), the global prevalence of EG.5 was 17.4%.
This is a notable rise from the data reported four weeks prior (week 25, 19 to June 25, 2023), when the global prevalence was 7.6%, wrote the WHO.
The U.K. Health Security Agency (UKHSA) today announced the Joint Committee on Vaccination and Immunisation (JCVI) published its new advice regarding persons eligible for COVID-19 booster vaccination in autumn 2023.
Announced on August 8, 2023, the JCVI considers it appropriate to offer COVID-19 vaccines to all adults aged 65 years and over.
From autumn 2023, JCVI additionally advises that a primary course COVID-19 vaccination for persons who have not had any COVID-19 vaccines before should consist of a single dose.
Professor Wei Shen Lim, Chair of COVID-19 immunization on the JCVI, said in a press release, "The autumn booster program will continue to focus on those at greatest risk of getting seriously ill."
"It is important that everyone eligible takes up a booster this autumn – helping to prevent them from hospitalizations and deaths arising from the virus over the winter months."
Specifically, the JCVI published the following sub-groups:
- residents in a care home for older adults
- all adults aged 65 years and over
- persons aged six months to 64 years in a clinical risk group, as laid out in the Immunisation Green Book, COVID-19 chapter (Green Book)
- frontline health and social care workers
- persons aged 12 to 64 years who are household contacts (as defined in the Green Book) of people with immunosuppression
- persons aged 16 to 64 years who are carers (as defined in the Green Book) and staff working in care homes for older adults.
Dr. Mary Ramsay, Director of Public Health Programmes at the UKHSA, commented, #The booster is being offered to those at higher risk of severe illness, and by taking up the booster vaccine this autumn, you will increase your protection ahead of winter, when respiratory viruses are typically at their peak."
To optimize protection over the winter months, the JCVI advises that the autumn program should aim to complete vaccinations by early December 2023, mindful that vaccine protection is highest in the first 3 months following vaccination.
COVID-19 vaccine effectiveness rates in the U.K. are posted at this link.
Novavax, Inc. today announced its operational highlights for the second quarter ended June 30, 2023.
"During the first half of 2023, Novavax has been focused on execution, making significant progress on all three of our key priorities. We have initiated the filing for authorization of our updated XBB COVID vaccine in the U.S., with submissions in the European Union and Canada to follow. We are manufacturing at commercial scale in support of our plan to deliver our vaccine on time for the fall season," said John C. Jacobs, President and Chief Executive Officer, Novavax, in a press release on August 8, 2023.
"We continue to work towards deriving additional value from our pipeline and technology and will be advancing our COVID-Influenza Combination vaccine candidate through the next stage gates and towards late-stage development."
Novavax also received first Full Marketing Authorization in Europe for Nuvaxovid™ as a primary series in individuals aged 12 and older and as a booster in adults aged 18 and older.
Since authorization, Nuvaxovid™, a protein-based vaccine, has been distributed in about 40 markets.
On July 11, 2022, Novavax announced an agreement with the U.S. HHS to secure 3.2 million doses of Novavax's COVID-19 vaccine.
And the company initiated the rolling submission of a U.S. Biologics License Application for full approval of the Novavax COVID-19 Vaccine, Adjuvanted for adults and adolescents aged 12 through 18.
