Vaccine Breaking News

Vaccine breaking news brought to you by Precision Vaccinations

May 30, 2023 • 11:54 am CDT
by Bojan Vuksanovic

The U.S. CDC Morbidity and Mortality Weekly Report (MMWR) Podcast Briefing, published today, offers an overview of the latest scientific information regarding mpox vaccinations.

This podcast discusses three MMWR reports as of the week of May 15, 2023.

First, although the number of mpox cases has decreased since the peak of the U.S. outbreak in August 2022, the risk for future outbreaks remains.

And clinicians need to be alert for new cases, and people at risk should continue to take prevention measures.

Second, a new report looking at data from 12 U.S. jurisdictions shows Bavarian Nordic JYNNEOS® (MVA-BN) vaccine effectively prevents mpox in people at high risk for mpox.

Third, a study of mpox patients in New York provides evidence that the JYNNEOS vaccine is highly effective against mpox. 

However, the CDC and other health agencies in France, South Korea, and Spain previously reported various mpox breakthrough cases in 2023.

May 30, 2023 • 7:52 am CDT
from Pixabay

Immorna today announced that the first subject had been dosed in the Company's First-In-Human Phase 1 multi-center study of JCXH-105, a self-replicating RNA (srRNA) vaccine being developed for the prevention of Shingles.

The U.S. Food and Drug Administration (FDA) cleared its investigational new drug application on January 9, 2023, to conduct a Phase 1 multi-center study of JCXH-105.

NgocDiep Le, M.D., Ph.D., Global Chief Medical Officer of Immorna, commented in a press release on May 30, 2023, "If proven successful in clinical studies, JCXH-105 may become a valuable alternative to current standard-of-care to meet the large world-wide medical need for Shingles prevention."

"Due to its self-replicating nature, JCXH-105 may be effective at a significantly reduced dose level compared to non-replicating conventional mRNA vaccines and thereby may cause less reactogenicity and substantially reduce the cost of production."

"In addition, due to the synthetic nature of all JCXH-105 vaccine components, there are no raw material limitations or production bottlenecks."

This Phase 1 study is a randomized, double-blinded, multi-center, active-controlled study to assess the safety, immunogenicity, and determine the Recommended Phase 2 Dose for JCXH-105 for seniors.

In this study, JCXH-105 will be compared to GSK's U.S. FDA-approved Shingrix® vaccine.

Other shingles vaccine development news is posted by Precision Vaccinations.

May 30, 2023 • 4:10 am CDT
NASA Earth Observatory May 2023

Valneva SE today announced filing a regulatory application with Health Canada for marketing approval of the single-shot chikungunya vaccine candidate, VLA1553.

If accepted by Health Canada, VLA1553 would become available for persons aged 18 years and above.

VLA1553 is currently the only chikungunya vaccine candidate worldwide for which regulatory review processes are underway. It could become the first licensed chikungunya vaccine to address this unmet medical need if approved.

A Biologic License Application is currently under priority review by the U.S. Food and Drug Administration with a Prescription Drug User Fee Act review goal date at the end of August 2023.

VLA1553 received FDA Fast Track and Breakthrough Therapy designations in 2018 and 2021, respectively. The program was also granted PRIority MEdicine designation by the European Medicines Agency in 2020.

Furthermore, Valneva plans to make regulatory submissions for VLA1553 in Europe in the second half of 2023.

Juan Carlos Jaramillo, MD, Chief Medical Officer of Valneva, commented in a press release on May 30, 2023, "Chikungunya represents a major threat for people traveling to or living in areas where chikungunya virus and the mosquitos that transmit it are present, including popular destinations for U.S. and Canadian travelers."

"No vaccine or specific treatments are currently available for this debilitating disease, and we will continue to work diligently to bring VLA1553 to different territories as soon as possible."

Chikungunya is a mosquito-borne viral disease caused by the chikungunya virus, transmitted by Aedes mosquitoes.

An infection leads to symptomatic disease in 72-92% of humans after four to seven days following the mosquito bite. While mortality is low, morbidity is high.

Beginning in 2014, chikungunya virus disease cases were reported among U.S. travelers returning from affected areas in the Americas, and local transmission was identified in Florida, Texas, Puerto Rico, and the U.S. Virgin Islands, says the U.S. CDC.

The high-risk areas of infection for travelers included the Americas, parts of Africa, and Southeast Asia, and the virus has spread to more than 110 countries.

May 29, 2023 • 4:13 pm CDT
U.S. FDA May 26, 2023

The U.S. Food and Drug Administration (FDA) recently issued a draft guidance titled: Diabetes Mellitus: Efficacy Endpoints for Clinical Trials Investigating Antidiabetic Drugs and Biological Products Guidance for Industry.

This draft guidance provides a 15-year update to the FDA's previous recommendations on efficacy endpoints for such products.

"Diabetes is a common disease that affects nearly 40 million people in the U.S. and is projected to affect more in the coming years. Therefore, the need for more antidiabetic treatment options is clear," said Lisa Yanoff, M.D., deputy director of the Office of Cardiology, Hematology, Endocrinology, and Nephrology in the FDA's Center for Drug Evaluation and Research, in a press release on May 26, 2023.

The draft guidance outlines the FDA's general recommendations around evaluating the efficacy of antidiabetic drugs for adults and children with type 1 and/or type 2 diabetes. 

As of May 29, 2023, the FDA has not approved a diabetes preventive vaccine.

May 29, 2023 • 3:49 pm CDT
by JL G.

S.K. Chemicals' SKYCovion COVID-19 vaccine has been authorized by the U.K.'s Medicines and Healthcare Products Regulatory Agency (MHRA).

This authorization is for use as a primary vaccination in those aged 18 and over. Decisions on which COVID-19 vaccines are deployed in the U.K. are taken by the Joint Committee on Vaccination and Immunisation.

As of May 26, 2023, it becomes the 8th COVID-19 vaccine authorized by the U.K.

The SKYCovion vaccine combines a part of the SARS-CoV-2 virus spike protein with an 'adjuvant' – an additional ingredient designed to trigger a more robust immune response. It is given as two injections, four weeks apart.

May 29, 2023 • 10:04 am CDT
by Gerd Altmann

Novavax, Inc. recently announced that Nuvaxovid™ had been recommended for full Marketing Authorization (MA) for use as a primary series in individuals aged 12 and older and as a booster in individuals aged 18 and older for the prevention of COVID-19 in the European Union (EU) following a positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency.

The European Commission is expected to make a final decision on the MA. 

Novavax COVID-19 vaccine Nuvaxovid was the first protein-based vaccine engineered from the genetic sequence of the SARS-CoV-2 beta coronavirus.

"The positive CHMP Opinion for full Marketing Authorization for our COVID vaccine brings us one step closer to full authorization and will provide an approval pathway for an updated vaccine in time for the fall," said John C. Jacobs, President and Chief Executive Officer, Novavax, in a press release on May 25, 2023.

In the EU, Nuvaxovid has been conditionally authorized as a two-dose primary series in adults and adolescents and as a booster dose in adults.

Novavax's COVID vaccine is authorized for use in more than 40 markets worldwide.

The trade name Nuvaxovid has not yet been approved by the U.S. Food and Drug Administration.

Novavax's vaccine is known as CovoVax™ and NVX-CoV2373 globally.

May 27, 2023 • 4:39 pm CDT
by Patou Ricard

After a lull of nearly two months throughout the country, the resurgence of avian influenza (bird flu) in France's South West in May 2023 has triggered an immediate response.

Reuters reported on May 26, 2023, France announced an avian influenza (bird flu) vaccination program would launch in late 2023. 

Marc Fesneau, Minister of Agriculture and Food Sovereignty, called on May 22, 2023, for all avenues to be explored to improve the fight against highly pathogenic avian influenza (HPAI), foremost among which is vaccination.

On April 6, 2023, France launched a tender for 80 million doses of bird flu vaccines. 

Temporary authorization for use has recently been submitted for vaccines for poultry species currently being assessed by the French Agency for Veterinary Medicinal Products and the European Medicines Agency.

To date, only one vaccine for chickens (Gallus gallus species) has marketing authorization in France (2006).

In the U.S., the Department of Agriculture's Agricultural Research Service recently confirmed they are testing several bird flu vaccine candidates. On May 16, 2023, the emergency use of an HPAI vaccine candidate to prevent additional deaths of California Condors. 

Additional avian and human bird flu vaccine development news as of May 27, 2023, is posted by Precision Vaccinations.

May 27, 2023 • 5:15 am CDT
by Jason Goh

According to Japan's National Institute of Infectious Diseases reported on May 14, 2023, the number of syphilis patients totaled 5,164 in 2023. The data for the same period in 2022 was 3,630.

The IDWR Surveillance Data Table week #19 confirmed Tokyo had the most cases at 1,332, followed by Osaka with 699 cases and Fukuoka with 257 cases.

According to the Institute, cases of congenital syphilis have been increasing in recent years, with 20 cases reported in 2022. In 2023, six patients were confirmed by early April.

Congenital syphilis is caused by the bacterium Treponema pallidum, which can be passed from mother to child during fetal development or at birth. Up to half of all babies infected with syphilis in the womb die shortly before or after birth.

"There is a possibility that cases of congenital syphilis will increase along with those of syphilis," commented Prof. Satoshi Takahashi, who heads the Japanese Society for Sexually Transmitted Infections, according to local media on May 24, 2023.

"Syphilis is a curable disease, so people should get tested without hesitation if they have worrisome symptoms or concerns."

As of April 11, 2023, the U.S. Centers for Disease Control and Prevention reported 176,713 syphilis cases in 2021 and 2,855 congenital syphilis cases, resulting in 220 stillbirths and infant deaths, a YOY increase of 32%. 

Unfortunately, the U.S. Food and Drug Administration has not approved a syphilis vaccine as of May 27, 2023.

May 27, 2023 • 4:43 am CDT
U.S. CDC Travel Advisory For Mexico May 26, 2023

The U.S. Centers for Disease Control and Prevention (CDC) today confirmed some US residents returning from Mexico were diagnosed with suspected fungal meningitis infections that have led to severe illness and death.

In a Level 2, Practice Enhanced Precautions advisory issued on May 26, 2023, the CDC stated travelers with these infections had medical or surgical procedures that involved injection of an anesthetic into the area around the spinal column (i.e., epidural) performed at clinics in Matamoros, including River Side Surgical Center and Clinica K-3.

If you had a procedure involving an epidural injection of an anesthetic in Matamoros, Mexico, any time since January 1, 2023, learn what additional steps you should take, says the CDC.

There are millions of fungal species, but only a few hundred of them can make people sick. Fungal meningitis infections are not contagious and are not transmitted from person to person.

Although anyone can get fungal meningitis, people with weakened immune systems are at increased risk.

Certain health conditions, medications, and surgical procedures may weaken the immune system. Symptoms of fungal meningitis infections include fever, headache, stiff neck, nausea, vomiting, confusion, or sensitivity to light.

Fungal meningitis is treated with IV (injected through a vein) and oral medications. The CDC says that treatment length can vary depending on the fungus type.

May 26, 2023 • 1:09 pm CDT
by Mantel Blatt

The U.K. Health Security Agency (UKHSA) today published an analysis focused on the resurgence of mpox in England.

As of May 24, 2023, the UKHSA reported 20 new cases of mpox.

 Of these, 19 were in England (10 cases were presumed to have acquired mpox in the U.K., eight were acquired outside the U.K., and one was waiting for classification), and one was in Scotland.

The UKHSA did not disclose the vaccination status of the mpox cases.

During 2022, there were 3,732 confirmed and highly probable mpox cases reported in the U.K. Of these, 3,553 were in England.

Before 2022, cases diagnosed in the U.K. had been imported from countries where mpox is endemic or contacts with documented epidemiological links to imported cases. Between 2018 and 2021, there were 7 cases of mpox in the U.K. 

Anyone eligible for mpox vaccination in the U.K. is urged to come forward for the vaccine in the coming months to protect themselves before the summer of 2023.

Steve Russell, NHS director of vaccinations and screening, stated in March 2023, "There is still time to get your first and second doses if you haven't already, which will provide long-term protection against the virus and any possible future outbreaks, so please do book an appointment while the offer is available on the NHS."

Bavarian Nordic's JYNNEOS® (MVA-BN) vaccine is offered in the U.K. as well as in the U.S.

Last week, the U.S. Centers for Disease Control and Prevention confirmed a cluster of mpox infections in mostly vaccinated men in the Chicago, Illinois area.

Mpox is a sexually transmitted disease, similar to HPV and hepatitis, that is vaccine-preventable.

May 26, 2023 • 10:33 am CDT
U.S. CDC Flu trends May 26, 2023

The U.S. Centers for Disease Control and Prevention (CDC) today announced week #20 is the last full version of FluView for the 2022-2023 influenza season.

Starting with week #21, an abbreviated summer version of FluView will be published. The full version is expected to resume for week #40 of 2023, which is the start of the 2023-2024 influenza season.

As of May 26, 2023, seasonal influenza activity remains low nationally, with outpatient respiratory illness below baseline in eight of 10 HHS regions.

Unfortunately, 154 pediatric flu fatalities have been reported so far this season.

The good news is the majority of influenza viruses tested are in the same genetic subclade and antigenically similar to the influenza viruses included in this season’s influenza vaccine.

The CDC continues to recommend that everyone ages six months and older get an annual flu shot as long as flu activity continues in their area, or intend to visit a country where the local flu season is accelerating.

Various influenza vaccines remain available at health clinics and pharmacies in the U.S.


May 25, 2023 • 2:24 pm CDT
from Pixabay

Biofabri and IAVI recently announced signing an agreement for the end-to-end development of tuberculosis (TB) vaccine candidate MTBVAC. This agreement provides a framework for the future collaboration that the partners first announced in 2021.

After securing sufficient funding, IAVI plans to begin an efficacy clinical trial in 2024. 

MTBVAC is a highly promising vaccine candidate that has the potential to be used as an alternative to BCG vaccination in infants and for the prevention of TB disease in adolescents and adults. 

"The world urgently needs a new, effective vaccine that can prevent TB disease in adults, adolescents, and infants," said Dr. Mark Feinberg, president, and CEO of IAVI, in a press release on May 17, 2023.

"We are honored to work with Biofabri and our other collaborators to advance MTBVAC."

"In addition, we are actively seeking the support of global health funders and other partners, public and private, to ensure that this promising vaccine candidate has the potential to be part of a solution to ending the TB epidemic." 

Should MTBVAC be safe and efficacious, Biofabri will ensure that the TB vaccine is manufactured and supplied in sufficient quantities globally and is accessible at affordable prices in low- and middle-income countries.

Precision Vaccinations post other TB vaccine and outbreak news.

May 25, 2023 • 10:56 am CDT
U.S. FDA Approval May 25, 2023

The U.S. Food and Drug Administration (FDA) today approved Pfizer Inc.'s oral antiviral Paxlovid™ for treating mild-to-moderate COVID-19 in adults at high risk for progression to severe COVID-19, including hospitalization or death.

Paxlovid is the fourth drug, but the first oral antiviral approved to treat COVID-19 in adults.

Paxlovid manufactured and packaged under the emergency use authorization (EUA) and distributed by the U.S. Department of Health and Human Services will continue to be available to ensure continued access for adults, as well as treatment of eligible children ages 12-18 who are not covered by the FDA's approval on May 25, 2023.

"While the pandemic has been challenging for all of us, we have made great progress mitigating the impact of COVID-19 on our lives," said Patrizia Cavazzoni, M.D., director for the FDA's Center for Drug Evaluation and Research, in today's press release.

"Today's approval demonstrates that Paxlovid has met the agency's rigorous standards for safety and effectiveness and that it remains an important treatment option for people at high risk for progression to severe COVID-19, including those with prior immunity."

"The FDA remains committed to working with sponsors to facilitate the development of new prevention and treatment options for COVID-19." 

Paxlovid is not approved or authorized for use as a pre-exposure or post-exposure prophylaxis to prevent COVID-19.

May 24, 2023 • 3:17 pm CDT
by Margaux Mercier

Prensa Latina recently reported Cuba's COVID-19 vaccines, Soberana 02, Soberana Plus, and Abdala, received the sanitary registration granted by the Center for State Control of Medicines, Medical Equipment, and Devices for their proven efficacy.

The experts and scientists ratified the safety that characterizes Cuba's COVID-19 vaccines, firstly due to the very nature of the technological platforms used and secondly, because they have high thermo-stability.

Unlike others requiring special storage conditions, Cuba's vaccines can be stored between two and eight degrees Celsius at freezing temperatures.

During the clinical studies, vaccine efficacy was higher than 90%.

As of May 24, 203, Cuba is among the world's top 10 countries with most citizens immunized against the SARS-CoV-2 coronavirus, which raises the level of protection to more than 90% of Cuban inhabitants.

May 24, 2023 • 12:29 pm CDT
U.S. Geological Survey May 2023

The Pan American Health Organization (PAHO) recently stated the detection of bird flu outbreaks in Latin America and the Caribbean is a situation never recorded before.

The identified influenza type A Highly Pathogenic Avian Influenza (HAPI) outbreaks are mainly located in areas of the Pacific flyway.

As of May 18, 2023, agricultural authorities in Argentina, Bolivia, Brazil, Canada, Chile, Colombia, Costa Rica, Cuba, Ecuador, Guatemala, Honduras, Mexico, Panama, Peru, U.S., Uruguay, and Venezuela have detected outbreaks of HPAI A(H5N1) viruses in domestic birds, farm poultry and/or wild birds, and in mammals.

Among the mammals identified, red foxes and skunks were the most frequently affected in North America, and fur seals in South America.

To date and since the introduction of avian influenza A (H5N1) in the Americas in 2014, three human infections caused by avian influenza A(H5N1) have been reported: the first in the U.S., reported in April 2022, the second in Ecuador, which was notified in January 2023, and the third in Chile, which was announced in March 2023.

In the U.S., the Audenz™ monovalent cell-based vaccine was authorized on January 31, 2020.

Recently, the U.S. FDA issued a Supplemental Approval in November 2021 for using Audenz in persons at increased risk of exposure to the influenza A virus H5N1 subtype.

The FDA confirmed annual flu shots are not designed to protect people from pandemic influenza.