Vaccine News

Vaccine news brought to you by Precision Vaccinations.

Jun 26, 2023 • 9:18 am CDT
STI-1558 is a prodrug

Sorrento Therapeutics, Inc. today announced the full enrollment in a pivotal Phase 3 study of the oral Mpro inhibitor, Ovydso (STI-1558), in mild or moderate symptomatic adults infected with SARS-CoV-2, or COVID-19.

Sorrento anticipates that top-line data from the study will be available in the third quarter of 2023.

Once the data is finalized, Sorrento plans to open discussions with regulatory authorities worldwide to discuss the path required for each particular authority for full approval of Ovydso.

If the trial meets its endpoints, the company has agreements with the China Health Authority and the National Medical Products Administration (NMPA) for an application review.

“We are pleased to see that Ovydso has enrolled quickly for successful completion of enrollment for the phase 3 pivotal trial in China. We look forward to seeing the final data and to working closely with the NMPA during the review to evaluate this as a potential stand-alone treatment for COVID-19 patients as rapidly as possible,” stated Henry Ji, Ph.D., Chairman and CEO of Sorrento, in a press release on June 26, 2023.

STI-1558 is a prodrug, and its active form AC1115 binds to Cys-145 of the catalytic domain of Mpro, which is 100% conserved in all SARS-CoV-2 variants and achieves a broad-spectrum anti-SARS-CoV-2 activity.

STI-1558 is also a Cathepsin L inhibitor, which may block effective viral entry into host cells without accelerating viral mutations.

Sorrento is a clinical and commercial stage biopharmaceutical company based in California. 

Jun 24, 2023 • 3:29 pm CDT
by Omar Medina

Pfizer Inc. recently announced that the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) unanimously voted to recommend PREVNAR 20® (20-valent Pneumococcal Conjugate Vaccine) for routine use to help protect infants and children from invasive pneumococcal disease (IPD) caused by the 20 Streptococcus pneumoniae serotypes covered by the vaccine and for the prevention of otitis media in infants six weeks through five years of age caused by the original seven serotypes contained in PREVNAR®.

These provisional recommendations will be reviewed and finalized by the director of the CDC and the Department of Health and Human Services.

“We are thrilled with today’s ACIP decision as it recognizes the increased level of protection that PREVNAR 20 will provide to millions of infants and children against pneumococcal disease,” said  Luis Jodar, Ph.D., Chief Medical Affairs Officer, Vaccines/Antivirals and Evidence Generation, Pfizer, in a press release on June 22, 2023.

Previously, the European Medicines Agency approved the brand name Apexxnar in February 2022.

Jun 23, 2023 • 4:48 pm CDT
by Tammon

The Florida Health Department recently published an updated Mosquito-Borne Disease Surveillance that revealed additional dengue and malaria patients in Florida.

As of June 17, 2023, the Weekly Arbovirus Report confirmed:

  • Four cases of dengue were reported in persons with international travel. In 2023, 88 travel-associated dengue cases were reported. And two cases of locally acquired dengue have been reported.
  • Another case of locally acquired malaria was reported in Sarasota County. In 2023, two cases of locally acquired malaria have been reported.

In response to these mosquito-transmitted diseases, Florida has issued alerts for Sarasota and Manatee counties regarding malaria.

And in Miami-Dade County, a dengue alert was issued in April 2023.

The Florida Department of Health is working with local partners and county mosquito control in these areas to mitigate the risk of further mosquito transmission.

Florida continues statewide surveillance for mosquito-borne illnesses, including West Nile virus, Eastern equine encephalitis, St. Louis encephalitis, malaria, chikungunya, and dengue.

From a vaccination perspective, one dengue vaccine is approved in the U.S., and malaria vaccines are currently available in Africa as of June 23, 2023.

Jun 23, 2023 • 4:12 pm CDT
Emergency Management Sarasota County, FL

The Florida Department of Health (DOH) in Sarasota and Manatee Counties recently confirmed a second locally-acquired malaria case.

As of June 19, 2023, this patient was being treated for this mosquito-cause infection.

This case has been identified as the P. vivax malaria species, which is not as fatal as other species.

In response, a mosquito-borne illness alert was issued for Sarasota and Manatee counties.

On May 26, 2023, DOH released information on the first confirmed local malaria case, who was treated and recovered.

Effective treatment is readily available through Florida hospitals and other healthcare providers.

The Florida Department of Health confirmed aerial and ground mosquito spraying is being conducted in these counties to mitigate the risk of further transmission.

Malaria is not transmitted from person to person.

Only infected Anopheles mosquitoes can transmit malaria to humans.

Malaria infects approximately 219 million people each year, with an estimated 660,000 deaths, mostly children in Africa. 

The U.S. Centers for Disease Control and Prevention (CDC) recently stated the risk of locally acquired malaria in the U.S. is extremely low. 

About 2,000 malaria cases are diagnosed annually in the U.S., most in international travelers.

However, Florida has had malaria outbreaks in the past.

In 2003, eight locally acquired P. vivax malaria cases were reported in Palm Beach County, FL. 

From a prevention perspective, malaria vaccines have already been approved.

The World Health Organization recommended the Mosquirix™ malaria vaccine in 2021, and the R21/Matrix-M™ vaccine was approved for use in Africa in 2023.

Jun 23, 2023 • 3:33 pm CDT
UKHSA flu results June 2023

The UK Health Security Agency (UKHSA) recently reported that during week #24, from most indicators, influenza activity remained stable in the United Kingdom.

As of June 22, 2023, the UKHSA confirmed there were no influenza confirmed outbreaks were reported in England.

In week #24, influenza remained low and stable at 0.4% compared with the previous week, with the highest positivity seen in the 15 to 44 age group at 0.9%.

And influenza ICU admissions remained low and stable within the baseline range of activity. 

Other flu seasonality news is posted by Precision Vaccinations.

Jun 23, 2023 • 3:15 pm CDT
U.S. CDC

Invivyd, Inc. recently announced positive initial data from its ongoing Phase 1 clinical trial of its lead investigational monoclonal antibody (mAb) candidate, VYD222.

VYD222 is a broadly neutralizing, half-life extended mAb candidate in development for the prevention of symptomatic COVID-19 in vulnerable populations, such as immunocompromised people.

Initial Phase 1 data show that a single administration of VYD222 was generally well-tolerated at all three dose levels tested, with no serious adverse events reported to date.

At the lowest VYD222 dose tested (1500 mg), geometric mean serum neutralizing titers were 3245.1 (95% CI: 1882.5, 5594.0) against Omicron XBB.1.5 at Day 7, with a geometric mean 38.87-fold rise (95% CI: 10.3, 146.8) from baseline to Day 7 (n=8).

Greater VYD222 dose levels are designed to provide greater protection from any potential loss of neutralization activity as SARS-CoV-2 evolves.

Dave Hering, chief executive officer of Invivyd, stated in a press release on June 22, 2023, "Based on previously published clinical data from randomized controlled clinical trials, we believe that mAb directed against the receptor binding domain of the SARS-CoV-2 spike protein offer an attractive safety profile, even at higher doses, and that strong serum neutralization activity would be predictive of clinical benefit."

Additional COVID-19 monoclonal antibody news is posted by Precision Vaccinations.

 

Jun 23, 2023 • 7:40 am CDT
by Charlotte

The U.S. Centers for Disease Control and Prevention (CDC) today announced the mpox outbreak in Chicago, Illinois, has reached 40 individuals.

As of June 23, 2023, the CDC's Morbidity and Mortality Weekly Report confirmed that mpox vaccine breakthrough cases were reported to the Chicago Department of Public Health.

The observed proportion of cases among persons who had received JYNNEOS® (MVA-BN) smallpox/mpox or ACAM2000 smallpox vaccines in this cluster was unusual.

Mpox breakthrough cases averaged eight months since the last vaccination.

During March 18–June 12, 2023, 40 laboratory-confirmed mpox cases were identified in Chicago, including 22 (55%), five (13%), and 13 (33%), respectively, among patients who had received two doses of JYNNEOS or one dose of ACAM2000 vaccine, those who had received one vaccine dose of JYNNEOS vaccine, and those who had not received any vaccines for mpox.

All cases occurred among persons assigned male sex at birth; 37 (93%) identified as male and 28 (70%) as gay.

The median age was 33 (IQR = 23–49).

Eleven (28%) patients were living with HIV, 10 of whom had received two doses of JYNNEOS or one dose of ACAM2000 vaccine and whose HIV was well-controlled (CD4 count >200 cells/mm3 and viral load <200 viral copies/mL).

Three (8%) patients experienced concurrent sexually transmitted infections during mpox diagnosis.

Of six live births, two neonates developed lesions within one week after their mothers became symptomatic.

This investigation is ongoing. However, no similar clusters are being seen elsewhere in the U.S.

Preliminary sequencing indicates the virus is the same B.1 variant of Clade IIB, the predominant variant of the 2022–2023 outbreak.

The CDC wrote that this increase in mpox cases before significant summer events scheduled nationwide and in Chicago raised concerns about possible future case increases.

Although the cause of this cluster has not yet been determined, leading hypotheses include a potentially high number of sexual exposures in a network with many vaccinated persons, decreased vaccine effectiveness due to waning of humoral immunity, or vaccine mishandling or administration errors.

Mpox outbreak news and other sexually transmitted disease vaccine news are posted by Precision Vaccinations.

Jun 22, 2023 • 1:28 pm CDT
U.S. CDC - Chikungunya outbreak June 2023

Throughout 2023, Chikungunya outbreaks have been reported in various countries in the Region of the Americas.

On June 22, 2023, Susan Hills, MBBS, MTH, led the U.S. Centers for Disease Prevention and Control (CDC) Chikungunya Vaccines Work Group presentation, highlighting the ongoing outbreak in the Republic of Paraguay.

As of June 4, 2023, 167,239 Chikungunya cases and 263 related deaths in 2023.

Furthermore, Paraguay's geographic neighbors Argentina, Brazil, and Uraguy have been impacted.

To alert international travelers, the CDC issued a Level 1 - Practice Usual Precautions Travel Health Notice in April 2023.

From 2006–2021, 4,590 chikungunya cases in travelers were confirmed in the U.S.

Chikungunya outbreaks are caused by the chikungunya virus and is spread to humans through mosquito bites. The CDC stated that people at risk for severe disease include infants, older adults, and those with comorbidities.

People should seek medical care if they develop fever, joint pain, headache, muscle pain, joint swelling, or rash.  

Unfortunately, the CDC has not recommended a preventive vaccine in 2023.

There are two Chikungunya vaccine candidates conducting late-stage clinical trials.

The VLA1553 monovalent, single-dose, live-attenuated vaccine candidate has been assigned a U.S. FDA Prescription Drug User Fee Act review goal date at the end of August 2023 and has filed a regulatory application with Health Canada.

Additionally, the CDC reviewed surveys on June 22, 2023, regarding awareness of chikungunya and the value of a chikungunya vaccine among travelers.

Only 18% had heard of chikungunya before the survey, and few were aware of pending vaccine approvals.

Jun 22, 2023 • 11:19 am CDT

The U.K. Health Security Agency today published the National Influenza and COVID-19 Report for week #25.

The overall positivity for Respiratory Syncytial Virus (RSV) remained low at 0.4%, with the highest positivity in those under five years old at 1.6%.

And emergency department attendance for acute bronchiolitis remained stable nationally in the U.K.

Additionally, In week #24, influenza activity remained stable from most indicators, and COVID-19 activity decreased.

In the U.S., RSV seasonality is generally identified in the state of Florida. As of mid-June 2023, Florida has not reported an RSV outbreak.

Jun 22, 2023 • 10:59 am CDT
UKHSA COVID-19 report June 22, 2023

The U.K. Health Security Agency (UKHSA) today announced COVID-19 surveillance data indicates hospital admission rates in the U.K. have decreased in almost all age groups in week #24 compared with the previous week.

On June 22, 2023, the Respiratory Datamart reported that SARS-CoV-2 positivity decreased to 4.2% compared with the previous week.

Overall, through syndromic surveillance indicators, emergency department attendance for covid-like illness remained stable nationally.

This UKHSA report is based on data from week 24 (between June 12 and June 18, 2023) and, for some indicators, daily data up to June 20, 2023.

Jun 22, 2023 • 9:58 am CDT
from Pixabay

The U.S. CDC recently published new guidance on Measles during the summer of 2023. Measles outbreaks are occurring in all World Health Organization regions.

Over the past year, measles outbreaks have been reported in the European, African, Eastern Mediterranean, Western Pacific, and Southeast Asian regions.

On June 21, 2023, Health Alert Network Health Advisory (CDCHAN-00493) offered guidance for measles prevention to international travelers and to be on alert for future measles cases in 2023.

The measles virus is contagious and easily spread while flying in an airplane or riding in buses or trains.

As of June 8, 2023, CDC has been notified of 16 confirmed U.S. measles cases across 11 jurisdictions, with 88% linked to international travel.

Based on current estimates, twice as many Americans are planning to travel internationally in 2023 compared with 2022. Many countries and popular travel destinations 

To prevent measles infection and spread from importation, all U.S. residents should be up to date on their measles vaccinations, especially before international travel, regardless of the destination.

As of June 22, 2023, various measles vaccines are authorized worldwide.

Jun 21, 2023 • 4:21 pm CDT
U.S. CDC typhoid vaccine June 2023

The U.S. Centers for Disease Control and Prevention (CDC) recently confirmed an outbreak of extensively drug-resistant (XDR) typhoid fever continues to occur in 2023.

As of June 16, 2023, the CDC's Level 1 - Practice Usual Precautions notice says cases of XDR typhoid fever have been reported worldwide, mostly among travelers returning from Pakistan.

If you are visiting Pakistan or other countries in South Asia where typhoid is common, protect yourself by getting a typhoid fever vaccination before your trip.

In the U.S., two types of typhoid fever vaccines are available. 

If you were vaccinated in the past, ask your doctor or pharmacist if it is time for booster vaccination, says the CDC.

And take extra care to follow safe food and water guidelines during your trip and wash your hands thoroughly with soap and water before eating or touching food.

Do not prepare food for others if you become ill.

If you get sick while traveling, seek medical care. 

The strains (kind) of Typhi that cause XDR typhoid fever do not respond to most antibiotics used to treat the disease, says the CDC.

Visit Getting Health Care During Travel to learn how to connect with a doctor or medical services during your trip.

If you get sick after returning to the U.S., seek medical care, and tell your healthcare provider where and when you traveled.

As of June 21, 2023, typhoid fever vaccine news is posted by Vax-Before-Travel.

Jun 21, 2023 • 4:01 pm CDT
FIFA Women’s World Cup 2023

The U.S. Department of State recently issued two travel advisories that indicate Australia and New Zealand are prime destinations for a summer vacation in 2023.

This is essential news since the FIFA Women’s World Cup 2023 will occur across Australia and New Zealand in nine cities from July 20 through August 20, 2023.

On June 16, 2023, the State Department issued a Level 1: Exercise Normal Precautions notice for Australia.

And a similar travel advisory was issued for New Zealand.

Before visiting these countries in 2023, the U.S. government suggests enrolling in the Smart Traveler Enrollment Program to receive alerts during an emergency.

From a health perspective, dengue outbreaks are a risk in this area.

The U.S. CDC says to check the travel vaccines and medicines list and visit your healthcare provider at least a month before visiting these countries in 2023.

Jun 21, 2023 • 1:41 pm CDT
New York State Health Dept poliovirus June 2023

The U.S. CDC's Advisory Committee on Immunization Practices (ACIP) workgroup focused on polio and poliovirus today proposed updated guidance regarding vaccinations in the U.S.

The ACIP began debate on updating its vaccination recommendation following one paralytic polio case in an unvaccinated adult in Rockland County, NY was confirmed in 2022.

Furthermore, wastewater testing confirmed poliovirus detections in several New York counties in 2022 and 2023.

The CDC stated this finding likely indicated about 1 to 2 thousand people in southern New York had mostly asymptomatic infections.

As of June 21, 2023, the ACIP committee is voting on this language: Adults who have received a primary series of tOPV or inactivated poliovirus vaccine (IPV) in any combination and are at increased risk of poliovirus exposure may receive another dose of IPV.

And the available data do not indicate the need for more than a single lifetime booster dose with IPV for adults.

Sanofi Pasteur's single-antigen Imovax Polio® (Ipol®) is a highly purified IPV with enhanced potency, says the U.S. FDA

Furthermore, this CDC guidance would apply to adults at increased risk of exposure to poliovirus, including travelers who are going to countries where polio is epidemic or endemic.

Globally, several countries have reported polio outbreaks in 2023. To alert international travelers, the CDC recently reissued a polio alert.

Jun 21, 2023 • 9:05 am CDT
by Lora Leathco

GSK plc today announced new data from the AReSVi-006 phase III trial evaluating the efficacy of a single dose of AREXVY™ against lower respiratory tract disease caused by the respiratory syncytial virus (RSV) in adults aged 60 years and older over multiple RSV seasons and after annual revaccination.

The results presented on June 21, 2023, show that one dose of AREXVY is efficacious against RSV-LRTD and severe LRTD over two full RSV seasons.

In a press release, Tony Wood, Chief Scientific Officer of GSK, stated, "These data show the efficacy of a single dose of our vaccine over two RSV seasons against RSV-LRTD, including in the populations most at risk due to age or underlying medical conditions."

"This reinforces our confidence in its potential to make a significant public health impact."

"We look forward to discussing these results with regulators and vaccine recommending bodies and collecting more data from the ongoing clinical development program."

As of June 2023, there are two approved RSV vaccines for older people in the U.S.

UPDATE - The ACIP voted to recommend AREXVY on June 21, 2023.