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Sorrento Therapeutics, Inc. announced today it received clearance from the U.S. FDA to initiate clinical trials with STI-1557, its next-generation mRNA vaccine against SARS-CoV-2 Omicron variants.

This mRNA vaccine candidate incorporates a mutation in the furin cleavage site that prevents the S1 subunit cleavage from the spike protein from anchoring on the muscle cell membrane.

The modification was introduced to prevent the leakage of the S1 subunit from the expressed spike protein (S protein) into the blood circulation, which is known in part to potentially cause undesirable side effects in vital organ tissues following the administration of the current FDA-approved mRNA vaccines.

The mRNA is encapsulated in a Sorrento proprietary lipid nanoparticle formulation to protect mRNAs from degradation and enable the potent translation of the S protein in host cells after intramuscular delivery, thus inducing an adaptive immune response.

The preclinical work that supported this investigational new drug application was published online in Molecular Therapy Nucleic Acids on November 3, 2022, a Cell Press partner journal, and will appear in the December 2022 print issue.

Additional COVID-19 vaccine news is posted at CoronavirusToday.com/Vaccines.

Vaccine Treats: 
COVID-19
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by Gerd Altmann
Live Blog Update Author: 
Don Hackett
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San Diego
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According to the U.S. Centers for Disease Control and Prevention, the ongoing opioid epidemic is a national public health issue exacerbated by the escalating use of synthetic opioids.

To address this epidemic, the U.S. Food and Drug Administration (FDA) accepted Emergent BioSolutions Inc.'s supplemental New Drug Application (sNDA) for NARCAN® (naloxone HCI) Nasal Spray as an over-the-counter (OTC) emergency treatment for known or suspected opioid overdose.

Emergent's sNDA has been granted Priority Review by the FDA and, if approved, would be the first 4 mg naloxone nasal spray available OTC in the U.S. 

The FDA's Prescription Drug User Fee Act goal date is March 29, 2023.

Since its approval in 2015, Emergent has distributed millions of prescription NARCAN devices across the U.S.

Currently, people can purchase NARCAN® directly from their pharmacy without a prescription from their doctor.

"As a leader in the fight to help combat the opioid epidemic, Emergent is committed to increasing access and awareness of naloxone, and we are taking this step to help address the rising and a devastating number of opioid overdoses and fatalities happening across the country," said Robert G. Kramer, president and CEO of Emergent BioSolutions, in a related press release on December 6, 2022.

According to the CDC, deaths related to synthetic opioids increased nearly 60% from 2019 to 2020.

And in 2021, about 71,000 people died from opioids containing fentanyl.

Note: NARCAN® Nasal Spray is a prescription medicine used for the treatment of a known or suspected opioid overdose emergency with signs of breathing problems and severe sleepiness or not being able to respond. Please see the full Prescribing Information.

Vaccine Treats: 
Opioid Overdose
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DRUG POLICY ALLIANCE
Live Blog Update Author: 
Don Hackett
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Gaithersburg
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Pfizer Inc. and Clear Creek Bio, Inc. today announced a research collaboration and exclusive license agreement to advance the discovery and development of potential inhibitors of the SARS-CoV-2 papain-like protease (PLpro) for the oral treatment of COVID-19.

PLpro is an essential enzyme, along with the main protease (Mpro), which plays an important role in viral replication.

Charlotte Allerton, Chief Scientific Officer, Anti-Infectives, and Head of Medicine Design, of Pfizer, stated in a press release on December 6, 2022, “It is critical that we try to stay ahead of the virus, continuing to advance clinical development opportunities for our current oral therapy as well as innovating through our internal programs and strategic partnerships to bring forward additional monotherapy and/or combination treatment candidates that we believe may play a role in the ongoing fight against COVID-19.”

Under the terms of the agreement, the two companies will work together to identify a PLpro candidate to progress into the clinic. At that time, Pfizer will be solely responsible for further development and commercialization activities.

Clear Creek Bio will receive an undisclosed upfront payment and is eligible for additional potential payments.

Additional COVID-19 antiviral news is posted at PrecisionVaccinations.com/Antivirals.

Vaccine Treats: 
COVID-19
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Image Caption: 
by Gerd Altmann
Live Blog Update Author: 
Don Hackett
Location Tags: 
Cambridge
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SQZ Biotechnologies Company today announced that the U.S. FDA granted Fast Track Designation for the Enhanced Antigen Presenting Cell (eAPC) candidate for the treatment of HPV16+ advanced or metastatic solid tumors.

HPV16+ cancers are caused by the expression of E7 and E6 oncoproteins, a source of immunogenic neoantigens.

The SQZ® eAPC platform simultaneously delivers five different mRNAs—each encoding for a different protein that plays a part in stimulating key T cell activation signals required to generate an immune response against tumors—to four different cell types.

The company also presented clinical data from its ongoing Antigen Presenting Cells (APC) and eAPC clinical trials at the European Society for Medical Oncology Immuno-Oncology Congress.

Data also demonstrated that its APC and eAPC therapeutic candidates were well-tolerated among patients treated in its trials.

Manufacturing of the cell product took less than 24 hours, and the median viability of all lots in both clinical trials was greater than 90%.

In the SQZ® eAPC clinical trial, scans showed stable disease as the best overall response for two out of four evaluable patients in low-dose Cohort 1.

A positive ELISpot response for the E7 antigen was observed in one of these patients and correlated with prolonged stable disease.

“Receiving FDA Fast Track Designation underscores the significant potential of our SQZ® eAPC candidate, which is designed to generate an even more powerful immune response than our APC candidate,” said Marshelle Smith Warren, M.D., Chief Medical Officer at SQZ Biotechnologies, in a press release on December 6, 2022.

“The team is working diligently to add more eAPC sites to our study to achieve our goal of a highest-dose monotherapy data readout by the middle of 2023.”

FDA Fast Track Designation is designed to accelerate the development and review of treatments for serious and life-threatening diseases where no therapy currently exists or where the treatment in discovery may be better than what is currently available.

Additional HPV vaccine news is posted at PrecisionVaccinations.com/HPV.

Vaccine Treats: 
HPV Cancers
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by Luis Oliveira
Live Blog Update Author: 
Staff Review
Location Tags: 
Boston
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Given the increase in highly pathogenic avian influenza (HAPI) outbreaks during 2022 in the Region of the Americas, the Pan American Health Organization/World Health Organization (PAHO/WHO), the surveillance of exposed persons is recommended.

As of epidemiological week #48 of 2022, agriculture authorities in Canada, Colombia, Ecuador, Mexico, Peru, the U.S., and Venezuela have detected outbreaks of HPAI H5 viruses in poultry farms, backyards, and wild birds. 

The PAHO/WHO recommends that the Member States strengthen coordination between sectors involved in alerting and responding to zoonotic events.

And implement the necessary measures to contain emerging pathogens that may put public health at risk.

In accordance with the seasonal pattern of HPAI, the number of outbreaks is expected to increase in the coming months of 2022 and 2023.

PAHO/WHO recommended on December 3, 2022, monitoring the occurrence of influenza-like illness or severe acute respiratory infection in people exposed to birds (domestic, wild, or in captivity) infected with influenza viruses.

Given the detection of an infection in humans, early notification is essential for an investigation and implementation of adequate measures that include the early isolation and treatment of the case and the active search for other instances associated with the outbreak.

In the U.S., the Eurasian H5N1 strain first appeared in January 2022 and has affected 46 states and led to the loss of over 53.7 million birds as of December 13, 2022.

The U.S. government has approved a vaccine for one type of bird flu virus and could distribute it if a person-to-person outbreak occurs.

The U.S. Food and Drug Administration (FDA) has authorized CSL Seqirus' Audenz™ monovalent cell-based vaccine.

Notably, the FDA says the annual flu shot is ineffective against HAPI viruses.

Other avian influenza news is posted at PrecisionVaccinations.com/Avain.

Vaccine Treats: 
Avian Flu
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PAHO map
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Staff Review
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Central America
Vaccine: 
Audenz Avian Influenza Vaccine
JYNNEOS vaccine breakthrough cases

More Mpox Vaccine Breakthrough Cases

Monkeypox cases post vaccination confirmed
December 6, 2022

Cholera Outbreaks

Cholera Outbreaks September 2025

The World Health Organization (WHO) has recorded seven cholera pandemics over the past two centuries. The current (7th) cholera epidemic is considered to have started in 1961. As of September 2025, over 409,222 cholera/Acute Watery Diarrhoea cases and 4,738 deaths were reported globally, from 31 countries, with six of the 31 countries reporting case fatality rates above 1%. The WHO's Global Cholera and Acute Watery Diarrhoea Dashboard was updated in 2025. In 2024, 804,721 cholera cases and 5,805 related fatalities were reported from 33 countries. Data show that 472,697 cholera cases were reported to the WHO in 2022, up from 223,370 in 2021.

The U.S. Centers for Disease Control and Prevention (CDC) has identified an unprecedented global increase in cholera outbreaks over the last four years: 2022, 2023, 2024, and 2025. In addition, the Pan American Health Organization (PAHO) and the European CDC, and the WHO have reported active cholera transmissions in Angola, Benin, Cameroon, the Democratic Republic of the Congo, Eswatini, Ethiopia, India, Haiti, Kenya, Malawi, Mozambique, Myanmar, Nepal, Niger, Nigeria, Somalia, South Africa, South Sudan, Tanzania, Uganda, and Zambia, and Syria.

Cholera Cases in the U.S.

With modern water systems, there are now typically fewer than 20 cholera cases a year. Nearly all cholera cases reported in the U.S. are acquired during international travel. As of May 2025, there were (1) cholera cases reported in the U.S. As of December 31, 20224, week #52, eight cholera cases were reported to the CDC this year. In 2023, there were 17 cases, and in 2022, the CDC confirmed that eight travelers infected with cholera arrived from Pakistan, Iraq, and Bangladesh. Additionally, the CDC's Clinician Outreach and Communication Alert in 2023 reported an unprecedented global increase in cholera infections.

Cholera Vaccines

As of September 2025, various cholera vaccines have been approved by the WHO but remain in limited availability globally.

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Cholera is a vaccine preventable disease causing outbreaks in 2025
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Cholera
Airport terminal

Cholera Returns to the U.S.

Over twenty countries have active cholera transmission
December 5, 2022
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Approximately 30% of children exposed to the Zika virus before birth were diagnosed with neurological impairments or microcephaly during their first years of life.

Approximately 2.6% of children born to Zika-infected mothers had microcephaly at birth or when first assessed, rising to 4% across the early preschool years. 

The new research published in The Lancet Regional Health – Americas is based on an analysis of 13 studies conducted from 2015 to 2017 in Brazil, providing the clearest evidence of the scale of the impact associated with Zika infection during an expecting mother's pregnancy.

"The findings underscore the continued need to develop a safe and effective vaccine for preventing Zika virus infections during pregnancy," said Dr. Elizabeth Brickley, Associate Professor of Epidemiology at the London School of Hygiene and Tropical Medicine and a co-author of the study.

"While gaps in population-level immunity to the virus persist, the threat of a Zika virus re-emergence remains a concern for public health," wrote GAVI on December 2, 2022.

In 2022, 31,453 Zika cases were reported in the Region of the Americas.

As of December 5, 2022, the U.S. FDA has not approved a Zika vaccine candidate.

Vaccine Treats: 
Zika
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by Michelle Raponi
Live Blog Update Author: 
Karen McClorey Hackett
Location Tags: 
Brazil
Vaccine: 
mRNA-1893 Zika Vaccine
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To better address the evolving risk of type 2 circulating vaccine-derived poliovirus (cVDPV2), the Global Polio Eradication Initiative (GPEI) with countries are deploying an innovative novel oral polio vaccine type 2 (nOPV2) to reduce the spreading of poliovirus.

The GPEI recently reported about 525 million doses of the nOPV2 polio vaccine had been administered across 25 countries under its WHO Emergency Use Listing.

As of November 30, 2022, an additional 15 countries have met the requirements for nOPV2 use in the event of an outbreak.

The new vaccine is a modified version of the type 2 monovalent Oral Polio Vaccine, which clinical trials have shown provides comparable protection against poliovirus while being more genetically stable and less likely to be associated with the emergence of cVDPV2.

This means that nOPV2 has the potential to be a significant tool to help stop polio outbreaks, says the GPEI.

In 2022, poliovirus was confirmed in non-endemic countries in Africa, Asia, Europe, India, Israel, the United Kingdom, and the state of New York.

To notify people of their potential polio health risks, the U.S. CDC issued an updated global Alert - Level 2, Practice Enhanced Precautions on November 30, 2022.

As of December 5, 2022, the nOPV2 vaccine is not approved by the U.S. FDA.

The IPV vaccine has been offered in the U.S. since 2022.

Additional polio outbreak information is posted at PrecisionVaccinations.com/Polio.

Vaccine Treats: 
Polio
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GPEI
Live Blog Update Author: 
Don Hackett
Location Tags: 
Geneva
Vaccine: 
nOPV2 Polio Vaccine