Vaccine News

Vaccine news brought to you by Precision Vaccinations.

May 8, 2023 • 1:59 pm CDT
UNICEF cervical cancer rates May 2023

UNICEF recently announced it would supply 52 countries with human papillomavirus (HPV) vaccines. In 2023 alone, UNICEF will provide one in four countries worldwide with this life-saving vaccine.

And seven countries, Bangladesh, Cambodia, Eswatini, Kiribati, Mongolia, Nigeria, and Togo, intend to introduce HPV vaccines to their routine immunization programs in 2023. 

On April 28, 2023, UNICEF confirmed just one in eight girls are vaccinated against HPV, the leading cause of cervical cancer.

And since 2019, HPV vaccination coverage has decreased by 15%, representing one of the largest backslides of any vaccine during the pandemic.

Oluwaseun Ayanniyi, a Contracts Specialist in the Vaccine Centre of UNICEF’s Supply Division in Copenhagen, commented that she is optimistic that significant ground can be regained to prevent cervical cancer.

HPV vaccination can help prevent certain cancers for boys and girls, says the U.S. CDC. These vaccines are generally available at health clinics and pharmacies in the U.S.

As of May 8, 2023, the U.S. Food and Drug Administration has approved various vaccines that can prevent certain sexually transmitted diseases such as Mpox.

May 8, 2023 • 7:22 am CDT
by Mojca-Peter

CureVac N.V. today announced that the first participant was dosed in a combined Phase 1/2 study of multivalent, modified mRNA seasonal flu vaccine candidates developed in collaboration with GSK is being conducted in the U.S. and Belgium.

The tested multivalent vaccine candidates address all four WHO-recommended flu strains.

"Our clinically validated technology platform and second-generation mRNA backbone give us great confidence as we continue clinical development of novel vaccine candidates to address seasonal flu," said Dr. Myriam Mendila, Chief Development Officer of CureVac, in a press release on May 8, 2023.

"There are still unmet needs as seasonal flu is ever-evolving and immune responses to current vaccines remain a challenge, particularly in older adults."

"The flexibility, speed, and scalability of CureVac's end-to-end mRNA capabilities position us well to develop and deliver seasonal flu vaccines together with GSK that combat dominant strains of the season as they emerge."

As previously reported, in CureVac and GSK's ongoing Phase 1 trial in older and younger adults of a monovalent, modified mRNA seasonal flu vaccine candidate, preliminary data showed a favorable tolerability profile and no concerning safety signals. In addition, the preliminary immunogenicity data indicated strong hemagglutinin inhibition immune responses in line with a licensed flu comparator vaccine beginning at the lowest tested dose.

The CureVac-GSK infectious disease collaboration was first announced in July 2020.

May 7, 2023 • 3:57 pm CDT
WHO Influenza Report May 2023

The World Health Organization (WHO) recently published Influenza Update N° 444, indicating that some Southern Hemisphere countries reported increased influenza detections.

On May 3, 2023, the WHO reported in the Caribbean and Central American countries, influenza activity of mainly influenza B/Victoria lineage viruses was low or below baseline in most countries.

Moreover, increases in influenza activity were reported in a few countries, and activity was moderate in Jamaica.

In tropical Africa, influenza detections were low in reporting countries. Influenza A virus detections outnumbered B virus detections.

In Southern Asia, influenza activity remained low, with influenza A(H3N2) predominant, followed by B/Victoria lineage viruses. However, increased activity was reported in Bhutan and Sri Lanka.

In South-East Asia, influenza activity remained elevated mainly due to detections in Malaysia and Singapore.

However, in Malaysia, activity decreased.

But there was an increased proportion of influenza A viruses over the past several weeks, and influenza A viruses predominated during this period.

On the other hand, influenza A(H3N2) viruses remained predominant in Singapore.

In the temperate zones of the southern hemisphere, influenza activity remained low.

And influenza activity increased slightly in Australia and Chile, and pneumonia surveillance in South Africa. 

As of May 7, 2023, the WHO continues endorsing flu shots for the summer holiday season, wherever influenza outbreaks occur.

In the U.S., various influenza vaccines remain available at health clinics and community pharmacies. 

As of early March 2023, about 173 million flu shots had been distributed during the 2022-2023 flu season. 

May 7, 2023 • 3:33 pm CDT
U.S. FDA May 4, 2023

The U.S. Food and Drug Administration (FDA) announced on May 4, 2023, a future meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC).

On June 15, 2023, the VRBPAC will meet in an open session to discuss and make recommendations on selecting strain(s) to be included in the periodic updated COVID-19 vaccines for the 2023-2024 vaccination campaign.

This discussion will include consideration of the vaccine composition for fall to winter 2023-2024. And it will be open for viewing by the public and will be hosted at this YouTube link

The Docket Number is FDA-2023-N-1553.

The VRBPAC provides independent expert advice to the FDA on broad scientific topics or certain products to help the agency make sound decisions based on the available science. Advisory committees make non-binding recommendations to the FDA, which generally follows the recommendations but is not legally bound to do so. 

The FDA currently endorses mRNA and protein-based COVID-19 vaccines and monoclonal antibody therapies.

On April 4, 2023, InflaRx N.V.'s Gohibic (vilobelimab), a first-in-class monoclonal anti-human complement factor C5a antibody, was granted an Emergency Use Authorization by the FDA.

Recently, the World Health Organization announced the ending of its pandemic declaration for COVID-19 since it is now an established and ongoing health issue that no longer constitutes a public health emergency of international concern.

May 7, 2023 • 2:06 pm CDT
U.S. CDC anthrax May 2023

The Express News Service today reported 12 cases of anthrax, and one related fatality was recently reported in the villages of Dasmantpur.

Two others were being treated, and nine others are currently stable.

Preliminary examination suggests locals of Tentuliguda village reportedly consumed cow meat, after which they began showing symptoms of anthrax.

The Koraput district of Odisha, India, is an area endemic for anthrax.

Last year, anthrax was confirmed in 36 people in Tengwe in Zimbabwe, after consuming undercooked meat.

According to the U.S. CDC, cutaneous anthrax in humans is associated with exposure to infected animals or animal products and has a case fatality rate of up to 20% if untreated.

People can get sick with anthrax if they come in contact with infected animals or contaminated animal products. Anthrax can cause severe illness in both humans and animals. 

The Anthrax Vaccine Adsorbed (AVA) protects against anthrax and does not contain any anthrax bacteria and cannot give people anthrax.

It is not typically available to the general public, says the CDC. 

The Food and Drug Administration approved the vaccine for routine occupational use (before possible exposure) and post-event emergencies.

In the U.S., Emergent BioSolutions Inc.'s AV7909 (AVA) vaccine has been funded partly by the government for several years and is approaching authorization.

May 7, 2023 • 12:30 pm CDT
NY Dept of Health May 2023

The New York (N.Y.) Department of Health recently issued an updated Poliovirus Wastewater Surveillance Report. Wastewater is sewage containing feces flushed down the toilet and other water from household drains. 

Polio is highly contagious, and people can spread the virus even if they don't know they're sick. However, individuals infected with polio shed the virus in their stool, says N.Y.

On May 1, 2023, NY reported 1,170 samples had been tested for polio, with one positive sample of concern found in Rockland County.

In 2022, sequencing analysis confirmed the presence of poliovirus in a total of 100 positive samples of concern in Sullivan, Rockland, Orange, Nassau, and New York City. 

N.Y.'s Health Department also clarified wastewater collected in sewer systems could not be a polio infection or transmission source for the general public. It does not contaminate drinking water, including tap water, streams, and lakes.

The U.S. CDC announced on November 30, 2022, that it would expand wastewater testing. Dr. José R. Romero, Director of CDC's National Center for Immunization and Respiratory Diseases, indicated that poliovirus testing would continue into early 2023. 

In 2022, about 35 countries have confirmed similar findings from wastewater testing.

The U.S. CDC confirms polio is a vaccine-preventable disease.

And in 2023, N.Y. recommends a one-time polio vaccination booster for certain people. In addition, various polio vaccines are available at clinics and pharmacies in the U.S.

May 5, 2023 • 4:05 pm CDT
SIGA Technologies, Inc.

SIGA Technologies, Inc. today reported financial results ($8.3 million in revenue) for the three months ended March 31, 2023. Most of this revenue came from the Mpox oral treatment TPOXX®.

"First quarter product revenues primarily reflect the sale of oral TPOXX to the U.S. Department of Defense ("DoD"), which marks the third product delivery to the DoD within the past twelve months," said Phil Gomez, CEO of SIGA, in a press release on May 4, 2023.

"Including the $5 million of deliveries in the first quarter, we are targeting approximately $11 million of oral TPOXX deliveries to the DoD in 2023."

"In addition, based on the anticipated expiration this year of significant quantities of TPOXX held within the U.S. Government's Strategic National Stockpile ("SNS"), we are targeting for this year approximately $113 million of oral TPOXX deliveries to the SNS."

"We will continue to build and meet the demand for oral TPOXX across geographic regions worldwide and continue to work toward deliveries this year of IV TPOXX to the SNS."

TPOXX is a novel small-molecule antiviral known as tecovirimat and ST-246®, available as an orally administered and IV formulation for treating human disease caused by the variola virus.

TPOXX was approved in the U.S. (July 13, 2018), Canada, U.K., and Europe to treat smallpox and Mpox in 2022.

However, recent reports indicate uncertain product efficacy.

The U.S. CDC published Notes from the Field on April 28, 2023, describing New York City patients with Mpox who developed new lesions after completing tecovirimat treatment, suggesting post-treatment lesions might occur more commonly than previously reported.

As of April 26, 2023, the CDC confirmed 87,078 Mpox cases and 130 related fatalities from 111 counties since May 2022.

And as of May 5, 2023, Bavarian Nordic JYNNEOS® (MVA-BN) vaccine remains available to prevent Mpox infections.

May 5, 2023 • 3:23 pm CDT
U.S. CDC Mpox outbreaks May 2023

The World Health Organization (WHO) Africa Region recently reported new Mpox cases were reported from the Democratic Republic of the Congo (DRC) and other countries in the past two weeks.

Of reported Mpox cases as of April 30, 2023, 106 new cases were reported from the DRC, two from Nigeria, two from Liberia, and one from Ghana on 

Since the start of 2023, DRC has reported 277 laboratory-confirmed cases.

Nineteen (19) Mpox-related fatalities have been reported in the African region since 2022 from Nigeria (9), Ghana (4), Cameroon (3), Central African Republic (1), Mozambique (1), and Sudan (1).

And in the European Region, 17 cases of mpox have been identified from 8 countries and areas over the past four weeks.

Throughout the Mpox outbreak identified in May 2022, 45 countries and areas throughout the European Region have reported cases.

In the U.S., the CDC has reported 30,361 Mpox cases and 42 related fatalities.

As of May 5, 2023, Mpox vaccines, testing, and treatments remain available in most countries.

May 5, 2023 • 10:10 am CDT
by Fas from Pixabay

The U.K. Health Security Agency today announced that parents in England should check their children's measles, mumps, and rubella (MMR) vaccine records following an increase in measles cases.

As of May 4, 2023, HPR volume #17, issue 5, revealed from January to April 20, 2023, there were 49 lab-confirmed measles cases in England.

Thirty-three (67%) of these measles cases were in London, 40% in children under five years, and 27% in those 15 to 34 years.

An analysis of data published by Public Health England highlighted that population immunity levels in the U.K. were below those required to interrupt measles transmission in many birth cohorts.

Uptake for the first dose of the MMR vaccine in children aged two years in England is 89%, and uptake of two MMR doses at age five years is 85.5%.

This data is below the 95% target the World Health Organization set as necessary to achieve and maintain elimination.

In a related press release, NHS Director of Vaccinations and Screening Steve Russell commented, "The MMR vaccine has helped prevent the development of potentially life-threatening illness among millions, and it is clear that when uptake falls, infections rise."

"So I strongly urge parents to review the status of their child's vaccinations to protect them and others from MMR."

In the U.S., the CDC recently reported ten measles cases in eight jurisdictions (Kentucky, Utah) so far in 2023 and 121 measles cases (Ohio) in 2022.

Internationally, measles outbreaks have been confirmed in various countries, such as India, with over 60,000 cases.

Measles is a very contagious disease but is preventable by vaccination.

Various MMR vaccines are generally available in clinics and community pharmacies in the U.S.

May 5, 2023 • 8:56 am CDT
WHO COVID-19 case may May 4, 2023

The World Health Organization (WHO) today announced the ending of the COVID-19 pandemic, which began in late 2019.

The first cases of novel SARS-CoV-2 coronavirus were detected in China in December 2019.

On May 5, 2023, the WHO Director-General concurred with advice regarding the ongoing COVID-19 pandemic. He determined that COVID-19 is now an established and ongoing health issue that no longer constitutes a public health emergency of international concern.

While the global risk assessment remains high, there is evidence of reducing risks to human health driven mainly by high population-level immunity from infection, vaccination, or both.

For example, the WHO Edition #141, announced on May 4, 2023,  indicates a decrease in COVID-19 cases of 17% and a 30% reduction in related fatalities compared to the previous 28 days.

 

May 4, 2023 • 2:40 pm CDT
U.S. Embassy Lima map May 4, 2023

The U.S. Department of State recently announced an update to its Level 2: Exercise Increased Caution travel advisory for the Republic of Peru.

On May 2, 2023, the State Department highlighted some areas in Peru have an increased risk of civil unrest. And confirmed U.S. government personnel can not travel freely throughout Peru for security reasons.

And do not travel to these areas:

  • The Colombian-Peruvian border area in the Loreto Region,
  • The Valley of the Apurímac, Ene, and Mantaro Rivers, including areas within the Departments of Ayacucho, Cusco, Huancavelica, and Junin, and,
  • The Puno Region, including the Peruvian side of Lake Titicaca, and the Apurimac Region due to civil unrest.

U.S. travelers participating in Ayahuasca and Kambo ceremonies should be aware that numerous persons, including U.S. citizens, have reported that while under the influence of these substances, they have witnessed or been victims of sexual assault, rape, theft, serious health problems and injuries, and even death.

If you visit Peru, the local embassy suggests enrolling in the Smart Traveler Program to receive alerts during an emergency.

The U.S. Embassy Lima is located atAvenida La Encalada cdra. 17 s/n, Surco, Lima 33, Peru.

From a health perspective, the U.S. CDC suggests pre-trip travel vaccinations for diseases such as yellow fever, malaria, and dengue, as well as route vaccinations such as measles and an annual flu shot.

These vaccines are generally available at certified travel clinics and pharmacies in the U.S.

May 4, 2023 • 1:17 pm CDT
WHO COVID-19 Edition #141 May 4, 2023

The World Health Organization (WHO) today announced a decrease of 17% in COVID-19 cases and a 30% reduction in related fatalities, respectively, compared to the previous 28 days.

However, Edition #141 indicates this positive pandemic picture is mixed at the regional level.

At the regional level, the number of newly reported 28-day COVID-19 cases increased across three of the six WHO regions: 
the Eastern Mediterranean Region (+8%), the Western Pacific Region (+15%), and the South-East Asia Region 
(+454%).

While cases decreased in three WHO regions: the African Region (-49%), the European Region (-37%), and the Region of the Americas (-34%). 

As of May 4, 2023, most countries have COVID-19 vaccines, antivirals, and monoclonal antibody therapies available.

Previously, a non-peer-reviewed study revealed on April 26, 2023, that the SARS-CoV-2 XBB.1.16 virus lineage had become the most predominant variant in India. The study also shows that the clinical features and outcome of XBB.1.16* cases were similar to those of other co-circulating Omicron lineage infected cases in Maharashtra, India.

Updated on May 7, 2023 - insert relevant study and related link.

May 4, 2023 • 10:42 am CDT
by Kevin Ellis

The U.S. Centers for Disease Control and Prevention (CDC) recently confirmed Maricopa County, Arizona, experienced its fifth and largest West Nile Virus (WNV) outbreak in 2021.

As of April 28, 2023, the greater Phoenix area reported 1,487 WNV cases, 1,014 (68%) hospitalizations, and 101 (7%) related fatalities.

Most identified WNV cases resulted in neuroinvasive disease and occurred among older adults.

The reason for the unprecedented WNV outbreak in 2021 remains unknown.

Since WNV was first detected in 2003, it has become endemic in Maricopa County.

In 2022, California and Colorado (204) also reported WNV cases.

The CDC says WNV is a mosquito-borne disease and is the leading domestically acquired arboviral disease. WNV can cause severe illness affecting the brain and spinal cord, with an associated case fatality rate of 10%.

As of May 4, 2023, no U.S. FDA-authorized West Nile virus vaccines exist.

May 4, 2023 • 10:04 am CDT
by Kevin Hartung

InflaRx N.V. recently announced that Gohibic (vilobelimab), a first-in-class monoclonal anti-human complement factor C5a antibody, has been granted an Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) for the treatment of COVID-19 in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation, or extracorporeal membrane oxygenation.

The FDA issued EUA #118 on April 14, 2023.

InflaRx has a supply of Gohibic available and is working to ramp up production at its third-party manufacturer to roll out supply in the U.S. as soon as possible.

In a related press release, Prof. Niels C. Riedemann, CEO and Founder of InflaRx, said, "We are thrilled and very proud that the FDA has issued a EUA for vilobelimab to treat this very sick patient group, recognizing the lifesaving potential of this first-in-class drug."

According to the U.S. National Institutes of Health (NIH), monoclonal antibody (mAbs) products that target the SARS-CoV-2 coronavirus spike protein have been shown to have clinical benefits in limiting and treating infections that cause COVID-19. mAbs treatments block SARS-CoV-2 from entering cells in the human body.

May 4, 2023 • 7:12 am CDT
Moderna Inc. May 4, 2023

Moderna, Inc. today announced financial results and provided business updates for the first quarter of 2023.

"We had a strong first quarter, with $1.9 billion in revenue, clearly indicating that we are on our way to deliver on the $5 billion of signed Advance Purchase Agreements for 2023," said Stéphane Bancel, Chief Executive Officer of Moderna, in a press release.

"In addition, we are encouraged by the progress of new COVID-19 vaccine contracts in the U.S. for this fall with pharmacy chains, hospital networks, and multiple U.S. government agencies."

"Similar discussions are ongoing with Japan, the EU, and other key markets such as Australia, which recently ordered additional COVID-19 vaccines."

"..... we are fully preparing for potential commercial launches of two products in 2024, our RSV and flu vaccines."

Moderna's respiratory pipeline includes Phase 3 trials against RSV, influenza, and a next-generation COVID-19 candidate.

The mRNA pipeline includes four additional influenza vaccines with expanded antigens, vaccines against other respiratory pathogens (e.g., hMPV), and six combination vaccine programs.

Moderna's unedited press release is posted at this link.