Vaccine News

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.

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.

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.

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.

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.

The peer-review journal JAMA Network today published updated U.S. Preventive Services Task Force (USPSTF) tuberculosis (TB) screening and treatment guidelines.

The USPSTF estimated TB prevalence is about 5% or up to 13 million persons.

In the U.S., TB remains a significant preventable disease, including active tuberculosis, which may be infectious, and latent tuberculosis infection (LTBI), which is asymptomatic and not infectious but can later progress to active disease.

Announced on May 2, 2023, the USPSTF concluded with a moderate net benefit in preventing active TB by screening for LTBI in persons at increased risk for tuberculosis infection.

The precise prevalence rate of LTBI in the US is difficult to determine.

TB is spread through respiratory transmission.

Approximately 30% of persons exposed to Mycobacterium tuberculosis will develop LTBI, and if left untreated, about 5% to 10% of healthy, immunocompetent persons will progress to having active tuberculosis disease.

This recommendation replaces the 2016 USPSTF recommendation on LTBI screening.

In the U.S., various cities and states are confronting TB outbreaks in 2023.

The Centers for Disease Control and Prevention reported on March 23, 2023, TB cases increased by 5% or more in some cities, such as Houston, in 2022.

Unfortunately, this recommendation does not mention the 100-year-old BCG vaccine as an option to protect children from TB.

As of May 3, 2023, numerous countries offer various BCG vaccines to children to prevent TB.