Vaccine News

The Bill & Melinda Gates Medical Research Institute today announced that a Phase 3 clinical trial to assess the efficacy of the M72/AS01E tuberculosis (TB) vaccine candidate is now underway in South Africa.

At full capacity, the trial will include up to 20,000 participants, including people living with HIV, at up to 60 trial sites in seven countries.

If shown to be well-tolerated and effective, M72/AS01E could potentially become the first vaccine to help prevent pulmonary TB in adolescents and adults, the most common form of the disease.

Furthermore, M72/AS01E would be the first new TB vaccine in over a century.

While TB is one of the world’s deadliest infectious diseases, the only available vaccine is Bacille Calmette-Guerin (BCG), which dates back to 1921.

BCG vaccines initially targeted against TB, tuberculosis meningitis, and non-specific protective effects against respiratory tract infections and certain cancers.

Various reports indicate that the BCG vaccine offers inadequate protection for adolescents and adults against the pulmonary form of the disease, which is primarily responsible for transmitting the TB bacterium.

The journal Vaccines recently published a Short Communication that presented a benefit–risk assessment for the Novavax COVID-19 protein-based vaccine (NVX-CoV2373).

Published on March 16, 2024, this analysis used data on myocarditis/pericarditis cases observed in the NVX-CoV2373 clinical studies, real-world data of mRNA COVID vaccine effectiveness against predominant SARS-CoV-2 strains in early 2023, and recent COVID-19 burden of disease data from the U.S.

The benefits of NVX-CoV2373 vaccination were estimated as the number of COVID-19 cases, hospitalizations, and deaths prevented. The risks of myocarditis/pericarditis cases and related hospitalizations and deaths occurring within seven days of vaccination were also estimated.

In our analysis, vaccination with NVX-CoV2373, per 100,000 vaccinated, prevented an estimated 1805 COVID-19 cases, compared with an estimated 5.3 excess myocarditis/pericarditis cases.

The number of COVID-19 hospitalizations and deaths prevented were also greater than vaccine-associated myocarditis/pericarditis hospitalizations and deaths.

Our analysis indicates a positive benefit–risk balance for NVX-CoV2373, concluded these researchers.

In October 2023, the U.S. Food and Drug Administration amended the EUA of the Novavax COVID-19 Vaccine, Adjuvanted (Nuvaxovid™ XBB.1.5) for use in individuals 12 and older, to include the 2023-2024 formula. 

In the U.S., the current Novavax COVID‑19 Vaccine is available at certain pharmacies, including Costco, CVS Pharmacy, Giant, Publix, Rite Aid, and Stop & Shop.

The U.S. National Center for Health Statistics (NCHS) Mortality Surveillance data available on March 14, 2024, indicates that 0.7% of the deaths that occurred during the week ending March 9, 2024 (Week 10) were due to influenza.

This percentage increased (≥ 0.1 percentage point change) compared to last week's data.

NCHS's data also confirmed that 13 influenza-associated pediatric deaths were reported to the U.S. CDC during Week 10. The total number of pediatric deaths for the 2023-2024 flu season is now 116. 

As of March 17, 2024, the CDC continues to recommend that everyone six months and older get an annual flu vaccine as long as influenza viruses are spreading. Vaccination can still provide benefits this flu season.

Various egg, cell, and nasal flu shots remain available at most community pharmacies in the U.S.

The composition of flu vaccines is reviewed annually, and new flu vaccines are manufactured each year. For the 2024-2025 flu season, many countries are transitioning to trivalent flu vaccines.

Various reports suggest that Africa's mpox Clade 1 outbreak has recently intensified. As of mid-March, the Democratic Republic of the Congo (DRC), Eurosurveillance, and the World Health Organization released updated mpox outbreak figures for 2024.

These reports revealed 14,626 suspected cases for the last year, with 654 fatalities. This equates to a case-fatality rate (CFR) of 4.5%.

Separately, the U.S. Centers for Disease Control and Prevention (CDC) and the Infectious Diseases Society of America estimated the CFR to be approximately 7.4% in the DRC.

Despite this concerning situation, limited genomic information is available on the circulating mpox viruses, which suggests that they belong to Clade I. 

This finding demonstrates that mpox transmission through sexual contact may extend beyond clade IIb, says the CDC.

During a digital briefing on March 14, 2024, Agam Rao, MD CAPT, U.S. Public Health Service, reconfirmed the Advisory Committee on Immunization Practices recommended on October 25, 2023, vaccination with the 2-dose JYNNEOS® (MVA-BN®, IMVAMUNE®) vaccine series for persons aged 18 years and older at risk for mpox.

Since the Clade 2 outbreak began in May 2022, the overall vaccine coverage in the U.S. for one dose is 40%, and for two doses, it is 25%.

The U.S. Food and Drug Administration initially approved JYNNEOS for smallpox in 2019. JYNNEOS remains available in the U.S. at specific clinics and community pharmacies.

The United States government recently issued a strong warning regarding the ongoing measles outbreaks in 46 countries.

And the federal government is supporting Chicago's efforts to curb the spread of the highly infectious measles virus.

To clarify its vaccination recommendations, on March 13, 2024, the U.S. Centers for Disease Control and Prevention (CDC) updated its Level 1 Travel Health Advisory to ensure that all international travelers are fully protected against this vaccine-preventable disease.

Vaccination with a measles-containing vaccine is the best way to make sure that you are protected. Even young infants should receive one dose of the MMR vaccine, says the CDC.

If you are unsure if you or your travel companions are fully protected against measles, schedule an appointment to see your clinician or pharmacist at least six weeks before traveling so that you have enough time to get vaccinated.

However, some people should not get a measles-containing vaccine or should wait. If you don't think you can safely receive one, talk to your clinician and consider making alternative travel plans.

Individuals must take the necessary steps to safeguard their health and the health of others by following these guidelines, says the CDC.

As of March 16, 2024, measles vaccines are offered at community pharmacies in the U.S.

The Walgreens Flu Index© offers the latest information on flu activity specific to individual cities in the U.S.

This information is compiled using retail prescription data for antiviral medications used to treat influenza across all Walgreens locations. It offers insight into which populations are experiencing the highest incidence of the flu.

As of March 9, 2024, the Index listed these cities:

1. Ft. Smith-Fayetteville-Springdale-Rogers, Ark.
2. Oklahoma City, Okla.
3. El Paso, Texas (Las Cruces, N.M.)
4. Little Rock-Pine Bluff, Ark.
5. Omaha, Neb.
6. Lincoln & Hastings-Kearney, Neb.
7. Joplin, Mo.-Pittsburg, Kan.
8. Lansing, Mich.
9. Bluefield-Beckley-Oak Hill, W.Va.
10. Tulsa, Okla.

 It's important to note that the Flu Index is not intended to show the severity or intensity of flu activity.

From a severity perspective, the U.S. CDC reported on March 15, 2024, that thirteen influenza-associated pediatric deaths occurring during the 2023-2024 season were reported last week throughout the United States, bringing the season total to 116 pediatric deaths.

The CDC encourages everyone to discuss flu vaccines or treatments with a healthcare provider.

SIGA Technologies, Inc. today reported financial results for the three and twelve months ended December 31, 2023.

"In 2023, SIGA had approximately $131 million in product revenues and approximately $84 million of pre-tax operating income," stated Diem Nguyen, Chief Executive Officer, in a press release on March 12, 2024.

"These financial results represent a significant increase over the 2022 financial results; product revenues increased 51% over the corresponding 2022 amount."

In 2023, SIGA had product sales of approximately $98 million in the fourth quarter of oral TPOXX® (tecovirimat, ST-246®), a novel small-molecule drug, to the U.S. Strategic National Stockpile ("SNS"); approximately $11 million of product sales of oral TPOXX to the U.S. Department of Defense, of which roughly $6 million was recognized in the fourth quarter; and approximately $21 million of international sales, of which approximately $12 million was recognized in the fourth quarter.

In the first two months of 2024, the Company delivered an additional approximately $15 million of oral TPOXX to the SNS, substantially completing the oral TPOXX order received in July 2023.

It also delivered an additional approximately $7 million of oral TPOXX to European countries and Canada.

Highlighting the continuing diversification of the Company's revenue base, the Company has received procurement orders for oral TPOXX from over 25 countries over the past two years.

As an example of the diversification trend, in October 2023, the Company reported the creation by the European Commission's DG HERA (Health Emergency Preparedness and Response Authority) of a joint procurement framework contract under which participating countries from the European Union and the European Free Trade Association can efficiently order oral TPOXX.

Under this mechanism, 13 countries ordered $18 million of oral TPOXX in the fourth quarter, and revenues were recorded for deliveries on substantially all of these orders in the fourth quarter or the first two months of 2024.

On March 12, 2024, SIGA's Board of Directors declared a special cash dividend of $0.60 per share, an increase of $0.15 per share from last year's special cash dividend.

In 2023, the Company paid a special cash dividend of $0.45 per share and repurchased approximately 1.7 million shares of its common stock. 

The first human case of Mpox was identified in the Democratic Republic of Congo (DRC) in 1970.  The World Health Organization Mpox External Situation Report #31 confirmed on December 22, 2023, that it has received mpox case reports from 115 affected countries since May 2022. 

IN 2024, mpox outbreaks have been confirmed in various countries, including the United States and the DRC.

The U.S. CDC issued a Level 2 travel advisory health advisory in February 2024, alerting international travelers regarding mpox outbreaks in African countries.