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Apr 15, 2023 • 7:41 am CDT
by Mirka P.

A meeting of the U.S. FDA's Peripheral and Central Nervous System Drugs Advisory Committee is scheduled for June 9, 2023.

This FDA Committee's digital presentation will discuss the supplemental biologics license application for LEQEMBI™ (lecanemab) solution for intravenous infusion, submitted by Eisai, Inc., for treating early Alzheimer's disease (AD).

The Committee will discuss the confirmatory study, BAN2401-G000-301, conducted to fulfill post-marketing requirement 4384-1, detailed on January 6, 2023, FDA approval letter.

Confirmatory studies verify and describe a product's clinical benefit after receiving an FDA accelerated approval. Accordingly, its application was granted Priority Review, with a Prescription Drug User Fee Act action date of July 6, 2023.

LEQEMBI is a humanized immunoglobulin gamma 1 monoclonal antibody, not a preventive vaccine.

As of April 15, 2023, the FDA has not approved any Alzheimer's vaccine candidate.

FDA advisory committees provide independent expert advice on topics or specific products to help the agency make sound decisions based on the available science. Advisory committees make non-binding recommendations.

The FDA generally follows these recommendations but is not legally bound to do so.

Apr 14, 2023 • 5:31 pm CDT
U.S. State Department map April 14, 2023

The U.S. Department of State reissued its Level 3: Reconsider Travel for the Independent State of Papua New Guinea.

On April 11, 2023, the State Department announced travelers should reconsider visiting Papua New Guinea due to crime, civil unrest, and piracy.

U.S. government employees must obtain authorization before traveling to areas of concern, including the southern part of Bougainville and the provinces of Southern Highlands, Western Highlands (excluding Mt. Hagen), Eastern Highlands (excluding Goroka), Hela, Enga, Jiwaka, and other areas of Papua New Guinea where one is unable to fly directly.

Additionally, the Travel Advisory says 'do not travel' to:

  • Southern Bougainville, particularly areas near the Panguna mine.
  • The Highlands region, other than the towns of Mt. Hagen and Goroka.

And there have been reports of criminals attacking resorts popular with foreign tourists to steal goods and money. And police presence is limited outside of the capital, Port Moresby.

Furthermore, piracy is active in the waters surrounding Papua New Guinea, located in the eastern area of New Guinea, the world's second-largest island. The western half of the island is part of Indonesia.

Travelers by boat should reconsider travel to the Bismarck and Solomon Seas along Papua New Guinea's north and eastern coasts. In 2021 and 2022, the Embassy was aware of at least three occasions in which sailboats operated by or carrying U.S. citizens were boarded by criminals and, in one incident, severely injured the captain.

From a health perspective, the U.S. CDC suggests various travel vaccines before visiting Papua New Guinea.

Apr 14, 2023 • 5:08 pm CDT
ECDC Influenza map April 14, 2023

The Weekly Influenza Surveillance Report #14, published today by the U.S. Centers for Disease Control and Prevention (CDC), indicates good news for the USA.

As of April 14, 2023, the CDC says seasonal influenza activity remains low nationally, with eight of 10 regions below their respective baselines.

However, the European CDC reported on April 14, 2023, there was a 15% influenza positivity for week 14/2023.

Of 41 countries and areas in Europe reporting on the spread of influenza viruses, 16 reported widespread activity across the Region.

The CDC continues to suggest anyone concerned about respiratory viruses should speak with a healthcare provider regarding their flu shot option.

Apr 14, 2023 • 1:13 pm CDT
U.S. HHS April 14, 2023

U.S. HHS Secretary Becerra today announced that in the coming weeks, he would issue an amendment to the declaration under the Public Readiness and Emergency Preparedness (PREP) Act for medical countermeasures against COVID-19. 

In light of the significant impact of the PREP policy on the healthcare landscape and to provide further clarity, HHS offered additional information about key elements of its plan's flexibilities and protections on April 14, 2023, that will remain in place moving forward.

For example, extending protection coverage for COVID-19 vaccines, seasonal influenza vaccines, and COVID-19 tests will be enhanced.

And PREP Act immunity from liability will be extended through December 2024 to pharmacists, pharmacy interns, and pharmacy technicians to administer COVID-19 and seasonal influenza vaccines and COVID-19 tests, regardless of any USG agreement or emergency declaration.

In the month remaining before the end of the COVID-19 Public Health Emergency, HHS stated it would continue to work closely with its partners, including Governors, state, local, Tribal, and territorial agencies, industry, and advocates to ensure an orderly transition.

Additional, unedited information is posted at this HHS link.

Apr 14, 2023 • 10:00 am CDT
ECDC Influenza Update April 2023

The European Centre for Disease Prevention and Control (ECDC) recently published an influenza update for week #14, indicating flu positivity was about 15%.

Announced on April 14, 2023, the ECDC confirmed of the 41 countries and areas reporting data on influenza viruses:

  • 3 reported no activity (Georgia, Kazakhstan, and Kyrgyzstan),
  • 9 reported sporadic spread (eastern, northern, and southern Region),
  • 5 reported local spread (France, Malta, Serbia, Slovakia and Kosovo,
  • 8 reported regional spread (Albania, Austria, Bosnia and Herzegovina, Czechia, Lithuania, Republic of Moldova, Romania and Ukraine, and,
  • 16 reported widespread activity (across the Region).

The ECDC added seasonal influenza is a vaccine-preventable disease that annually infects over 10% of Europe's population.

When planning a European visit, the U.S. Centers for Disease Control and Prevention suggests discussing flu shot options with a healthcare provider.

Apr 14, 2023 • 6:42 am CDT
by David Mark

SAB Biotherapeutics today announced that the U.S. Food and Drug Administration (FDA) had granted Fast Track designation for SAB-176, an investigational therapeutic for Type A and Type B influenza illness in high-risk patients, including those who have anti-viral resistant strains.

SAB-176 offers the potential for additional treatment for influenza, particularly in higher-risk patients.

SAB also received FDA guidance and regulatory alignment on advancing SAB-176 into the next development phase by initiating a Phase 2b dose-range finding efficacy and safety trial in high-risk patients for developing severe disease.

SAB-176 is a novel, highly potent immunotherapy grounded in the fundamentals of the natural immune response to neutralize Type A and Type B influenza viruses, which mutate rapidly.

SAB-176 has undergone multiple clinical and pre-clinical studies, including a Phase 1 trial in healthy volunteers and a Phase 2a challenge study completed last year.

In the Phase 2a study, SAB-176 showed broad cross-protection that included influenza strains not explicitly targeted in manufacturing the therapeutic.

"We are pleased to receive the FDA Fast Track designation for SAB-176. Influenza continues to be one of the biggest public health challenges the world faces continuingly, with an excessively high number of hospitalizations and deaths each year," said Eddie Sullivan, Ph.D., co-founder, President & CEO of SAB Biotherapeutics, in a press release on April 13, 2023.

"We are excited about the potential role SAB-176 can play in tackling a highly mutagenic pathogen like influenza."

SAB-176 is also being studied in emerging and mutating pandemic strains by targeting multiple epitopes of the virus rather than a single epitope. 

While Tamiflu® is an effective therapy for treating influenza if used within two days of symptom onset, some patients still develop severe disease and resistant strains of influenza to anti-viral drugs. 

Throughout the 2022-2023 flu season in the U.S., over 171 million influenza vaccines were distributed, which remain available at health clinics and pharmacies.

Apr 13, 2023 • 3:34 pm CDT
by Monica Volpin

The Florida Health Department reported as of week #13, there had been 59 travel-associated dengue cases. And, as of April 8, 2023, there are now 2 locally acquired dengue cases confirmed in 2023. 

In 2022, Florida reported 903 travel-associated and 68 locally-acquired dengue cases.

In the Region of the Americas, 46 countries and territories reported dengue cases in 2022. For example, dengue was reported in 28 of 32 Mexico states last year.

These countries confirmed about 2.8 million dengue cases, representing a two-fold increase compared to 2021.

Dengue is a vaccine-preventable disease, and as of April 13, 2023, two vaccines are authorized in various countries.

 

Apr 13, 2023 • 2:02 pm CDT
WHO COVID-19 dashboard April 13, 2023

The World Health Organization (WHO) today published its weekly epidemiological update focused on the COVID-19 pandemic. 

On April 13, 2023, the WHO's Edition #138 highlighted very positive trends.

Over the last 28 days (March 13 to April 9, 2023), COVID-19 cases decreased by 28%.

And related fatalities declined by 30% compared to the previous period.

However, contrary to the global trend, increases in reported COVID-19 cases and deaths were seen in the South-East Asia and Eastern Mediterranean regions and several individual countries.

At the regional level, the number of newly reported 28-day cases decreased across four of the six WHO regions: The African Region (-45%), the Western Pacific Region (-39%), the Region of the Americas (-33%), and the European Region (-22%).

While case numbers increased in two WHO regions: the South-East Asia Region (+481%) and the Eastern Mediterranean Region (+144%).

The highest numbers of new 28-day cases were reported at the country level from the U.S., the Russian Federation, the Republic of Korea, Brazil, and France.

The WHO suggests international travelers remain fully protected against COVID-19 by speaking with a healthcare provider to determine if a Spring or Summer COVId-19 booster is recommended, as well as various travel vaccines.

Apr 13, 2023 • 11:29 am CDT
U.S. CDC yellow fever endemic South America countries 2023

The yellow fever virus (YFV) is a reemerging global health threat in 2023, driven by several factors, including the increased spread of the mosquito vector.

Although protective YFV vaccines exist, recent outbreaks in South America indicate a void in treatment options in countries such as Brazil.

To establish innovative treatment options for patients with severe YFV infection, researchers recently tested 37 YFV-specific neutralizing monoclonal antibodies (mAbs) isolated from previously vaccinated humans.

They identified two capable of potently neutralizing multiple pathogenic primary YFV isolates.

Using hamster and nonhuman primate models of lethal YFV infection, they demonstrate that a single administration of either potently neutralizing mAbs during acute infection fully controlled viremia.

And it prevented severe disease and death in treated animals.

'Given the potential severity of YFV-induced disease, these results show that these antibodies could effectively save lives and fill a much-needed void in managing YFV cases during outbreaks, wrote these researchers in a Science Translational Medicines article published on March 29, 2023.

In the U.S., the YF-Vax® vaccine is available as of April 13, 2023, at certified clinics and travel pharmacies. 

Furthermore, the International Certificate of Vaccination, known as the yellow card, is required to enter certain countries in 2023.

Apr 13, 2023 • 11:03 am CDT
by Arek Socha

Various types of COVID-19 vaccines have been approved to reduce the disease burden during the recent pandemic. To better appreciate differences, South Korean researchers conducted an observational study to evaluate the effectiveness of Novavax's NVX-CoV2373 and BNT162b2 vaccines in protecting adults.

This non-peer-reviewed study was published on February 19, 2023, and compared the results from 3,019 recipients of NVX-CoV2373 and 3,027 recipients of BNT162b2 vaccines.

The 40-week risk ratios for recipients of the NVX-CoV2373 vaccine compared with recipients of the BNT162b2 vaccine were 1.169 (95% CI, 1.015 to 1.347) for laboratory-confirmed SARS-CoV-2 infection.

And 0.504 (95% CI, 0.126 to 2.014) for severe SARS-CoV-2 infection.

The estimated risk of severe infection was 0.001 events per 1000 persons (95% CI, 0 to 0.003) for the NVX-CoV2373 vaccine and 0.002 events per 1000 persons (95% CI, 0.001 to 0.006) for the BNT162b2 vaccine.

These researchers wrote this 'study identifies the reduced risk of SARS-CoV-2 infection and severe infection after receipt of three doses of either NVX-CoV2373 or BNT162b2 vaccines in Korean adults.

The study authors did not declare any competing industry interest.

Apr 13, 2023 • 10:40 am CDT
WHO Africa malaria map March 2023

The University of Oxford today announced the R21/Matrix-M™ malaria vaccine was licensed for use in Ghana by the country’s Food and Drugs Authority.

This announcement marks the first regulatory clearance for the R21/Matrix-M malaria vaccine for use in any country for children at the highest risk of death from malaria.

According to the press release on April 13, 2023, the R21/Matrix-M vaccine has demonstrated high levels of efficacy and safety in Phase II trials, including amongst children who received a booster dose of R21/Matrix-M at one year following a primary three-dose regime.

The R21/Matrix-M malaria vaccine is a low-dose vaccine that can be manufactured at scale and modest cost, enabling as many as hundreds of millions of doses to be supplied to African countries which are suffering a significant malaria burden.

According to the U.S. Centers for Disease Control and Prevention, malaria is a vaccine-preventable mosquito-borne disease caused by a parasite. Malaria vaccines like Mosquirix™ and R21 have been reported effective at preventing disease. 

As of April 13, 2023, these malaria vaccines are unavailable in the U.S.

Apr 12, 2023 • 4:04 pm CDT
U.S. National COVID-⁠19 Preparedness Plan April 12, 2023

The U.S. government today announced it is releasing the National COVID-19 Preparedness Plan. This plan lays out the roadmap to help fight COVID-19 in the future.

'We look to a future when Americans no longer fear lockdowns, shutdowns, and our kids not going to school,' wrote the U.S. government on April 12, 2023. 

'It's a future when the country relies on the powerful layers of protection we have built."

"And invests in the next generation of tools to stay ahead of this coronavirus."

The President's National COVID-19 Preparedness Plan focuses on four key goals, which are linked here.

Apr 12, 2023 • 1:22 pm CDT
from Pixabay

INOVIO today announced that an abstract had been accepted for presentation for INO-4201 as an Ebola booster for Merck's Ervebo® (rVSV-ZEBOV) vaccine at the 33rd European Congress of Clinical Microbiology and Infectious Diseases (ECCMID).

"We are pleased that lead investigator Dr. Angela Huttner will have the opportunity to share important new humoral and cellular response data at ECCMID from our recently completed Phase 1b trial of INO-4201 as an Ebola booster vaccine candidate for Ervebo," said Dr. Laurent Humeau, INOVIO's Chief Scientific Officer, in a press release on April 12, 2023.

INO-4201 is a DNA vaccine targeting Zaire Ebola virus (ZEBOV) glycoprotein, designed to prevent infection.

INO-4201 encodes for a synthetic consensus antigen encompassing ZEBOV genetic variability from various outbreak strains to broaden immune coverage for divergent ZEBOV variants.

The Ebola virus family includes four virus species that cause periodic outbreaks of a highly contagious and lethal human infectious disease called Ebola Virus Disease (EVD).

New research suggests dormant Ebola virus in a previously infected survivor could re-emerge up to nearly five years later and again allow human-to-human transmission.

The Ebola virus is classified as a Category A Priority Pathogen by the U.S. Centers for Disease Control and Prevention.

Also, the World Health Organization lists EVD as a priority for research and development in emergency contexts and coordinates planning to prevent and respond to Ebola epidemics.

Ebola vaccines have been approved and deployed in Africa.

Apr 12, 2023 • 1:03 pm CDT
U.S. CDC ACIP meeting, Atlanta GA

The U.S. Centers for Disease Control and Prevention (CDC) today announced a previously unscheduled meeting of the Advisory Committee on Immunization Practices (ACIP) focused on COVID-19 vaccinations.

According to the CDC's website, on April 12, 2023, the ACIP will digitally meet on April 19, 2023, at 11 am EST. This meeting's agenda has yet to be posted for public review, and no registration is required to watch the webcasts.

A summary of recent changes (last updated March 16, 2023) is posted on this CDC page.

Updated on April 19, 2023, with the meeting's agenda.

Apr 12, 2023 • 10:51 am CDT
by Pete Linforth

Moderna Inc. recently confirmed it has five influenza vaccine candidates in clinical development. As of April 11, 2023, these flu shots include:

  • mRNA-1010, a seasonal quadrivalent vaccine using strains recommended by the World Health Organization,
  • mRNA-1011/1012, a seasonal penta-/hexa-valent vaccine candidate that includes more hemagglutinin antigens (e.g. H3, H1) to expand strain matching,
  • mRNA-1020/1030, a seasonal vaccine candidate that includes neuraminidase antigens to target more conserved regions of the virus.

The Company's first vaccine candidate against influenza is mRNA-1010, developed in adults and is currently being evaluated in two Phase 3 trials.

The first Phase 3 trial (P301) was conducted in the Southern Hemisphere to evaluate the safety and non-inferior immunogenicity compared to a licensed flu vaccine.

The previously announced interim results from the P301 trial indicated that mRNA-1010 demonstrated superiority in geometric mean titers (GMT) for A/H3N2 and non-inferiority in GMT for A/H1N1.

However, mRNA-1010 did not meet non-inferiority for both influenza B/Victoria- and B/Yamagata-lineage strains.

But, mRNA-1010 demonstrated an acceptable safety and tolerability profile in the trial, and the independent Data and Safety Monitoring Board (DSMB) for P301 did not identify any safety concerns.

The second Phase 3 trial (P302) is being conducted in the Northern Hemisphere to evaluate the safety and non-inferior efficacy compared to a licensed flu vaccine.

The independent DSMB has completed the first interim analysis of efficacy and informed the Company that mRNA-1010 did not meet the statistical threshold necessary to declare early success and recommended that the trial continues with efficacy follow-up towards the next analysis.

The DSMB did not identify any safety concerns, and blinded follow-up for safety and efficacy is ongoing in this trial.

A preliminary immunogenicity analysis from a subset of participants in the P302 trial has also been completed.

In this analysis, mRNA-1010 demonstrated geometric mean titer ratios consistent with superiority against both influenza A strains (A/H1N1, A/H3N2) and consistent with non-inferiority against both influenza B strains (B/Victoria, B/Yamagata) relative to the licensed comparator.

The P302 study did not pre-specify success criteria for immunogenicity endpoints.

Additionally, the Company announced it had developed an update to mRNA-1010 that is expected to have improved immunogenicity against influenza B strains. It also announced plans to initiate a confirmatory Phase 3 trial in 2023.

Stéphane Bancel, Chief Executive Officer of Moderna, commented in a related press release, "With mRNA-1010, our first investigational vaccine against seasonal flu, we are encouraged by the consistently strong immunogenicity results against influenza A, and titers consistent with non-inferiority against influenza B strains in the most recent Phase 3 trial."

"With our mRNA platform and technology, as well as our agile manufacturing capabilities, we are confident that we can quickly develop safe and effective vaccines to address critical unmet needs."