Vaccine News

Brii Biosciences Limited today announced that it has entered into agreements with VBI Vaccines, Inc., ensuring expansion and control of future clinical and commercial supplies of BRII-179, a late-stage clinical asset in Brii Bio's HBV functional cure portfolio.

Brii Bio confirmed on February 13, 2024, that it will initially issue a $2.5 million promissory note to VBI. This will eliminate royalty and milestone payments for PreHevbri. The note will increase to $10 million upon meeting specific conditions, securing all of VBI's intellectual properties for BRII-179, with associated payments also eliminated.

In addition, subject to certain approvals, Brii Bio and VBI will work together to transfer the manufacturing technologies of BRII-179 to a site designated by Brii Bio.

Upon completing essential activities relating to such technology transfer, subject to certain potential adjustments, Brii Bio will issue up to an additional $8 million promissory note to VBI.

After satisfaction of certain conditions, Brii Bio will also take control of VBI's Rehovot-based manufacturing facilities for BRII-179 and PreHevbrio™ (PreHevbri®, Sci-B-Vac®) for $10 million cash on or after June 30, 2024, when Brii Bio and VBI plan to enter into supply agreement under which Brii Bio will become VBI's commercial supplier for PreHevbrio and PreHevbri.

Separately, subject to achievement of certain conditions by VBI, Brii Bio will secure an exclusive license to develop and commercialize VBI-1901, VBI's glioblastoma immunotherapeutic candidate, in the Asia Pacific region excluding Japan and issue a $5 million promissory note to VBI. VBI-1901 has received fast-track and orphan drug designations from the U.S. Food and Drug Administration and is conducting a Phase 2b study.

Dr. Zhi Hong, Ph.D., Chairman and Chief Executive Officer of Brii Bio, stated in a press release, "As Brii transitions to late-stage development of HBV programs, a global manufacturing strategy becomes critically important."

"We look forward to working with the biologics manufacturing experts at the Rehovot site and timely integration of our R&D and manufacturing capabilities."

According to the U.S. CDC, Hepatitis B is a vaccine-preventable liver infection caused by the HBV. It is spread when blood, semen, or other body fluids from a person infected with the virus enter the body of someone who is not infected. Not all people newly infected with HBV have symptoms, but for those that do, symptoms can include fatigue, poor appetite, stomach pain, nausea, and jaundice. 

As Lunar New Year festivities take place worldwide, there have been reports of avian influenza outbreaks in Asia and sporadic cases of human infections.

In light of this health risk, the World Health Organization (WHO) issued an updated Disease Outbreak News (DONs) on February 13, 2024, with prevention advice titled "Avian Influenza and Lunar New Year Festivities: Vigilance and Precautions" in February 2024.

During February 2024, WHO avian influenza alerts were issued for:

• Influenza A (H1N1) variant virus - Brazil, 7 February 2024
• Avian Influenza A (H5N1) - Cambodia, 8 February 2024
• Influenza A(H1N1) variant virus - Spain, 9 February 2024
• Avian Influenza A(H10N5) and Influenza A(H3N2) coinfection - China, 13 February

The WHO says vigilance remains crucial, although most human infections have been sporadic following contact with infected poultry and/or their environments, with no evidence of sustained human-to-human transmission.

Birds are the natural hosts for avian influenza viruses.

After an A(H5N1) virus outbreak in 1997 in poultry in Hong Kong SAR, China, since 2003, this avian and other influenza viruses have spread from Asia to Europe and Africa. I

Beginning in 2013, human infections with the influenza A(H7N9) virus were reported in China.

WHO DONs provide information on confirmed acute public health events or potential events of concern. For more details, please refer to the WHO Influenza (avian and other zoonotic) factsheet.

As of 2024, the U.S. government has invested tens of millions in vaccines protecting people from certain avian influenza viruses. Furthermore, the U.S. says annual flu shots are unlikely to protect people during avian influenza (bird flu) outbreaks.

In May 2022, when the mpox outbreak was first reported in Europe, most government health agencies started giving out Bavarian Nordic's JYNNEOS® (MVA-BN®, IMVAMUNE®) vaccine for free to eligible individuals.

As per a recent alert by the U.S. CDC COCA, only 25% of the two million eligible people have completed the JYNNEOS two-dose vaccination series in the U.S.

The CDC stated on February 12, 2024, that although the number of mpox outbreaks in the U.S. has decreased significantly since the summer of 2022, small clusters of the disease continue to occur, and severe manifestations of mpox, including deaths, are still being reported in 2024.

Furthermore, the CDC strongly urges clinicians, health departments, and community-based organizations to continue recommending the two-dose JYNNEOS vaccine to eligible individuals.

And the CDC is encouraging those who have only received one dose to get the second dose to obtain the best possible protection.

Moreover, the U.S. FDA recently approved JYNNEOS to prevent mpox infection, regardless of the mpox virus Clade.

This vaccine is generally available in major cities at health clinics and pharmacies. If you need more information about this update or wish to provide feedback, please get in touch with the CDC at [email protected].

As we approach Spring 2024, many individuals eagerly anticipate the end of the 2023-204 flu season. However, this flu season continues to pose a significant health risk for many people.

Globally, the World Health Organization recently released Influenza Update N° 464, indicating a decrease in influenza detections.

In North America, influenza activity is elevated, albeit declining.

The U.S. CDC reported on February 9, 2024, that seasonal influenza activity remained high across the nation, with certain regions, such as regions 5 and 7, experiencing significant increases.

Additionally, the Walgreens Flu Index®, which provides a state and market-specific overview of flu activity, identified its top 10 cities confronting flu outbreaks as of February 3, 2024.

These cities are as follows:

1. Oklahoma City
2. Dallas-Ft. Worth
3. Tyler-Longview
4. Little Rock-Pine Bluff
5. Corpus Christi
6. Waco-Temple-Bryan
7. San Antonio
8. Lafayette
9. Monroe, La.-El Dorado
10. El Paso, Texas, including Las Cruces, N.M.

Note: Walgreens data is limited to the markets with its 8,700 pharmacy locations.

Unfortunately, the CDC confirmed eight influenza-associated pediatric deaths were reported during Week #5, bringing the 2023-2024 season total to 74 pediatric deaths.

The CDC continues recommending various flu shots for most people and encourages everyone to speak with a doctor, nurse, or pharmacist regarding any influenza questions.

As of late January 2024, over 157 million influenza vaccines were distributed in the U.S. this flu season.

The journal Eurosurveillance Rapid Communication published a study on January 25, 2024, that concluded Beyfortus™ (Nirsevimab) was about 69% effective at preventing pediatric respiratory syncytial virus (RSV) hospitalizations in infants.

In the context of moderate to high immunization coverage (84%) among neonates, this study provides early real-world evidence of nirsevimab immunization protecting infants from severe RSV disease in Luxembourg.

In 2023, 241 children under five years of age were hospitalized with a laboratory-confirmed RSV infection, compared with 389 cases in 2022, representing decreases of 38% (389 vs. 241) in cases under five years of age and 69% (232 vs. 72) in cases of infants under six months old.

The researchers concluded, 'Our study shows the impact of nirsevimab in mitigating severe RSV disease among infants during the first RSV season following the national implementation of passive immunization achieving high coverage in Luxembourg. There was a significant increase in the age of hospitalized children, and most severe RSV-related hospitalizations occurred in non-immunized children."

In previous clinical trials. nirsevimab showed between 74% and 86% efficacy against medically-attended lower respiratory tract infections caused by RSV in healthy infants.

As of February 2024, Beyfortus's availability in the U.S. has significantly improved.

The U.S. Centers for Disease Control and Prevention (CDC) issued a Travel Health Notice today confirming a chikungunya virus outbreak is impacting several municipalities in Timor-Leste, also known as East Timor.

Located about 2,000 miles north of Australia, local media recently reported about 183 chikungunya cases.

Timor-Leste's Vice-Minister of Health previously noted that "since the Restoration of Timor-Leste's Independence, we have faced many problems, including several diseases. Being a tropical country, our country is considered an endemic zone for several infectious diseases (malaria, dengue) caused by vectors (mosquitoes)."

On February 8, 2024, the CDC said people could avoid this mosquito-transmitted disease by using insect repellent, wearing long-sleeved shirts and pants, staying in places with air conditioning, or using window and door screens.

If infected, you should seek medical care if you develop fever, joint pain, headache, muscle pain, joint swelling, or rash during or after travel.

However, chikungunya can be fatal.

A recent study published by the Lancet Infectious Diseases journal found chikungunya disease is associated with an increased risk of death for up to 84 days after symptom onset.

Furthermore, the CDC stated in this Level 2 - Practice Enhanced Precautions Notice that if you are pregnant, reconsider travel to Timore-Leste, mainly if you are close to delivering your baby. Mothers infected around the time of delivery can pass the virus to their baby before or during delivery.

Newborns infected this way or by mosquito bites are at risk for severe illness, including poor long-term outcomes.

While the U.S. FDA recently approved Valneva SE's IXCHIQ® Chikungunya Vaccine, the CDC has yet to authorize its use in the U.S.

The CDC's vaccine committee is scheduled to review this vaccine on February 28, 2024. They intend to review proposed policy options for chikungunya vaccine use among U.S. adults traveling abroad.

As of February 2024, several countries have recently confirmed chikungunya outbreaks,

Numerous countries are reporting measles cases as the global resurgence extends into 2024.

For example, there has been a  measles outbreak in England.

The U.K. Health Security Agency (UKHSA) today announced that 118 laboratory-confirmed measles cases were confirmed in England last week, bringing the total number of measles cases to 465 since October 2023.

Of these cases, 71% (329 of 465) have been reported in the West Midlands, 13% in London, and 7% in Yorkshire and The Humber. The remaining cases were reported in other regions of England.

The majority (66%) of these cases are in unvaccinated children under the age of 10.

Dr Vanessa Saliba, UKHSA Consultant Epidemiologist, stated in a press release on February 8, 2024, "MMR vaccine uptake has been falling over the last decade with 10% of children starting school in England not protected."

"Parents should be aware that measles is a nasty illness for most children and, sadly for some, can be very serious and life-changing, but it is completely preventable."

"I strongly urge parents to take up the offer as soon as possible and protect their child now."

According to the U.S. CDC, measles is caused by a highly contagious virus that spreads through the air by direct contact with infectious droplets or by airborne spread when an infected person breathes, coughs, or sneezes.

All international travelers, including young children, should be fully vaccinated against measles, as infected people can spread measles up to four days before and after a rash. 

Worldwide, there was a 64% increase in measles cases in 2023 compared to 2022. 

As of 2024, the CDC maintains a global Watch-Level 1, Practice Usual Precautions, Travel Health Notice, identifying measles outbreaks in 47 countries.