Vaccine News

Vaccine news brought to you by Precision Vaccinations.

Aug 23, 2024 • 7:12 am CDT
Walgreens Respiratory Index August 19, 2024

Novavax Inc. today announced, 'We are working productively with the U.S. Food and Drug Administration (FDA) as they complete their review, including providing additional information as needed, and the FDA has committed to moving swiftly on regulatory authorization.'

'We expect to have authorization in time for peak vaccination season.'

Novavax filed for U.S. Emergency Use Authorization of our 2024-2025 formula protein-based COVID-19 vaccine (NVX-CoV2705) in June 2024.

In the United States, Novavax's products have been and will be available after FDA authorization in thousands of locations nationwide, including pharmacies.

For example, Walgreens recently confirmed their pharmacists are available to help patients navigate the latest vaccination guidance, including the timing of vaccinations, given the uneven geographical spreading of the coronavirus.

Additionally, numerous countries have authorized Novavax's COVID-19 vaccines over the past few years.

Novavax wrote on August 22, 2024, 'Our 2024-2025 formula COVID-19 vaccine targets JN.1, the "parent strain” of currently circulating variants and should provide acceptable coverage and cross-reactivity against JN.1 lineage viruses, including KP.2.3, KP.3, KP.3.1.1 and LB.1.1.'

'Upon authorization, Novavax’s vaccine will be the only protein-based option available in the U.S. for individuals aged 12 and older to prevent COVID-19.' 

On August 8, 2024, Novavax reported it achieved total revenue of $415 million in the second quarter of 2024 and ended the period with $1.1 billion in Cash.

Aug 23, 2024 • 5:56 am CDT
US CDC Travel Alert August 2024

Cuba's Minister of Public Health, José Ángel Portal Miranda, recently announced over 400 Oropouche virus disease cases have been confirmed on the island since late May 2024.

According to Cuba Headlines reporting, Cuba ranks second in the Region of the Americas for the number of infections behind Brazil (7,284).

Infected biting midges and some mosquitoes are spreading the virus.

Currently, there are no efficient vector control measures for the Culicoides paranesis.

As of August 23, 2024, the U.S. Centers for Disease Control and Prevention (CDC) says there is no evidence of local transmission of Oropouche virus disease in the United States. However, various states, such as Florida (12), report travel-related cases.

The virus was first detected in 1955 in Trinidad and Tobago near the Oropouche River. Since then, outbreaks of the Oropouche virus have been reported in Bolivia, Brazil, Colombia, Ecuador, French Guiana, Panama, and Peru.

The incubation period for Oropouche virus disease is 3–10 days, says the U.S. CDC. Typically, the disease starts with the abrupt onset of fever (38-40°C), followed by a headache, chills, myalgia, and arthralgia.

People typically recover without long-term sequelae. However, there have been a few deaths reported and vertical transmission of Oropouche virus causing fetal deaths and congenital abnormalities.

The best way to protect themselves from Oropouche is to prevent bites from biting midges and mosquitoes.

According to the CDC's Level 2 Travel Health Advisory, updated on August 15, 2024, travelers to Cuba should prevent bug bites during visits to protect themselves from infection, as there are no vaccines to prevent Oropouche virus disease.

Note - Headlines was edited on Aug, 24, 2024,

Aug 22, 2024 • 12:35 pm CDT
ECDC mpox case map

The World Health Organization (WHO) announced today that three vaccines are available to prevent mpox in different countries.

Published on August 22, 2024, the WHO's Disease Outbreak News confirmed the MVA-BN® (JYNNEOS®, IMVAMUNE®), LC16-KMB, and OrthopoxVac are available in certain countries. However, OrthopoxVac has not yet been commercialized.

Based on extensive clinical research, the WHO recommends using MVA-BN or LC16 vaccines when the others are not available.  

While the ACAM2000® live vaccinia virus vaccine is authorized to prevent mpox and smallpox infections, the WHO does not recommend it.

Furthermore, mpox vaccination is recommended by WHO and the U.S. CDC for individuals at high risk of exposure, such as when visiting mpox outbreak areas.

Aug 22, 2024 • 10:40 am CDT
by Cheryl Holt

Takeda Canada Inc. today annonced a new report, Enhancing Diagnosis, Access, Care, and Treatment, highlighting the urgent need for innovative funding models and collaboration to help accelerate Canada’s National Strategy for Drugs for Rare Diseases.

Nearly 200 novel drugs for rare diseases are being developed and are expected to launch in Canada within the next ten years. It’s estimated only 5% of rare diseases have an approved treatment.

A “rare” disease is any disease that affects a minimal number of individuals. It is often genetic, chronic throughout a patient’s life, and life-threatening. With rare diseases affecting relatively limited patients, innovative treatments are often unavailable.

The impact of rare diseases is significant, with approximately one in 12 Canadians, two-thirds of whom are children.

“Canadians living with rare diseases have every reason to be optimistic,” says Durhane Wong-Rieger, President & CEO of the Canadian Organization for Rare Disorders, in a press release on August 22, 2024.

“Hundreds of new therapies are being developed, many targeting the 95% of rare diseases with no known treatment! We must leverage the $1.5 billion Rare Disease Drug Strategy,

The journey toward appropriately managing a rare disease is long and challenging. On average, it takes 6 to 8 years before a patient receives a correct diagnosis; this time, they will see an average of eight physicians and receive two to three misdiagnoses.

Takeda also produces innovative products, such as QDENGA®, an approved two-dose vaccine that prevents dengue fever and/or severe dengue in adults caused by any of the four serotypes of the dengue virus.

This dengue vaccine is authorized in about 40 countries and does not require pre-admission testing.

Aug 21, 2024 • 3:29 pm CDT
USAID August 2023

The United States Agency for International Development (USAID) announced up to an additional $35 million in emergency health assistance to bolster response efforts for the clade Ib mpox outbreak in Central and Eastern Africa, pending U.S. Congressional Notification.

This new commitment on August 20, 2024, brings the total U.S. government support for the affected countries in the region to more than $55 million in response to the ongoing mpox outbreak. 

USAID support includes assistance with surveillance, diagnostics, risk communication, community engagement, infection prevention and control, case management, and vaccination planning and coordination. 

The USAID support includes donating 50,000 doses of the third-generation JYNNEOS® (MVA-BN®, IMVAMUNE®) mpox / smallpox vaccine to the Democratic Republic of the Congo (DRC), the country most severely impacted by the outbreak.

Since 2023, this mpox outbreak has extended beyond the DRC, with several other countries in the region reporting cases in 2024, including countries where mpox has historically not been reported. 

The current mpox outbreak differs in disease severity from the global clade II outbreak that began in May 2022, impacting the United States.

Aug 21, 2024 • 1:51 pm CDT
Ebola emergence mapped | University of Oxford

According to real-world evidence published in The Lancet Infectious Diseases today, this analysis is the first to provide estimates of Merck's Ervebo® (rVSV-ZEBOV) vaccine against Zaire Ebolavirus disease amid the widespread use of the vaccine during a large outbreak.

Announced on August 20, 2024, these findings confirm that Ervebo is highly protective against 84% (95% credible interval, 70% to 92%) of Ebolavirus disease and supports its use during outbreaks, even in challenging contexts such as in the eastern Democratic Republic of the Congo (DRC).

This finding is essential since Ebolaviruses are endemic in the DRC.

In a related Editorial, the authors wrote the 2018–20 Ebola virus disease epidemic in the DRC resulted in 3,470 reported cases and remains the second-largest Ebolavirus outbreak in recorded history worldwide. The initial Ebola outbreak was in 1976. 

In November 2019, the World Health Organization prequalified the Ervebo vaccine. The U.S. Food and Drug Administration approved it on December 19, 2019.

Médecins Sans Frontières (Doctors Without Borders) funded this study.

Aug 21, 2024 • 9:57 am CDT
US CDC yellow fever case map 2024

In 2024, yellow fever outbreaks remain a health threat in tropical regions of Africa and South America. The good news is that vaccines have been proven safe and effective for protecting international travelers visiting these areas.

However, new yellow fever vaccines with improved production scalability and enhanced efficacy are needed to reduce outbreaks.

The Lancet Infectious Diseases recently published results from a first-in-human phase 1 study on the safety and immunogenicity of a new Vero cell line-derived yellow fever vaccine, vYF-247.

Produced by Sanofi, the vYF-247 vaccine showed similar safety and immunogenicity to the U.S. FDA-approved YF-VAX vaccine.

These researchers concluded that the vYF-247 vaccine with a 5 Log CCID50 dose showed optimal viremia, safety, and immunogenicity and was chosen for further development.

Until a new vaccine is approved, the YF-VAX® vaccine remains available at travel clinics and pharmacies in the United States. For those travelers who were already vaccinated, the U.S. CDC says yellow fever vaccine booster doses are unnecessary.

Aug 21, 2024 • 4:53 am CDT
US CDC Measles Case Map August 21, 2024

The Oregon Health Authority (OHA) has reported four new measles cases in 2024, bringing the total to 30 across three counties. Marion County has the most cases, followed by Clackamas County and Multnomah County.

As of August 21, 2024, all measles patients were unvaccinated, and twelve were younger than ten.

These counties and OHA have been sharing information with the public so “we can let members of the public know they may have been exposed to measles,” Clackamas County Health Officer Sarah Present, M.D. said in a recent press release.

Dr. Present noted that since measles is so contagious, an estimated 96% of the population needs to have received two doses of measles vaccine to protect the community's most vulnerable members via community or “herd” immunity.

In Oregon, measles vaccines are available at health clinics and local pharmacies.

As of August 15, 2024, the U.S. CDC confirmed that 27 U.S. jurisdictions reported 219 measles cases this year. In 2023, 20 jurisdictions reported 59 measles cases for the entire year.

Aug 20, 2024 • 3:39 am CDT
from Pixabay

Emergent BioSolutions today announced it has pledged to donate 50,000 doses of its ACAM2000® (Smallpox (Vaccinia) Vaccine, Live) through a humanitarian relief organization to the Democratic Republic of the Congo (DRC) and the other impacted countries of Burundi, Kenya, Rwanda, and Uganda.

In October 2023, Emergent filed a supplemental Biologics License Application to the U.S. FDA seeking an expanded indication for the ACAM2000 vaccine to include immunization against the mpox virus. The FDA target for review completion in the third quarter of 2024.

These efforts are in response to the WHO’s recent statement declaring that the upsurge of mpox clade 1 in African countries constitutes a public health emergency of international concern under the International Health Regulations.

“Africa CDC estimated they will need 10 million doses to control the epidemic in the continent,” said Dr. Raina McIntyre, Professor of Global Biosecurity, NHMRC L3 Research Fellow, Head, Biosecurity Program, Kirby Institute, University of New South Wales Sydney, in a press release on August 19, 2024.

“It is unlikely there will be enough supply of 3rd generation vaccines (JYNNEOS®, MVA-BN®) to control the epidemic in Africa, given demand in other countries.”

Aug 20, 2024 • 3:11 am CDT
by Mircea Iancu

A recent study found that the Fluad® MF59-adjuvanted influenza vaccine (aTIV) was more effective than the high-dose flu vaccine (HD-TIV) at preventing severe respiratory complications in older adults with risk factors.

Published in Open Forum Infectious Diseases on August 16, 2024, the study included 1,115,725 aTIV and 2,561,718 HD-TIV recipients. For the primary outcome, the analysis found comparable effectiveness between aTIV and HD-TIV (rVE [95% CI]: 5.2% [-5.9–15.1]) among those with 0 risk factors, whereas aTIV was more effective than HD-TIV among patients with ≥1, 1–2, or ≥3 risk factors (12.5% (10.0–15.0), 18.4% (13.7–22.9), and 10.4% (7.4–13.3), respectively).

The same trends were observed for the secondary outcomes.

Previous studies have found the two vaccines to be similar in effectiveness in older adults.

The Fluad vaccine has an extensive clinical legacy and has been licensed in 30 countries since its first approval in 1997. Fluad is available at most pharmacies in the U.S. for the 2024-2025 flu season.

Aug 19, 2024 • 4:00 pm CDT
from Pixabay

Throughout 2024, Cuba has been grappling with an outbreak of Oropouche Fever. And now, its western neighbor, the United States, has started to report cases related to travelers from Cuba.

The Florida Department of Health (FDH) has recently reported 11 Oropouche Fever cases.

As of August 10, 2024, these Florida cases had their onset in 2024 and were found in individuals who had traveled to Cuba two weeks before showing symptoms.

The Oropouche reported cases were found in the following Florida counties: Hillsborough (4), Lee (2), Miami-Dade (1), Orange (2), and Polk (2).

Throughout 2024, more than 8,000 Oropouche cases, including two deaths and five cases of vertical transmission, were reported by the U.S. CDC.

According to the CDC, approximately 60% of people infected with the Oropouche virus become symptomatic. The incubation period is typically 3–10 days. Although people exposed to biting midges or mosquitoes infected with the virus are most at risk for developing the disease, the risk factors for more severe Oropouche virus are not well-defined.

The initial clinical presentation is similar to diseases caused by dengue, Zika, and chikungunya viruses.

In the U.S., healthcare providers should contact local health departments to facilitate diagnostic testing.

As of August 19, 2024, no approved Oropouche vaccines are available.

In addition to Oropouche cases, FDH reported 18 locally acquired dengue fever virus cases and numerous travel-related dengue cases as of week #32.

Aug 19, 2024 • 12:40 pm CDT
US CDC Mpox Travel Advisory Map - August 2024

The World Health Organization (WHO) today announced temporary (one-year) recommendations for States Parties experiencing the upsurge of monkeypox virus (MPXV) clade 1 detections, including, but not limited to, the Democratic Republic of the Congo (DRC), Burundi, Kenya, Rwanda, and Uganda.

The upsurge of mpox cases in the DRC in 2024 and its neighboring countries is driven by outbreaks associated with two sub-clades of clade I MPXV: clade Ia and clade Ib.

These WHO recommendations include establishing or strengthening cross-border collaboration arrangements for surveillance and management of suspect mpox cases and providing information to travelers and conveyance operators without resorting to general travel and trade restrictions unnecessarily impacting local, regional, or national economies.

As of August 19, 2024, the WHO Committee considered the event “extraordinary” because of the increase in mpox clade I disease occurrence in the DRC and the emergence of the new MPXV clade Ib.

Clade I mpox was classically described in studies conducted by WHO in the 1980s to have a mortality rate of approximately 10%, with most deaths occurring in children.

MPXV clade Ia is endemic in the DRC. The disease primarily affects children. Data available for 2024 show an aggregated case fatality rate of 3.6%, and the spread is likely sustained through multiple modes of transmission, including person-to-person transmission following zoonotic introduction in a community.

MPXV clade Ib is a new strain of MPXV that emerged in the DRC. It is transmitted between people, presumed via sexual contact, which has been spreading in the eastern part of the country.

Although first characterized in 2024, estimates suggest it emerged around September 2023.

The outbreak associated with clade Ib in the DRC primarily affects adults and is spreading rapidly, sustained largely, but not exclusively, through transmission linked to sexual contact and amplified in networks associated with commercial sex and sex workers.

Furthermore, these African countries are to initiate plans to advance mpox vaccination activities targeting people at high risk of infection. As of August 19, 2024, various reports indicate that (10 million) mpox vaccines are being produced to meet potential outbreak demand.

In early August 2024, the U.S. CDC issued a Level 2 - Practice Enhanced Precautions, Travel Health Advice, recommending various mpox protection tactics, including (JYNNEOS) vaccination. 

These new WHO recommendations are intended to be implemented by those States Parties in addition to the current standing recommendations for mpox, which will be extended until August 20, 2025.

Aug 19, 2024 • 9:24 am CDT
by Gerd Altmann

With the World Health Organization announcing new alerts regarding the mpox virus clade 1 outbreak in African countries and Europe confirming travel-related cases, many governments were concerned about vaccine supply.

To alleviate those concerns, Bavarian Nordic (BN) A/S recently announced an update on plans to produce additional JYNNEOS® (MVA-BN®, IMVAMUNE®) vaccine supplies to tackle the current mpox outbreak.

On August 17, 2024, BN wrote, It would appear that mpox will remain a constant threat to public health, and the company is working closely with the Africa CDC to expand further the manufacturing capacity to produce the mpox vaccine in Africa through transfer of technology to selected African manufacturers.

BN has informed the Africa CDC that, in addition to current orders, it has the capacity to manufacture 10 million doses by the end of 2025 and could already supply up to 2 million doses in 2024.

"We are prepared to work with the Africa CDC and the international community to play our role in protecting and saving lives around the World and to contain the latest outbreak,” said Paul Chaplin, President & CEO of Bavarian Nordic, in a press release.

Since the mpox clade 2 outbreak began in May 2022, BN has supplied more than 15 million doses of the mpox vaccine to more than 76 countries.

While several vaccine efficacy studies have reported JYNNEOS's efficacy against clode 2 between 20% and 80%, studies on clade 1 efficacy are pending. 

In the United States, the JYNNEOS vaccine remains available at specific clinics and pharmacies.

Aug 18, 2024 • 7:25 am CDT
US CDC measles outbreak map August 14, 2024

The World Health Organization (WHO) recently reported that measles outbreaks continue in various countries in 2024, such as India.

To alert international travelers, the U.S. Centers for Disease Control and Prevention (CDC) republished a global Watch-Level 1, Practice Usual Precautions, Travel Health Notice on August 14, 2024, identifying measles outbreaks in 56 countries.

Within the United States, the CDC has reported 219 measles cases in 27 jurisdictions this year, led by the states of Illinois and Oregon. Most of these cases are related to unvaccinated travelers.

The CDC writes that 'all international travelers should be fully vaccinated against measles with two doses of the measles-mumps-rubella (MMR) vaccine, including an early dose for infants 6–11 months.

However, the CDC does not recommend a third dose of MMR vaccination during or when visiting measles outbreaks.

In the U.S., MMR vaccines are available at most clinics and community pharmacies.

Aug 18, 2024 • 6:23 am CDT
WHO August 17, 2024

The World Health Organization (WHO) recently announced that mass mpox vaccination is not recommended against this sexually transmitted disease.

On August 17, 2024, the WHO confirmed international travelers who may be at risk based on an individual assessment with their healthcare provider may wish to consider vaccination before visiting countries reporting mpox outbreaks, such as in Africa.

Recently, the WHO Director-General announced that he had triggered the process for Emergency Use Listing of mpox vaccines. The WHO currently recommends two new vaccines against mpox disease and continues listing an older smallpox vaccine as an option.

The United States Food and Drug Administration (FDA) Approved Bavarian Nordic's JYNNEOS® (MVA-BN, IMVANEX®, IMVAMUNE®) Smallpox and Mpox Vaccine on September 24, 2019. The U.S. began offering the JYNNEOS vaccine to healthcare staff in Boston on May 24, 2022, in response to the Clade 2 mpox global outbreak.

JYNNEOS remains available in the U.S. at certain clinics and pharmacies.

Additionally, Japan's K.M. Biologics' LC16 "KMB" freeze-dried smallpox vaccine has been approved by the WHO, Japan's Ministry of Health, Labor, and Welfare, and other countries.

The older ACAM2000® live vaccinia virus vaccine is authorized to prevent mpox and smallpox infections in various countries. However, the safety profile of ACAM2000 vaccination includes risks for myocarditis and pericarditis.

The WHO writes, 'Results from vaccine effectiveness studies indicate that a good level of protection is provided against mpox (Clade 2) following vaccination. Further studies on the use of vaccines for mpox (Clade 1) will provide additional information on the effectiveness of these vaccines in different settings.'