Travel Vaccine Breaking News

Travel vaccine breaking news brought to you by Vax Before Travel.

Jul 10, 2023 • 11:36 am CDT
by Adrian P.

The U.S. Centers for Disease Control and Prevention (CDC) recently issued a statement confirming when and explaining how the new COVID-19 vaccines will be available after September 2023.

The CDC stated on July 6, 2023, the new monovalent XBB.1.5 composition vaccines will be the first COVID-19 vaccines to be available directly from the pharmaceutical manufacturers as part of the commercial market rather than through the United States Government (USG).

It is anticipated that USG will stop the regular threshold/replenishment ordering mechanism for all COVID-19 vaccines and ancillary supplies on August 3, 2023.

Providers are encouraged to place necessary orders before that cutoff date.

Suppose a provider requires additional supply to be responsive to demand after USG closes the current ordering mechanism. In that case, COVID-19 vaccines will remain available for ordering via the established out-of-cycle request process.

The public will continue to be directed to Vaccines.gov to find providers offering COVID-19 vaccines.

CDC will provide access to COVID-19 vaccines for uninsured individuals once COVID-19 vaccines become commercially available.

Uninsured children can receive COVID-19 vaccines through the existing Vaccines for Children program.

And uninsured adults can receive COVID-19 vaccines through a new temporary program called the Bridge Access Program for COVID-19 Vaccines and Treatments.

As of July 7, 2023, more than 304.7 million doses of COVID-19 vaccine have been administered and reported by Federal Retail Pharmacy Program participants in the US. This includes 8 million doses administered onsite to long-term care facilities in the early days of the COVID-19 vaccination program.

Furthermore, detail on the current recommended vaccine schedules for each age group can be found on the CDC website.

Jul 10, 2023 • 10:29 am CDT
U.S. CDC Peru vaccinations 2023

According to numerous reports, the Republic of Peru is confronted with another Guillain-Barré Syndrome (GBS) outbreak.

The Peruvian Government recently published Supreme Decree No. 019-2023-SA in the Official Gazette El Peruano, declaring a national health emergency due to the unusual increase in GBS cases in 18 of the country's 24 departments.

As reported on July 10, 2023, 182 cases of GBS have been confirmed, and four people have died since June 2023, per MercoPress.

Peru's president Dina Boluarte also issued a decree allocating $3.27 million for an action plan to improve patient care, including acquiring 5,000 immunoglobulin vials for treating patients affected by GBS.

Issued on July 8, 2023, this emergency declaration will be valid for 90 calendar days.

The U.S. Centers for Disease Control and Prevention (CDC) says GBS is the most common form of acute flaccid paralysis worldwide. It is characterized by motor weakness and other symptoms.

The CDC reported in a November 2020 Research Letter that from May 20–July 27, 2019, the Government identified 683 suspected or confirmed GBS cases in Peru.

Of the 683 GBS patients, 287 (42%) had descending muscle weakness, and 446 (65.3%) had ascending muscle weakness.

Of 426 patients for whom hospitalization data were available, 64 (15%) required mechanical ventilation.

Of 147 patients with an electrodiagnostic exam, 100 (68%) had acute motor axonal neuropathy.

The CDC stated this GBS outbreak was unusual because of the many cases. The incidence rate was nearly 25 times higher than expected.

And the rapid increase in numbers was followed by an equally precipitous decrease, which might suggest a point-source exposure. 

Jul 10, 2023 • 8:10 am CDT
U.S. CDC norovirus trend July 6, 2023

Vaxart, Inc. recently announced positive topline data from the dose-ranging Phase 2 clinical trial of its oral pill bivalent norovirus vaccine candidate.

This study's preliminary results showed robust serum immune responses across all doses at Day 29 relative to Day 1.

Both doses showed a similar increase in serum antibody responses with no statistical difference between the medium and high dose arms, and the mucosal and cell-based assay data will be available later.

Dr. James F. Cummings, Vaxart's Chief Medical Officer, commented in a press release on July 6, 2023, "These data, additional forthcoming data from this study, and the data we expect from our norovirus challenge study, will help inform our selection of dosage levels in a larger Phase 2b study."

"And support an End-of-Phase 2 meeting with the U.S. Food and Drug Administration."

"Our bivalent vaccine is designed to target the most important genogroups, GI and GII, and specifically to cover the important strains, GI.1 and GII.4. GII.4 currently causes the majority of norovirus disease in humans." 

This Phase 2 dose-ranging study demonstrated that the bivalent norovirus vaccine candidate was well tolerated, with a favorable safety profile.

This is the seventh clinical trial completed in Vaxart's norovirus program, and it supports previous findings of robust immunogenicity and benign tolerability. 

As of July 10, 2023, Vaxart's vaccine is one of several norovirus vaccine candidates conducting clinical research.

Norovirus is a very contagious virus that causes vomiting and diarrhea. Anyone can get infected and sick with norovirus. The U.S. Centers for Disease Control and Prevention (CDC) says norovirus cases generally occur most frequently during late fall, winter, and early spring.

The CDC publishes the Norovirus Outbreak Map and posts Norovirus National Trends.

Jul 9, 2023 • 4:16 pm CDT
by Gisela Merkuur

While official updates on H5N1-infected cats in Poland have increased over the past week, Polish authorities provided the European Centre for Disease Prevention and Control (ECDC) with an update, confirming that a total of 24 sick or dead cats were positive for influenza A(H5N1) virus (bird flu).

According to ECDC's testing guidance on avian influenza viruses in humans, any person exposed to sick/dead cats confirmed with A(H5N1) infection who develops symptoms should be tested as soon as possible for A(H5N1).

And persons exposed to sick/dead cats confirmed with A(H5N1) infection are advised to monitor their symptoms for 10–14 days after the last exposure and self-isolate if they develop symptoms.

They are also advised to wear a surgical mask or FFP2 respirator when in contact with others, seek medical advice and report it to public health authorities immediately.

And recently, the Italian Ministry of Health announced on July 6, 2023, that several dogs (and one cat) on a farm in Brescia, Italy, recently hit by avian influenza (bird flu), have seroconverted.

And the Italian Union of Public Medicine Veterinarians confirmed this HPAI H5N1 belonging to clade 2.3.4.4 b, and in particular to the H5N1-A/Herring_gull/France/22P015977/2022-like genotype, responsible for the cases reported in northern Italy in gulls.

This virus also has a mutation considered a marker of adaptation of mammalian viruses (T271A in the PB2 protein) with a possible increase in its zoonotic potential.

This mutation sparked considerable concern earlier this year when it was detected in infected mink in the fall of 2002, wrote the Avian Flu Diary.

The ECDC stated that considering the information and genomic data available until now and the fact that no human cases related to this event have been reported so far, ECDC assesses the current risk to the general public as low.

However, the risk is considered moderate for persons exposed to sick and/or dead cats confirmed with A(H5N1) infection, particularly if they belong to a vulnerable population group (immunocompromised people).

Considering the existing uncertainties, this assessment is preliminary and will be reviewed as soon as more information becomes available, says the ECDC.

Jul 9, 2023 • 3:38 pm CDT
by Richard Mcall

The European Centre for Disease Prevention and Control recently published a Communicable Disease Threats Report (CDTR) for week #27, which included a mpox outbreak update.

The weekly number of mpox cases reported in the EU/EEA peaked in July 2022, and since then, a steadily declining trend has been observed.

Mpox is a viral disease, and the outbreak that began in May 2022 was driven by human-to-human transmission via close contact with infected individuals. 

As of July 8, 2023, this CDTR confirmed since the last monthly update, 13 cases of mpox have been reported by Portugal (12) and Norway (1).

Portugal reported in the latest epidemiological update (June 30, 2023) that following three months with no new mpox cases, information is available for seven of the 12 patients; all were male, five (71%) were 20–29 years old, five presented with exanthema, and four are HIV-positive.

Based on evidence from the current outbreak and the declining number of new infections in the WHO European Region, the CDTR says the overall risk of mpox infection is moderate for men with sex with men and low for the broader population in the EU/EEA.

As of July 9, 2023, the leading mpox vaccine is JYNNEOS®.

As of June 27, 2023, 1,237,235 JYNNEOS doses (1st and 2nd) had been administered in 57 U.S. Jurisdictions. The U.S. CDC's vaccine advisory committee recently presented no recommendation for a third Jynneos dose.

Other sexually transmitted disease vaccine news is posted at Precision Vaccinations.

Jul 9, 2023 • 2:22 pm CDT
WHO WPV1 and cVDPV polio map July 4, 2023

The Global Polio Eradication Initiative (GPEI) reported this week, three African nations reported continuing polio outbreaks.

Burkina Faso reported it's first circulating vaccine-derived poliovirus type 2 (cVDPV2) case of the year.

Chad reported two more cVDPV2 cases increasing its total for the year to ten.

And Nigeria reported six more polio cases, raising its total to 16 in 2023.

Furthermore, various countries reported cVDPV2-positive environmental samples as of July 5, 2023.

Previously, the World Health Organization (WHO) reconfirmed that the spread of poliovirus remained a Public Health Emergency of International Concern. As of July 2023, the WHO recommends travelers to polio-outbreak areas be fully vaccinated.

As of July 9, 2023, various polio vaccines are available worldwide.

Jul 8, 2023 • 1:42 pm CDT
by Nel Botha

As more countries reported measles outbreaks this year, the U.S. Centers for Disease Control and Prevention (CDC) is arming travelers with information on preventing this highly contagious, vaccine-preventable disease.

On June 29, 2023, the CDC updated its Travel Health Advisory that confirmed many international destinations are reporting increased numbers of cases of measles in 2023.

For example, Austria reported 130 cases of measles in 2023. Styria is the most affected region with 102 cases reported since the beginning of the outbreak in week 4, 2023.

And in Germany, 54 suspected and confirmed cases were reported as of July 2, 2023.

The CDC's Level 1 Global Measles advisory says travelers are at risk of measles if they have not been fully vaccinated two weeks prior to departure or have not had measles in the past and travel internationally to areas where measles is spreading.

And all international travelers, including infants 6–11 months of age and preschool-aged children, should be fully vaccinated against measles according to CDC's measles recommendations for international travel.

If you are not sure if you or your travel companions are fully protected against measles, schedule an appointment to see your clinician at least 1 month before traveling.

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

Furthermore, international travelers should seek medical care if they develop a rash, high fever, cough, runny nose, or red, watery eyes. Travelers with suspected measles should notify the healthcare facility before visiting so staff can implement precautions to prevent the spread within the facility.

As of July 8, 2023, various measles prevention vaccines are available in the U.S. and worldwide.

Jul 8, 2023 • 9:38 am CDT
by Clayton Majona

The Republic of South Africa's  National Institute for Communicable Diseases (NICD) today reported the year-long measles outbreak continues in the northern provinces.

As of July 7, 2023, the NICD confirmed in the past week (week #25) that ten laboratory-confirmed measles cases were detected across the country, most of which were from Limpopo (6).

In week #25, Limpopo reported a total of 5 cases.

The vaccination campaign in Limpopo province targeting the 5-15 years age group has come to an end with overall vaccination coverage of 56%.

To achieve a higher coverage rate, the NICD is informed that a mop-up campaign will be conducted through the end of August 2023.

Various measles vaccines are available globally, and most health agencies recommend full vaccination before visiting measles outbreak areas.

The NICD says measles is a highly contagious disease caused by an airborne virus. Complications are more serious in those who catch measles as young infants and in children who are malnourished.

Infected patients with measles present with fever and with a rash. The rash looks like small, red, flat spots over the body. The rash does not form blisters, nor is it itchy or painful.

Other signs include cough, red eyes, and a running nose.

Complications of measles can include diarrhea, dehydration, brain infection, blindness, and death.

Jul 8, 2023 • 6:48 am CDT
by Ahmad Ardity

Novavax Inc. announced yesterday that it had reached an agreement with Canada, under which the country would pay $349.6 million to settle the forfeiting of certain doses of the company’s protein-based COVID-19 vaccine.

Novavax COVID-19 vaccine brands include Nuvaxovid™, CovoVax, NVX-CoV2373, and TAK-019.

Since authorization, over 100 million doses of Nuvaxovid have been distributed globally in about 40 markets.

As reported by BNN on July 7, 2023, this development results from a significant decrease in global demand for COVID-19 vaccines, leading to a surplus of unused doses.

The World Health Organization weekly epidemiological update edition #150 confirmed that during the previous 28 days, the COVID-19 pandemic has declined since mid-2022.

In addition to the settlement, Novavax also entered into a revised contract with Canada’s public works and government services department.

The terms of the advance purchase contract were amended to reflect the reduced number of vaccine doses due for delivery and the revised schedule for the remaining doses.

On June 6, 2023, the U.S. Food and Drug Administration confirmed Novavax COVID-19 Vaccine, Adjuvanted, was available in the U.S. for certain people. And on July 6, 2023, Nuvaxovid received Full Marketing Authorization in Europe as a primary series in individuals aged 12 and older and booster in adults. 

Jul 7, 2023 • 4:45 pm CDT
by Dave Ranck

The Florida Department of Health in Sarasota (DOH-Sarasota) recently reported two additional locally-acquired malaria infections caused by mosquito bites. 

The Plasmodium species reported were Plasmodium vivax as of July 1, 2023.

According to Florida's surveillance report #26, the new malaria cases were in similar locations in greater Sarasota as the previous four cases with onsets in May and June 2023.

Regarding Travel-Associated Malaria Cases, twenty-three cases of malaria with onset in 2023 have been reported in Florida. 

The countries of origin were Burundi, Côte D'Ivoire, Democratic Republic of the Congo (2), Equatorial Guinea, Ghana (2), Kenya, multiple countries (4), Nicaragua (2), Nigeria (2), Pakistan, Sierra Leone (2), Sudan, and Uganda (3).

The U.S. Centers for Disease Control and Prevention says malaria is a mosquito-borne disease.

Left untreated, malaria infections can develop severe complications. In 2020, an estimated 241 million cases of malaria occurred worldwide.

Malaria vaccines are currently in use in Africa and are reported to be effective at preventing disease.

As of July 7, 2023, the U.S. Food and Drug Administration had not approved a malaria vaccine for use in Florida.

Jul 7, 2023 • 2:17 pm CDT
by Bruno P.

Novavax, Inc. announced yesterday that its protein-based COVID-19 vaccine had been granted full Marketing Authorization (MA) by the European Commission in the European Union (EU).

The Nuvaxovid™ (NVX-CoV2373) vaccine is now fully authorized for use in the EU as a primary series in individuals aged 12 and older.

And as a booster dose in adults aged 18 and older to prevent COVID-19.

During the diminishing pandemic, Novavax's COVID vaccine has been authorized for use in more than 40 markets worldwide.

"This Marketing Authorization establishes the foundation for all future regulatory approvals for updated versions of our COVID vaccine, a necessity to ensure we can quickly get our vaccine to individuals in the EU," said John C. Jacobs, President and Chief Executive Officer, Novavax, in a press release on July 6, 2023.

"In addition to the EU, we are preparing to file for full approval in the U.S. and other markets and are committed to ensuring protein-based options are available worldwide."

"Vaccine choice remains an integral part of public health measures." 

The U.S. Food and Drug Administration has not yet approved the trade name Nuvaxovid™, nor has it been approved or licensed.

However, as of July 7, 2023, it has been authorized for emergency use under an Emergency Use Authorization for various people. In Europe, over ten COVID-19 vaccines are available.

Jul 7, 2023 • 12:40 pm CDT
by Manfred Richter

Eisai Co., Ltd. and Biogen Inc. announced today that the U.S. Food and Drug Administration (FDA) had approved the supplemental Biologics License Application (sBLA) supporting the traditional approval of LEQEMBI® (lecanemab-irmb) 100 mg/mL injection for intravenous use.

This approval makes LEQEMBI the first and only approved treatment shown to reduce the rate of disease progression and slow cognitive and functional decline in adults with Alzheimer's disease (AD).

In a phase 3 clinical trial, LEQEMBI demonstrated clinically meaningful slowing of cognitive and functional decline in a patient group generalizable to U.S. Medicare beneficiaries, which included a mix of racial and ethnic groups, patients with common comorbid conditions, concomitant medications, and patients with mild cognitive impairment (MCI) due to AD or mild AD.

Treatment with LEQEMBI should be initiated in patients with MCI or mild dementia stage of disease, the population in which treatment was initiated in clinical trials.

Furthermore, CMS confirmed that broader coverage of LEQEMBI is now available. The CMS-facilitated registry is now available for healthcare professionals to submit required patient data to CMS.

This action will facilitate reimbursement for and access to LEQEMBI across a broad range of healthcare settings in the U.S.

As of July 7, 2023, there are no approved Alzheimer's disease vaccines in the U.S.

Jul 6, 2023 • 12:34 pm CDT
WHO / PAHO July 5, 2023

The Pan American Health Organization / World Health Organization (PAHO/WHO) recently stated the seasonality of dengue in Central America and the Caribbean is a concern and recommends that Member States prepare plans to face possible outbreaks during the summer of 2023.

In 2023, through week #24, of the 2,102,848 dengue cases reported in the Region, 3,201 (0.15%) were classified as severe dengue.

Additionally, in the same period, 876 deaths were reported in the Region (case fatality rate: 0.042%).

The greatest number of dengue cases was observed in Brazil, with 1,515,460 cases, followed by Peru, with 169,504 
patients and Bolivia with 133,452 cases.

Regarding the number of severe dengue cases, Brazil led with 654 instances, Colombia with 652 instances, Peru with 597, Bolivia with 590 patients, and Mexico with 573 cases, says the PAHO/WHO.

According to the Centers for Disease Control and Prevention (CDC), dengue is a vectorborne infectious disease caused by four dengue viruses and is endemic in about 125 countries. 

The CDC recently reissued a Travel Health Advisory regarding dengue outbreaks in Asia and the Pacific Islands.

In the U.S., Florida has reported the most locally-acquire and travel-related dengue cases in 2023.

Dengue is also a vaccine-preventable disease. In 2022, a seconded dengue vaccine was approved for use by certain countries.

Jul 6, 2023 • 6:48 am CDT
by Later Jay

The Lancet Infectious Diseases recently published results from a  phase 1 clinical trial of a Lyme disease vaccine candidate, showing that Valneva's VLA15 produces a strong but waning immune response against six common strains of the Borrelia burgdorferi bacterium found in Europe and the United States.

Valneva Austria researchers led this company-sponsored, partially randomized, observer-masked study of the novel, multivalent outer surface protein A (OspA) subunit vaccine candidate.

OspA is one of the most dominant surface proteins expressed by the bacteria when present in a tick.

VLA15 produced immune responses for all strains, but responses were greater in the higher-dose adjuvanted groups. And one month after the third dose, responses declined, reaching baseline by one year.

And a booster dose given 13 months after the first dose triggered a strong immune response for about six months.

This study's findings are good news since Lyme borreliosis is the most common tick-borne disease in the northern hemisphere.

In Europe, there are estimated to be more than 200,000 cases each year. And in the U.S., approximately 30,000 patients per year.

In a related commentary also published by The Lancet, Nicole Bézay, and colleagues reported Valneva's novel vaccine represents a milestone in our fight against Lyme disease."

Initially developed by France-based Valneva SE, New York-based Pfizer, Inc. is VLA15's current development and commercialization collaboration.

Pfizer previously indicated it could submit a Biologics License Application in 2025 and Marketing Authorization Application in Europe in 2026, subject to positive data.

Jul 6, 2023 • 5:44 am CDT
by A. Kasakow

Local media today reported Moderna Inc. intends to establish its Chinese headquarters in Shanghai to promote the research, development, production, and sales of messenger RNA vaccines and drugs in China.

Yicai Global confirmed on July 6, 2023, Moderna signed a memorandum of understanding and a land deal with Shanghai's Minhang district government,  marking the Massachusetts-based firm's first investment in China.

Sources told Yicai Global that Moderna's investment will total USD1 billion.

Additionally, Moderna will build a plant in China to make respiratory disease vaccines, such as those against respiratory syncytial virus (RSV) and influenza.

As the recent global pandemic fades, there is market pressure on Moderna to find new vaccine products for its foraying into  China, wrote Yicai.