Vaccine News

Vaccine news brought to you by Precision Vaccinations.

May 11, 2023 • 10:47 am CDT
U.S. CDC Mpox case map May 9, 2023

The World Health Organization (WHO) today announced that the Fifth Meeting of the International Health Regulations Emergency Committee on the Multi-Country Outbreak of Mpox decided to end the public health emergency of international concern (PHEIC).

As of May 11, 2023, data sources indicate about 87,000 Mpox cases have been confirmed globally, with 30,395 cases and 42 related fatalities in the U.S. since early May 2022.

The WHO committee stated having considered the significant decline in the global spread of mpox and the gains achieved in the control of the outbreak in many countries; the Committee advised that the event requires a transition from a PHEIC to a robust, proactive and sustainable mpox response and control program.

The Committee emphasized the need for long-term attention and support, including financial aid, particularly for countries where Mpox occurs regularly, and advised that Standing Recommendations would now be a more appropriate tool to manage the immediate, short, and long-term public health risks posed by Mpox.

In the U.S., an initial Mpox outbreak was declared in August 2022. On October 27, 2022, the Mpox public health emergency in San Francisco ended, followed by New York City in November 2022.

And on January 31, 2023, the U.S. HHS did not renew the Mpox public health emergency declaration.

However, recent Mpox outbreaks have been reported in Chicago.

Furthermore, the U.S. Food and Drug Administration previously approved vaccines can prevent certain sexually transmitted diseases such as Mpox.

And the oral TPOXX® (Tecovirimat) treatment remains available in the U.S.

May 11, 2023 • 10:20 am CDT
U.S. CDC May 11, 2023

The U.S. Centers for Disease Control and Prevention (CDC) has scheduled for today at 2 pm ET a Clinician Outreach and Communication Activity (COCA) call with updated recommendations for COVID-19 vaccine use.

During this COCA Call on May 11, 2023, presenters will discuss updated COVID-19 vaccine recommendations by age group and for those with immunocompromise.

Sara Oliver, MD, MSPH, and Evelyn Twentyman, MD, MPH, will also highlight optional COVID-19 vaccine doses for specific populations.

With a simplified schedule, the CDC recommends that everyone stay up to date with recommended COVID-19 vaccines to better protect themselves from severe illness.

Most people in the United States have not yet received an updated (bivalent) mRNA COVID-19 vaccine, with less than 17% uptake.

The Webinar Link: https://www.zoomgov.com/j/1619378091; ID: 161 937 8091; Passcode: 499465.

May 11, 2023 • 7:29 am CDT
ECDC dengue map May 2023

Takeda today announced its dengue vaccine QDENGA® had received several approvals, including one by Brazil's National Health Surveillance Agency in March 2023 for use in individuals between 4 years and 60 years to protect against all four serotypes.

Brazil's approval marks the first approval of QDENGA in Latin America, where dengue is endemic in various countries.

Recently, Costa Rica confirmed a unique dengue outbreak.

QDENGA is the only dengue vaccine approved for use regardless of previous exposure and without needing pre-vaccination testing.

Takeda's press release on May 11, 2023, confirmed it continues progressing with additional regulatory filings, such as the U.S.

The U.S. CDC published provisional data as of May 5, 2023, indicating the U.S. States, led by Florida, have reported 98 dengue cases in 2023, and U.S. Territories have confirmed 238 dengue cases this year.

May 10, 2023 • 2:59 pm CDT
SOUTH AFRICA TRAVEL DIRECTORY 2023

The Kingdom of Lesotho recently confirmed a measles outbreak in the capital city of Maseru, which has a population of over 300,000.

In response, through the Maseru District Health Management Team, the Ministry of Health launched a measles vaccination campaign in mid-April 2023. 

Measles is a severe disease that can be prevented with safe and effective vaccines.

Lesotho is located in the country of South Africa, which has been reporting measles outbreaks in 2023.

South Africa's National Institute for Communicable Diseases reported in April the percentage of samples testing positive for measles remained at 27%.

Unfortunately, the Mountain Kingdom's 2022 measles vaccination campaign turnout was about 33% in 2022.

Before 2019, Lesotho had gone about ten years without a measles outbreak.

Measles outbreak news and alerts are posted by Vax-Before-Travel.

May 10, 2023 • 11:31 am CDT
WHO malaria map May 2023

Vakzine Projekt Management GmbH (VPM) today announced the successful licensing of the novel R21/Matrix-MTM Malaria Vaccine by the Ghana Food and Drugs Authority.

On May 10, 2023, VPM confirmed in a press release that the R21/Matrix-M™ vaccine has emerged as the most effective vaccine against malaria.

This innovative malaria vaccine was initially developed by the lab research team of Adrian Hill, Director of the University of Oxford's Jenner Institute.

Based on available clinical data in 2023, the R21/Matrix-M™ vaccine's efficacy is greater than 75%, far above the effectiveness of the other approved malaria vaccine, Mosquirix™ (RTS,S/AS01).

Notably, the manufacturing capacity of 200 million doses/year by SII will increase the current supply capacities by >20-fold globally.

Malaria is one of the leading causes of pediatric morbidity and mortality in sub-Saharan Africa. And that children under five account for approximately 80% of all malaria-related fatalities, says the WHO Africa.

Four African countries accounted for just over half of all malaria deaths worldwide: Nigeria (31.3%), the Democratic Republic of the Congo (12.6%), the United Republic of Tanzania (4.1%), and Niger (3.9%).

And in the Northern Hemisphere, Costa Rica recently reported 105 positive malaria cases.

Malaria outbreak news is posted by Vax-Before-Travel.

May 10, 2023 • 9:48 am CDT
by Marci Marc

Sinovac Biotech Ltd. today announced it would provide its CoronaVac® vaccine to self-paying groups in Hong Kong and confirmed a donation plan.

Additionally, the company will collaborate with local charity groups to provide donations, giving more children in Hong Kong access to free its inactivated original strains COVID-19 vaccine.

On March 31, 2023, the Government of the Hong Kong Special Administrative Region announced that beginning April 20, 2023, high-risk groups would be able to receive free doses of COVID-19 vaccines.

Whereas low-risk groups, including children, can only receive their vaccines via the private market through self-pay.

"SINOVAC's ongoing fight against COVID-19 is based on our mission to 'supply vaccines to eliminate human diseases,'" said Yin Weidong, Chairman, President, and CEO of SINOVAC, in a press release on May 10, 2023.

"From developing the COVID-19 vaccine to obtaining market approvals, from the first CoronaVac® shipment landing in Hong Kong 800 days ago to the rollout of a massive public vaccination program, SINOVAC and Hong Kong have taken steps together to emerge from the shadows of the pandemic."

CoronaVac® is the first COVID-19 vaccine to be used in children from as young as three years old, under the World Health Organization's Emergency Use List.

As of March 2023, CoronaVac® has been authorized for use in more than 60 countries, regions, and international organizations. But not in the U.S.

The cumulative global vaccine supply exceeds 2.9 billion doses.

May 9, 2023 • 12:54 pm CDT
U.S. CDC Micronesia map May 2023

The U.S. Department of State today reissued its lowest-level travel advisory for the Federated States of Micronesia (FSM), including the island states of Pohnpei, Kosrae, Chuuk, and Yap.

On May 8, 2023, the State Department's Level 1: Exercise Normal Precautions advisory for this western Pacific Ocean U.S. Territory suggests visiting the FSM websites of the Department of Health and Social Services for the latest information from the Government of Micronesia.

And the U.S. CDC recommends visitors confirm their immunization for Routine and Travel related diseases, such as measles.

A measles outbreak was recently declared in a neighboring territory, American Samoa.

Should visitors need assistance, the U.S. Embassy in Kolonia is located at 1286 U.S. Embassy Pl., Kolonia, Pohnpei, FM 96941.

May 9, 2023 • 8:45 am CDT
by Senjin Pojskić

Novavax, Inc. today announced that its COVID-Influenza Combination (CIC), stand-alone influenza, and high-dose COVID vaccine candidates all showed a reassuring preliminary safety profile and comparable reactogenicity to individual Novavax influenza and COVID vaccine candidates or authorized influenza vaccine comparators.

Additionally, all three vaccines demonstrated preliminary robust immune responses.

In all groups, no adverse events (AE) of special interest, no potentially immune-mediated medical conditions, and no treatment-related serious AEs.

"The reactogenicity results support our previous observations that this technology is well suited for combination vaccines because large amounts of antigen can be incorporated without impacting tolerability," said Filip Dubovsky, President, Research and Development, Novavax, in a press release on May 9, 2023.

"The immune responses we observed were robust, and the data we have shared today significantly increase the probability of Phase 3 success."

Furthermore, the highest dose stand-alone COVID vaccine candidate achieved statistically significant anti-S IgG and neutralization responses, approximately 30% higher than Novavax's prototype COVID vaccine while maintaining comparable safety and reactogenicity to the currently authorized dose level of Nuvaxovid™.

Various CIC vaccine candidates are in late-stage development as of May 9, 2023.

May 9, 2023 • 3:00 am CDT
V-Safe After Vaccination Health Checker

The U.S. Centers for Disease Control and Prevention (CDC) recently announced that it would soon close enrollment in V-Safe for COVID-19 vaccines.

The CDC confirmed that very few new data are being reported to the V-Safe system.

Since its launch in December 2020, over 10 million participants have completed more than 151 million health surveys about their experiences following COVID-19 vaccination.

Furthermore, V-Safe data have been included in more than 20 scientific publications.

V-Safe was explicitly developed for COVID-19 vaccines and has been an essential component of the pandemic vaccine safety monitoring systems that have successfully and comprehensively characterized the safety of the COVID-19 vaccines used in the U.S.

After May 19, 2023, those who had enrolled and participated in V-Safe cannot add new COVID-19 vaccine doses to their account. Health check-ins (and follow-up calls, if needed) for any doses added before May 19 will continue until June 30.

V-Safe participants will continue to have access to their account to review previous entries and to complete remaining health check-ins until June 30, 2023.

The CDC is developing a new version of V-Safe, launching later in 2023, which will empower users to share their post-vaccination experiences with new vaccines.

V-Safe users or others who get vaccinated can continue to report any possible health problems or adverse events following vaccination to the Vaccine Adverse Event Reporting System.

The CDC and the U.S. Food and Drug Administration closely monitor the safety of vaccines in the United States.

May 9, 2023 • 2:40 am CDT
by Max P.

A recent Research Letter published by the JAMA Network found that local adverse event rates were highest following intradermal administration of the Mpox vaccine.

During the early stages of the Mpox outbreak in 2022, many countries adopted a dose-sparing schedule with 0.1-mL intradermal MVA-BN (JYNNEOS®) vaccine recommended for the preexposure and 0.5-mL subcutaneous vaccine for postexposure prophylaxis, two doses given four weeks apart.

As reported on May 4, 2023, the adverse event rate was highest following dose one of intradermal vaccination (53%) and lowest following dose two of subcutaneous vaccination (31%).

The most common adverse events were local redness, itching, and swelling following intradermal vaccination and local pain, swelling, and redness following subcutaneous vaccination.

During May 2023, the JYNNEOS vaccine is readily available in most countries. Furthermore, there has been a resurgence of Mpox cases in various cities, such as Chicago, Paris, and Seoul.

May 8, 2023 • 4:39 pm CDT
U.S. CDC map of Chile May 2023

The U.S. Department of State reissued its Level 2: Exercise Increased Caution advisory today regarding civil unrest in the Republic of Chile. 

On May 8, 2023, the State Department confirmed street crime is common, and the rates of violent crime are increasing in Chile.

Moreover, large-scale demonstrations periodically occur in Santiago and other cities in Chile.

Demonstrations can occur with little or no notice and often result in disruptions to transportation, including public buses and Santiago metro services.

If you visit Chile, the local U.S. embassy suggests enrolling in the Smart Traveler Program to receive Alerts in an emergency.

From a health perspective, the U.S. CDC suggests travelers speak with a healthcare professional regarding their vaccination needs, such as for measles protection.

May 8, 2023 • 1:59 pm CDT
UNICEF cervical cancer rates May 2023

UNICEF recently announced it would supply 52 countries with human papillomavirus (HPV) vaccines. In 2023 alone, UNICEF will provide one in four countries worldwide with this life-saving vaccine.

And seven countries, Bangladesh, Cambodia, Eswatini, Kiribati, Mongolia, Nigeria, and Togo, intend to introduce HPV vaccines to their routine immunization programs in 2023. 

On April 28, 2023, UNICEF confirmed just one in eight girls are vaccinated against HPV, the leading cause of cervical cancer.

And since 2019, HPV vaccination coverage has decreased by 15%, representing one of the largest backslides of any vaccine during the pandemic.

Oluwaseun Ayanniyi, a Contracts Specialist in the Vaccine Centre of UNICEF’s Supply Division in Copenhagen, commented that she is optimistic that significant ground can be regained to prevent cervical cancer.

HPV vaccination can help prevent certain cancers for boys and girls, says the U.S. CDC. These vaccines are generally available at health clinics and pharmacies in the U.S.

As of May 8, 2023, the U.S. Food and Drug Administration has approved various vaccines that can prevent certain sexually transmitted diseases such as Mpox.

May 8, 2023 • 7:22 am CDT
by Mojca-Peter

CureVac N.V. today announced that the first participant was dosed in a combined Phase 1/2 study of multivalent, modified mRNA seasonal flu vaccine candidates developed in collaboration with GSK is being conducted in the U.S. and Belgium.

The tested multivalent vaccine candidates address all four WHO-recommended flu strains.

"Our clinically validated technology platform and second-generation mRNA backbone give us great confidence as we continue clinical development of novel vaccine candidates to address seasonal flu," said Dr. Myriam Mendila, Chief Development Officer of CureVac, in a press release on May 8, 2023.

"There are still unmet needs as seasonal flu is ever-evolving and immune responses to current vaccines remain a challenge, particularly in older adults."

"The flexibility, speed, and scalability of CureVac's end-to-end mRNA capabilities position us well to develop and deliver seasonal flu vaccines together with GSK that combat dominant strains of the season as they emerge."

As previously reported, in CureVac and GSK's ongoing Phase 1 trial in older and younger adults of a monovalent, modified mRNA seasonal flu vaccine candidate, preliminary data showed a favorable tolerability profile and no concerning safety signals. In addition, the preliminary immunogenicity data indicated strong hemagglutinin inhibition immune responses in line with a licensed flu comparator vaccine beginning at the lowest tested dose.

The CureVac-GSK infectious disease collaboration was first announced in July 2020.

May 7, 2023 • 3:57 pm CDT
WHO Influenza Report May 2023

The World Health Organization (WHO) recently published Influenza Update N° 444, indicating that some Southern Hemisphere countries reported increased influenza detections.

On May 3, 2023, the WHO reported in the Caribbean and Central American countries, influenza activity of mainly influenza B/Victoria lineage viruses was low or below baseline in most countries.

Moreover, increases in influenza activity were reported in a few countries, and activity was moderate in Jamaica.

In tropical Africa, influenza detections were low in reporting countries. Influenza A virus detections outnumbered B virus detections.

In Southern Asia, influenza activity remained low, with influenza A(H3N2) predominant, followed by B/Victoria lineage viruses. However, increased activity was reported in Bhutan and Sri Lanka.

In South-East Asia, influenza activity remained elevated mainly due to detections in Malaysia and Singapore.

However, in Malaysia, activity decreased.

But there was an increased proportion of influenza A viruses over the past several weeks, and influenza A viruses predominated during this period.

On the other hand, influenza A(H3N2) viruses remained predominant in Singapore.

In the temperate zones of the southern hemisphere, influenza activity remained low.

And influenza activity increased slightly in Australia and Chile, and pneumonia surveillance in South Africa. 

As of May 7, 2023, the WHO continues endorsing flu shots for the summer holiday season, wherever influenza outbreaks occur.

In the U.S., various influenza vaccines remain available at health clinics and community pharmacies. 

As of early March 2023, about 173 million flu shots had been distributed during the 2022-2023 flu season. 

May 7, 2023 • 3:33 pm CDT
U.S. FDA May 4, 2023

The U.S. Food and Drug Administration (FDA) announced on May 4, 2023, a future meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC).

On June 15, 2023, the VRBPAC will meet in an open session to discuss and make recommendations on selecting strain(s) to be included in the periodic updated COVID-19 vaccines for the 2023-2024 vaccination campaign.

This discussion will include consideration of the vaccine composition for fall to winter 2023-2024. And it will be open for viewing by the public and will be hosted at this YouTube link

The Docket Number is FDA-2023-N-1553.

The VRBPAC provides independent expert advice to the FDA on broad scientific topics or certain products to help the agency make sound decisions based on the available science. Advisory committees make non-binding recommendations to the FDA, which generally follows the recommendations but is not legally bound to do so. 

The FDA currently endorses mRNA and protein-based COVID-19 vaccines and monoclonal antibody therapies.

On April 4, 2023, InflaRx N.V.'s Gohibic (vilobelimab), a first-in-class monoclonal anti-human complement factor C5a antibody, was granted an Emergency Use Authorization by the FDA.

Recently, the World Health Organization announced the ending of its pandemic declaration for COVID-19 since it is now an established and ongoing health issue that no longer constitutes a public health emergency of international concern.