Coronavirus Breaking News

The coronavirus disease COVID-19 is currently reaching pandemic levels in various countries.

May 12, 2023 • 7:30 am CDT
Pixabay

Data published by Sanofi today from the HARMONIE Phase 3b clinical trial show an 83.21% (95% CI 67.77 to 92.04; P<0.001) reduction in hospitalizations due to RSV-related lower respiratory tract disease (LRTD) in younger infants who received a single dose of Beyfortus® (Nirsevimab).

While the U.S. Food and Drug Administration approved a multi-dose, injectable monoclonal antibody (mAbs) therapy in 1998, this new therapy has been authorized in Canada, Europe, and the U.K. as of May 12, 2023.

The Hospitalized RSV Monoclonal Antibody Prevention (HARMONIE) study is a large (8,000), multi-country interventional clinical trial aiming to determine the efficacy and safety of a single intramuscular dose of nirsevimab, with data collected in a real-world setting during the 2022-2023 RSV season. 

The data from HARMONIE also show that nirsevimab reduced the incidence of hospitalizations due to severe RSV-related LRTD (patients whose oxygen level is under 90% and require oxygen supplementation) by 75.71% (95% CI 32.75 to 92.91; P<0.001).

Additionally, nirsevimab demonstrated a reduction of 58.04% (95% CI 39.69 to 71.19; P<0.001) in the incidence of all-cause LRTD hospitalization compared to infants who received no RSV intervention.  

Throughout HARMONIE, nirsevimab maintained a favorable safety profile, consistent with the pivotal trial results.

In a press release, Dr. Simon Drysdale, Consultant Pediatrician in Infectious Diseases at St. George’s University Hospital NHS Foundation Trust and Co-Chief Investigator of HARMONIE, stated, “RSV-related chest infections lead to high numbers of infants under 12 months old being hospitalized every year."

"These data reinforce the potential public health benefit of nirsevimab in helping reduce the strain on hospitals caused each year by RSV.”

Additional RSV vaccine and monoclonal antibody news are posted by Precision Vaccinations. 

May 11, 2023 • 4:16 pm CDT
BWH, Boston, MA 2023

The first participant recently received a dose of a Zika virus vaccine candidate in a phase 1 clinical trial conducted by the University of Liverpool at the Clinical Research Facility within the Royal Liverpool University Hospital.

This study is essential since Zika remains an ongoing threat, with thousands of cases of the mosquito-borne virus reported annually, in countries such as Brazil, Belize, Guatemala, Paraguay, and Bolivia.

And in 2023, Puerto Rico reported 21 probable Zika cases.

And pregnant women continue at the highest risk for the infection as the virus can cause severe fetal congenital disabilities, such as microcephaly, a condition where a baby's head is much smaller than expected.

It's hoped that the vaccine, designed to be suitable for use during pregnancy, wrote these researchers on May 2, 2023.

“Zika should not be forgotten, especially since climate change contributes to the spread of the Aedes mosquitoes to countries without immunity. Vaccines like ours will enable us to be better prepared for the next Zika outbreak,” commented Dr. Krishanthi Subramaniam in a press release on April 27, 2023.

The vaccine originates from a 2016 Zika Rapid Response grant awarded to Dr. Tom Blanchard and colleagues at the University of Manchester in collaboration with the UK Health Security Agency.

Dr, Blanchard has since developed several iterations to enhance the vaccine's effectiveness and manufacturing scale-up.

Liverpool researchers have been driving this project forward since 2017. The team has used an approach to develop a vaccine based on studies to understand immunity to Zika and other related viruses.

As of May 11, 2023, there are no U.S. FDA-approved Zika vaccines.

May 11, 2023 • 2:58 pm CDT
Puerto Rico Zika cases May 2023

The recent Aboviral Diseases Report of the Puerto Rico Department of Health indicates the Zika virus has returned in 2023.

As of May 5, 2023, Report #17 data indicates 21 probable Zika cases were confirmed in 2023.

Since its first detection in March 2014, the Pan American Health Organization (PAHO) has confirmed local transmission of Zika in all countries and territories in the Region of the Americas, except for continental Chile, Uruguay, and Canada.

In 2022, Barbados had the highest Zika incidence and case fatality rate. Other Zika outbreak countries were Guatemala, El Salvador, and Costa Rica.

Zika is a viral disease transmitted by mosquitoes, says the PAHO. About 25% of infected people may develop symptoms. The illness is usually mild, lasting between two and seven days.

However, the Puerto Rico Department of Health and the U.S. CDC surveyed women who gave birth to infants from August to December 2016.

This survey determined there are no known ways to prevent the adverse effects of Zika infection during pregnancy.

One is Microcephaly, a condition where a baby's head is much smaller than expected. 

As of May 11, 2023, there are no approved vaccines to prevent Zika infections.

May 11, 2023 • 12:40 pm CDT
Osana 2023

The Republic of Costa Rica Ministry of Health continues to monitor work on dengue cases in different areas such as Sarapiquí and Río Cuarto.

As of May 9, 2023, epidemiological week #16, a total of 1,179 cases of dengue were reported, with the Huetar Caribe and Central Sur regions presenting the most cases.

Given the previous declaration of a dengue outbreak by the North Central Region, a total of seven officers were displaced to work in the town of Santa Rita and Río Cuarto to assist with fumigation efforts.

Costa Rica was included in the U.S. CDC's recent dengue outbreak travel advisory for the Americas.

Almost half of the world's population, about 4 billion people, live in areas with a risk of dengue. Moreover, dengue is often a leading cause of illness in high-risk areas, says the U.S. CDC.

Dengue is caused by one of four related viruses. For this reason, people can be infected with dengue multiple times in their life.

Approximately 1 in 20 patients with dengue virus disease progress to develop a severe, life-threatening disease called severe dengue.

Dengue vaccines are approved and available in certain countries as of May 11, 2023.

Additional Costa Rica disease outbreak news is posted by Vax-Before-Travel.

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.