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Novotech recently released the latest global clinical trial landscape report on HIV, a condition now affecting more than 39 million people.
According to the HIV Global Clinical Trial Landscape report published on December 18, 2023, the biopharma industry has initiated over 1,000 HIV clinical trials worldwide since 2018.
The distribution of the trials is as follows: Asia-Pacific accounts for 29% of trials, Europe at 28%, and North America at 26%, while the Rest of the World contributes a moderate share of 17%.
The report delves into the multifaceted landscape of HIV, focusing on its impact, treatment, and global initiatives.
It begins by elucidating HIV's progression, from its attack on the immune system to the potential development of AIDS. In the United States, there were 1.2 million HIV cases, leading to 19,986 deaths in 2022.
At the report's core lies the worldwide strategy articulated by organizations such as WHO, the Global Fund, and UNAIDS to eradicate the HIV epidemic by 2030.
Moreover, the report explores cutting-edge research, including long-acting injectables, HIV vaccines, and gene editing, underscoring the potential to find an HIV cure.
As of December 31, 2023, there are no approved HIV vaccines available, but several vaccine candidates are conducting studies.
Novotech's research analyst team provides these expert reports every month, free of charge.
Mexico's president recently announced a "super pharmacy" that will help patients nationwide access medicines and vaccines.
According to VOA reporting on December 29, 2023, President Andrés Manuel López Obrador's solution is a centralized warehouse on the outskirts of Mexico City intended to complement local health facilities.
If a patient can't get needed medications at a local hospital, the patient's doctor or pharmacist could have it delivered from the 40,000-square-meter warehouse.
"The pharmacy is going to be big, big, big, and it is going to have all the medications used in the health system," López Obrador said.
The question is whether Mexico can overcome its history of being bad at regulating the pharmaceutical industry, buying medicines, storing them, and distributing them. Extreme centralization also hasn't helped Mexico much in the past in many areas, wrote VOA/AP.
The U.S. Centers for Disease Control and Prevention (CDC) recently updated its Mexico Yellow Book for 2024, identifying numerous endemic diseases such as dengue, varicella, and measles.
And the CDC issues Travel Health Alerts regarding specific disease outbreaks in Mexico and advises that all travelers should be updated on their routine immunizations and travel vaccinations.
Thailand is a geographically diverse country, a little smaller than Texas, and a trendy destination for millions of tourists.
As New Year's Eve 2023 approaches, the U.S. Centers for Disease Control and Prevention (CDC) recently stated transmission of the Zika virus is a health risk in Thailand.
And the Hong Kong Centre for Health Protection (CHP) of the Department of Health confirmed it is aware of the recent Zika outbreaks in Thailand.
According to Thailand's Bureau of Epidemiology, 742 Zika cases have been recorded in 2023, which is much higher than in the past three years.
Among the recent Zika cases, 160 were recorded in Bangkok, which has about 11 million residents.
Given the Zika cases in Thailand this year, the CHP specifically reminded members of the public, especially pregnant women and women preparing for pregnancy, that they must adopt necessary precautions against mosquito-borne diseases.
Furthermore, the U.S. Embassy in Thailand recently informed U.S. citizens that the CDC says that if you decide to travel, prevent mosquito bites and sexual exposure to Zika during and after travel, and wait two months after returning before becoming pregnant.
From a prevention perspective, there are no approved Zika vaccines as of December 30, 2023. However, several vaccine candidates are conducting clinical research.
As the 2023 flu season draws to a close, the U.S. Centers for Disease Control and Prevention (CDC) announced today that seasonal influenza activity is elevated and above baseline in all 10 HHS Regions.
And outpatient respiratory illness is above baseline nationally for the eighth consecutive week.
As of December 29, 2023, the CDC confirmed a total of 20 pediatric deaths have occurred during the 2023-2024 season.
Last flu season, the CDC reported 183 pediatric deaths.
The CDC also estimated that there have been at least a total of 4,500 deaths from flu so far this season.
To reduce the health risks from the flu, the CDC recommends that everyone six months and older get an annual flu vaccine as long as influenza viruses are spreading.
Vaccination in late December 2023 can still provide benefits into 2024.
The good news is that over 155 million flu shots have been distributed in the U.S. this season. These egg, cell, and nasal-based flu shots remain available at most pharmacies.
Jiangsu Recbio Technology Co., Ltd. today announced that the novel adjuvanted recombinant shingles vaccine candidate REC610 recently achieved positive results in the interim analysis of the first-in-human clinical trial in the Philippines.
Published on December 29, 2023, the Interim Analysis results showed that REC610 demonstrated an overall favorable safety and tolerability profile in healthy participants aged 40 and above after two vaccination doses.
REC610 induced strong gE-specific humoral and cellular immune responses, which were evident after the first vaccination and peaked 30 days after the second vaccination.
The humoral and cellular immune responses were comparable between REC610 and the Shingrix® vaccine comparison group, and the immune response level in the REC610 group was numerically higher than that in the Shingrix group.
REC610 is intended to prevent shingles in adults aged 40 and above. It is equipped with a novel adjuvant BFA01 independently developed by the Company, which can promote the production of high levels of VZV glycoprotein E (gE)-specific CD4+ T cells and antibodies.
REC610 received a drug clinical trial approval notice issued by the National Medical Products Administration in October 2023. It is approved as a preventive 3.3 biological product in its Phase I and III clinical trials in China.
The Company will soon adopt a randomized, double-blind, parallel controlled phase I clinical trial in 180 healthy adult subjects aged 40 and above in Mainland China to evaluate the safety, tolerability, and immunogenicity of REC610.
According to statistics, China's population aged 40 and above is approximately 700 million, and about 6 million new shingles cases occur each year in China.
Furthermore, the incidence of shingles has gradually become younger in recent years.
Only Shingrix is on the market in China, and there is a strong demand for import substitution, according to Jiangsu Recbio Technology's press release.
Beginning in January 2024, Chongqing Zhifei Biological Products will have exclusive rights to import and distribute Shingrix in China.
The World Health Organization (WHO) recently published its External Situation Report #31 regarding the ongoing, multi-country outbreak of mpox.
Based on the data reported on December 22, 2023, the mpox outbreak continues in most WHO regions, while more extensive transmission has been observed in the European Region and the Region of the Americas.
A total of 906 additional mpox cases were reported in November 2023, representing a 26% increase compared to October.
The United States of America (299 vs. 135) reported the most significant increase in the Americas. The states of California, New York, and Texas have reported the most mpox cases.
Around half (52%) of cases with available information in this outbreak are reported to be in persons living with HIV.
The U.S. CDC's Advisory Committee on Immunization Practices voted on October 25, 2023, to recommend the routine use of the JYNNEOS® vaccine for people at risk of mpox infection.
However, only 23% of the at-risk population has been fully vaccinated nationally as of December 2023.
On December 7, 2023, the CDC published an advisory stating the JYNNEOS is expected to be effective for both Clade I and Clade II MPXV infections. However, real-world data is lacking, reported the European CDC.
According to the CDC, approximately 1.2 million JYNNEOS vaccine doses have been administered in the U.S. since the mpox outbreak began in May 2022.
Despite a global reduction in Zika cases since a peak in 2017, the Pan American Health Organization (PAHO) recently confirmed the circulation of this mosquito-borne virus in 89 countries worldwide.
However, Zika outbreaks escalated in certain countries in the Region of the Americas in 2023.
The PAHO's data dashboard indicates there have been 35,538 confirmed Zika cases this year.
Ten countries, led by Brazil, have accounted for about 89% of Zika cases recorded over the past decade.
This year, Brazil has reported over 33,000 Zika cases.
In the United States, the Centers for Disease Control and Prevention (CDC) says mosquitoes continue to spread Zika throughout Puerto Rico.
About 25% of infected people develop Zika symptoms, and the illness is usually mild, lasting between two and seven days.
Moreover, Congenital Zika-associated syndrome is a set of anomalies, such as microcephaly, seen in infants born to mothers with a history of gestational Zika fever, says the CDC.
The PAHO and other health agencies have stated that vaccination is the best option to prevent further infections.
But, as 2024 approaches, no Zika vaccine has been approved by any health authority.
Clinical trials involving DNA, modified vaccinia Ankara vector platform, and purified inactivated virus vaccine candidates have shown they can induce neutralizing antibodies.
Since 2016, about $350 million of funding has been allocated for Zika vaccine candidates.
According to local media, Brazil's Ministry of Health announced it would integrate the Qdenga® tetravalent vaccine into its Unified Health System (SUS).
The two-dose, 0.5 mL each, three months apart, Qdenga vaccinations are scheduled to launch in February 2024.
About 5 million vaccinations in 2024 will be focused on specific audiences and priority regions without pre-administration testing.
"The Ministry of Health assessed the cost-benefit relationship and the issue of access, as in a country like Brazil, it is necessary to have an adequate quantity of vaccines for the size of our population. Following the favorable opinion of Conitec, we will be the first country to provide public access to this vaccine as an immunizer under SUS," said Health Minister Nísia Trindade, reported Folha de Paulo on December 22, 2023.
The World Health Organization recently confirmed dengue is endemic in about 125 countries.
During 2023, the most significant number of dengue outbreaks were reported in Brazil, with over 2.5 million patients.
Qdenga was initially authorized in Indonesia, followed by Argentina, Denmark, Germany, Portugal, and Thailand. This dengue vaccine is not approved in the U.S.
Note: This article was updated for clinical accuracy on January 10, 2024.
