Sanofi to launch new drug for Hemophilia A, a rare bleeding disorder

Sanofi, a French pharmaceutical company, plans to launch a new drug for a rare bleeding disorder called hemophilia A this year. The therapy, which is being developed in collaboration with Swedish drugmaker Sobi, is currently awaiting approval from the U.S. Food and Drug Administration (FDA). The FDA is expected to make a decision on the approval status by February 28th.

Hemophilia A is a genetic disorder in which the blood does not clot properly. This disorder is inherited and can affect both males and females. Symptoms can range from minor to severe, depending on the amount of clotting factor present in the blood.

Another biotech company, BioMarin, has already developed a therapy called valoctocogene roxaparvovec, which is available in Europe as Roctavian for hemophilia A. However, the therapy is still awaiting approval from the FDA. 

BioMarin is hoping that new Phase III data, which is expected in early 2023, will improve its chances of getting approved. The ongoing study, GENEr8-3, by BioMarin uses a primary endpoint of change in factor VIII activity, testing valoctocogene roxaparvovec alongside corticosteroid use.

Pfizer is also developing a therapy for a less common form of the disorder called Hemophilia B. Hemophilia B is caused by deficiencies in factor IX. Pfizer plans to present additional data from the Phase III BENEGENE-2 study (NCT03861273) of its therapy, PF-06838435, in adult males with severe Hemophilia B at a scientific conference in early 2023. 

Pfizer has already announced that BENEGENE-2 has achieved its primary endpoint of non-inferiority and superiority in the annualized bleeding rate (ABR), which is considered a validated marker of hemophilia activity.

Sanofi has also followed Pfizer’s footsteps by establishing a rebate program for a blood disorder treatment called Cablivi. The program promises medical institutions a refund if inpatient treatment fails. 

To qualify, patients must receive the drug in a hospital setting, and Sanofi will only cover the cost of up to six doses for those who do not respond, or up to 12 doses for those who worsen while on treatment. Cablivi became the first drug approved in the United States in 2019 for acquired thrombotic thrombocytopenic purpura (aTTP).

 

Uganda Red Cross Society's RevolRevolutionizing Menstrual Hygiene

The Uganda Red Cross Society (URCS) is taking a step towards a brighter future for girls and women in Uganda with their innovative factory that aims to revolutionize menstrual hygiene.

This factory will not only improve the lives of 50,000 girls and women by providing access to menstrual hygiene products, but it will also empower them by providing employment and training opportunities.

The funding for this project has come from the Randal Charitable Foundation, UK, with Dr Nik Kotecha OBE DL, Founder and Chair of Trustees of the Randal Charitable Foundation, saying, “This project is so beneficial to the community because, without access to high-quality sanitary pads and toilets, or washrooms for changing, many girls and women are not able to go far from their homes. The consequence of this is that they often cannot attend school, and in many cases become trapped in their homes unable to earn a living to support their families.”

The factory will manufacture 200,000 reusable pads per year, which is the equivalent of 50,000 four-pad packs. 20% of these pads will be given to 10,000 vulnerable girls in school for free, while the remaining 80% will be sold to 40,000 girls and women in the wider community at a subsidized price, ensuring the long-term sustainability of the manufacturing facility.

The project will not only provide employment and training opportunities, but it will also impart specific skills such as recordkeeping and marketing, as well as support supervision and monitoring. Each female trainee is targeted to produce 50 reusable pads per day, which equates to 1,000 per year.

Once the first group of 20 trainees has mastered the skills to produce the reusable pads, they will then recruit another group of 20 to expand their labour force.

It’s a sad reality that many girls in Uganda miss school days or other important activities due to lack of access to menstrual hygiene products. This not only affects their education but also their future prospects. The URCS factory aims to change this by providing girls with the necessary menstrual hygiene products to keep them in school.

The URCS factory project is part of a collaboration between the Uganda Red Cross Society and the Ministry of Education and Sports, as well as other partners, which in 2019 launched a countrywide initiative called, ‘Keep a Girl in School’. The main aim of this project is to improve menstrual health management among primary and secondary school-going adolescents in vulnerable communities.

 

Uganda’s Ebola-free: A Triumph of Preparedness and Early Response

Uganda has been declared Ebola-free by the World Health Organization (WHO) after the latest outbreak of the virus claimed almost 60 lives in about five months. The outbreak of the deadly virus was declared over after 42 days without a new case being reported, which is double the incubation period for the virus according to WHO protocols. The highly contagious disease spreads through direct contact with bodily fluids, and causes fatigue, fever and bleeding from the eyes and nose. It kills almost half of those who become infected.

This outbreak, which involved the Ebola Sudan strain of the virus, began in September and killed 56 people, including seven healthcare workers, and caused 142 confirmed infections. The virus spread through parts of the country, with officials hesitant to impose another ban on movement within the country in the wake of recent coronavirus lockdowns. Only in December were a curfew and restrictions on movement introduced in the affected districts. By then, the United States and other countries had issued orders to screen all travelers from Uganda arriving at their airports.

The acting director of Africa’s Centers for Disease Control, Ahmed Ogwell Ouma, has praised the Ugandan government for its “excellent” coordination of Ebola containment measures, saying it had taken approximately 70 days to bring the outbreak under control. African health authorities had prioritized preparedness for the deadly virus after devastating outbreaks of the Ebola Zaire strain in Guinea, Liberia and Sierra Leone between 2013 and 2016 killed more than 11,300 people. Those outbreaks inspired global fear that air travel could allow the virus to spread across the world in a matter of hours. That fear helped galvanize research and funding for vaccines to protect against the Zaire strain of the virus.

Three candidate vaccines in development for the Ebola Zaire strain were sent to Uganda, with the first arriving on December 8, to be evaluated in a clinical trial being run by the Makerere University Lung Institute, as there is currently no vaccine proven to be effective against the Sudan strain of the virus. Critics have said an opportunity was missed as the candidate vaccines only arrived as the virus was waning. The delays meant a chance to trial the drugs amid an evolving outbreak was missed. However, the limited trial did prove the vaccines safe to use on humans. In December, doctors discharged the last known Ebola patient in Uganda from hospital, allowing President Yoweri Museveni to lift all Ebola-related restrictions and curfews for the holiday season.

“Today we join the Government of Uganda to declare the end of the Sudan Ebola Virus Outbreak in the Country,” said Dr Matshidiso Moeti, WHO’s Regional Director for Africa. The WHO’s Moeti further added, “With no vaccines and therapeutics, this was one of the most challenging Ebola outbreaks in the past five years, but Uganda stayed the course and continuously fine-tuned its response. Two months ago, it looked as if Ebola would cast a dark shadow over the country well into 2023, as the outbreak reached major cities such as Kampala and Jinja, but this win starts off the year on a note of great hope for Africa.”

The end of the Ebola outbreak in Uganda is certainly a cause for celebration and relief, but it also serves as a reminder of the importance of preparedness and early response in the face of deadly epidemics. The Ebola virus is a highly contagious and deadly disease, and it is essential that countries and international organizations take the necessary steps to prevent and contain outbreaks as quickly as possible. The WHO’s announcement of Uganda being Ebola-free is an encouraging sign for the continent of Africa and the rest of the world, showing that with proper coordination and response, it is possible to overcome even the most challenging of outbreaks.

 

Uganda; 100,000 new Asthamic cases reported annually for the past three years

UGANDA – According to research conducted by the Makerere University Lung Institute, two out of every ten young people between the ages of 12 and 15 exhibit symptoms of asthma, a respiratory health condition that usually shows symptoms including coughing, wheezing, and difficulty in breathing.

Since 2018, the institution has examined 895 secondary school students within Kampala, Wakiso, and Mukono districts. Of those, 177 were found to have asthmatic symptoms.

Graph showing the number of students with asthmatic symptoms

Dr. Rebecca Nantanda, a consultant pediatrician and lung specialist who oversaw the study’s execution, said that the majority of people who tested positive for asthma were ignorant despite exhibiting symptoms in 33.9% of cases.

64 of the students exhibited significant symptoms, but none of their assessments were correct, and several of them were receiving care for other conditions.

The institute had previously analyzed children and adults to discover how prevalent the illness was, but data on youths had been lacking.

According to recent data, merely less than half of persons in this age range who were aware of their condition had it under control, with few episodes and a reduced need for treatment.

The Ministry of Health (MOH) was informed of these findings, and officials confirmed that medical professionals lacked sufficient training mostly in asthmatic diagnosis.

Asthma diagnosis is still done by health professionals using what they learned in medical school, according to Dr. Frank Mugabe, the Principal Medical Officer in charge of Non-Communicable Diseases (NCDs) at the Ministry of Health. This is true despite evolving methods of diagnosis and treatment.

In agreement with the survey’s findings, he claims that more people are developing asthma, as evidenced by the fact that over 100,000 new cases have been reported annually for the past three years, according to their statistics.

He states that they registered 133,000 instances in 2020 and 124,000 in 2021 as a result of COVID-19-related limitations. He asserts that as of the end of October this year, there had been 106,000 instances reported, and he anticipates that they may top the numbers from the year 2020.

All age groups had the greatest prevalence of asthma in Kampala, West Nile, and South Western Uganda. Mugabe explains this by pointing to significant levels of air pollution.

Five more nations, including Malawi, South Africa, Ghana, and Zimbabwe, participated in the same research, Achieving Control of Asthma in Children in Africa (ACACIA).

Exchange of vital health data across platforms and regions to manage the worldwide spread of infectious illnesses

According to an exclusive analysis from the BroadReach Group, the benefit of exchanging crucial health data across platforms and geographies to manage the worldwide spread of infectious illnesses as travel grows following the COVID-19 pandemic is emphasized.

The Broadband Group identifies three essential international standards that establish worldwide best practices for the protection of general personal information and personal health information.

“The General Data Protection Regulation (GDPR) in Europe, the Health Insurance Portability and Accountability Act (HIPAA) in the USA and the private sector-led HITRUST Alliance,” revealed the advisory firm.

The BroadReach Group hosted a webinar to address competing goals in light of October’s Cybersecurity Awareness Month, focusing on how smart policies, considerate frameworks, and underpinning technology may support both data privacy and data sharing.

The webinar covered the importance of health data ownership, data protection vs data sharing, and data residency, including personal ownership of health data, and public and private organizations’ challenges and responsibilities in keeping it safe and secure,” the Group announced in a release.

Dr. Farley R. Cleghorn, global head of health practice at Palladium Group, and Dr. Justin Maeda, principal regional collaborating centers (RCC) coordinator at the Africa Center for Disease Control (CDC), participated in the discussion as Ruan Viljoen, chief technology officer at BroadReach Group, served as its moderator.

Health data is the most sensitive personal data we can store and warrants an even stricter duty of care. We should not put individuals in a position where they should have to trade their privacy in order to receive good healthcare,” said Viljoen.

The leaders also acknowledged that governments are the guardians of their citizens’ human rights and as a result, have the primary duty for protecting their citizens’ data, even if they recognized that the problem is complicated and that a multi-sectoral solution is required.

Individuals need to take control of their health data. You should assume you have a right to that information, that you can control your information, and that you can use it for your own benefit,” highlighted Dr. Cleghorn.

They stressed that, at a time when cyber-security has grown increasingly crucial in healthcare as assaults escalate, governments might safeguard their citizens by disaggregating patients’ health data to make it impersonal and unrecognizable to third parties.

Attackers are quite patient and look around – recent studies show that it takes organisations an average of 271 days before they detect that they have been breached, and another 70-odd days to rectify the situation,” highlighted the Chief Technology Officer.

He outlined how cyberattacks impair service delivery, which is harmful in the healthcare industry, and cause reputational and financial damage. He also said that it can take some time for a business to go back to normal.

1400 healthcare workers to get Ebola preparation and response training from WHO and Kenya

The World Health Organization (WHO) and Kenya’s Ministry of Health will train roughly 1,400 healthcare professionals on how to be ready for an Ebola epidemic.

In a news statement, the ministry stated that as Uganda works to control the present epidemic, the Ebola response actions are a part of continuous efforts to protect against a potential importation of the deadly Ebola virus illness into the nation.

“The training, that kicked off this week, has seen 75 health workers drawn from the national level and Nairobi County receive essential information and techniques required to deal with the disease,” said the Ministry of Health.

The agency said that the training was connected in series to the county and sub-county levels in the 20 counties most vulnerable to the importation of EVD and that the health professionals had received training on readiness and reaction.

The training session comes in response to a notice issued by the Kenyan ministry to all counties nationwide and worries expressed by Ugandan health officials over an increase in confirmed Ebola cases to 109 with 30 fatalities.

Ebola virus disease is a severe and often fatal illness in humans caused by the Ebola virus. The virus is normally found in animals but spread from animals to human beings and occurs when there is interaction between the infected animals and healthy humans,” the statement said.

Furthermore, a recent notice sent by the Ugandan government to Kenya is in accordance with East African Community Health standards on an epidemic of the illness discovered in Ngabano hamlet of Madudu Sub County in Central Uganda.

The Ministry of Health further warned that human-to-human transmission of Ebola happens through direct or indirect contact with bodily fluids including as blood, sweat, urine, sperm, vaginal secretions, diarrhea, and vomitus from an infected individual.

As a result, the Kenyan government has advised all county governments to be watchful and increase monitoring, particularly around borders.

Screen at risk populations including travellers, truck drivers, bush meat handlers and healthcare workers as well as sensitize the community to identify suspected cases,” the ministry urged county administrations.

Additionally, county governments have been advised to mobilize fast-reaction teams to assist with case identification and prompt reporting.

They were also asked to engage key stakeholders to start preventative, readiness, and response efforts, as well as to educate healthcare personnel on infection, prevention and control measures, case management, and sample management.

Six months COVID-19 control transition plan launched by ACT-Accelerator

The Access to COVID-19 Tools (ACT) Accelerator has initiated a six-month initiative focused on vaccinating high-risk groups, providing new treatment options, enhancing testing, and assuring long-term access to COVID-19 tools.

The strategy was created in response to the fact that numerous conversations are presently taking place concerning modifications that need to be done to strengthen the global health architecture for pandemic preparation and response (PPR) based on the world’s experience with COVID-19.

More than 1.6 billion vaccinations have now been given to Advance Market Commitment nations via the ACT-Accelerator, with 75% of the COVAX vaccines going to low-income nations.

Additionally, a media release states that low and middle-income countries (LMICs) have received more than 145 million tests, 40 million treatment courses, and personal protective equipment totaling US$2 billion.

Another notable accomplishment of the effort is the agreement on voluntary licensing for oral antivirals and the halving of the cost of quick diagnostics.

The modifications to the ACT- Accelerator’s organizational structure and operational procedures, which take into account the COVID-19 virus and pandemic’s dynamic nature, will guarantee that nations continue to have access to COVID-19 tools over the long term and in the case of disease outbreaks.

The strategy specifies how international health organizations, the government, civic society, and other partners will work together to support nations with long-term COVID-19 control through the ACT-Accelerator.

A list of tasks that will be maintained, changed, retired, or kept on standby is also included in the plan. The transition plan supports ACT-A organizations as they advance their COVID-19 finance, implementation, and mainstreaming initiatives.

The activity of the ACT-A partners will concentrate on three main topics in the coming phase: Activities in R&D and market-shaping to guarantee a pipeline of new and enhanced goods Tools for COVID-19 and institutional arrangements for ongoing COVID access 19 immunizations, examinations, and treatments for all nations, including efforts on introducing new products in-country using oxygen (e.g., new oral antivirals).

In support of national and international goals, the strategy will also assure the protection of sensitive populations.

The proposal also calls for the creation of a new ACT-A Tracking and Monitoring Taskforce that will be co-chaired by senior government representatives from India and the United States and the reactivation of the Facilitation Council at the political level in the event of a serious disease outbreak.

Furthermore, the World Health Organization expressed alarm that the coronavirus is “running freely” and cautioned that the epidemic is “nowhere near ended,” noting fresh waves throughout the globe.

Tedros Adhanom Ghebreyesus expressed concern that the number of cases was increasing and “adding to the strain on already overburdened health systems and health professionals.”

Tedros advised governments to use tried-and-true strategies like masking, better ventilation, and test-and-treat protocols in the face of escalating COVID transmission and hospitalization rates.

Positively, the recently introduced bivalent booster vaccines, which are effective against both the primary coronavirus strain and the currently circulating omicron subvariants BA.4 and BA.5, may offer improved protection against infection and transmission as well as more durable protection against serious illness.

 

Rise in Ebola infections and fatalities in Uganda

According to data from the Ministry of Health, the number of confirmed Ebola cases in Uganda has increased to 16, while the death toll from the disease has risen to four.

Apart from the four confirmed deaths, 17 other fatalities are likely Ebola cases, according to Ministry of Health Spokesperson Emmanuel Ainebyoona. Uganda, has 16 confirmed cases of the Ebola virus, with an additional 18 cases being considered likely instances of infection, he continued.

Currently, the epidemic has reached three districts in central Uganda. Mubende has already banned large public gatherings and placed limitations on non-essential travel.

According to Ainebyoona, “Cases recorded beyond Mubende include three in Kyegegwa and one in Kassanda but all connected to the index case in Mubende.” He also noted that “there are no verified cases in  Kampala.”

The Uganda Virus Research Institute is analyzing samples from suspected cases, according to health authorities.

The ministry urged locals to follow preventative measures and report any suspected instances to authorities or nearby medical facilities.

New Measles-Rubella Dose for Children Is Introduced by the Health Ministry

As part of the routine immunization schedule, the Ministry of Health (MOH) has added a second dose of the measles-rubella vaccine for children older than one and a half years.

Dr Alfred Driwale, the manager of Uganda’s National Expanded Immunization Program (UNEPI), reassured the public that the global goal is to eradicate measles, and Uganda has chosen to start administering the vaccine in two doses since the current one only gives 85% protection.

A measles-rubella vaccination is administered to a kid at nine months of age, according to the current national schedule. The newly introduced second dosage, which will begin in March, will be given to infants aged one and a half years.

According to the Ministry of Health, all children between the ages of one and four will need to receive a second dose of the measles-rubella vaccine by October 2022; at that point, all children will need to have had doses of the vaccine in order to be deemed completely immunized.

While at the launch conference, countries discussed experiences on the introduction of vaccinations after the first year of life of children but also what Uganda may learn from abroad, which also included other immunization specialists from elsewhere in Africa.

According to Dr Simon Antara, Executive Director of the African Field Epidemiology Network (AFENET), Ghana has been an excellent example of a country that is performing well after one year of heavy coverage of recently launched vaccinations.

He stated that societies must be prepared to absorb new vaccinations when they become available, as immunization programs will evolve in response to the illness load that countries now experience.

Uganda, on the other hand, has plans to provide several new vaccinations for infants above the age of one year, including those against meningitis and yellow fever, initially in endemic regions. Dr Driwale notes that thus far, for children over a year old, they only have HPV for ten-year-old females and Tetanus for teenage girls.

As the COVID-19 pandemic reached its peak, the World Health Organization has been reporting that countries experienced significant disruptions in the uptake of routine vaccines. However, according to Dr Driwale, these disruptions only occurred early on in Uganda’s experience, and the nation quickly developed stability in its healthcare system that allowed it to connect with people with routine services.

 

Africans’ average lifespan has increased by 10 years

CONGO BRAZZAVILLE – According to the World Health Organization (WHO) evaluation reports, advances in the delivery of essential health services between 2000 and 2019 led to an average rise of 10 years in healthy life expectancy per person in the African region.

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