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Since the global shortage of oral cholera vaccines (OCV) is forecast to continue until 2025, including in the United States, two companies today announced they are taking action to increase supply.
On August 25, 2023, GC Biopharma confirmed that it signed an MOU with Eubiologics for a co-production of Euvichol®, a World Health Organization (WHO) certified vaccine.
The two companies will coproduce Eubiologics in the first half of 2024 to supply to UNICEF, which has requested an additional supply to cope with the recent spread of cholera infection in many regions, including Africa.
Kyeong-Ho Min, Vice President of Eubiologics, commented in a press release, "With the more frequent floods and droughts due to climate change and global warming, the world is currently experiencing rapid spread of cholera, leading to a shortage of vaccine supply."
Under the MOU, Eubiologics, a developer and producer of Euvichol, takes charge of the bulk vaccine production, and GC Biopharma will be in control of the packaging process, including vial bottling.
Euvichol is an OCV jointly developed by Eubiologics and the International Vaccine Institute that obtained WHO Prequalification in 2015.
Since supplying to UNICEF in 2016, the cumulative supply has exceeded 100 million vaccine doses. Eubiologics is currently providing 100% of cholera vaccines administered by UNICEF.
During 2023, about 49 million OCV doses have been requested, of which 39% were approved for 11 countries, according to WHO report #5.
The WHO stated in August 2023, the current cholera epidemic has deteriorated. Therefore, the WHO assessed the risk of cholera outbreaks at the global level as very high.
The Republic of Finland recently reported another H5N1 avian influenza outbreak at a fur farm involving blue foxes. This outbreak, reported by EuroNews on August 24, 2023, increases the number of 'bird flu' outbreaks at such farms to 23.
In June 2023, several outbreaks of H5N1 were identified among larids in Finland. The first cases in fur farms were detected in July.
Given these findings, the Finnish authorities decided to cull 120,000 foxes and mink on farms affected by the epidemic.
Finland is Europe's leading producer of fox fur, with around 400 fur farms. For example, FashionFinFur is owned by a fur-farming family in Vörå, Finland, that has been In the business since the 1980s.
In the northern hemisphere, bird flu outbreaks among birds, mammals, and people continue in 2023.
As of August 2023, access to bird flu vaccines is controlled by government agencies.
According to recent reports from South America, infectious diseases may continue spreading in late 2023.
A new study forecasrs a 20% increase in dengue, Zika, and chikungunya cases over the next 30 years. Higher temperatures are already causing the diseases carried by the Aedes aegypti mosquito to spread in cooler regions like southern Brazil and southern Europe.
A study conducted at the University of Michigan concluded after analyzing the incidence of these mosquiuteo-transmitted diseases in Manaus, Recife, Rio de Janeiro, and São Paulo, Brazil.
"Brazilian health agencies need to be prepared not only for the increased incidence of diseases like dengue and Zika but also for longer transmission seasons and broader geographic areas of occurrence," affirms epidemiologist Andrew Brouwer, co-author of the study and researcher at the University of Michigan School of Public Health.
According to Brazil's Center for Arbovirus Emergency Operations, 635 fatal dengue cases had been reported by June 11, 2023, an increase of 22% compared to the same period in 2022.
The agency's most recent update, released by the Ministry of Health, shows 1.3 million probable dengue cases so far this year, while the total number for 2022 was 1,450,270 cases.
The study also showed more potential for Zika epidemics than current levels in all the analyzed climatic scenarios, where the threat had been expected to drop because of extreme heat.
Zika and dengue spread most quickly at average daily temperatures around 30° Celsius, but outbreaks are still possible at 35°C.
As of August 24, 2023, two dengue vaccines are available in certain countries. However, there are no approved Zika vaccines available.
The U.S. Centers for Disease Control and Prevention (CDC) published a Morbidity and Mortality Weekly Report (MMWR) on August 25, 2023, with updated recommendations of the Advisory Committee on Immunization Practices (ACIP) for the 2023–24 Influenza Season.
The primary updates to this new MMWR include the following two topics: 1) the composition of 2023–24 U.S. seasonal influenza vaccines and 2) updated recommendations regarding influenza vaccination of persons with egg allergy.
First, the composition of 2023–24 U.S. influenza vaccines includes an update to the influenza A(H1N1)pdm09 component. U.S.-licensed influenza vaccines will contain HA derived from:
1) an influenza A/Victoria/4897/2022 (H1N1)pdm09-like virus (for egg-based vaccines) or an influenza A/Wisconsin/67/2022 (H1N1)pdm09-like virus (for cell culture-based and recombinant vaccines).
2) an influenza A/Darwin/9/2021 (H3N2)-like virus (for egg-based vaccines) or an influenza A/Darwin/6/2021 (H3N2)-like virus (for cell culture-based and recombinant vaccines).
3) an influenza B/Austria/1359417/2021 (Victoria lineage)-like virus.
4) an influenza B/Phuket/3073/2013 (Yamagata lineage)-like virus.
Second, the ACIP recommends that all persons aged ≥6 months with egg allergy should receive an influenza vaccine.
Any influenza vaccine (egg-based or non-egg-based) that is otherwise appropriate for the recipient’s age and health status can be used.
It is no longer recommended that persons with allergic reactions to eggs involving symptoms other than urticaria should be vaccinated in an inpatient or outpatient medical setting supervised by a healthcare provider who can recognize and manage severe allergic reactions if an egg-based vaccine is used.
Egg allergy alone necessitates no additional safety measures for influenza vaccination beyond those recommended for any vaccine recipient, regardless of the severity of a previous reaction to an egg.
Furthermore, all flu shots for 2023-2024 should be administered in settings in which personnel and equipment needed for rapid recognition and treatment of acute hypersensitivity reactions are available.
A summary of these recommendations is posted on this CDC webpage.
The U.S. Centers for Disease Control and Prevention (CDC) today announced a meeting of the Advisory Committee on Immunization Practices (ACIP) will be held on September 12, 2023, at 10 a.m. ET.
The agenda for this ACIP meeting will include, but is not limited to, a discussion of COVID-19 vaccines and related votes.
For more information on the meeting agenda, visit https://www.cdc.gov/vaccines/acip/meetings/index.html.
The CDC's website publishes Interim Clinical Considerations for the use of COVID-19 vaccines in the U.S., which include a FAQs webpage.
As of August 18, 2023, more than 307 million doses of various COVID-19 vaccines had been administered and reported by the Federal Retail Pharmacy Program. A total of 21 retail pharmacy partners are participating in the program, with more than 41,000 locations nationwide, including long-term care pharmacies.
UPDATED on September 12, 2023 - CDC slide presentations.
SK bioscience today announced that the company has entered into a collaboration agreement with Vaxxas to develop a second-generation typhoid conjugate vaccine.
SK bioscience’s SKYTyphoid™ vaccine will be reformulated to be ‘printed’ onto the thousands of tiny microprojections covering the Vaxxas patch to be delivered directly to the abundant immune cells just under the skin surface.
This reformulation aims to enhance access and broaden markets where traditional intramuscular delivery using needles and syringes has been employed.
Under the agreement announced on August 23, 2023, SK bioscience will supply the antigen utilized by its typhoid conjugate vaccine, SKYTyhpoid™, jointly developed by SK bioscience and the International Vaccine Institute.
Vaxxas, an Australian company, will be responsible for reformulating the SKYTyphoid antigen so that it can be applied to its proprietary HD-MAPs and then conduct preclinical studies, which, if successful, will be followed by a Phase I human clinical trial.
Jaeyong Ahn, CEO of SK bioscience said in a press release, “Typhoid fever is a dangerous disease that frequently occurs in low- and middle-income countries, but the utilization of typhoid vaccines has been limited due to the requirement for vaccines that remain stable under varying temperatures and those that can be administered without medical supervision."
This collaboration with Vaxxas provides an opportunity to overcome those challenges."
The project is expected to be completed within two years from initiation to reporting the data from the Phase I clinical trial and is supported by grant funding received from Wellcome.
According to the World Health Organization, an estimated 9 million cases of typhoid fever occur globally each year. Symptoms include prolonged high fever, fatigue, headache, nausea, abdominal pain, and constipation or diarrhea, with mortality rates up to 30%.
As of August 24, 2023, typhoid vaccines are available in the U.S. and internationally.
The U.S. Centers for Disease Control and Prevention (CDC) website reported yesterday that a new variant of SARS-CoV-2 betacoronavirus called BA.2.86 was detected in samples from people in Denmark and Israel, and at least two cases have been identified in the United States.
This variant is notable because it has multiple genetic differences from previous versions of SARS-CoV-2.
BA.2.86 may be more capable of causing infection in people who have previously had COVID-19 or who have received COVID-19 vaccines.
Scientists are evaluating the effectiveness of the forthcoming, updated COVID-19 vaccine. CDC’s current assessment is that this updated vaccine will effectively reduce severe disease and hospitalization.
Based on what the CDC knows on August 23, 2023, there is no evidence that this variant is causing more severe illness.
This CDC assessment may change as additional scientific data are developed.
The Government of Hong Kong Special Administrative Region's Centre for Health Protection (CHP) of the Department of Health today announced it is closely monitoring a human case of avian influenza A(H5N6) in the Mainland.
The CHP report on August 23, 2023, says the 27-year-old woman lives in Dazhou, Sichuan, and was admitted for treatment on July 22. This report did not disclose how or where she became infected with 'bird flu' nor the outcome.
On July 23, 2023, the Alert Response Level under the Government's Preparedness Plan for an Influenza Pandemic was activated.
From 2014 to date, 86 human cases of avian influenza A(H5N6) have been reported by Chinese health authorities. A high percentage of infections (52%) lead to death.
The CHP says that travelers to the Mainland or other affected areas must avoid visiting wet markets, live poultry markets, or farms. And they should strictly observe personal and hand hygiene when visiting any place with live poultry.
The Food and Agriculture Organization of the United Nations, the World Health Organization (WHO), and the World Organisation for Animal Health urged countries in July 2023 to work together across sectors to save as many animals as possible and to protect people.
The current outbreaks of avian influenza ("bird flu") have caused devastation in animal populations, including poultry, wild birds, and some mammals. Although primarily affecting animals, these outbreaks pose ongoing risks to humans, says the WHO.
Since the annual flu shot is not designed to be effective against bird flu viruses, the U.S. government has invested in various avian influenza vaccines.
In June 2023, the U.S. Centers for Disease Control and Prevention confirmed about 20 million H5N1 and 12 million H7N9 vaccines were available in the U.S. National Strategic Stockpile.
