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Idaho-based Therapeutic Solutions International, Inc. reported potent synergy between its tumor blood vessel targeting StemVacs-V iPSC immunotherapy and several classical tumor-specific therapeutic vaccines.
In a series of experiments, tumor growth administration of dead tumor cells together with StemVacs-V resulted in potent immunological memory to the tumor cells, which could be transferred to immunologically naïve mice.
Additionally, the experiments demonstrated killing tumor cells using conventional approaches such as chemotherapy, when performed together with StemVacs-V iPSC, led to the development of immunological memory towards specific cancer.
"By targeting the blood vessels that feed the cancer, StemVacs-V iPSC causes enhanced necrotic cell death, which stimulates systemic immunity against cancer throughout the whole body," said Dr. James Veltmeyer, Chief Medical Officer of the Company, in a press release issued on June 7, 2021.
"We are extremely enthusiastic by the current data showing that our blood vessel targeting approach can be used to synergize with both cancer immunotherapies and non-immune therapies of cancer such as chemotherapy and radiation therapy."
The company stated It is believed that by starving the cancer of its blood supply, StemVacs-V iPSC may convert cold tumors to immunotherapy sensitive "hot tumors."
"This new finding is extremely exciting because it opens the door to synergies with other immunotherapies such as CAR-T therapies, which although successful in liquid tumors, to date have not yielded promising results in solid and/or cold tumors," commented Timothy Dixon, President, and CEO of the Company.
Therapeutic Solutions International is focused on immune modulation for the treatment of several specific diseases.
The WSJ reported today the US Federal Aviation Administration (FAA) is requiring updates to passenger and baggage weight estimates. Each airline must submit a plan by June 12, 2021, explaining which average weights for passengers and baggage they’ll use, including phones and clothing.
Airline officials say the weight estimates previously used for passengers and baggage are going up to 10%. That will affect some flights, possibly requiring that more passengers get bumped or more baggage left behind, said the WSJ.
Furthermore, the FAA will approve each airline’s plan.
This new initiative was outlined in a May 2021 FAA advisory.
The FAA Advisory Circular provided operators with guidance on developing and receiving approval for a Weight and Balance (W&B) control program for aircraft operated under Title 14 of the Code of Federal Registry.
Although the purpose is supposed to improve flight safety, it could also lead to fares based on a passenger's weight, warns public interest law professor John F. Banzhaf, B.S.E.E., J.D., Sc.D., George Washington University Law School.
Since many airlines already charge an additional fee if a passenger's bag is heavier than the airline decrees, similar principles could well be applied to airline passengers themselves, wrote Prof Banzhaf on June 9, 2021.
It is not illegal under federal law, not under most states and local jurisdictions, to discriminate against people who are obese.
Requiring obese air passengers to bear more of the costs they now impose on the majority who are not obese is consistent with the concept of differential health insurance premiums which Banzhaf and his law students helped develop. This concept was adopted by the National Association of Insurance Commissioners, added Prof Banzhaf.
Current overweight passenger policies vary by airline.
New York-based Pfizer Inc. announced today that the U.S. Food and Drug Administration (FDA) had approved PREVNAR 20™ for the prevention of invasive disease and pneumonia caused by the 20 Streptococcus pneumoniae serotypes in the vaccine in adults ages 18 years and older.
PREVNAR 20 includes capsular polysaccharide conjugates for the 13 serotypes already included in Prevnar 13®. The vaccine also contains capsular polysaccharide conjugates for seven additional serotypes that cause invasive pneumococcal disease (IPD) and has been associated with high case-fatality rates, antibiotic resistance, and/or meningitis.
Overall, the seven additional serotypes in PREVNAR 20 account for approximately 40% of all pneumococcal disease cases and deaths in the USA.
“Today’s approval of PREVNAR 20 marks a significant step forward in our ongoing fight to help address the burden of pneumococcal disease, including pneumonia in adults, and broadens global protection against more disease-causing serotypes than any other pneumococcal conjugate vaccines,” said Kathrin U. Jansen, Ph.D., SVP and Head of Vaccine Research & Development, Pfizer, in a press statement.
In the USA, more than half of all cases of invasive pneumococcal disease (IPD), including bacteremia and meningitis, in adults ages 65 or older are due to the 20 serotypes in PREVNAR 20. These 20 serotypes are estimated to cause up to 250,000 cases of IPD and community-acquired pneumonia and more than 10,000 deaths in adults ages 18 or older.
Following today’s FDA approval, the U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices is expected to meet in October 2021 to discuss and update recommendations on the safe and appropriate use of pneumococcal vaccines in adults.
The US Centers for Disease Control and Prevention (CDC) issued a Level 1 Travel Alert on June 3, 2021, regarding a diphtheria outbreak in the Dominican Republic.
In recent years, vaccination against diphtheria in the Dominican Republic has declined, and health officials there are now reporting cases of the disease among children throughout the country. Anyone who is unvaccinated or not fully vaccinated against diphtheria is at risk of getting sick when visiting the Dominican Republic.
In 2021, between epidemiological week #1 and #15, two countries have reported confirmed cases of diphtheria on the island of Hispaniola: the Dominican Republic with 12 confirmed cases including 9 deaths, and Haiti with 11 confirmed cases including 2 deaths.
Diphtheria is a serious infection caused by strains of bacteria called Corynebacterium diphtheriae that make toxins (poison). Infection can lead to difficulty breathing, heart failure, kidney failure, paralysis, and even death, says the CDC. Even with proper treatment, about 10% of people with respiratory diphtheria will die. Without treatment, up to half of the patients can die from the disease.
The CDC recommends diphtheria, tetanus, and pertussis (whooping cough) vaccination for all travelers.
The DTaP is only for children younger than 7 years old, while the Tdap vaccine is only for older people.
Because of age or health conditions, some people should not get certain vaccines or wait before getting them. Ask your healthcare professional for more information, says the CDC.
The Dominican Republic is the second-largest and most diverse Caribbean country, home to over 10 million people. Situated just two hours south of Miami, the Dominican Republic is surrounded by the Atlantic Ocean on the north and the Caribbean Sea on the south, and nearly 1,000 miles of coastline.
Local airports and other ports of entry will perform a breath test on about 15% of arriving travelers and all those who present symptoms upon arrival. Passengers under the age of five and crew members are exempt from this procedure. Passengers who present a COVID-19 vaccination card and/or a negative PCR test taken within 72 hours before arrival in the Dominican Republic will be exempted from the random test.
Health Canada announced on June 8, 2021, it has completed a safety review confirming that the use of non-steroid anti-inflammatory drugs (NSAIDs) such as acetylsalicylic acid (aspirin), ibuprofen, naproxen, diclofenac, and celecoxib, starting from approximately 20 weeks of pregnancy or later, may cause rare but serious kidney problems in an unborn baby.
These problems can lead to low amniotic fluid levels and possible complications, such as impaired lung maturation and loss of joint movement (limb contractures) in the newborn baby.
As a result of its findings, Health Canada advises that pregnant women not use NSAIDs from approximately 20 to 28 weeks of pregnancy unless advised to do so by their healthcare professional. The use of NSAIDs remains contraindicated (must not be used) in the last trimester of pregnancy (i.e., beyond 28 weeks to the end of pregnancy).
If a healthcare professional decides that the use of NSAIDs between 20 and 28 weeks of pregnancy is necessary, Health Canada recommends that they use the lowest effective dose for the shortest duration possible and that they consider monitoring amniotic fluid levels via ultrasound if treatment extends beyond 48 hours.
These new recommendations do not apply to the use of low-dose (81 mg) aspirin, pediatric-only formulations (i.e., those only indicated for children less than 12 years of age), or NSAIDs administered directly to the eye.
The U.S. FDA mentioned this alert in November 2020.
Health Canada confirmed it continues to monitor the situation closely and will take further action to help protect the health and safety of Canadians, if necessary. This includes continuing to work with Canadian manufacturers of NSAID products to take appropriate action in Canada in light of this new evidence. Related prescription and non-prescription NSAID product labels in Canada will be updated with this new information.
VBI Vaccines Inc. announced that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation for VBI-1901, a cancer vaccine immunotherapeutic candidate for treating recurrent glioblastoma (GBM) patients with first tumor recurrence.
VBI-1901 is a novel cancer vaccine immunotherapeutic candidate developed using enveloped virus-like particle technology to target two highly immunogenic cytomegalovirus antigens, gB, and pp65.
An FDA Fast Track Designation expedites the review of new therapies to treat serious conditions and fill an unmet medical need. And underscores the significant need for new therapies for recurrent GBM patients. Glioblastoma is the most common malignant brain and other CNS tumors accounting for about 47% of all cases.
GBM also referred to as a grade IV astrocytoma, is a fast-growing and aggressive brain tumor. It invades the nearby brain tissue but generally does not spread to distant organs.
Francisco Diaz-Mitoma, M.D., Ph.D., VBI’s Chief Medical Officer, stated in a press statement, “Building on the encouraging data seen to-date, including updated tumor responses and improvement in overall survival compared to historical controls ... we look forward to working closely with the FDA as we progress this cancer vaccine immunotherapeutic candidate with the hope of improving outcomes for adults with recurrent GBM.”
VBI Vaccines Inc. is a biopharmaceutical company based in Massachusetts, driven by immunology in the pursuit of powerful prevention and treatment of disease.
Carnival Cruise Line confirmed on June 7, 2021, its plans to return to guest operations from Port of Galveston in Texas on July 3rd. However, Carnival's revised vaccine policy may conflict with the State of Texas.
Carnival Cruise stated in a press release, 'guests who have received their final dose of a U.S. FDA Authorized COVID-19 vaccine at least 14 days before the beginning of the cruise and have proof of vaccination, following current guidelines from the U.S. Centers for Disease Control and Prevention (CDC), may board their ship.
"We appreciate the progress and support for our U.S. restart from the CDC and other key federal agencies; however, the current CDC requirements for cruising with a guest base that is unvaccinated will make it very difficult to deliver the experience our guests expect, especially given the large number of families with younger children who sail with us."
"As a result, our alternative is to operate our ships from the U.S. during July 2021 with vaccinated guests," commented Christine Duffy, president of Carnival Cruise Line.
Carnival's plans may need to be modified since Texas Governor Gregg Abbott signed Senate Bill 968 on June 7, 2021.
This legislation includes a clause that 'bans businesses from requiring proof of the vaccine from their customers.'
Businesses may still implement “COVID-19 screening and infection control protocols under state and federal law to protect public health,” according to the new law.
In reaction, Carnival spokesperson Vance Gulliksen notified the Houston Chronicle on June 8th, “The law provides exceptions for when a business is implementing COVID protocols per federal law, which is consistent with our plans to comply with the U.S. CDC’s guidelines.”
“We are evaluating the legislation."
On May 5, 2021, the CDC released the next phases of the Framework for Conditional Sailing Order (originally issued October 30, 2020) for cruise ships operating or seeking to operate in U.S. waters.
As of June 8, 2021, the State of Texas a very low SARS-CoV-2 inflection rate (<3%) and an increasing rate of COVID-19 vaccinations (23m+).
Johnson & Johnson (J&J) announced it 'welcomes the recommendation by the World Health Organization (WHO) Strategic Advisory Group of Experts on Immunization for the Janssen Ebola vaccine regimen, Zabdeno® (Ad26.ZEBOV) and Mvabea® (MVA-BN-Filo).
The Janssen Ebola vaccine therapy consists of two components; Zabdeno is given first, and Mvabea is administered approximately 8-weeks later as a booster. This therapy can be deployed during Ebola outbreaks for individuals at risk of exposure and preventively, before outbreaks, for national and international first responders.
J&J stated on June 4, 2021, 'this recommendation is an important milestone for our Ebola vaccine and our mission to help prevent and control Ebola outbreaks. It follows Marketing Authorisation by the European Commission in July 2020 and WHO Prequalification in April 2021.'
'We are now focused on securing national registrations for the vaccine in Ebola-affected countries in Africa.'
The frequency of Ebola outbreaks in Africa continued into 2021.
The first Ebola virus disease outbreak occurred in remote villages in Central Africa, near tropical rainforests, in 1976. The 12th Ebola virus disease outbreak was declared in February 2021.
The Ebola virus is a zoonotic pathogen that causes severe hemorrhagic fever in humans, known as Ebola virus disease, says the U.S. CDC. The virus first spreads to people through direct contact with animals' blood, body fluids, and tissues. Ebola virus then spreads to other people through direct contact with body fluids of a sick person with or who has died from EVD.
The Johnson & Johnson Ebola vaccine regimen was developed and is manufactured using Janssen’s proprietary AdVac® viral vector technology. To date, more than 235,000 people have received at least the first dose of the Ebola vaccine, including 190,000 who have been fully vaccinated with both doses.
At New Brunswick, NJ-based J&J, more than 130,000 employees worldwide are blending heart, science, and ingenuity to profoundly change the trajectory of health for humanity.
