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The European Medicines Agency (EMA) announced on March 4, 2021, the latest safety data for the Comirnaty Vaccine (Pfizer-BioNTech) are in line with the known benefit-risk profile, and the outcomes of the related assessments are presented in this update.
The benefits of Comirnaty in preventing COVID19 continue to outweigh any risks, and there are no recommended changes regarding the use of this vaccine, says the EMA.
Safety updates provide the outcomes of the assessment of emerging data since marketing authorization for COVID-19 vaccines. Diarrhea and vomiting after vaccination have been identified as new side effects.
The EMA’s Pharmacovigilance Risk Assessment Committee carries out the assessments based on all available data.
Comirnaty was authorized in the European Union on December 21, 2020, for use in people aged 16 years and older to prevent the development of COVID-19 when infected with the coronavirus SARS-CoV-2. Comirnaty contains a molecule called mRNA, which the body uses to produce the SARS-CoV-2 spike protein temporarily.
The U.S.Centers for Disease Control and Prevention (CDC) issued a Level 1 Travel Alert for many parts of Central and South America, Mexico, and the Caribbean regarding Dengue virus risks. The CDC published an updated Dengue risk map for the Americas and the Caribbean.
Because mosquito bites spread dengue, all travelers to risk areas should prevent mosquito bites, said the CDC on March 2, 2021. You can find the right insect repellent by using EPA's search tool.
As of February 17, 2021, the CDC had confirmed five travel-related dengue cases in the continental US and 42 dengue cases in Puerto Rico during 2021.
Dengue disease can take up to 2 weeks to develop, with an illness generally lasting less than a week. Health effects from dengue include fever, headache, nausea, vomiting, rash, muscle and joint pain, and minor bleeding.
Dengue can become severe within a few hours. Severe dengue is a medical emergency, usually requiring hospitalization. In severe cases, health effects can include hemorrhage, shock, organ failure, and death says the CDC.
Learn more about dengue how to prevent it on CDC’s dengue page for travelers. An updated dengue vaccine approved list is found on this webpage.
California-based Sorrento Therapeutics, Inc. announced on March 2, 2021, that it had received clearance from the FDA for its Investigational New Drug application for its Phase 1 study of safety pharmacokinetics of intranasal STI-2099 (COVI-DROPS) in both healthy volunteers and patients with mild COVID-19.
Treatment with STI-2099 has the potential to halt the COVID-19 infection at the earliest stage in the nasal passages before it has a chance to spread to the lungs, and if the infection has already hit the lungs, prevent the development of severe infections.
This small volume IV-push formulation is tested against the dominant strain of the SARS-CoV-2 virus in the USA and the emerging UK variant.
“We plan to use our intranasal formulation technology, which allows administering a drug via simple drops in the nose, for other antibodies we are currently developing with a goal of providing coverage against all variants of the SARS-CoV-2 virus that might evade inhibition from treatment with existing therapies,” commented Dr. Henry Ji, Chairman, and CEO of Sorrento, in a press statement.
Sorrento is a clinical-stage, antibody-centric biopharmaceutical company developing new therapies to treat cancers and COVID-19.
California-based NGM Biopharmaceuticals, Inc. announced it had dosed the first patient in an expansion of its ongoing Phase 1b proof-of-concept study of NGM120 in patients with metastatic pancreatic cancer.
NGM120 is an antagonistic antibody that binds glial cell-derived neurotrophic factor receptor alpha-like (GFRAL) and inhibits growth differentiation factor 15 (GDF15) signaling.
This placebo-controlled study will evaluate the effect of NGM120 on both cancer and cancer-related cachexia.
Cachexia is the uncontrolled wasting of both skeletal muscle and fat linked to many cancers. It is estimated to affect 60% to 80% of advanced cancer patients and to be responsible for approximately 30% of all cancer deaths.
This proof-of-concept expansion represents a pre-planned progression of an ongoing Phase 1a/1b dose-finding clinical trial NGM is conducting in patients with select advanced solid tumors and metastatic pancreatic cancer.
“We are pleased to advance NGM120 into a placebo-controlled, Phase 1b expansion in patients with metastatic pancreatic cancer. Patients with this aggressive disease are in particularly dire need of therapeutic solutions to fight their disease and enhance their quality of life,” commented Alex DePaoli, M.D., SVP, Chief Translational Officer at NGM, in a press release.
“Our approach of targeting the GDF15 receptor, GFRAL, gives NGM120 a novel profile in the GDF15 inhibition space and enables us to evaluate NGM120 as a potential treatment for both cancer-related cachexia and underlying cancer.”
NGM is a biopharmaceutical company focused on discovering and developing novel therapeutics based on a scientific understanding of key biological pathways underlying liver and metabolic diseases, retinal diseases, and oncology.
Texas Governor Greg Abbott issued an Executive Order (GA-34) on March 2, 2021, lifting the mask mandate in Texas and increasing the capacity of all businesses and facilities in the state to 100 percent.
"With the medical advancements of vaccines and antibody therapeutic drugs, Texas now has the tools to protect Texans from the virus,” commented Governor Abbott in a press release. Make no mistake, COVID-19 has not disappeared, but it is clear from the recoveries, vaccinations, reduced hospitalizations, and safe practices that Texans are using that state mandates are no longer needed."
"We must now do more to restore livelihoods and normalcy for Texans by opening Texas 100 percent."
Today's announcement does not abandon safe practices that Texans have mastered over the past year. Instead, it is a reminder that each person has a role to play in their own personal safety and the safety of others. With this executive order, we are ensuring that all businesses and families in Texas have the freedom to determine their own destiny."
This executive order rescinds most of the Texas Governor's earlier executive orders related to COVID-19. Effective next Wednesday, all businesses of any type may open to 100% capacity. Businesses may still limit capacity or implement additional safety protocols at their own discretion.
However, if COVID-19 hospitalizations in any of the 22 hospital regions in Texas reaches above 15% of the hospital bed capacity in that region for seven straight days, a County Judge in that region may use COVID-19 mitigation strategies. However, County Judges may not impose jail time for not following COVID-19 orders nor may any penalties be imposed for failing to wear a face mask. If restrictions are imposed at a County level, those restrictions may not include reducing capacity to less than 50% for any type of entity.
The US Centers for Disease Control and Prevention (CDC) announced on February 26, 2021, it is closely following the new Ebola Virus Disease (EVD) outbreaks in the Democratic Republic of the Congo (DRC) and Guinea.
The CDC stated 'Air travel has the potential to transport people, some of whom may have been exposed to a communicable disease, anywhere across the globe in less than 24 hours. Therefore, out of an abundance of caution, the U.S. government will institute public health measures for the minimal number of travelers arriving from DRC and Guinea.'
In March 2021, the U.S. government will funnel travelers from DRC and Guinea to six U.S. airports.
Airlines will collect and transmit passenger information to the CDC for public health follow-up and intervention for all passengers boarding a flight to the U.S. in DRC or Guinea within the previous 21 days. Passengers can expect verification of data on arrival to ensure completeness and accurateness of contact information.
This personal health information will be shared with U.S. state and local health departments to monitor arrivals in their jurisdiction appropriately.
The CDC continues to say the 'risk of Ebola to the United States is extremely low.'
Pennsylvania-based INOVIO Pharmaceuticals, Inc. announced it met primary and secondary endpoints among all evaluable subjects for the REVEAL 1 trial. This trial is one of two ongoing pivotal, randomized, double-blind, multi-center, placebo-controlled, Phase 3 trials (REVEAL 1 and REVEAL 2) evaluating the safety, tolerability, and efficacy of VGX-3100 to treat HPV-16/18-associated cervical high-grade squamous intraepithelial lesions (HSIL) using the company's proprietary CELLECTRA® 5PSP device.
Dr. Mark Einstein, M.D., MS, FACS, FACOG, Principal Coordinating Investigator for the REVEAL 1 trial, said in a press statement, "There is a very significant need for a non-surgical therapeutic for young women suffering from HPV-associated cervical dysplasia."
"These results are very encouraging and show that we are headed in the right direction."
For the primary endpoint of histopathological regression of HSIL combined with a virologic clearance of HPV-16 and/or HPV-18 at week 36, the percentage of responders was 23.7% (31/131) in the treatment group, versus 11.3% (7/62) in the placebo group (p=0.022; 12.4% difference in percentage, 95%CI: 0.4,22.5), thus achieving statistical significance.
All secondary efficacy endpoints were achieved.
These endpoints were: a) regression of cervical HSIL to normal tissue combined with HPV-16/18 viral clearance, b) regression of cervical HSIL alone, c) regression of cervical HSIL to normal tissue, and d) HPV-16/18 viral clearance alone.
INOVIO is a biotechnology company focused on rapidly bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases, cancer, and diseases associated with HPV.
The US Centers for Disease Control and Prevention (CDC) announced on February 24, 2021, another Ebola virus outbreak in the Democratic Republic of the Congo (DRC) has been identified. This outbreak is in the North Kivu (Kivu Nord) province.
On February 7, 2021, the DRC Ministry of Health declared the 12th outbreak of Ebola. The 10th outbreak occurred in the same region and lasted nearly 2 years.
Travelers to this area of eastern DRC could be infected with Ebola if they come in contact with an infected person’s blood or other body fluids. Travelers should seek medical care immediately if they develop fever, muscle pain, sore throat, diarrhea, weakness, vomiting, stomach pain, or unexplained bleeding or bruising during or after travel, says the CDC.
If US citizens are traveling to this area, the US Department of State suggests enrolling in the Smart Traveler Enrollment Program to receive security updates and information about getting help in the event of an emergency.
Approved Ebola vaccines and treatment information are posted on this webpage.
France-based Transgene and BioInvent International AB announced that the first patient in a Phase I/IIa clinical trial of the novel dual mechanism-of-action oncolytic Vaccinia virus BT-001 had been enrolled at Institut Bergonié, located in Bordeaux, France.
By selectively targeting the tumor microenvironment, BT-001 is expected to elicit a much stronger and more effective antitumoral response. Also, delivering the anti-CTLA4 antibody directly to the tumor microenvironment aims to induce local Treg depletion and strong therapeutic activity.
Consequently, by reducing systemic exposure, the safety and tolerability profile of the anti-CTLA4 antibody will be greatly improved.
Hedi Ben Brahim, Chairman, and CEO of Transgene, stated in a press release, “This first Invir.IO™ based oncolytic virus entering the clinic has been shown to induce long-lasting antitumor immune responses and abscopal effects in several preclinical tumor models; in these experiments, the activity of BT001 was further enhanced through combination with an anti-PD-1 antibody treatment. It has a unique mode of action, and the outstanding results so far indicate it could make a significant difference to cancer patients.”
Transgene (Euronext: TNG) is a publicly-traded French biotechnology company focused on designing and developing targeted immunotherapies for the treatment of cancer. Transgene’s programs utilize viral vector technology with the goal of indirectly or directly killing cancer cells.
