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Today, the Japan Times reported a government spokesman discussed the possibility of extending the current State of Emergency in Tokyo, Osaka, and other prefectures beyond the May 31, 2021, expiration date.
For example, Japan placed the Okinawa Prefecture under the State of Emergency through June 20th.
Recently, the U.S. CDC announced, 'because of the current situation in Japan even fully vaccinated travelers may be at risk for getting and spreading COVID-19 variants and should avoid nonessential travel to Japan.'
This Level 3 Travel Alert issued on May 19, 2021, says, 'if you must travel to Japan, get fully vaccinated before travel. See the CDC recommendations for fully vaccinated travelers and unvaccinated travelers.’
To increase COVID-19 vaccine availability, Japan authorized its version of the Moderna COVID-19 vaccine on May 22nd.
If you are planning to visit Japan, foreign nationals who have stayed in any of the following 159 countries/regions within 14 days before the application for landing are denied to enter Japan according to Article 5 of the Immigration Control and Refugee Recognition Act, unless special exceptional circumstances are found.
Furthermore, when returning to the USA, all air passengers, including U.S. citizens and fully vaccinated people, are required to have a negative COVID-19 test result from no more than 3 days before travel or documentation of recovery from COVID-19 in the past 3 months before they board a flight to the USA, states the CDC.
Japan-based Takeda Pharmaceutical Company Limited announced that its dengue vaccine candidate (TAK-003) demonstrated continued protection against dengue illness and hospitalization, regardless of an individual’s previous dengue exposure.
Furthermore, Takeda stated in a press statement issued on May 22, 2021, 'no important safety risks were identified through three years after vaccination in the ongoing pivotal Phase 3 Tetravalent Immunization against Dengue Efficacy Study (TIDES) trial in Latin America and Asia.'
Takeda's TAK-003 is a live-attenuated tetravalent dengue vaccine candidate, preventing dengue fever caused by any of the four serotypes of the dengue virus that causes dengue. TAK-003 (TDV) is based on a live-attenuated dengue serotype 2 virus, which provides the genetic “backbone” for all 4 dengue serotypes.
“Dengue epidemics occur suddenly, and hospitals can become overwhelmed with severe disease cases and people seeking testing,” commented LakKumar Fernandoi, M.D., Center for Clinical Management of Dengue and Dengue Haemorrhagic Fever, Negombo General Hospital, Sri Lanka, and a primary investigator of the TIDES trial.
The safety and efficacy results from the 36-month follow-up exploratory analysis of TIDES found TAK-003 demonstrated overall vaccine efficacy (VE) of 62.0% (95% CI: 56.6% to 66.7%) against virologically-confirmed dengue (VCD), with 65.0% VE (95% CI: 58.9% to 70.1%) in seropositive individuals and 54.3% VE (95% CI: 41.9% to 64.1%) in seronegative individuals.
TAK-003 also demonstrated 83.6% VE (95% CI: 76.8% to 88.4%) against hospitalized dengue, with 86.0% VE (95% CI: 78.4% to 91.0%) in seropositive individuals and 77.1% VE (95% CI: 58.6% to 87.3%) in seronegative individuals.
Observations of varied VE by serotype remained consistent with previously reported results. No evidence of disease enhancement was observed. TAK-003 was generally well tolerated, and there were no important safety risks observed.
This study's results reinforce the potential of TAK-003 to help protect those living in or traveling to dengue-endemic countries.
“Our dengue vaccine candidate continued to protect against dengue throughout three years and was especially robust in preventing hospitalization,” added Derek Wallace, VP, Dengue Global Program Leader at Takeda.
Dengue viruses are spread to people through the bite of an infected Aedes species (Ae. aegypti or Ae. albopictus) mosquito. Dengue is common in more than 100 countries around the world, says the U.S. CDC.
The CDC recently issued Travel Alert regarding Dengue outbreaks in the Americas, Asia, and the Pacific Islands.
Takeda Pharmaceutical is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people, and the planet. For more information, visit www.TakedaVaccines.com.
In recent years, the World Health Organization (WHO) sounded the alarm over worrying trends in the global response to malaria, wrote Dr. Pedro Alonso, Director, Global Malaria Programme.
"Progress has leveled off, and many countries hardest hit by malaria have been losing ground.'
'At the same time, a growing number of countries with a low burden of malaria have been moving with steady determination towards the target of zero malaria, providing a source of inspiration for all malaria-endemic nations that are working to stamp out the disease.'
The risk for acquiring malaria differs substantially from traveler to traveler and from region to region, even within a single country.
According to this new report published in April 2021, eight E-2020 member countries reported zero indigenous cases of malaria in 2020, a remarkable achievement in view of the ongoing global COVID-19 pandemic.
Maintaining zero cases is a testament to their commitment to protect hard-won gains and keep the disease at bay.
The WHO and partners continue to stand by all countries that are working to end this deadly scourge at every step of the journey. The road to malaria elimination is not quick, nor is it easy. But with sustained commitment and collaboration, we can achieve our common vision of a malaria-free world.
More than a dozen malaria vaccine candidates are now in clinical development. Europe’s medicine agency approved the RTS,S vaccine in July 2015, suggesting that it be used in Africa for babies at risk of getting malaria.
RTS, S/AS01 is a recombinant vaccine candidate consisting of the P. falciparum circumsporozoite protein from the pre-erythrocytic stage. Mosquirix does not provide complete protection against malaria caused by P. falciparum.
Basel-based Roche announced on May 20, 2021, interim results from the Phase III IMpower010 study, showing for the first time that treatment with Tecentriq® (atezolizumab) following surgery and chemotherapy reduced the risk of disease recurrence or death (disease-free survival; DFS) by 34% (hazard ratio [HR]=0.66, 95% CI: 0.50–0.88) in people with Stage II-IIIA non-small cell lung cancer (NSCLC), whose tumors express PD-L1 ≥1%, compared with best supportive care (BSC).
In this population, median DFS was not yet reached for Tecentriq compared with 35.3 months for BSC.
In the larger population of all randomized Stage II-IIIA study participants, Tecentriq reduced the risk of disease recurrence or death by 21% (HR=0.79, 95% CI: 0.64–0.96) after a median follow-up of 32.2 months.
Tecentriq increased DFS by a median of seven months (42.3 months versus 35.3 months with BSC).1 Safety data for Tecentriq were consistent with its known safety profile, and no new safety signals were identified.
Tecentriq is a monoclonal antibody designed to bind with a protein called Programmed Death Ligand-1 (PD-L1), which is expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors.
“These landmark Phase III data demonstrate for the first time that cancer immunotherapy can bring a clinically meaningful improvement to certain people with early lung cancer in the adjuvant setting,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “These results lay the groundwork for a new approach to the treatment of early-stage lung cancer and bring us closer to our goal of providing an effective and tailored treatment option for every person diagnosed with this disease.”
The full results of IMpower010 will be presented in the lung cancer oral abstract session (Abstract #8500) on Sunday 6 June (08:00–11:00 EDT) at the 2021 ASCO Annual Meeting.
The U.S. Food and Drug Administration (FDA) announced the approval of Rybrevant (amivantamab-vmjw) as the first treatment for adult patients with non-small cell lung cancer whose tumors have specific types of genetic mutations: epidermal growth factor receptor (EGFR) exon 20 insertion mutations.
The FDA's approval of Rybrevant was granted to Pennsylvania-based Janssen Pharmaceutical Companies of Johnson & Johnson.
“The approval of RYBREVANT, along with the companion diagnostic test, addresses a high unmet need in the treatment of people with genetically defined non-small cell lung cancer,” said Peter Lebowitz, M.D., Ph.D., Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC.
The FDA also approved the Guardant360 CDx (Guardant Health Inc.) as a companion diagnostic for Rybrevant.
“Advances in precision oncology continue to facilitate drug development, allowing diseases like lung cancer to be subset into biomarker-defined populations appropriate for targeted therapies,” commented Julia Beaver, M.D., chief of medical oncology in the FDA’s Oncology Center of Excellence and acting deputy director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research, in a press release.
“With today’s approval, for the first time, patients with non-small cell lung cancer with EGFR exon 20 insertion mutations will have a targeted treatment option.”
Researchers evaluated Rybrevant’s efficacy in a study of 81 patients with non-small cell lung cancer and EGFR exon 20 insertion mutations whose disease had progressed on or after platinum-based chemotherapy.
The main outcome measured was the overall response rate (proportion of patients whose tumor is destroyed or reduced by a drug). In the trial population in which all patients received Rybrevant, the overall response rate was 40%. The median duration of response was 11.1 months, with 63% of patients had a duration of 6 months or more.
The most common side effects of Rybrevant include rash, infusion-related reactions, skin infections around the fingernails or toenails, muscle and joint pain, shortness of breath, nausea, fatigue, swelling in the lower legs or hands or face, sores in the mouth, cough, constipation, vomiting, and changes in certain blood tests. Rybrevant should be withheld if patients develop symptoms of interstitial lung disease and permanently discontinued if interstitial lung disease is confirmed.
Patients taking Rybrevant should limit sun exposure during and for two months after treatment. Rybrevant may cause problems with vision. Rybrevant can also cause fetal harm when administered to a pregnant woman; therefore, the pregnancy status of females of reproductive potential should be confirmed before treatment is started.
Rybrevant received Priority Review and Breakthrough Therapy designation for this indication.
According to the American Cancer Society, lung cancer is the most common cancer type and the leading cause of cancer-related deaths worldwide, with non-small cell lung cancer accounting for 80% to 85% of all lung cancers. Approximately 2% to 3% of patients with non-small cell lung cancer will have EGFR exon 20 insertion mutations, a group of mutations on a protein that causes rapid cell growth, and consequently, helps cancer spread. EGFR exon 20 insertion mutations are the third most common type of EGFR mutation.
This review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence.
The US Centers for Disease Control and Prevention (CDC) reported on May 21, 2021, that during Week #19, Influenza-like Illness (ILI) remained stable (change of ≤ 0.1%), with about 1.2% of patient visits due to ILI.
This ILI percentage is below the national baseline of 2.6%, for this time during the annual flu season, says the CDC.
While seasonal influenza viruses are detected year-round in the USA, flu viruses are most common during the fall and winter. Of the 8,084 specimens tested by public health laboratories last week, there were (0) confirmations for influenza viruses.
However, the percentages of visits for ILI last week continued to increase among persons aged 0–4 years and 5–17 years, while the remaining age groups have experienced a stable trend.
The good news from the CDC is 'no influenza-associated pediatric deaths were reported to CDC during week #19. During the entire 2020-2021 flu season in the USA, just (1) influenza-associated pediatric death has been reported to CDC. During the last flu season, the CDC confirmed 198 influenza-associated pediatric deaths.'
Furthermore, the Influenza Hospitalization Surveillance Network reported that between October 1, 2020, and April 30, 2021, the overall cumulative hospitalization rate is lower than rates for any season since routine data collection began in 2005, including the low severity 2011-12 season.
The Weekly U.S. Influenza Summary Update is published weekly from October through May annually. The U.S. influenza surveillance system is a collaborative effort between CDC and its many partners in state and local health departments, public health and clinical laboratories, vital statistics offices, healthcare providers, clinics, and emergency departments.
BioNTech Europe GmbH confirmed on May 20, 2021, it has agreed with the Republic of Turkey’s Ministry of Health to supply 60 million additional doses of the companies’ mRNA COVID-19 vaccine, with an option for an additional 30 million doses.
This second supply agreement brings the total number of Cominraty vaccine doses to Turkey to up to 120 million, all of which will be delivered in 2021.
“We are hopeful that this agreement will further boost Turkey’s COVID-19 vaccination drive. Pfizer is committed to contributing to public health in Turkey and very proud to have a global partner such as BioNTech in the global fight against the pandemic,” commented M. Cem Açık, Pfizer Country Manager Turkey, in a press statement.
The Comirnaty vaccine, based on BioNTech’s proprietary mRNA technology, was developed by BioNTech and Pfizer.
Do not administer the Pfizer-BioNTech COVID-19 vaccine to individuals with a known history of a severe allergic reaction to any component of the Pfizer-BioNTech COVID-19 vaccine.
Germany-based BioNTech SE is the Marketing Authorization Holder in the European Union and the holder of emergency use authorizations or equivalent in the United States (jointly with Pfizer), United Kingdom, Canada, and other countries in advance of a planned application for full marketing authorizations in these countries.
A recently published analysis by McKinsey & Company says, 'the standard view in the pharmaceuticals industry has been that it takes many years to develop a new drug. And, until recently, that has generally been true.'
This new McKinsey analysis of all new drugs developed since 2000 shows that the mean development timeline, from the start of clinical testing to approval, is nearly ten years.
The same holds for new anti-infective vaccines such as human papillomavirus, shingles, and pneumococcal infections.
Remarkably, just 11 months after the SARS-CoV-2 beta coronavirus sequence was published, humans began receiving COVID-19 vaccines in December 2020. Since then, over 126 million people in the USA have been fully vaccinated against COVID-19.
Previously, the fastest vaccine development was for the mumps virus, which took four years during the 1960s.
Leaders in the pharmaceutical and biotechnology industries are debating which parts of this hyper-accelerated development cycle are ephemeral and which parts will live on, says McKinsey. The companies that can make changes in these areas can trigger lasting transformations—and bring life-changing therapies to patients that much faster.
The authors of this analysis issued on May 13, 2021, included Gaurav Agrawal, Robert Hermann, Rosa Poetes, Michael Steinmann, and Martin Møller.
