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For the second time in 2021, the US Centers for Disease Control and Prevention (CDC) expanded the Influenza Risk Assessment Tool (IRAT) listing on May 5, 2021, increasing the number of zoonotic influenza viruses on their watchlist to a record high of twenty-one.
The IRAT is used to assess the potential pandemic risk posed by influenza A viruses that are not currently circulating in people.
The CDC updated their IRAT listing to included the avian H5N8 virus following the announcement by Anna Popova, Chief State Sanitary Physician of the Russian Federation, of the first detection of human infection with this particular subtype.
Since this February 2021 announcement, the World Health Organization (WHO) and the European CDC determined the risk of human infection to be low or very low. The U.S. CDC similarly ranks this virus as being moderate-to-low-risk at this time, reported the Avian Flu Diary.
The WHO says Zoonotic influenza refers to a disease caused by animal influenza viruses that cross the animal–human divide to infect people. People can be infected with influenza viruses that are usually circulating in animals, such as avian influenza virus subtypes A(H5N1) and A(H9N2) and swine influenza virus subtypes A(H1N1) and (H3N2).
In early March 2021, the WHO called for developing a Candidate Vaccine Virus against avian H5N8 in case this influenza strain becomes a more common zoonotic threat.
Furthermore, the U.S. CDC reported on April 16, 2021, one human infection with a novel influenza A virus in Wisconsin after the person had direct contact with swine. That person was infected with an influenza A(H1N1) variant (A(H1N1)v) virus.
The U.S. Department of Health and Human Services (HHS) announced on May 4, 2021, the availability of approximately $250 million to develop and support a community-based workforce who will serve as trusted voices sharing information about vaccines, increase COVID-19 vaccine confidence, and address any barriers to vaccination for individuals living in vulnerable and medically underserved communities.
This funding will help community-based organizations to hire and mobilize community outreach workers, community health workers, social support specialists, and others to conduct on-the-ground outreach to educate and assist individuals in getting the information they need about vaccination, help make vaccine appointments, and assist with transportation needs.
“Increasing public confidence in COVID-19 vaccines and boosting uptake remains a critical part of our fight against this virus,” said HHS Secretary Xavier Becerra in a press statement.
To apply for the Community-Based Workforce for COVID-19 Vaccine Outreach Program Notice of Funding Opportunity, visit Grants.gov. Applications are due May 18, 2021. HHS Frequently Asked Questions are published on this webpage. HHS is located at 200 Independence Avenue, S.W., Washington, D.C. 20201.
The US Centers for Disease Control and Prevention (CDC) recently confirmed it is transitioning to reporting 'only patients with COVID-19 vaccine Breakthrough Infection hospitalized or died to help maximize the quality of the data collected.'
That change in reporting will begin on May 14, 2021.
In preparation for that transition, the number of reported breakthrough cases will not be updated on May 7, 2021, stated the CDC. As of May 9th, the CDC disclosed the total number of vaccine Breakthrough Infections reported was 9,245.
According to the CDC, a COVID-19 vaccine Breakthrough Infection case is a 'person who has SARS-CoV-2 RNA or antigen detected on a respiratory specimen collected ≥14 days after completing the primary series of a U.S. Food and Drug Administration (FDA)-authorized COVID-19 vaccine.
State health departments have been reporting Breakthrough cases to CDC, which monitors patient demographics, geographic location, time since vaccination, vaccine type or lot number, and SARS-CoV-2 lineage.
As of April 26th, the CDC received reports of vaccine breakthrough infections from 46 U.S. states and territories. The key demographics were Females 63%; People aged ≥60 years 45%; Asymptomatic infections 27%; Hospitalizations 9%; and Deaths 1%.
The CDC stated it is leading multiple vaccine effectiveness studies to ensure COVID-19 vaccines are working as expected to bring more data to the public.
Currently, the CDC has Authorized three experimental COVID-19 vaccines, which are pending U.S. FDA Approvals.
The Republic of the Maldives announced on May 1, 2021, the Health Protection Agency (HPA) clarified the COVID-19 related requirements for visitors to visit the island nation.
To ensure the safety of all, HPA has made it a mandatory requirement for all tourists, including those who have completed the prescribed dose(s) of a COVID-19 vaccine, to present a negative result for a Nucleic Acid Test (PCR test) for COVID-19 on arrival effective May 3, 2021.
The sample for said PCR test must be taken not more than 96 hours before the scheduled time of departure from the first port of embarkation en route to the Maldives.
The Maldives comprises about 1100 islands in the Indian Ocean that spans across the equator. Only 200 of the islands are inhabited, and a select few on each of the atolls are resorts, and some of the islands are used for industry and agriculture.
The beauty of the Maldives is not only above the water, says Visit Maldives.com.
The Maldives is home to about five percent of the planet’s reefs that come with an explosion of color contributed by soft and hard corals that form them. The reefs are home to a thousand species of fish. Lured by the rich nutrients that flow in with the currents, large pelagic fishes such as manta rays and whale sharks also make the Maldives their home.
A global biotechnology company announced that its PARP inhibitor pamiparib had received conditional approval from the China National Medical Products Administration (NMPA) for the treatment of patients with germline BRCA (gBRCA) mutation-associated recurrent advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more lines of chemotherapy.
BeiGene, Ltd.'s new drug application was previously granted priority review by the Center for Drug Evaluation (CDE) in July 2020.
Beijing and Cambridge, MA-based BeiGene stated in its press release issued on May 7, 2021, it is preparing to launch pamiparib this month (May'21).
“Today’s NMPA approval makes pamiparib the third BeiGene internally discovered and developed medicine to receive marketing authorization, an incredible company milestone validating our scientific innovations,” commented Xiaobin Wu, Ph.D., President, Chief Operating Officer, and General Manager of China at BeiGene, in a press statement.
The NMPA conditional approval of pamiparib for treating patients with advanced ovarian, fallopian tube, or primary peritoneal cancer is based on clinical results from a pivotal Phase 2 portion of the Phase 1/2 trial (NCT03333915). A total of 113 patients in China with high-grade, non-mucinous, epithelial ovarian cancer (including fallopian or primary peritoneal cancer), harboring gBRCA mutations, following at least two prior lines of standard chemotherapy, were enrolled in the pivotal Phase 2 portion of the trial, including 90 patients with advanced platinum-sensitive ovarian cancer (PSOC), and 23 patients with advanced platinum-resistant ovarian cancer (PROC).
Clinical efficacy data in the pamiparib label in China, as assessed by the independent review committee (IRC) per RECIST v1.1, were based on 101 patients evaluable for efficacy analysis, including 82 patients with PSOC and 19 patients with PROC.
For patients with PSOC, with a median follow-up time of 17.0 months, the objective response rate (ORR) was 68.3% (95% CI: 57.1, 78.1), and the median duration of response (DoR) was 13.8 months (95% CI: 10.97, 20.73); for patients with PROC, the median follow-up time was 11.6 months, the ORR was 31.6% (95% CI: 12.6, 56.6) and the median DoR was 11.1 months (95% CI: 4.21, 16.59).
The safety profile of pamiparib in the label in China was based on 317 patients who received pamiparib as monotherapy in three clinical trials. The most common adverse reactions (≥10%) were anemia, nausea, leukopenia, neutropenia, vomiting, fatigue, thrombocytopenia, decreased appetite, diarrhea, abdominal pain, aspartate aminotransferase (AST) increased, alanine aminotransferase (ALT) increased, blood bilirubin increased, and lymphopenia.
Grade ≥3 adverse reactions occurred in 55.8% of patients, with the most common (≥1%) being anemia, neutropenia, leukopenia, thrombocytopenia, lymphopenia, vomiting, fatigue, diarrhea, nausea, and AST increased. Serious adverse reactions occurred in 21.5% of patients, with the most common (≥1%) anemia and leukopenia.
The recommended dose of pamiparib is 60 mg twice daily (BID) taken orally.
In China, ovarian cancer is the deadliest gynecologic cancer, responsible for approximately 22,500 deaths every year, and the five-year survival rate among Chinese patients is about 40%.
Pamiparib is an inhibitor of PARP1 and PARP2, which has demonstrated pharmacological properties such as brain penetration and PARP-DNA complex trapping in preclinical models. Discovered by BeiGene scientists, pamiparib is currently in global clinical development as a monotherapy or in combination with other agents for a variety of solid tumor malignancies.
To date, more than 1,200 patients have been enrolled in clinical trials of pamiparib.
In China, pamiparib received conditional approval to treat patients with germline BRCA (gBRCA) mutation-associated recurrent advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more lines of chemotherapy in May 2021. Full approval for this indication is contingent upon results from ongoing corroborative trials confirming the clinical benefit of pamiparib in this population.
BeiGene is a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide. BeiGene is a headquarter-less company by design, with a growing global team of approximately 6,000 colleagues across five continents. To learn more about BeiGene, please visit www.beigene.com.
As the debate of when to open up the cruise industry as the COVID-19 pandemic subsides in Florida, media reporting indicates it may become a content between whose legal authority is greater, a US state or the Federal government.
The AP reported on May 7, 2021, Miami-based Norwegian Cruise Line (NCL) Holdings is threatening to keep its ships out of Florida after Governor Ron DeSantis signed Executive Order #21-102 on April 3, 2021, banning local businesses from requiring customers in Florida to show proof of COVID-19 vaccination.
NCL says the new Florida law is at odds with US Centers for Disease Control and Prevention (CDC) guidelines, which would let cruise ships operate in U.S. waters if nearly all passengers and crew members are vaccinated. “It is a classic state-versus-federal-government issue,” said Norwegian’s CEO, Frank Del Rio. “Lawyers believe that federal law applies and not state law, but I’m not a lawyer. And we hope that this doesn’t become a legal football or a political football.”
On April 28, 2021, NCL confirmed, 'We are committed to taking all appropriate actions to combat the spread of COVID-19 and are working closely and in partnership with local, state, federal, and global agencies. Our teams are working around the clock to do what is right for our guests and travel partners and keep them informed of the latest happenings.'
In conjunction with our second return to service announcement, we have extended our voluntary temporary suspension for Pride of America and Norwegian Bliss through July 2021 as well as various September and October voyages across the fleet.'
And 'Norwegian Joy, Norwegian Jade, Norwegian Getaway, Norwegian Epic, and Norwegian Gem now boast new homeports in Greece, Spain, Italy, and the Caribbean for six new itineraries.'
Since March 2020, the CDC has barred cruise ships from sailing in U.S. waters or stopping at U.S. ports.
However, some good news was announced on May 5, 2021.
The CDC released guidance for cruise ships to undertake simulated voyages with volunteer passengers as part of its COVID-19 Conditional Sailing Certificate (CSO) application. In addition, this release includes the COVID-19 Conditional Sailing Certificate application, which is the final step before restricted passenger voyages.
The CDC released the CSO in October 2020 to prevent the further spread of COVID-19 on cruise ships, from cruise ships into communities, and to protect public health and safety.
The US Centers for Disease Control and Prevention (CDC) Weekly Influenza Surveillance Report ending May 1, 2021, says 'seasonal influenza activity in the USA remains lower than usual for this time of year.'
The CDC reported only one sample out of 11,512 tested positive for influenza by public health laboratories during Week #17.
Furthermore, the CDC confirmed the Influenza Hospitalization Surveillance Network reported between October 1, 2020, and April 30, 2021, fourteen US states reported 226 laboratory-confirmed influenza hospitalizations for an overall cumulative hospitalization rate of 0.8 per 100,000 population.'
'This is lower than rates for any flu season since routine data collection began in 2005. Due to low case counts, only overall cumulative rates for the entire network are being reported this season.'
Another positive aspect of this week's CDC reported is 'no influenza-associated pediatric deaths were reported during Week #17. And just one influenza-associated pediatric death occurring during the 2020-2021 season has been reported to the CDC.
However, the CDC says health care-seeking behaviors have changed dramatically during the COVID-19 pandemic. Many people are accessing the health care system in alternative settings, which may or may not be captured all of the activity. Therefore, flu season activity levels should be interpreted with caution.
