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The U.S. Transportation Services Administration (TSA) confirmed air traveler screening at US-based airports had experienced ups and downs.
The TSA announced in a press release that its officers detected a record number of firearms at airport security checkpoints, establishing a 20-year record with three months remaining in 2021.
By October 3rd of this year, TSA officers had stopped 4,495 airline passengers from carrying firearms onto their flights.
TSA officers discovered 11 firearms in carry-on bags at airport checkpoints per million passengers screened so far in 2021. This activity compared to 5 firearms per million passengers in 2019.
The 2021 total surpasses the previous record of 4,432 firearms caught at checkpoints in the entire calendar year 2019.
The mission of the U.S. TSA is to 'Protect the nation's transportation systems to ensure freedom of movement for people and commerce.'
New Jersey-based Seqirus announced today that The New England Journal of Medicine had published absolute efficacy data on the company's cell-based quadrivalent influenza vaccine (QIVc) from a randomized controlled trial that met its primary endpoint.
The phase 3 study results indicate that the seasonal influenza vaccine was effective and produced a sufficient immune response against influenza in children and adolescents ≥2 to <18 years of age over three influenza seasons in the Southern (2017) and Northern (2017/18 and 2018/19) Hemispheres, compared to a non-influenza comparator.
This represents the first absolute efficacy study of a cell-based influenza vaccine in children as young as two years.
"In this study, QIVc demonstrates absolute efficacy in children and adolescents, showing consistent benefit across three seasons and eight countries. This is particularly impactful given the disease burden in children as young as two years of age," stated Jonathan Edelman, M.D., Vice President, Clinical Development at Seqirus and study author, in a press release.
"These data add to a growing body of evidence supporting the fact that our differentiated, cell-based seasonal influenza vaccine can help provide effective protection against flu."
QIVc utilizes a cell-based influenza vaccine manufacturing process, an alternative to traditional egg-based manufacturing.
Traditional egg-based vaccine production can cause the strain to mutate at several steps throughout the manufacturing process, leading to an antigenic mismatch between the circulating strains and the inactivated influenza strains contained within the seasonal influenza vaccine.
Cell-based influenza vaccines are designed to produce an exact match to the World Health Organization (WHO)-selected influenza virus strains by avoiding egg-adapted changes, and therefore have the potential for greater vaccine effectiveness.
The results of this study supported the recent U.S. Food and Drug Administration (FDA) approval for an expanded age indication for the use of QIVc in children ≥2 years of age.
QIVc is marketed in the U.S. as FLUCELVAX® QUADRIVALENT vaccine and is currently under review by the FDA for an expanded age indication for children.
Seqirus is part of CSL Limited and is one of the largest influenza vaccine providers in the world.
With historical data spanning the past 16 years, the Henley Passport Index is based on exclusive data from the International Air Transport Authority. The Index includes 199 different passports and 227 different travel destinations.
Updated quarterly, the Henley Passport Index is considered the standard reference tool for global citizens and sovereign states when assessing where a passport ranks on the worldwide mobility spectrum.
Released on October 5, 2021, the Q4 2021 Index ranks Japan, Singapore, Germany, and South Korea the highest.
Discover where your passport lies on the global mobility spectrum by comparing it with the other 198 passports and 226 destinations included on the Henley Passport Index.
The USA is ranked #7 for 2021.
On October 8, 2021, the U.S. Department of State issued a Passport Operations Update in Response to COVID-19.
You can find Frequently Asked Questions about U.S. passport operations by expanding the gray boxes linked here.
Furthermore, the State Department publishes various Travel Advisories for most countries. Note that conditions can change rapidly in a country at any time. To receive updated Travel Advisories and Alerts, choose the method that works best for you at travel.state.gov/stayingconnected.
The U.S. FDA published on October 13, 2021, a Briefing Document EUA amendment request for authorization for a booster dose for the Janssen COVID-19 Vaccine at least two months after a single-dose primary vaccination.
A section of the FDA Document focused on the safety of a 'booster' second dose says, 'The safety database to support the use of a booster dose comes primarily from study COV3009, with smaller contributions from studies COV1001, COV1002 and COV2001.'
'The total number of exposed subjects is 8,049.'
'The analyses of reactogenicity data during the seven days post-booster and the unsolicited AEs within 28 days post-booster do not appear significantly different from those for the single-dose primary vaccination and do not raise new safety concerns.'
'The limitations of these data include the length of the follow-up (median of 36 days of blinded follow-up post-dose 2 in study COV3009) and limited safety data are available for a booster dose administered six months after the primary dose (N=17).'
'While the overall size of the database (N=8049) may not be adequate to characterize infrequently occurring serious adverse events, the Sponsor has presented a plan (currently under review by FDA) to continue monitoring safety events following administration of a booster dose if authorization is granted.
The Vaccines and Related Biological Products Advisory Committee meeting to review this Document and others is scheduled for October 14 & 15, 2021.
The World Health Organization (WHO) announced Ebola vaccinations began today in the Democratic Republic of the Congo (DRC) North Kivu Province, where one Ebola case was confirmed on October 8, 2021.
This case lived in the same community where three members of the same family died in September 2021 after experiencing Ebola-like symptoms.
People at high risk, including contacts of the confirmed case and first responders, will receive vaccine doses as the health authorities move to curb the spread of the Ebola Zaire virus.
Already, more than 170 contacts have been identified, and teams are monitoring their health.
Vaccinators are using the "ring vaccination" approach, where contacts and contacts of contacts are vaccinated.
The WHO confirmed about 1,000 doses of the rVSV-ZEBOV Ebola vaccine and other medical supplies were delivered from the capital Kinshasa to Goma city in North Kivu.
About 200 doses were sent to Beni city near the Butsili health area, where the confirmed case was detected.
Furthermore, the DRC has more than 12,000 vaccine doses in Kinshasa that can be deployed if necessary.
"Ebola is a virulent, lethal virus that can spread aggressively and fast. But vaccines can create a firewall of protection around cases, stopping the chain of transmission, warning a potentially large outbreak and saving many lives," stated Dr. Matshidiso Moeti, WHO Regional Director for Africa, in a press release.
In addition, the WHO is in the process of shipping five tons worth of response supplies, including therapeutics, personal protective equipment, and laboratory materials, to the DRC.
Beni was one of the epicenters of the 2018–2020 Ebola outbreak in the eastern DRC and is about 50 km from Butembo City, which experienced an Ebola outbreak earlier in 2021.
Sporadic cases can occur following a major outbreak, but further genomic sequencing is needed to determine if this latest case is linked to the previous outbreaks, says the WHO.
The Democratic Republic of the Congo's National Institute of Biomedical Research's central laboratory in Kinshasa is currently testing samples of the confirmed case to identify the strain, and results are expected this week.
rVSV-ZEBOV is a recombinant, replication-competent Ebola vaccine produced by Merck and called Ervebo.
The vaccine's active ingredient is a live Vesicular Stomatitis Virus, in which its surface protein has been replaced with that of Zaire ebola virus disease. Inactive ingredients include recombinant human serum albumin, tromethamine buffer. In addition, this vaccine contains a trace amount of rice protein.
Ervebo is the first Ebola vaccine currently licensed by the U.S. Food and Drug Administration (FDA) to prevent Ebola virus disease (EVD).
The U.S. CDC has recently issued high-level Travel Advisories for the DRC focused on polio, meningitis, monkeypox, and COVID-19.
The U.S. Food and Drug Administration (FDA) approved Eli Lilly and Company's Verzenio® (abemaciclib), in combination with endocrine therapy (tamoxifen or an aromatase inhibitor), for the adjuvant treatment of adult patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, early breast cancer (EBC) at high risk of recurrence and a Ki-67 score of ≥20% as determined by an FDA-approved test, on October 13, 2021.
Ki-67 is a marker of cellular proliferation. And Verzenio is the first and only CDK4/6 inhibitor approved for this patient population.
"Over time, the collective results of the Verzenio clinical development program have demonstrated a differentiated CDK4/6 inhibitor profile, and the landmark data from the monarchE trial that supported this new indication in HR+ HER2- early breast cancer represent another important step forward for people who are in need of new treatment options," said Jacob Van Naarden, SVP, CEO of Loxo Oncology at Lilly and president, Lilly Oncology, in a press release.
"We are pleased with this initial approval in the adjuvant setting, and as these data continue to mature, we look forward to furthering opportunities to work with health authorities to expand the use of Verzenio in this setting."
This approval is based on efficacy results from an analysis of this subgroup with additional follow-up conducted post-hoc. In this analysis, Verzenio given in combination with ET continued to demonstrate a clinically meaningful benefit, with a 37 percent decrease in the risk of breast cancer recurrence or death compared to standard adjuvant ET alone for patients with high risk clinical and pathological features and a Ki-67 score ≥20% (HR: 0.626 [95% CI: 0.49-0.80]), and an absolute benefit in IDFS event rate of 7.1 percent at three years.
The number of IDFS events at this analysis was 104 with Verzenio plus ET compared to 158 with ET alone. Overall survival data were not mature, and additional follow-up is ongoing.
Adverse reactions from monarchE were consistent with the known safety profile for Verzenio.2 Safety and tolerability were evaluated in 5,591 patients.
For more than 50 years, Indiana-based Lilly has been dedicated to delivering life-changing medicines and support to people living with cancer and those who care for them. Lilly is determined to build on this heritage and continue making life better for all those affected by cancer around the world.
To learn more about Lilly's commitment to people with cancer, please visit www.LillyOncology.com.
The journal Nature published a Review on October 12, 2021, reporting pharma companies are racing to apply messenger-RNA (mRNA) technology to influenza vaccines.
These companies hope new mRNA influenza vaccines will have better efficacy against seasonal flu.
Existing flu shots built around inactivated viruses or recombinant proteins typically offer 40–60% protection against infection each year.
The U.S. CDC publishes the adjusted vaccine effectiveness estimates for influenza seasons from 2004-2021 at this link.
And in some flu seasons, a third 'booster' vaccination is required as flu shots' wane' towards the end of the season.
But making mRNA vaccines against the flu might be more challenging than crafting ones against COVID-19.
For one thing, it's no sure thing that mRNA can effectively deliver the main antigen found in influenza vaccines.
The full Review is found at this link.
Norway-based Ultimovacs ASA announced today continuing positive topline results in its ongoing U.S.-based Phase I clinical trial evaluating the Company’s universal cancer vaccine, UV1, in combination with the checkpoint inhibitor pembrolizumab as a first-line treatment in metastatic malignant melanoma.
The study had previously reached its primary endpoint of safety and tolerability and, at 24 months of follow-up, continues to demonstrate strong signs of clinical response.
In the Phase I trial, patients were initially treated for 14 weeks with UV1 in combination with pembrolizumab. At the cut-off date of October 12, 2021, every patient in the first cohort had been followed for at least 24-months from the start of their treatment.
After two years of follow-up, the overall survival rate was 80% in this first cohort of 20 patients.
As previously announced, the median progression-free survival for these patients was 18.9 months.
The 24-month follow-up data compares favorably with an earlier large-scale study of pembrolizumab alone, which showed an overall survival rate of 58% after 24 months and median progression-free survival of 5.5-11.6 months*.
“The combination of UV1 and pembrolizumab has a strong safety profile and provides a prolonged and effective clinical response in advanced melanoma,” commented Jens Bjørheim, Chief Medical Officer of Ultimovacs, in a press release.
“These two-year follow-up data suggest that the way in which UV1 mobilizes the immune system provides patients with lasting benefits.”
The 12-month follow-up data from Ultimovacs’ Phase I trial can be accessed here. For further information, please also see the Q2 2021 financial report.
To eradicate polio, the Global Polio Eradication Initiative (GPEI) brings together the latest scientific knowledge on the virus and tracks the status of the virus every week.
Following careful review of the safety and genetic stability data from mass immunization campaigns conducted with the novel oral polio vaccine type 2 (nOPV2), the Strategic Advisory Group of Experts on immunization (SAGE) endorsed on October 11, 2021, the transition to the following use phase for the polio vaccine.
Furthermore, the WHO’s independent Global Advisory Committee on Vaccine Safety (GACVS) and SAGE confirmed no major safety concerns associated with nOPV2.
These decisions mark the end of the vaccine’s initial use period and remove specific use criteria for countries affected by circulating vaccine-derived poliovirus type 2 (cVDPV2) outbreaks.
nOPV2 is being deployed under WHO’s Emergency Use Listing procedure (EUL) to enable rapid field availability. This means more countries will be eligible to use the vaccine under its WHO Emergency Use Listing recommendation.
nOPV2 vaccinations launched in March 2021, and to date, approximately 100 million doses have been administered to children across seven countries.
In addition to those who have already rolled out the new vaccine, sixteen other countries are also verified as ready to use nOPV2 by GPEI, and a further 17 are in the midst of preparations.
“We are very pleased with the SAGE’s endorsement of transitioning nOPV2 to the next rollout phase. Progress like this is a result of strong partnerships at every level, and we must continue forging forward together, using innovative tools like nOPV2 to reach every last child and end all forms of polio for good,” commented Akhil Iyer, the UNICEF Director of Polio Eradication.
Active cVDPV2 outbreaks are ongoing in more than twenty countries across Africa and Asia, and there have been recent detections of the poliovirus in Europe.
As of October 6, 2021, Madagascar confirmed one cVDPV1 case and three cVDPV1 positive environmental samples, and Nigeria confirmed 17 cVDPV2 cases.
And the final and official version of the Polio Eradication Strategy 2022-2026: Delivering on a Promise. The executive summary of the strategy has also been made available in all UN languages at this link.
