Tag Archives: GMP pharmaceutical storage

FDA approves drug to treat Parkinson’s Disease

Sentry BioPharma Services provides drug product management, global drug distribution, GMP storage and specialized services like pharmaceutical labeling, packaging and kitting.  Sentry plays a critical role in protecting temperature-sensitive product safety, identity, strength, purity and quality (SISPQ) for both  clinical trials and commercial drug distribution for a wide range of pharmaceutical and biotechnology clients. 

The focus of our post this week is Parkinson’s Disease and treatment.  Therefore, we are sharing this article from the FDA concerning its new drug approval of Xadago.

The U.S. Food and Drug Administration today approved Xadago (safinamide) tablets as an add-on treatment for patients with Parkinson’s disease who are currently taking levodopa/carbidopa and experiencing “off” episodes. An “off” episode is a time when a patient’s medications are not working well, causing an increase in Parkinson’s symptoms, such as tremors and difficulty walking.

“Parkinson’s is a relentless disease without a cure,” said Eric Bastings, M.D., deputy director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “We are committed to helping make additional treatments for Parkinson’s disease available to patients.”

An estimated 50,000 Americans are diagnosed with Parkinson’s disease each year, according to the National Institutes of Health, and about one million Americans have the condition. The neurological disorder typically occurs in people over age 60, though it can occur earlier, when cells in the brain that produce a chemical called dopamine become impaired or die. Dopamine helps transmit signals between the areas of the brain that produce smooth, purposeful movement – such as eating, writing, and shaving. Early symptoms of the disease are subtle and occur gradually. In some people, Parkinson’s disease progresses more quickly than in others.

The efficacy of Xadago in treating Parkinson’s disease was shown in a clinical trial of 645 participants who were also taking levodopa and were experiencing “off” time. Those receiving Xadago experienced more beneficial “on” time, a time when Parkinson’s symptoms are reduced, without troublesome uncontrolled involuntary movement (dyskinesia), compared to those receiving a placebo. The increase in “on” time was accompanied by a reduction in “off” time and better scores on a measure of motor function assessed during “on” time than before treatment.

In another clinical trial of 549 participants, the participants adding Xadago to their levodopa treatment had more “on” time without troublesome uncontrolled involuntary movement compared to those taking a placebo, and also had better scores on a measure of motor function assessed during “on” time than before treatment.

Certain patients should not take Xadago. These include patients who have severe liver problems, or who take a medicine used to treat a cough or cold called dextromethorphan. It also should not be taken by patients who take another medicine called a monoamine oxidase inhibitor (MAOI) because it may cause a sudden severe increase in blood pressure, or by those who take an opioid drug, St. John’s wort, certain antidepressants (such as serotonin-norepinephrine reuptake inhibitors, tricyclics, tetracyclics, and triazolopyridines), or cyclobenzaprine, because it may cause a life-threatening reaction called serotonin syndrome.

The most common adverse reactions observed in patients taking Xadago were uncontrolled involuntary movement, falls, nausea, and trouble sleeping or falling asleep (insomnia).

Serious, but less common, risks include the following: exacerbated high blood pressure (hypertension); serotonin syndrome when used with MAOIs, antidepressants, or opioid drugs; falling asleep during activities of daily living; hallucinations and psychotic behavior; problems with impulse control/compulsive behaviors; withdrawal-emergent hyperpyrexia (fever) and confusion; and retinal pathology.

The FDA granted approval of Xadago to Newron Pharmaceuticals.

Sentry BioPharma Services offers temperature sensitive biological product management to pharmaceutical companies, hospitals and organizations with need for validated  GMP storage, labeling, kitting and temperature-sensitive drug distribution services.  For more information about how Sentry’s GMP services can help protect the integrity and delivery of your biological products to patients, contact Sentry via email or by phone at 1-866-757-7400.

FDA’s Know Your Source: Protecting Patients from Unsafe Drugs

Beware of Rogue Wholesale Drug Distributors

Wholesale drug distributors are a link between manufacturers and health care professionals. Their role is to ensure prescription medications are delivered safely and efficiently to thousands of health care practitioners and pharmacies nationwide every day.

While the U.S. health care supply chain is one of the most secure and sophisticated in the world, there is a growing network of rogue wholesale drug distributors selling potentially unsafe drugs in the U.S. market.

kys

Reduce the Chance of a Potentially Unsafe Drug Reaching Your Patients

In order to protect your patients from unsafe or ineffective drugs, the FDA urges health care professionals to verify that their supplier is licensed by the state. Drugs from rogue wholesale drug distributors may harm your patients and expose them to unknown risks or side effects.  The FDA advises health care providers to know the source for prescription drugs.

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Verify that Your Wholesale Drug Distributor is Licensed in Your State

map

http://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/ucm281446.htm

For more information about Sentry’s pharmaceutical licensing, registration and international compliance program, contact Sentry via email or by phone at 1-866-757-7400.

For more information: http://www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ucm389121.htm

DoD | Human Trials Begin for Army-Developed Zika Vaccine

By Cheryl Pellerin, DoD News, Defense Media Activity / Published Nov. 8, 2016

A clinical trial began yesterday at the Walter Reed Army Institute of Research, where 75 participating healthy adults were vaccinated with a Zika virus vaccine that the institute’s scientists developed earlier this year, Walter Reed officials announced today.zika

Laboratory-confirmed Zika virus disease cases reported to ArboNET by state or territory as of Nov. 2, 2016. ArboNET is a national surveillance system for arthropod-borne virus diseases in the United States, such as those from ticks and mosquitoes.

The Phase 1 trial will test the safety and immunogenicity — the ability of the vaccine to trigger an immune response in the body — of the purified, inactivated Zika virus vaccine called ZPIV. The vaccine is being tested at WRAIR’s Clinical Trial Center in Silver Spring, Maryland.

“The Army has moved efficiently from recognizing Zika virus as a threat, producing ZPIV for use in animals and demonstrating its effectiveness in mice and monkeys, producing ZPIV for human testing, and now initiating clinical trials to establish its safety and build the case for subsequent efficacy trials,” Army Col. (Dr.) Nelson Michael, director of WRAIR’s Military HIV Research Program, or MHRP, and Zika program co-lead, said in a statement.

Efficacy refers to the vaccine’s ability to demonstrate a health effect when tested in a clinical trial.  “All of this,” he added, “was done in 10 months.”

Dr. Kayvon Modjarrad, Zika program co-lead and associate director for emerging infectious disease threats at WRAIR’s MHRP, said the Army was able to move so quickly in developing, manufacturing and testing a Zika vaccine “because of its extensive experience with this vaccine platform and longstanding investments in the understanding and mitigation of flaviviruses like yellow fever, dating back to the founding of WRAIR.”

DoD Zika Response

WRAIR officials say this study is part of the Defense Department response to the ongoing Zika outbreak in North and South America and Southeast Asia.

For service members, there are concerns about infection during deployment and travel, but also in the continental United States, where most military installations are concentrated in southern states. There, climate conditions and mosquito populations favor Zika transmission, WRAIR officials say.mosquito

Zika virus is transmitted to people primarily through the bite of an infected Aedes species mosquito — Aedes aegypti, shown here, and Aedes albopictus. The same mosquitoes spread dengue and chikungunya viruses. The mosquitoes typically lay eggs in and near standing water in things like buckets, bowls, animal dishes, flower pots and vases. They prefer to bite people and live indoors and outdoors near people. Mosquitoes that spread chikungunya, dengue, and Zika are aggressive daytime biters, but they can also bite at night. Mosquitoes become infected when they feed on a person already infected with the virus. Infected mosquitoes can then spread the virus to other people through bites. CDC photo by James Gathany

As of Nov. 2, according to the Centers for Disease Control and Prevention, 149 cases of Zika infection were confirmed in the military health system, including four pregnant service members and one pregnant family member.

Zika infection during pregnancy, CDC says, can cause a birth defect of the brain called microcephaly and other severe fetal brain defects.

Other problems have been detected among fetuses and infants infected with Zika virus before birth, such as defects of the eye, hearing deficits and impaired growth. And reports have increased about Guillain-Barré syndrome, an uncommon sickness of the nervous system, in areas affected by Zika, CDC says.

But even Zika infections without symptoms “can lead to severe birth defects and neurological complications,” Zika study principal investigator Army Maj. (Dr.) Leyi Lin said, adding, “A safe and effective Zika vaccine that prevents infection in those at risk is a global public-health priority.”

Zika and Other Flaviviruses

Flaviviruses like Zika are found mainly in mosquitoes and ticks and cause widespread morbidity and mortality worldwide. Other mosquito-transmitted viruses that are members of the flavivirus genus include yellow fever, or YF, dengue fever, Japanese encephalitis, or JE, and West Nile viruses, according to the CDC web page.

“We want to assess the safety and immune response of the ZPIV vaccine in JE and yellow fever YF vaccine recipients because these vaccines may alter the response to the ZPIV vaccine,” Lin said.

“Uniquely,” he added, “illness as a result of natural infection from JE, YF or Zika could be more severe when prior flavivirus infection or vaccination exists. Our study assesses co-vaccination to learn how to reduce risk when protecting against circulating flaviviruses.”

This is important for service members who are vaccinated against other flaviviruses and then stationed in or deployed to areas where Zika is becoming endemic, WRAIR scientists say.

Zika Vaccine Platform

WRAIR’s inactivated flavivirus vaccine platform was the same technology the institute used to create its Japanese encephalitis vaccine, licensed in 2009.

An earlier preclinical study found that rhesus monkeys vaccinated with ZPIV developed a strong immune response and were protected against two strains of Zika virus.

The National Institute of Allergy and Infectious Diseases, or NIAID, part of the National Institutes of Health, helped identify the viral strain used in the ZPIV vaccine, supported the preclinical safety testing and is sponsoring the conduct of this trial.

WRAIR, NIAID and the Department of Health and Human Services’ Biomedical Advanced Research and Development Authority, or BARDA, have established a joint research collaboration agreement to support the vaccine’s development.

The Pilot Bioproduction Facility at WRAIR manufactured the ZPIV vaccine being used in Phase 1 clinical studies, and the Army recently signed a cooperative research and development agreement to transfer the ZPIV technology to Sanofi Pasteur to explore larger-scale manufacturing and advanced development. BARDA recently awarded a six-year contract to Sanofi Pasteur to further develop this vaccine to licensure, according to the WRAIR release.

Other ZPIV Trials

WRAIR’s ZPIV candidate also will soon be part of an NIH trial that began in August. The NIH vaccine contains DNA that instructs volunteers’ cells to make certain Zika proteins that then illicit an immune response. As part of that study, WRAIR’s ZPIV vaccine will be given to volunteers as a booster after they receive the NIH DNA vaccine, WRAIR officials say.

Three more Phase 1 trials using ZPIV are scheduled to begin this year, the WRAIR release noted:

— St. Louis University researchers, through the NIAID-funded Vaccine and Treatment Evaluation Units network, will examine the optimal dose of the vaccine to be used in larger studies.

— Beth Israel Deaconess Medical Center and Harvard Medical School researchers will evaluate the safety and immune response from a compressed vaccine schedule.

— The Ambulatory Center for Medical Research, part of Ponce Health Sciences University in Puerto Rico, will examine the vaccine’s safety and immune response in participants who have already been naturally exposed to Zika or dengue viruses.

The WRAIR trial that began yesterday is sponsored by NIAID and funded by the Army and the Defense Department.

For more information about how Sentry’s proven vaccine management system can protect your vaccine throughout the global supply chain, contact Sentry via email or by phone at 1-866-757-7400.

For more information: http://www.defense.gov/DesktopModules/ArticleCS/Print.aspx?PortalId=1&ModuleId=753&Article=999584

CDC Report: First cases of Candida auris reported in U.S.

On Friday, November 4, 2016 the U.S. Centers for Disease Control and Prevention (CDC) announced the first cases of Candida auris were reported in the United States (U.S.).candida_strain

A strain of Candida auris cultured in a petri dish at CDC.
Photo Credit: Shawn Lockhart, CDC

Thirteen cases of Candida auris (C. auris), a serious and sometimes fatal fungal infection that is emerging globally, have been identified in the United States, according to the CDC. Seven of the cases occurred between May 2013 and August 2016 and are described today in CDC’s Morbidity and Mortality Weekly Report (MMWR). The other six cases were identified after the period covered by the report and are still under investigation.

The following map displays where Candida auris cases have been identified in the United States as of November 4, 2016.

candida

Source of map: https://www.cdc.gov/fungal/diseases/candidiasis/candida-auris.html

The report is the first to describe U.S. cases of C. auris infection. C. auris is often resistant to antifungal drugs and tends to occur in hospitalized patients. In June 2016, CDC issued a clinical alert describing the global emergence of C. auris and requesting that laboratories report C. auris cases and send patient samples to state and local health departments and CDC. Since then, CDC has been investigating reports of C. auris with several state and local health departments. The agency expects to continue to investigate possible cases as awareness of the emerging infection increases.

“We need to act now to better understand, contain and stop the spread of this drug-resistant fungus,” said CDC Director Tom Frieden, M.D., M.P.H. “This is an emerging threat, and we need to protect vulnerable patients and others.”

Among the seven cases detailed in the report, patients with C. auris were reported in four states: New York, Illinois, Maryland and New Jersey. All of the patients had serious underlying medical conditions and had been hospitalized an average of 18 days when C. auris was identified. Four of the patients died; it is unclear whether the deaths were associated with C. auris infection or underlying health conditions.

In two instances, two patients had been treated in the same hospital or long-term-care facility and had nearly identical fungal strains. These findings suggest that C. auris could be spread in healthcare settings.

Six of the seven cases were identified through retrospective review of hospital and reference laboratory records. Identifying C. auris requires specialized laboratory methods because it can easily be misidentified as another type of Candida infection, in which case patients may not receive appropriate treatment. Most of the patient samples in the current report were initially misidentified as another species of Candida.

Most of the C. auris strains from U.S. patients (71 percent) showed some drug resistance, making treatment more difficult. Samples of C. auris strains from other countries have been found to be resistant to all three major classes of antifungal medications. However, none of the U.S. strains in this report were resistant to all three antifungal drug classes. Based on laboratory testing, the U.S. strains were found to be related to strains from South Asia and South America. However, none of the patients travelled to or had any direct links to those regions. Most patients likely acquired the infections locally.

“It appears that C. auris arrived in the United States only in the past few years,” said Tom Chiller, M.D., M.P.H., chief of CDC’s Mycotic Diseases Branch. “We’re working hard with partners to better understand this fungus and how it spreads so we can improve infection control recommendations and help protect people.”

CDC recommends that healthcare professionals implement strict Standard and Contact Precautions to control the spread of C. auris. Facilities should conduct thorough daily and after-discharge cleaning of rooms of C. auris patients with an EPA-registered disinfectant active against fungi. Any cases of C. auris should be reported to CDC and state and local health departments. CDC can assist in identifying this particular type of Candida if needed.

In 2013, CDC issued a report describing antibiotic resistance threats in the United States that needed prompt action, including Candida infections. CDC’s Antibiotic Resistance Laboratory Network is providing additional lab support in four regional laboratories to test fungal susceptibility of Candida species and identify emerging resistance. CDC is also expanding tracking of this fungus through the Emerging Infections Program. Information gathered through these networks plays a key role in tracking resistance and informing policies and interventions.

The challenge of emerging antibiotic resistant threats like C. auris highlights the need for urgent, coordinated federal, state, local, and international public health response and the importance of CDC’s AR Solutions Initiative. The timely investments in the AR Solutions Initiative empower CDC to rapidly detect, investigate, and respond to emerging threats, like C. auris; prevent resistant infections from occurring and spreading across healthcare settings and the community; and innovate, supporting development of new diagnostics and drugs to test, treat, prevent infections, and save lives.

For more information about how Sentry can implement a custom solution to meet your unique pharmaceutical supply chain challenges, contact Sentry via email or by phone at 1-866-757-7400, for a complimentary, no obligation phone call with one of Sentry’s problem-solving experts.

For more information: https://www.cdc.gov/fungal/diseases/candidiasis/candida-auris.html

Features & Benefits of Sentry’s Pharmaceutical Labeling & Packaging Services

Sentry BioPharma Services specializes in pharmaceutical and medical device packaging projects of varying scale, complexity and sensitivity to time and temperature. Sentry’s  full service light manufacturing through Food & Drug Administration (FDA) compliant pharmaceutical labeling and custom kitting functions provide clients the ability to store bulk products yet deliver kitted solutions to clinical sites and commercial customers across the global. This one-stop shop structure married with Sentry’s Foreign Trade Zone (FTZ) offers optimal flexibility and cost effective solutions to even the most intricate of drug development projects.

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Sentry Labeling and Packaging

Features of Sentry’s Pharmaceutical Labeling and Packaging Solutions 

GMP operation compliant with FDA regulations

o    FDA labeler code (3007066137)

o    Segregated labeling and packaging area

o    Total label operation accountability (line clearance)

 

Diverse Clinical Trial Labeling & Packaging Support

o    Open and blinded

o    Multi-lingual

o    Peel-off / Perforated

o    Serialized

 

Pharmaceutical & Medical Device Packaging

o    Bulk

o    Double-blind

o    Package inserts

o    Single / Multi-dose cartons

o    Tamper evident seals

On-Demand Services

o    Configurable stock management

o    Expiration management of individual kit components

o    Extend expiration

o    Pharmaceutical kitting

o    Reduce at-risk inventory

 

Adaptable Scheduling

o    Batch or lot specific

o    Batch size

 

Benefits of Sentry’s Pharmaceutical Labeling and Packaging Solutions 

Streamlined Production throughout Drug Development Phases – Avoid cumbersome logistics among vendors with Sentry’s full scope services from GMP pharmaceutical storage, biopharmaceutical labeling and packaging and extensive distribution.

Accurate Inventory Control from Bulk to Finish –  Sentry’s compliant, validated inventory management system and batch record process allow for accurate tracking of inventory levels during clinical trials and commercial launch.

Cost Effective Manufacture – Reduce pharmaceutical drug development costs with Sentry’s flexible storage, labeling and packaging offerings before, during and after FDA approval.

For more information about how a coordinated GMP storage, packaging and distribution model may reduce risk and strengthen the structure of your supply chain, contact Sentry via email or by phone at 1-866-757-7400.

Sentry’s New Vaccine Storage Campaign

Sentry BioPharma Services is proud to announce its new vaccine storage and distribution services campaign. Sentry’s decade long commitment to protect product integrity  married with its state-of-the-art facility provides the life sciences industry with a unique level of quality, regulatory and operational advantages that strengthen the vaccine supply chain. Sentry’s vaccine program advantages include:

Proven Track Record of Compliant Vaccine Storage, Rotation And Vaccine Drug Distribution

vaccinecampaignSentry’s long and unblemished regulatory inspection history is a reflection of its superior approach to standard operating procedures and temperature sensitive product management.

Large Scale Repository and Tracking Capabilities Through Advanced Inventory Management Systems

Live 24/7 real-time inventory tracking ensures full visibility of inventory throughout an organization and accurate tracking compliant with GMP storage regulations 21 CFR Parts 210 and 211. High-touch communication with the Sentry Operations and Quality Teams provides proper distribution of vaccines for routine fulfillment or pandemic response.

Advanced Building Management Systems That Monitor And Control Temperature Of Storage Environments

Sentry’s validated cold chain storage environments minimize time-out-of-refrigeration (TOR) risks, helping to reduce or eliminate waste attributable to deficient storage methods. The facility’s multi-tiered security structure and flexible storage options help fulfill requirements for specific seasonal or stockpile campaigns.

Trusted By Hospitals, Government Healthcare Agencies, And Manufacturers To Protect Vaccine Products And Stockpile

Over its ten years as a contract service organization, Sentry has been a trusted partner to hospitals, vaccine manufacturers and government healthcare organizations concerned with drug product integrity, vaccine storage security, risk management and timely vaccine distribution.

For more information about how Sentry’s temperature sensitive product management expertise can help you optimize your seasonal vaccine stockpile requirements, contact Sentry via email or by phone at 1-866-757-7400.

2016-2017 Flu Season; Answers to Common FAQs

Sentry BioPharma Services provides vaccine product management services to a wide group of clients from U.S. Federal and State government agencies to vaccine manufacturers, with an emphasis on timely delivery of vital vaccines globally.  This is Sentry’s second article concerning influenza this season with an emphasis on preventing the flu within the general population of the United States.  Sentry acknowledges the Centers for Disease Control and Prevention (CDC) and its continued efforts in disseminating important information to benefit the health and well-being of all Americans.

New Flu Information for 2016-2017

fluvaccineGetting an annual flu vaccine is the first and best way to protect yourself and your family from
the flu. Flu vaccination can reduce flu illnesses, doctors’ visits, and missed work and school due to flu, as well as prevent flu-related hospitalizations. The more people who get vaccinated, the more people will be protected from flu, including older people, very young children, pregnant women and people with certain health conditions who are more vulnerable to serious flu complications. This page summarizes information for the 2016-2017 flu season.

 

What’s new this flu season?

A few things are new this season:

  • Only injectable flu shots are recommended for use this season.
  • Flu vaccines have been updated to better match circulating viruses.
  • There will be some new vaccines on the market this season.
  • The recommendations for vaccination of people with egg allergies have changed.

What flu vaccines are recommended this season?

This season, only injectable flu vaccines (flu shots) should be used. Some flu shots protect against three flu viruses and some protect against four flu viruses.

Options this season include:

  • Standard dose flu shots. Most are given into the muscle (usually with a needle, but one can be given to some people with a jet injector). One is given into the skin.
  • A high-dose shot for older people.
  • A shot made with adjuvant for older people.
  • A shot made with virus grown in cell culture.
  • A shot made using a vaccine production technology (recombinant vaccine) that does not require the use of flu virus.

Live attenuated influenza vaccine (LAIV) – or the nasal spray vaccine – is not recommended for use during the 2016-2017 season because of concerns about its effectiveness.

Table 1 below illustrates all the influenza vaccines that are FDA-approved for use in the United States during the 2016-2017 season.  Also, Table 2 identifies Contraindications and precautions to the use of influenza vaccines — United States, for the 2016–17 influenza season:

 

TABLE 1. Influenza vaccines — United States, 2016–17 influenza season

 

Trade name Manufacturer Presentation Age indication Mercury (from thimerosal)
µg/0.5 mL
Latex Route
Inactivated influenza vaccine, quadrivalent (IIV4), standard dose
Fluarix Quadrivalent GlaxoSmithKline 0.5 mL single-dose prefilled syringe ≥3 yrs NR No IM§
Flulaval Quadrivalent ID Biomedical Corp. of Quebec (distributed by GlaxoSmithKline) 0.5 mL single-dose prefilled syringe ≥3 yrs NR No IM
5.0 mL multi-dose vial ≥3 yrs <25 No IM
Fluzone Quadrivalent Sanofi Pasteur 0.25 mL single-dose prefilled syringe 6–35 mos NR No IM
0.5 mL single-dose prefilled syringe ≥36 mos NR No IM
0.5 mL single-dose vial ≥36 mos NR No IM
5.0 mL multidose vial ≥6 mos 25 No IM
Fluzone Intradermal
Quadrivalent
Sanofi Pasteur 0.1 mL single-dose prefilled microinjection system 18 through 64 yrs NR No ID**
Inactivated influenza vaccine, quadrivalent, cell culture-based (ccIIV4), standard dose
Flucelvax Quadrivalent Seqirus 0.5 mL single-dose prefilled syringe ≥4 yrs NR No IM
Inactivated Influenza Vaccine, trivalent (IIV3), standard dose
Afluria Seqirus 0.5 mL single-dose prefilled syringe ≥9 yrs†† NR No IM
5.0 mL multi-dose vial ≥9 yrs††
(needle and syringe)
18 through 64 years
(jet injector)
24.5 No IM
Fluvirin Seqirus 0.5 mL single-dose prefilled syringe ≥4 yrs ≤1 Yes§§ IM
5.0 mL multi-dose vial ≥4 yrs 25 No IM
Adjuvanted Inactivated Influenza Vaccine, trivalent (aIIV3), standard dose
Fluad Seqirus 0.5 mL single-dose prefilled syringe ≥65 yrs NR Yes§§ IM
Inactivated Influenza Vaccine, trivalent (IIV3), High Dose¶¶
Fluzone High-Dose Sanofi Pasteur 0.5 mL single-dose prefilled syringe ≥65 yrs NR No IM
Recombinant Influenza Vaccine, trivalent (RIV3)***
FluBlok Protein Sciences 0.5 mL single-dose vial ≥18 yrs NR No IM
Live Attenuated Influenza Vaccine, quadrivalent (LAIV4)†††
FluMist Quadrivalent MedImmune 0.2 mL single-dose prefilled
intranasal sprayer
2 through 49 yrs NR No NAS

Abbreviations: ACIP = Advisory Committee on Immunization Practices; ID = intradermal; IM = intramuscular; NAS = intranasal; NR = not relevant (does not contain thimerosal).
*Immunization providers should check Food and Drug Administration–approved prescribing information for 2016–17 influenza vaccines for the most complete and updated information, including (but not limited to) indications, contraindications, warnings, and precautions. Package inserts for U.S.-licensed vaccines are available at http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm093833.htm . Availability of specific products and presentations might change and differ from what is described in this table.
Standard dose intramuscular IIVs contain 15 µg of each vaccine HA antigen (45 µg total for trivalents and 60 µg total for quadrivalents) per 0.5mL dose.
§For adults and older children, the recommended site for intramuscular influenza vaccination is the deltoid muscle. The preferred site for infants and young children is the anterolateral aspect of the thigh. Specific guidance regarding site and needle length for intramuscular administration may be found in the ACIP General Recommendations on Immunization, available at http://www.cdc.gov/mmwr/preview/mmwrhtml/rr6002a1.htm.
Quadrivalent inactivated influenza vaccine, intradermal: a 0.1-mL dose contains 9 µg of each vaccine HA antigen (36μg total).
**The preferred injection site is over the deltoid muscle. Fluzone Intradermal Quadrivalent is administered using the delivery system included with the vaccine.
††Age indication per package insert is ≥5 years; however, ACIP recommends that Afluria not be used in children aged 6 months through 8 years because of increased risk for febrile reactions noted in this age group with Seqirus’ 2010 Southern Hemisphere IIV3. If no other age-appropriate, licensed inactivated seasonal influenza vaccine is available for a child aged 5 through 8 years who has a medical condition that increases the child’s risk for influenza complications, Afluria can be used; however, providers should discuss with the parents or caregivers the benefits and risks of influenza vaccination with Afluria before administering this vaccine. Afluria may be used in persons aged ≥9 years. Afluria is licensed for administration by jet injector for persons aged 18 through 64 years only.
§§Syringe tip cap might contain natural rubber latex.
¶¶High-dose IIV3 contains 60 μg of each vaccine antigen (180 μg total) per 0.5mL dose.
***RIV3 contains 45 μg of each vaccine HA antigen (135 μg total) per 0.5mL dose.
†††ACIP recommends that Flumist (LAIV4) not be used during the 2016–17 season.

TABLE 2. Contraindications and precautions to the use of influenza vaccines — United States, 2016–17 influenza season*

Vaccine Contraindications Precautions
IIV History of severe allergic reaction to any component of the vaccine or after previous dose of any influenza vaccine Moderate to severe illness with or without fever
History of Guillain-Barré syndrome within 6 weeks of receipt of influenza vaccine
RIV History of severe allergic reaction to any component of the vaccine Moderate to severe illness with or without fever
History of Guillain-Barré syndrome within 6 weeks of receipt of influenza vaccine
LAIV For the 2016–17 season, ACIP recommends that LAIV not be used. Content below is provided for information.
History of severe allergic reaction to any component of the vaccine† or after a previous dose of any influenza vaccine
Concomitant aspirin or salicylate-containing therapy in children and adolescents
Children aged 2 through 4 years who have received a diagnosis of asthma or whose parents or caregivers report that a health care provider has told them during the preceding 12 months that their child had wheezing or asthma or whose medical record indicates a wheezing episode has occurred during the preceding 12 months
Children and adults who have immunosuppression (including immunosuppression caused by medications or by HIV)
Close contacts and caregivers of severely immunosuppressed persons who require a protected environment
Pregnancy
Receipt of influenza antiviral medication within the previous 48 hours
Moderate to severe illness with or without fever
History of Guillain-Barré syndrome within 6 weeks of receipt of influenza vaccine
Asthma in persons aged ≥5 years
Other underlying medical conditions that might predispose to complications after wild-type influenza infection (e.g., chronic pulmonary, cardiovascular [except isolated hypertension], renal, hepatic, neurologic, hematologic, or metabolic disorders (including diabetes mellitus)

Abbreviations: ACIP = Advisory Committee on Immunization Practices; IIV = Inactivated Influenza Vaccine; LAIV = Live-Attenuated Influenza Vaccine; RIV = Recombinant Influenza Vaccine.
* Immunization providers should check Food and Drug Administration–approved prescribing information for 2016–17 influenza vaccines for the most complete and updated information, including (but not limited to) indications, contraindications, and precautions. Package inserts for US-licensed vaccines are available at http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm093833.htm .
History of severe allergic reaction (e.g., anaphylaxis) to egg is a labeled contraindication to the use of IIV and LAIV. However, ACIP recommends that any licensed, recommended, and appropriate IIV or RIV may be administered to persons with egg allergy of any severity (see Influenza Vaccination of Persons with a History of Egg Allergy).

What viruses do 2016-2017 flu vaccines protect against?

There are many flu viruses and they are constantly changing. The composition of U.S. flu vaccines is reviewed annually and updated to match circulating flu viruses. Flu vaccines protect against the three or four viruses that research suggests will be most common. For 2016-2017, three-component vaccines are recommended to contain:

  • A/California/7/2009 (H1N1) pdm09-like virus,
  • A/Hong Kong/4801/2014 (H3N2)-like virus and a
  • B/Brisbane/60/2008-like virus (B/Victoria lineage).

Four component vaccines are recommended to include the same three viruses above, plus an additional B virus called B/Phuket/3073/2013-like virus (B/Yamagata lineage).

When and how often should I get vaccinated?

Everyone 6 months and older should get a flu vaccine every year by the end of October, if possible. However, getting vaccinated later is OK. Vaccination should continue throughout the flu season, even in January or later. Some children who have received flu vaccine previously and children who have only received one dose in their lifetime, may need two doses of flu vaccine. A health care provider can advise on how many doses a child should get.

Can I get a flu vaccine if I am allergic to eggs?

The recommendations for people with egg allergies have been updated for this season.

  • People who have experienced only hives after exposure to egg can get any licensed flu vaccine that is otherwise appropriate for their age and health.
  • People who have symptoms other than hives after exposure to eggs, such as angioedema, respiratory distress, lightheadedness, or recurrent emesis; or who have needed epinephrine or another emergency medical intervention, also can get any licensed flu vaccine that is otherwise appropriate for their age and health, but the vaccine should be given in a medical setting and be supervised by a health care provider who is able to recognize and manage severe allergic conditions. (Settings include hospitals, clinics, health departments, and physician offices). People with egg allergies no longer have to wait 30 minutes after receiving their vaccine.

Flu Activity

What sort of flu season is expected this year?

It’s not possible to predict what this flu season will be like. While flu spreads every year, the timing, severity, and length of the season varies from one year to another.

Will new flu viruses circulate this season?

Flu viruses are constantly changing so it’s not unusual for new flu viruses to appear each year. For more information about how flu viruses change, visit How the Flu Virus Can Change.

Will the United States have a flu epidemic?

The United States experiences epidemics of seasonal flu each year. This time of year is called “flu season.” In the United States, flu viruses are most common during the fall and winter months. Influenza activity often begins to increase in October and November. Most of the time flu activity peaks between December and March and can last as late as May. CDC monitors certain key flu indicators (for example, outpatient visits of influenza-like illness (ILI), the results of laboratory testing and flu hospitalization and deaths). When these indicators rise and remain elevated for a number of consecutive weeks, flu season is said to have begun. Usually ILI increases first, followed by an increase in flu-associated hospitalizations, which is then followed by increases in flu-associated deaths.

For the most current influenza surveillance information, please see FluView at Weekly U.S. Influenza Surveillance Report.

When will flu activity begin and when will it peak?

The timing of flu is very unpredictable and can vary in different parts of the country and from season to season. Seasonal flu viruses can be detected year-round, however, seasonal flu activity can begin as early as October and continue to occur as late as May. Flu activity most commonly peaks in the United States between December and March.

How many people die from flu each year?

CDC does not count how many people die from flu each year. Unlike flu deaths in children, flu deaths in adults are not nationally reportable. However, CDC uses mortality data collected by the National Center for Health Statistics to monitor relative levels of flu-associated deaths. This system tracks the proportion of death certificates processed that list pneumonia or influenza as the underlying or contributing cause of death of the total deaths reported. This system provides an overall indication of whether flu-associated deaths are elevated, but does not provide an exact number of how many people died from flu. For more information, see Overview of Influenza Surveillance in the United States, “Mortality Surveillance.”

CDC also uses modeling studies to estimate numbers of flu-related deaths, but these studies apply only to past seasons and are not done each year. For more information, see Estimating Seasonal Influenza-Associated Deaths in the United States.

Why is it difficult to know how many people die from flu?

There are several factors that make it difficult to determine accurate numbers of deaths caused by flu regardless of reporting. Some of the challenges in counting influenza-associated deaths include the following: the sheer volume of deaths to be counted; the lack of testing (not everyone that dies with an influenza-like illness is tested for influenza); and the different coding of deaths (influenza-associated deaths are often a result of complications secondary to underlying medical problems, and this may be difficult to sort out). For more information, see Estimating Seasonal Influenza-Associated Deaths in the United States: CDC Study Confirms Variability of Flu.

Protective Actions

What should I do to protect myself from flu this season?

CDC recommends a yearly flu vaccine for everyone 6 months of age and older as the first and most important step in protecting against this serious disease.

In addition to getting a seasonal flu vaccine, you can take everyday preventive actions like staying away from sick people and washing your hands to reduce the spread of germs. If you are sick with flu, stay home from work or school to prevent spreading flu to others. In addition, there are prescription medications called antiviral drugs that can be used to treat influenza illness. Visit What you Should Know About Flu Antiviral Drugs for more information.

What should I do to protect my loved ones from flu this season?

Encourage your loved ones to get vaccinated. Vaccination is especially important for people at high risk for developing flu-related complications, and their close contacts. Also, if you have a loved one who is at high risk of flu complications and they develop flu symptoms, encourage them to get a medical evaluation for possible treatment with influenza antiviral drugs. CDC recommends that people who are at high risk for serious flu complications who get flu symptoms during flu season be treated with influenza antiviral drugs as quickly as possible. People who are not at high risk for serious flu complications may also be treated with influenza antiviral drugs, especially if treatment can begin within 48 hours.

Some children 6 months through 8 years of age will require two doses of flu vaccine for adequate protection from flu. Children in this age group who are getting vaccinated for the first time will need two doses of flu vaccine, spaced at least 28 days apart. Some children who have received flu vaccine previously and children who have only received one dose in their lifetime also may need two doses. Your child’s doctor or other health care professional can tell you if your child needs two doses. Visit Children, the Flu, and the Flu Vaccine for more information.

Children younger than 6 months are at higher risk of serious flu complications, but are too young to get a flu vaccine. Because of this, safeguarding them from flu is especially important. If you live with or care for an infant younger than 6 months of age, you should get a flu vaccine to help protect them from flu. See Advice for Caregivers of Young Children for more information. Also, studies have shown that getting the flu vaccine during pregnancy can protect the baby after birth for several months.

In addition to getting vaccinated, you and your loved ones can take everyday preventive actions like staying away from sick people and washing your hands to reduce the spread of germs. If you are sick with flu, stay home from work or school to prevent spreading flu to others.

Vaccine and Vaccination

How much flu vaccine will be available this season?

Flu vaccine is produced by private manufacturers, so supply depends on manufacturers. For the 2016-2017 season, manufacturers projected they would provide between 157 million and 168 million doses of injectable vaccine for the U.S. market. (Projections may change as the season progresses.)

Will live attenuated intranasal influenza vaccine (LAIV) be available this season even though it is not recommended for use?

FluMist Quadrivalent is still an FDA-licensed product. As such, there may be some supply of FluMist Quadrivalent on the U.S. market during the 2016-2017 season. It is important for clinicians and the public to be aware that because of concerns about this vaccine’s effectiveness, CDC recommends that this vaccine not be used during the 2016-2017 influenza season.

Where can I find information about vaccine supply?

Information about flu vaccine supply is available at Seasonal Influenza Vaccine & Total Doses Distributed.

When will flu vaccine become available?

Flu vaccine is produced by private manufacturers, so the timing of vaccine availability depends on when production is completed. As of late September, more than 90 million doses of 2016-2017 flu vaccine had already been distributed in the United States. Vaccine supply updates are available at the link above.

When should I get vaccinated?

Getting vaccinated before flu activity begins helps protect you once the flu season starts in your community. It takes about two weeks after vaccination for the body’s immune response to fully respond and for you to be protected so make plans to get vaccinated. CDC recommends that people get a flu vaccine by the end of October, if possible. However, getting vaccinated later can still be beneficial. CDC recommends ongoing flu vaccination as long as influenza viruses are circulating, even into January or later. Children aged 6 months through 8 years who need two doses of vaccine should get the first dose as soon as possible to allow time to get the second dose before the start of flu season. The two doses should be given at least 28 days apart.

Secure GMP storage and flu vaccine distribution services protect your refrigerated inventory throughout the temperature-controlled supply chain.  For more information about how Sentry’s vaccine storage and proven vaccine management system can protect your vaccine throughout the pharmaceutical global supply chaincontact Sentry via email or by phone at 1-866-757-7400.

For additional information please visit:

http://www.cdc.gov/flu/

http://www.cdc.gov/media/releases/2016/s0622-laiv-flu.html

 

New CDC Study: Influenza Vaccination Reduces Risk of Hospitalization by More Than Half Among Seniors

Influenza season is upon us, so now is an appropriate time to remind ourselves to line up for our flu shots.  Sentry BioPharma Services provides vaccine product management services to a wide group of clients from the US Federal and State government agencies to vaccine manufacturers, with an emphasis on timely delivery of vital vaccines globally.

Recently, the US Center for Disease Control (CDC) published a study on the beneficial effects of influenza vaccines on older populations within the USA.  We have provided an overview of the study below for your review and consideration.shutterstock_351328199

August 2, 2016—A new CDC study published today in the journal Clinical Infectious Diseases (CID) provides more evidence on the benefits of flu vaccination among older adults. The study looked at flu-associated hospitalizations among people 50 and older during the 2010-2011 flu season and found that people who had received a flu vaccine reduced their risk of flu-associated hospitalization by half.

People 65 and older are at high risk of serious flu complications and account for the majority of flu hospitalizations and deaths each year. The CID study “Case-control study of vaccine effectiveness in preventing laboratory-confirmed influenza hospitalizations in older adults, United States, 2010-11,” cites data from three recent influenza seasons, during which an estimated 115,000 to 630,000 hospitalizations and 5,000 to 27,000 deaths occurred. It’s estimated that people 65 and older accounted for between 54 percent and 71 percent of hospitalizations and between 71 percent and 85 percent of deaths.

The study, which compared 368 flu-hospitalized patients and compared them against case controls selected from the community, found that vaccinated people 50 years and older were 57 percent less likely to be hospitalized from flu than unvaccinated people. The benefits were similar by age group, including adults 75 years and older. This is a notable finding since flu effectiveness studies that have looked at how well vaccine protects against flu-related doctor’s visits have generally found that effectiveness is declines with age. This study indicates that protection against hospitalization was level among older people.

Annual influenza vaccination has been recommended for adults 65 and older in the U.S. since the 1960s and for adults 50 years and older since 2000. Since 2005, CDC has conducted annual influenza vaccine effectiveness studies to assess how well the vaccine works in preventing medically attended illness. Until recently, there have been few studies that look at how well the vaccine works in preventing more serious outcomes, like hospitalization. The CID study adds to a growing body of evidence that supports the importance of vaccination in order to prevent these more serious outcomes.

Study findings also support current U.S. recommendations for annual influenza vaccination among adults, especially among adults 65 years of age and older who are at high risk of influenza-associated complications. During 2015-2016, an estimated 66% of people 65 and older got a flu vaccine. While this is the highest vaccination rate among the public for any age group, that still leaves nearly one-third of people 65 and older unvaccinated.

Secure GMP storage and flu vaccine distribution services protect your refrigerated inventory throughout the temperature-controlled supply chain.  For more information about how Sentry’s vaccine storage and proven vaccine management system can protect your vaccine throughout the pharmaceutical global supply chain, contact Sentry via email or by phone at 1-866-757-7400.

Sentry Visits Biotech Clients in the Pacific Northwest to Discuss API Importation and FTZ Benefits

Sentry recently completed a week-long trip to the Pacific Northwest region to satisfy multiple requests to learn more about the company’s foreign trade zone (FTZ) service offering.  Client interest focused on importing high value active pharmaceutical ingredients (API) into Sentry’s FTZ for an indefinite storage term.

As supply chains become more intricate in our ever shrinking world, any weak link that chain can produce devastating results for temperature-sensitive biotech drug products.  “Most of us in pharma and biotech have our stories of disasters or near calamities concerning product movements globally” stated Tim Mitchell, President of Sentry.  “In light of the tremendous investment in treasury and time required to bring a new medication to market, it is critical to not allow product safety, identity, strength, purity and quality (SISPQ) to be impacted by delays which are inherent with the standard drug importation process.”

Sentry can help prevent time-out-of-temperature excursions through the utilization of its Foreign Trade Zone (FTZ), subzone 11 of zone 72 located at its facility in Indianapolis, Indiana.

What is a Foreign Trade Zone?ftza

The U.S. Foreign Trade Zone program was established by the Foreign Trade Zone Act of 1934 to “expedite and encourage foreign commerce” in the United States. Certain geographical areas, in or adjacent to Customs Ports of Entry, can obtain foreign trade zone (FTZ) status and receive commercial merchandise under the same Customs standards as if it were outside the commerce of the United States. Any merchandise, including pharmaceutical products, admitted and held in a foreign trade zone can be exempt of any Customs duties, tariffs and other ad valorem taxes. No duty or back taxes are charged on “value-added,” or foreign-sourced parts or materials incorporated into a finished product using U.S. parts and labor until the product is officially imported into the U.S. Commerce. This tariff and tax relief lowers the costs of U.S.-based organizations engaged in international trade while creating and retaining employment and capital investment opportunities that result from those operations.

Benefits to the Biopharmaceutical Industry

Pharmaceutical and biopharmaceutical companies can take advantage of Sentry’s GMP temperature-sensitive pharmaceutical storage and light manufacturing facility, which resides in a foreign trade zone.  Sentry’s FTZ allows drug product to reside within the product’s designated temperature range, (such as API, biologics, controlled substances, etc.), while awaiting clearance for importation by the U.S. Customs and Border Protection agency (CBP) and approved for distribution by the Food & Drug Administration (FDA).

During its stay in the FTZ, the biopharmaceutical product can be further labeled and secondarily packaged while greatly mitigating the numerous logistic and economic challenges encountered throughout the drug importation and development process.

Logistic Benefits 

Unlimited Storage Terms Term of pharmaceutical material storage in an FTZ is indefinite.
Eliminated U.S. Quota Restrictions Product previously subject to quota limitations is now exempt from such restrictions.
Strengthened Foreign Pharmaceutical Supply Chain Eliminate administrative and importation hold-ups at Customs and ports of entry by bringing product straight to our GMP pharmaceutical storage environments ensuring product integrity: safety, identity, strength, purity and quality (SISPQ) along the drug supply chain.
Uninterrupted Local Manufacture Prior to Importation Product can be labelled, kitted and packaged and stored in the United States until need for importation into U.S. Commerce and Customs Clearance.
Expedited Release to Market Product can be held in an FTZ until FDA approval, greatly reducing time and logistic hassle from manufacturer to end-user.

Economic Benefits 

Duty Deferral or Duty Aversion  Import, admit and hold product without paying U.S. Customs duties.
Zero Inventory Taxes All materials held in an FTZ are exempt from state, county and local ad valorem taxes.
Country of Origin Marking and Labeling Country-of-origin labels are non-required on product admitted to an FTZ freeing companies from this expense.

Sentry BioPharma Services’ pharmaceutical supply chain management expertise and FTZ status across all storage environments ensures product integrity and project management flexibility.

For more information about how Sentry’s Foreign Trade Zone can help you optimize your medical and pharmaceutical import/export process, contact Sentry via email or by phone at 1-866-757-7400.

Features & Benefits of a Pharmaceutical Foreign Trade Zone

What is a Foreign Trade Zone?

The U.S. Foreign Trade Zone program was established by the Foreign Trade Zone Act of 1934 to “expedite and encourage foreign commerce” in the United States. Certain geographical areas, in or adjacent to Customs Ports of Entry, can obtain foreign-trade zone (FTZ) status and receive commercial merchandise under the same Customs standards as if it were outside the commerce of the United States. Any merchandise, including pharmaceutical products, admitted and held in a foreign trade zone can be exempt of any Customs duties, tariffs and other ad valorem taxes. No duty or back taxes are charged on “value-added,” or foreign-sourced parts or materials incorporated into a finished product using U.S. parts and labor until the product is officially imported into the U.S. Commerce. This tariff and tax relief lowers the costs of U.S.-based organizations engaged in international trade while creating and retaining employment and capital investment opportunities that result from those operations.

Benefits to the Biopharmaceutical Industryshutterstock_367703690

Pharmaceutical and biopharmaceutical companies can take advantage of Sentry’s GMP temperature-sensitive pharmaceutical storage and light manufacturing facility, which  resides in a foreign trade zone.  Sentry’s zone allows drug product to reside within the product’s designated temperature range, (such as API, biologics, controlled substances, etc.), while awaiting clearance for importation by the CBP and approved for distribution by the Food & Drug Administration (FDA).

During its stay in the FTZ, the biopharmaceutical  product can be further labeled and secondarily packaged  while greatly mitigating the numerous logistic and economic challenges encountered throughout the  drug importation and development process.

Logistic Benefits 

Unlimited Storage Terms Term of pharmaceutical material storage in an FTZ is indefinite.
Eliminated U.S. Quota Restrictions Product previously subject to quota limitations is now exempt from such restrictions.
Strengthened Foreign Pharmaceutical Supply Chain Eliminate administrative and importation hold-ups at Customs and ports of entry by bringing product straight to our GMP pharmaceutical storage environments ensuring product integrity: safety, identity, strength, purity and quality (SISPQ) along the drug supply chain.
Uninterrupted Local Manufacture Prior to Importation Product can be labelled, kitted and packaged and stored in the United States until need for importation into U.S. Commerce and Customs Clearance.
Expedited Release to Market Product can be held in an FTZ until FDA approval, greatly reducing time and logistic hassle from manufacturer to end-user.

Economic Benefits 

Duty Deferral or Duty Aversion  Import, admit and hold product without paying U.S. Customs duties.
Zero Inventory Taxes All materials held in an FTZ are exempt from state, county and local ad valorem taxes.
Country of Origin Marking and Labeling Country-of-origin labels are non-required on product admitted to an FTZ freeing companies from this expense.

Sentry BioPharma Services’ pharmaceutical supply chain management expertise and FTZ status across all storage environments ensures product integrity and project management flexibility.

For more information about how Sentry’s Foreign Trade Zone can help you optimize your medical and pharmaceutical import/export process, contact Sentry via email or by phone at 1-866-757-7400.

Read more about the Greater Indianapolis Foreign Trade Zone: inzone.org