Tag Archives: vaccine management

CDC’s 2016 National Influenza Vaccination Week (NIVW)

The Centers for Disease Control and Prevention’s (CDC’s) National Influenza Vaccination Week (NIVW) is scheduled for December 4-10, 2016.  The CDC established National Influenza Vaccination Week (NIVW) in 2005 to raise public awareness about the importance of flu vaccination.  The 2016 national awareness week focuses on highlighting the importance of influenza vaccination and continuing flu vaccination through the holiday season and beyond.  To learn more about what is new for the 2016-2017 flu season, view the CDC’s Factsheet by clicking HERE.

It's National Influenza Vaccination Week (NIVW)! Did you know that flu season can begin as early as October, it usually peaks between December and February, and it can last as late as May? As long as flu virsues are spreading, it's not too late to get a flu vaccine to protect yourself and your loved ones through fall, winter and into spring. #GetAFluVax

NIVW Timing

Flu vaccination coverage estimates from past years have shown that influenza vaccination activity drops quickly after the end of November.

CDC and its partners choose to December for NIVW to remind people that even though the holiday season has arrived, it is not too late to get your flu vaccine.  As long as flu viruses are spreading and causing illness, vaccination can provide protection against the influenza virus and should continue.

Even if you haven’t yet received a vaccine and have already gotten sick with one flu virus, you can still benefit from vaccination since the flu vaccine protects against three or four different flu viruses (depending on which flu vaccine you get).

Flu Vaccination for People at High Risk

Another goal of NIVW is to communicate the importance of flu vaccination for people who are at high risk for developing flu-related complications.  People at high risk of serious flu complications include young children, pregnant women, people with certain chronic health conditions like asthma, diabetes, heart disease or lung disease, and people aged 65 years and older.  For people at high risk, getting the flu can mean developing serious flu-related complications, like pneumonia, or a worsening of existing health conditions, which can lead to hospitalization or death.

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.

To contact CDC by phone call (800) 232-4636 (800-CDC-INFO) or visit the website at

www.cdc.gov/flu/nivw .

FDA Releases Flu Vaccine Lots for the 2016-2017 Season

Cumulative 2016/2017 Season Lot Release Status (Updated 8/3/2016)

Flu vaccine lots that have been released by the U.S. Food & Drug Administration (FDA) and are available for national distribution by the vaccine manufacturers.

Manufacturer Total Number of Lots Released by FDA
Afluria – Seqirus Pty. Ltd. 19
Fluad – Seqirus, Inc. 0
Fluarix Quadrivalent – GlaxoSmithKline Biologicals 23
Flublok – Protein Sciences Corporation 0
Flucelvax Quadrivalent – Seqirus, Inc. 0
FluLaval Quadrivalent – ID Biomedical Corporation of Quebec 3
FluMist Quadrivalent – MedImmune, LLC 3
Fluvirin – Seqirus Vaccines Limited 9
Fluzone High Dose – Sanofi Pasteur, Inc. 2
Fluzone Quadrivalent – Sanofi Pasteur, Inc. 14

FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) met in Silver vials_v1Spring, Maryland, on March 4, 2016, to select the influenza viruses for the composition of the influenza vaccine for the 2016-2017 U.S. influenza season. During this meeting, the advisory committee reviewed and evaluated the surveillance data related to epidemiology and antigenic characteristics of recent influenza isolates, serological responses to 2015-2016 vaccines, and the availability of candidate strains and reagents.

The committee recommended that the trivalent formulation influenza vaccines for the U.S. 2016-2017 influenza season contain the following:

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

The committee also recommended that quadrivalent influenza vaccines contain the above three strains and the following additional B strain:

  • a B/Phuket/3073/2013-like virus (B/Yamagata lineage)

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 global supply chain, contact Sentry via email or by phone at 1-866-757-7400.

For information on seasonal flu vaccine distribution schedules, please contact the manufacturers listed in the table above directly.

The CDC & Sentry Gear Up for the 2016 Flu Season

Even though nearly half of the United States (U.S.) population gets a flu vaccine annually, the impact of influenza remains high. According to the Centers for Disease Control & Prevention (CDC), the flu costs the U.S. more than $87 billion annually and is responsible for the loss of close to 17 million workdays each flu season. Tens of thousands of people are hospitalized and thousands die from flu-related illnesses each year in the U.S.

Sentry BioPharma Services gears up for the 2016 flu season by promoting three strategies to combat illness:

  1. Get the 2016 flu vaccine.
  2. Exercise good health habits.
  3. See your doctor for an antiviral medication to treat the flu if you get sick.

August 29, 2013, Atlanta, GA - Chris Summerrow (left), Director of Business and Continuity Management, UPS, speaks with Dr. Ali Khan, Director, Office of Public Health Preparedness and Response, in the Emergency Operations Center at the CDC.

Flu Vaccine Facts

The seasonal flu vaccine protects against the influenza viruses that research indicates will be most common during the upcoming season. Trivalent vaccines are made to protect against three flu viruses; an influenza A (H1N1) virus, an influenza A (H3N2) virus, and an influenza B virus. Quadrivalent vaccines protect against four viruses; the same viruses as the trivalent vaccine as well as an additional B virus.

Flu vaccines CANNOT cause the flu. Flu vaccines are made with either killed or weakened viruses.

Flu vaccines are safe. Serious problems from the flu vaccine are very rare. The most common side effect that a person is likely to experience is either soreness at the injection site, or runny nose in the case of nasal spray. These side effects are generally mild and usually go away after a day or two. Visit Influenza Vaccine Safety for more information.

Can the flu be treated?

Yes. There are prescription medications called “antiviral drugs” that can be used to treat influenza illness.

What are antiviral drugs?

Antiviral drugs are prescription medicines (pills, liquid, an inhaled powder, or an intravenous solution) that fight against the flu in your body. Antiviral drugs are not sold over-the-counter. You can only get them if you have a prescription from your doctor or health care provider. Antiviral drugs are different from antibiotics, which fight against bacterial infections.

What should I do if I think I have the flu?

If you get the flu, antiviral drugs are a treatment option. Check with your doctor promptly if you have a high risk condition and you get flu symptoms. Flu symptoms can include fever, cough, sore throat, runny or stuffy nose, body aches, headache, chills and fatigue. Your doctor may prescribe antiviral drugs to treat your flu illness.

Should I still get a flu vaccine?

Yes. Antiviral drugs are a second line of defense to treat the flu if you get sick. A flu vaccine is still the first and best way to prevent influenza.

What are the benefits of antiviral drugs?

When used for treatment, antiviral drugs can lessen symptoms and shorten the time you are sick by 1 or 2 days. They also can prevent serious flu complications, like pneumonia. For people with a high risk medical condition, treatment with an antiviral drug can mean the difference between having milder illness instead of very serious illness that could result in a hospital stay.

What are the possible side effects of antiviral drugs?

Some side effects have been associated with the use of flu antiviral drugs, including nausea, vomiting, dizziness, runny or stuffy nose, cough, diarrhea, headache and some behavioral side effects. These are uncommon. Your doctor can give you more information about these drugs or you can check the CDC or the Food and Drug Administration (FDA) websites.

When should antiviral drugs be taken for treatment?

Studies show that flu antiviral drugs work best for treatment when they are started within 2 days of getting sick. However, starting them later can still be helpful, especially if the sick person has a high risk health condition or is very sick from the flu. Follow instructions for taking these drugs.

What antiviral drugs are recommended this flu season?

There are three FDA-approved influenza antiviral drugs recommended by CDC this season to treat influenza. The brand names for these are Tamiflu® (generic name oseltamivir), Relenza® (generic name zanamivir), and Rapivab® (generic name peramivir). Tamiflu® is available as a pill or liquid and Relenza® is a powder that is inhaled. (Relenza® is not for people with breathing problems like asthma or COPD, for example.) Rapivab® is administered intravenously by a health care provider.

How long should antiviral drugs be taken?

To treat the flu, Tamiflu® and Relenza® are usually prescribed for 5 days, although people hospitalized with the flu may need the medicine for longer than 5 days. Rapivab® is administered intravenously for 15 to 30 minutes.

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 global supply chain, contact Sentry via email or by phone at 1-866-757-7400.

Sentry Promotes the WHO’s 2016 World Hepatitis Day

Today, July 28, 2016, Sentry BioPharma Services joins the World Health Organization (WHO) in promoting 2016 World Hepatitis Day by raising public awareness about this preventable and curable disease.

According to the WHO, “Viral hepatitis infection is widely spread, affecting 400 million people worldwide – over 10 times the number of people infected with HIV. Globally, about 1.4 million people die each year from hepatitis. It is estimated that only 5% of people with chronic hepatitis know of their infection, and less than 1% have access to treatment.

Yet, hepatitis is fully preventable and treatable. There are effective vaccines and treatments for Hepatitis B, and over 90% of people with Hepatitis C can be cured with treatment. The vision of eliminating hepatitis as a public health threat by 2030 can be achieved, if people and countries affected by this disease were better equipped and enabled to “know hepatitis” and “act now”.

Globally, most people who need treatment have not been treated, largely due to a lack of awareness, and access to hepatitis treatment services.  Over 90% of people with Hepatitis C can be completely cured of the virus within 3–6 months.  Appropriate treatment of Hepatitis B and C can prevent the development of the major life-threatening complications of chronic liver disease: cirrhosis and liver cancer.”

The U.S. Food and Drug Administration (FDA) approved seven (7) therapies to treat Hepatitis B and twelve (12) therapies to treat Hepatitis C.

FDA Approved Treatments for Hepatitis B

hepB

FDA Approved Treatments for Hepatitis C

hepC

Sentry BioPharma Services offers GMP storage and global drug distribution services to protect your refrigerated inventory throughout the pharmaceutical and biological product supply chain.  For more information about how Sentry’s temperature-controlled storage and proven drug distribution system can protect the supply of your hepatitis therapy, contact Sentry via email or by phone at 1-866-757-7400.

Sentry Strengthens the Pharmaceutical Supply Chain

Biological drugs are generally more delicate and sensitive to temperature than their
pharmaceutical counterparts, thus introducing risks into the global biopharma supply chain.
Longer transit times, extreme climate change between origination and destination, and shipping delays all increase the risk profile during transport.  Product compromise due to temperature fluctuation can cause millions of dollars in revenue loss and delay delivery of drugs and therapeutics to patients.  Sentry Biopharma Services strengthens the pharmaceutical supply chain by helping clients manage these risks.

MATURITY OF PHARMACEUTICAL COLD CHAIN MANAGEMENT

15 years ago cold chain management was still a buzz phrase that only a few companies could actually deliver.  However, the unique transportation challenges of biopharma products have driven the need to control temperature variability throughout the drug supply chain which has transformed pharmaceutical cold chain management into a burgeoning industry.  Specialized providers like Sentry BioPharma Services now offer dedicated services designed to preserve the integrity of biological products throughout all phases of the pharmaceutical supply chain. Large and small biotech organizations increasingly turn to these specialized providers in a shift from the traditional in-house pharmaceutical logistics model to an outsourced one.

SELECTING A PHARMACEUTICAL SUPPLY CHAIN PARTNER

Although outsourcing to a pharmaceutical supply chain provider can provide many benefits, not every potential partner has the capability to provide services on a global scale. A qualified cold chain logistics expert must be experienced and compliant in all facets of biopharma cold chain management.  This includes domestic and international shipping, drug product handling and tracking, GMP storage and international drug distribution. The provider must have the experience, systems and processes in place to handle the diverse and changing needs of the global biopharmaceutical industry. Criteria that biopharma manufacturers should consider when evaluating potential partners include:

  1. A robust quality systemglobe
  2. Specialized GMP storage facilities and equipment
  3. A reputation for technological innovation
  4. Compliance with global pharmaceutical cold chain regulations
  5. An efficient and reliable biopharma and logistics network
  6. Anti-counterfeiting capabilities
  7. Impeccable customer service record

PHARMACEUTICAL COLD CHAIN REGULATIONS & BEST PRACTICES

As pharmaceutical cold chain management has become a more critical component in the global biopharmaceutical supply chain, regulatory agencies and industry associations have been launched solely to develop standards for compliance in this market.  Achieving regulatory compliance was a much simpler task in traditional supply chain models of the past. Now, due to an increasingly complex set of social, scientific and political pressures, industry mandates and international regulations have become significantly more stringent. Each country has its own body of rules and guidelines governing the shipment and handling of pharmaceutical and biological products. A qualified pharmaceutical cold chain management and 3PL partner must demonstrate compliance with international guidelines.

In addition to mandates prescribed by external regulatory agencies, the industry has begun to develop its own body of industry-accepted standards for biopharmaceutical distribution and handling. Several prominent groups have been formed throughout the world to discuss regional challenges and issues; collaborate on problem-solving; examine emerging trends; and define industry best practices. A pharmaceutical cold chain management partner should be familiar with the standards being developed by leading international pharmaceutical discussion groups.

REPUTATION FOR PRISTINE QUALITY AND IMPECCABLE CUSTOMER SERVICE

A GMP-compliant third-party logistic (3PL) partner must be committed to excellence in quality control and customer service.  As an extension of the drug or vaccine manufacturer’s business, the pharmaceutical 3PL provider must operate as a vested stakeholder to protect product integrity as well as the manufacturer’s business viability and reputation in the marketplace. Measures of excellence in the pharmaceutical cold chain include:

  • A corporate culture of accountability and commitment to the mission
  • Knowledge of best practices for GMP storage, global drug distribution and vaccine management
  • Independent quality assurance personnel, processes and evaluations
  • Careful biological product handling and temperature-sensitive product shipping
  • A uniformed process for continuously improving quality, operations and customer service
  • A singular focus that allows the contract service provider to be an expert

SPECIALIZED GMP STORAGE FACILITIES

At various points in the pharmaceutical supply chain, active pharmaceutical ingredients (APIs), excipients, components, intermediates and finished pharmaceutical products may need to be stored for varying lengths of time, from a few days to a several months.  Short-term or long-term GMP storage facilities might be needed to temporarily house: inventory overflow from a primary GMP warehouse; primary or secondary packaging components that are awaiting assembly; finished drug products that are awaiting international drug distribution; and/or inbound pharmaceutical product shipments that are clearing U.S. Customs. While several pharmaceutical small molecule formulations remain stable at ambient temperature conditions, many biologic products must be maintained within tighter temperature tolerances in refrigerated (+2°C to +8°C), frozen (-10°C to -20°C) and ultra-low storage (-70 to -90°C). Traditional pharmaceutical supply chain facilities are not always designed to accommodate these conditions.

In these situations, a cold chain logistics partner can provide immediate access to a state-of-the-art GMP storage facility that has been designed to meet the unique requirements of temperature-sensitive drug products. It must offer: validated, temperature controlled storage and temperature-monitoring equipment; redundant power, cooling and environmental monitoring systems; redundant data storage capabilities; and sophisticated data security systems.

For more information about how Sentry’s cold chain management programs can ensure biological product integrity in every phase of the pharmaceutical supply chain, contact Sentry via email or by phone at 1-866-757-7400.