October 27, 2020

Covid-19: The Race for a Vaccine Continues

Covid-19: The Race for a Vaccine

The race to save lives has begun. Scientists around the world are speeding to develop a vaccine for COVID-19, a disease that has claimed the lives of more than half a million lives worldwide, and sickened millions of others. Vaccine development usually takes 10 to 15 years, and the long, involved process takes a tremendous amount of public and private involvement. At the current rate of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections that cause COVID-19 disease, though, the world does not have 10 to 15 years to wait.

COVID-19 Race for a vaccine

On July 18, 2020, the World Health Organization (WHO) reviewed 23 candidate vaccines in clinical evaluation. Many were still in Phase 1 to establish their safety and dosage at the time of the WHO review, while others were in Phase 2 to establish their performance under ideal and controlled performance. As of that mid-July WHO review, three clinical trials had entered Phase 3 for testing on large numbers of people, although one vaccine trial had not yet recruited candidates.

Why Must We Wait So Long?

Most vaccines in development never make it to licensing – in fact, many vaccine candidates never make to clinical evaluation on real humans because they fail to produce the desired immune response in the pre-clinical stages of testing in cell cultures and lab animals.

Regulators set a high bar for vaccination approval and often require years’ worth of safety data because, unlike medicines that treat diseases, vaccines are administered to healthy people to prevent illness. Releasing a vaccine could potentially do more harm than good, so many regulatory bodies set stiff guidelines for approval.

covid-19-race for A CURE

It is not yet clear what data federal regulators would accept as proof that a vaccine is safe and successful in the middle of the pandemic. On June 30, 2020, the U.S. Food and Drug Administration (FDA) said a vaccine must prevent COVID-19 or decrease the severity of illness in at least 50 percent of people who receive the vaccine. The FDA may consider some vaccine candidates for its Accelerated Approval pathway, but that the vaccine candidate must demonstrate an identifiable immune response or other measure that shows it is reasonably likely that the vaccine would provide clinical benefit. Regulators in other nations have not yet announced what they would consider acceptable criteria for approval, which creates a challenge for vaccine makers trying to gain approval.

More Challenges for Vaccine Makers

Vaccine makers also face challenges determining the best way to trigger the immune response. Vaccines typically work by exposing the body to the antigens of a particular pathogen to activate the immune system without causing disease. Made with weakened or inactivated form of the pathogen, these vaccines are often difficult to develop and produce quickly. Because of the urgent nature of the pandemic, researchers are looking for innovating ways to introduce antigens and otherwise activate an immune response to SARS-CoV-2. Four of the 23 vaccine candidates in clinical testing use an approach that involves engineering messenger RNA (mRNA) that tells human cells how to create the antigens themselves.

RACE FOR A VACCINE COVID-19

Moderna is one of those four companies. On July 15, 2020, the biotech company published data from an early-stage trial that shows its vaccine caused patients to generate an immune response by developing antibodies, although it caused some side effects. Supported by the National Institutes of Health, the study showed volunteers who receive the vaccine produced substantially more neutralizing antibodies than do most patients who have recovered from COVID-19. A second injection administered four weeks after the initial vaccination was necessary to produce a dramatic immune response. Vaccine experts were not impressed, however, concerned that the data was long on text and short on proof.

Other research teams, such as University of Oxford/AstraZeneca are using viral vector vaccines to speed up the process. Viral vector vaccines use a harmless virus as a kind of Trojan horse that carries the pathogen’s genetic material into cells in order to trigger an immune response. The team released more information about its coronavirus vaccine candidate, AZD1222, on July 20, 2020.

Developing a COVID-19 vaccine will be one of the most exciting and important events in human history, with the potential to save millions of lives around the world. Join us next month when we review the next leg of the race for a COVID-19 vaccine.

To View Frank Magliochetti Press Releases Please CLICK HERE

Frank Magliochetti owes his professional success to his expertise in two areas: medicine and finance. After obtaining a BS in pharmacy from Northeastern University, he stayed on to enroll in the Masters of Toxicology program. He later specialized in corporate finance, receiving an MBA from The Sawyer School of Business at Suffolk University. His educational background includes completion of the Advanced Management Program at Harvard Business School and the General Management Program at Stanford Business School. Frank Magliochetti has held senior positions at Baxter International, Kontron Instruments, Haemonetics Corporation, and Sandoz. Since 2000, he has been a managing partner at Parcae Capital, where he focuses on financial restructuring and interim management services for companies in the healthcare, media, and alternative energy industries. Last year, he was appointed chairman of the board at Grace Health Technology, a company providing an enterprise solution for the laboratory environment. Most recently; Frank was appointed Chairman and Chief Executive Officer at Designer Genomics International, Inc. The Company has accumulated a growing body of evidence that highlights a link between alterations in the immune and inflammatory systems and the development of chronic human disease. The Company is visionary and has established itself as a leader in the field of inflammatory and immune genetic DNA and RNA biomarkers that play a causative role in debilitating conditions, such as atherosclerosis/heart disease, diabetes, arthritis, inflammatory bowel disease, post-traumatic stress disorders (PTSD) and cancer.
A proprietary state-of-the art data mining bioinformatics program, called ‘cluster analysis’ will be used to measure disease development susceptibility with potential for earlier diagnosis and intervention. The company is developing a healthcare program based on its proprietary genetic panels that will allow people to be their own healthcare advocate and take an active role in their health status as well as longevity.

Mr. Frank Magliochetti MBA
Managing Partner
Parcae Capital

www.parcaecapitalcorp.com
www.frankmagliochetti.com

Sources

https://coronavirus.jhu.edu/map.html

https://www.historyofvaccines.org/content/articles/vaccine-development-testing-and-regulation

https://www.who.int/publications/m/item/draft-landscape-of-covid-19-candidate-vaccines

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-takes-action-help-facilitate-timely-development-safe-effective-covid

https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/accelerated-approval

https://www.nejm.org/doi/full/10.1056/NEJMoa2022483

https://www.astrazeneca.com/media-centre/press-releases/2020/astrazeneca-and-oxford-university-announce-landmark-agreement-for-covid-19-vaccine.html

Trends in Healthcare to Watch for in 2020

5 Trends to Watch for in 2020

Healthcare is changing at the speed of light as researchers discover new treatments and as developers create new technologies that improve the health and well-being of the public. A dizzying array of new healthcare products will hit the market in the next year. Here are five of the most important healthcare trends to watch in 2020.

5 Must-Watch Healthcare Trends for 2020

1. AI and Machine Learning

Artificial intelligence (AI) and machine learning use computers that study algorithms and statistical models – and learn from them – without guidance from humans. Machine language systems can solve problems just as a clinician might – by weighing evidence. Unlike a single clinician, though, these systems can simultaneously observe and process a nearly limitless number of inputs.

Using insights from past data to make informed clinical decisions is the essence of evidence-based medicine. Researchers have traditionally used mathematical equations, such as linear regression, to identify and characterize patterns within data. AI uses machine learning to uncover complex associations that fit easily into mathematical equations. Using sophisticated machine learning and very large data sets allows AI to predict outcomes and estimate patient risk faster – and sometimes better – than clinicians and medical researchers.

2. Laboratory Informatics

A rising need for laboratory automation, development of integrated lab informatics solutions, growing demand for biobanks/biorepositories to store millions of biological samples used in research, and the ongoing struggle to comply with regulatory standards is fueling growth for laboratory informatics.

Laboratory informatics (LI) is information technology that uses instruments, software, and data management tools to capture, migrate, process, and interpret scientific data for immediate and future use.

Laboratory informatics will grow from USD 2.6 billion in 2019 to USD 3.8 billion by 2024, according to MarketsandMarkets, and boast a 7.5 percent compound annual growth rate (CAGR) during the forecast period. High accuracy and efficiency of laboratory informatics results, rising burden certain diseases, and increasing applications of LI solutions are driving this market.

3. Silver Technology

In 2018, the number of people over the age of 65 surpassed the number of children younger than 5 years for the first time in history, according to Our World in Data. “Silver technology” provides healthcare solutions that support that aging population.

Technology has historically helped improve the health of older adults through diagnostics, communications, imaging, and health informatics. Silver technology in 2020 will help reframe the delivery of healthcare, and facilitate communication between older adults, their family caregivers, and service providers.

Technology can help older adults live independently longer, manage medications, monitor changes in cognition, stay connected with friends and family members, drive a car, and access healthcare. Some technologies, such as health information technology (HIT), remote monitoring and telehealth, technologies that allow adults to age safely in place, mobile health technologies and workforce-training technologies, will have a profoundly positive effect for older adults in 2020.

4. Wearable Fitness Technology

Fueled by consumer appetite for sophisticated gadgets, rising popularity of wearable fitness and medical devices, growing popularity of the IoT, expanding awareness about the importance of fitness, and the increase in disposable incomes in developing economies, wearable fitness technology will likely trend upwards in 2020. MarketsandMarkets says that the wearable fitness technology market earned USD 5.77 billion in 2016 and predicts it will take in USD 12.44 billion by 2022, growing at a CAGR of 13.7 percent.

Major trends in wearable fitness technology include smartphone apps featuring advanced data analysis, advanced sensors capable of tracking athletic performance and other qualitative attributes, purpose-specific wearables, and even the integration and implantation of technology with and in the human body.

Wearable technology products, such as smart watches and wristbands, spurred an evolution in fitness technology. The wearable fitness technology of 2020 will include a wide variety of smart apparels and other innovative products, such as smart shoesheadbands, and more.

5. 5G Mobile Healthcare Technology

5G will become widely available starting in 2020. In fact, Verizon CEO Hans Vestberg says that half of the United States will have the technology by then.

The transition from 4G to 5G will open new cloud applications for the healthcare industry. 5G provides mobile data speeds that are up to 10 times faster than 4G and up to 100 times faster than other existing networks. Faster speeds will support real-time, high-quality video for telemedicine that allows patients to interact with their care teams, remote patient monitoring, virtual and augmented reality for use in clinician training, and other emerging medical technologies that test the limits of existing network speeds. 5G will also alleviate concerns about internet of things (IoT) and potentially allow billions of monitoring devices and wearables that provide essential information about patients’ well-being.

Spurred by advances in computer technology and research, the medical world will continue to change in 2020 and beyond. These changes will likely help older adults live independently longer and help the next generation be healthier.

To View Frank Magliochetti Press Releases Please CLICK HERE

Frank Magliochetti owes his professional success to his expertise in two areas: medicine and finance. After obtaining a BS in pharmacy from Northeastern University, he stayed on to enroll in the Masters of Toxicology program. He later specialized in corporate finance, receiving an MBA from The Sawyer School of Business at Suffolk University. His educational background includes completion of the Advanced Management Program at Harvard Business School and the General Management Program at Stanford Business School. Frank Magliochetti has held senior positions at Baxter International, Kontron Instruments, Haemonetics Corporation, and Sandoz. Since 2000, he has been a managing partner at Parcae Capital, where he focuses on financial restructuring and interim management services for companies in the healthcare, media, and alternative energy industries. Earlier this year, he was appointed chairman of the board at Grace Health Technology, a company providing an enterprise solution for the laboratory environment.

My background includes completion of the Advanced Management Program at Harvard Business School and the General Management Program at Stanford Business School. Frank Magliochetti has held senior positions at Baxter International, Kontron Instruments, Haemonetics Corporation, and Sandoz. Since 2000, he has been a managing partner at Parcae Capital, where he focuses on financial restructuring and interim management services for companies in the healthcare, media, and alternative energy industries. Earlier this year, he was appointed chairman of the board at Grace Health Technology, a company providing an enterprise solution for the laboratory environment.

Mr. Frank Magliochetti MBA
Managing Partner
Parcae Capital

https://twitter.com/F_Magliochetti1
www.parcaecapitalcorp.com
www.frankmagliochetti.info 

SOURCES

https://www.facs.org/media/press-releases/2019/carrano102919

https://www.marketsandmarkets.com/Market-Reports/lab-informatic-market-203037633.html?gclid=Cj0KCQiAtf_tBRDtARIsAIbAKe1NAHHnFhIGLrwW1avAsxlVwwOrsLY0wjIxMikZeJcNPY_4njamWTsaAu-IEALw_wcB

https://ourworldindata.org/population-aged-65-outnumber-children

https://www.marketsandmarkets.com/Market-Reports/wearable-fitness-technology-market-139869705.html

https://www.wearable-technologies.com/tag/smart-shoes/

https://www.usa.philips.com/c-e/smartsleep/deep-sleep-headband.html

https://www.advisory.com/research/health-care-it-advisor/it-forefront/2019/04/5g-transformation

https://www.cnbc.com/2019/08/01/verizon-ceo-sees-functioning-5g-wireless-in-half-the-us-next-year.html?__twitter_impression=true

Healthcare: Ready for Blockchain Technology


Using Blockchain Technology in Healthcare

Healthcare requires prompt access to confidential patient information – lives can sometimes depend on it. Easy access comes at a price, though, as easily accessible information puts patient privacy and hospital data at risk. Blockchain technology has the potential to revolutionize healthcare by providing access to secure, accurate information.
Health information technology is becoming more crucial to the healthcare system, as doctors and nurses now spend more time typing than talking to patients, according to a study by Mayo Clinic. Health information technology is also important to patients who go to different practitioners and specialists who may not have access to the electronic healthcare records (EHR) system their primary physicians may use. Lack of access to health records can lead to repeat lab work, dangerous drug interactions, and more. Blockchain can help eliminate unnecessary repeat lab work, manage medications from different prescribers, and provide a patient’s vaccination history.  Access to healthcare information is also essential for insurance providers and researchers. Many are turning to blockchain.

What exactly is blockchain?
A very succinct history of the platform; An unknown person or group calling itself Satoshi Nakamoto started blockchain technology in 2009, it was started as a way to move the digital currency, bitcoin. In the years since, the uses for blockchain have expanded to exchange other types of digital assets, such as data.
Blockchain is an activity log that is tamper-proof, time-stamped and shared across a network of computers. Each transaction going into the log, or central database, is enclosed in a block and linked in chronological order to create a public chain, hence the name “blockchain.”
The blocks cannot be deleted, changed or otherwise modified, which means that blockchain creates an indelible write-once-read-only record that a transaction occurred.

Blockchain has three main components:

1.  Digital transactions – the information or digital asset stored in the blockchain
2.  Distributed network – a decentralized peer-to-peer (P2P) architecture featuring “nodes” of participants, each of whom stores a copy of the blockchain and is authorized to validate and certify any digital transactions on the network
3.  Shared ledger – the participants record ongoing transactions in a ledger shared by all the members, who verify the transactions using algorithms; the transaction is added to the record after a majority of members validate it

How Blockchain Technology can Improve Healthcare
Information management is one of the largest problems facing healthcare today. Spread across multiple and sometimes-inaccessible systems, information may not be available when needed most; unfettered access to this information can be a security risk. Blockchain could change all that by creating a decentralized system accessible to only those who hold the right keys.
The lack of a central administrator creates transparency, in that no single individual or organization can change the information, as could happen if the information were to live in the physical memory of one system. Furthermore, all of the members of the blockchain remain in control of their transactions and information.
Each member connected to the blockchain has two keys – a public key, which acts as a visible identifier, and a secret private key. One must have the private key to unlock a member’s identity and see what information on the blockchain is relevant to that member’s profile. This cryptographically links the two keys in such a way that only those who have the secret private key can identify the member.

As healthcare institutions provide services to patients, they track clinical information in their existing health IT systems. The institution then use application programming interfaces (APIs) to direct the patient’s public (non-identifiable) ID and standard data fields to the blockchain, where the blockchain stores each transaction by the patient’s public ID. Computer software processes the incoming transactions to make them searchable.
Healthcare institutions and other organizations can use APIs to query the blockchain directly to view non-identifiable patient information, such as age, gender and medical condition. Analysis of the information gained from these queries can lead to new insights into healthcare.

Patients who wish to share their identity with healthcare organizations may do so by providing their private keys, which allows the healthcare organizations to unlock patients’ data. The data remains unidentifiable to those without the private key.

Today, most healthcare organizations rely on health information exchanges (HIEs) and other methods of centralized data aggregation to gather wide scale health data. Blockchain creates a decentralized standardized method, which ensures accountability and easy access. The structure of blockchain offers a unique combination of access scalability, security, and data privacy that can facilitate the sharing and security of healthcare information. Many more uses will unfold for blockchain technology in all aspects of healthcare, research, laboratory management, record keeping, accountability, Q.A., and even insurance.

To View Frank Magliochetti Press Releases Please CLICK HERE

Frank Magliochetti owes his professional success to his expertise in two areas: medicine and finance. After obtaining a BS in pharmacy from Northeastern University, he stayed on to enroll in the Masters of Toxicology program. He later specialized in corporate finance, receiving an MBA from The Sawyer School of Business at Suffolk University. His educational background includes completion of the Advanced Management Program at Harvard Business School and the General Management Program at Stanford Business School. Frank Magliochetti has held senior positions at Baxter International, Kontron Instruments, Haemonetics Corporation, and Sandoz. Since 2000, he has been a managing partner at Parcae Capital, where he focuses on financial restructuring and interim management services for companies in the healthcare, media, and alternative energy industries. Earlier this year, he was appointed chairman of the board at Grace Health Technology, a company providing an enterprise solution for the laboratory environment.

Mr. Frank Magliochetti MBA
Managing Partner Parcae Capital
www.parcaecapitalcorp.com
www.frankmagliochettinews.com

Genome Editing – Progressing Trend

The Rush for Genome Editing

Frank Magliochetti Report

The Rush for Genome Editing

Gene-editing technology has sparked a frenzy of competitors fueled to develop the first of what may be thousands of treatments for genetic disorders.

From science fiction of movies like Jurassic Park to the reality of GMO foods, the concept of customizing plants, animals and even human genomes has mesmerized our imagination and culture for decades. This obsession is not surprising considering the remarkable impact of genetic engineering on our lives, and the promise it may hold for our future.crispr-genome-editing-franlmagliochetti-report_northandoverma

Modifying the genes of an organism is no easy task. It’s not as simple as removing the parts you do not like with an eraser. It involves making changes at a molecular level that are both complex and challenging.

One concern among scientists is the modifications made in human germline cells – i.e. the sperm or the egg. These are genetic changes that would actually be passed on through generations and the fear is that there could be unexpected side effects. Couple that with the ethical concerns of people misusing this technology to intentionally modify the genome to make “designer babies” with enhanced characteristics. These are some real concerns that are causing scientists to pause and weigh the pros and cons of use of this technology.

More and more companies are racing to stay ahead of the trend and become the leaders in the field.

In Cambridge MA, Intellia Therapeutics Inc. has a 65,000 square foot build out underway, however, it is still planning to functioning while under construction.

Intellia is one of a trio of startups in the Cambridge area working locally in the biotech niche known as CRISPR-Cas9. The gene-editing technology was frank-magliochetti-report_intelliadiscovered just four years ago.

Drug development historically has been a slow process – it often takes more than a decade to bring a medicine from lab to marketplace. But that’s changing, thanks to new machines that can screen drug targets faster and an entrepreneurial environment that’s more akin to high-tech than Big Pharma.frankmagliochettireport_genome_editing

Intellia has high-profile collaboration deals with Swiss drug giant Novartis AG and Regeneron Pharmaceuticals Inc. of Tarrytown, N.Y. It raised $108 million in an initial public offering in May. Their scientists are working on gene-editing treatments for everything including the hepatitis B virus to a rare form of blindness. If all goes well, it could move its earliest drug candidates into clinical trials within 18 to 24 months.

Competitors for Intellia include Editas Medicine and Crispr Therapeutics Inc. both completed their own IPOs this year. There are more to come: all with the heightened interest of investors. These companies are in a race to develop the first treatment based on gene editing.

Genome editing is going to be a hot trend to watch in 2017 and for many years to come.

Frank Magliochetti is Managing Partner for Parcae Capital.

  • North Andover, Massachusetts

This column of posts is directed at the Healthcare Industry.  Frank plans to release a new site dedicated to the industry.  He currently assists companies who are building, restructuring, transforming and resurrecting there business’s. An example of his client base are, Xenetic Biosciences , IPC Medical Corp, Just Fellowship Corp, Environmental Services Inc., Parsons Post House LLC, ClickStream Corporation as well as having a business talk radio show; The Business Architect on the URBN network.

frankmagliochetti_ParcaeCapital

Innovative Developments in Medical History

Preventative Vaccines:  Bexsero & Trumenba

Frank Magliochetti Report

One of the biggest public health epidemics occurred back in 2014; Ebola and Meningococcal B were responsible. These two diseases took 10,000 people in Sierra Leone, Guinea and Liberia. These three countries have weak health systems, which is the reason why they were unable to treat their people.

In order to fight this disease, which made its first appearance in 1976,  WHO (World Health Organization) had been trying to find a cure for many years. On August 8, 2015, WHO declared that Ebola and Meningococcal B is a disease of international concern and thus began the search for its vaccine. By late October, 2015 WHO had finally come up with two vaccines that were guaranteed to prevent Meningococcal B. Sadly; the cure for Ebola has not yet been found however, its vaccines trials are currently being conducted in Sierra Leone.who_frankmagliochettireport

Meningococcal B is caused by bacteria called “Neisseria Meningitidis”. Neisseria Meningitidis has five serogroups: B, C, Y, W and A. The most common serogroups that affect people in the US is B, C and Y.

Meningococcal B disease is not caught through the air. In fact, it is a diseasewhich is transmitted from one person to another in close physical contact. The disease commonly spreads faster in the family due to the exchange of fluids from daily contact. The disease is found at the back of the throat and later causes sepsis. Sepsis is transferred to the blood that infects the blood stream, which causes damage to the brain and spinal column. Meningococcal B often results in liver failure, vision loss, amputation of limbs and death.

bexsero-frankmagliochettireportThe two vaccines Bexsero and Trumenba specifically treat Meningococcal B and were approved by the FDA in October 2015. The trials for Bexsero were conducted in UK, Chile, Australia and Canada amongst 2,600 young adults and adolescents. The results were that the three infectious strains that cause Meningococcal were destroyed.

Another 5,000 participants in the trials conducted in the USA experienced headache, muscle and joint pain, chills, fatigue and diarrhea after receiving the vaccine. Whereas, 15,000 participants experienced less side effects. All in all, the FDA approved the vaccines because the side effects were not viewed aslong term or fatal.

An accelerated approval was used by the FDA to make this vaccine go public claiming that Meningococcal B is a life-threatening disease. The effectiveness of Bexsero was approved two months prior to the trials being conducted.

FDA recommends that the vaccine should be given to infants, children from the ages of ten till twenty three and people who have a weak immune system. It is recommended that more than one dosage should be given to people having serogroup B Meningococcal.

Anna Jaques, a non-profit Hospital in Newburyport, Massachusetts has taken extra measures and brought more doctors and experts on anna_jaques_hospitaltheir team to prepare themselves if a patient with Ebola or Meningococcal B comes to their door.

https://www.ajh.org/

Anna Jaques is a remarkable medical facility housed with some of the top health care professionals North of Boston.

Frank Magliochetti

With 2016 being the year of medical innovations, the vaccine for Meningococcal B has come as a godsend that will save millions of lives in rural areas where this disease is commonly found. The vaccines are set to be released worldwide by the end of the year.

Other News and information on Trumenba and Bexsero

Trumenba Offical Website:

http://www.trumenba.com/

Important Safety Information

  • Trumenba should not be given to anyone with a history of a severe allergic reaction after a previous dose of Trumenba
  • Individuals with weakened immune systems may have a reduced immune response
  • The most common adverse reactions were pain at the injection site, fatigue, headache, muscle pain, and chills
  • Data is not available on the safety and effectiveness of using Trumenba and other meningococcal group B vaccines interchangeably to complete the vaccination series
  • Tell your healthcare provider prior to the vaccination if you are pregnant, or plan to become pregnant
  • Ask your healthcare provider about the risks and benefits of Trumenba. Only a healthcare provider can decide if Trumenba is right for you or your child

 

trumenba-frankmagliochettireportIndication

  • Trumenba is a vaccine indicated for individuals 10 through 25 years of age for active immunization to prevent invasive disease caused by Neisseria meningitidisgroup B
  • Trumenba is approved based upon demonstrated immune response against four group B strains representative of prevalent strains in the US. The effectiveness of Trumenba against diverse group B strains has not been confirmed

Bexsero

Official Site

https://www.gsksource.com/pharma/content/gsk/source/us/en/brands/bexsero/pi/po.html?cc=3282D9F3E686&pid=

Important Safety Information

Indication

BEXSERO is a vaccine indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B. BEXSERO is approved for use in individuals 10 through 25 years of age.

Approval of BEXSERO is based on demonstration of immune response, as measured by serum bactericidal activity against three serogroup B strains representative of prevalent strains in the United States. The effectiveness of BEXSERO against diverse serogroup B strains has not been confirmed.Bexsero_logo_4C_temp_norDNA_bigger

  • BEXSERO is contraindicated in cases of hypersensitivity, including severe allergic reaction, to any component of the vaccine, or after a previous dose of BEXSERO
  • Appropriate observation and medical treatment should always be readily available in case of an anaphylactic event following the administration of the vaccine
  • The tip caps of the prefilled syringes contain natural rubber latex, which may cause allergic reactions in latex-sensitive individuals
  • Syncope (fainting) can occur in association with administration of BEXSERO. Ensure procedures are in place to avoid injury from falling associated with syncope
  • The most common solicited adverse reactions observed in clinical trials were pain at the injection site (≥83%), myalgia (≥48%), erythema (≥45%), fatigue (≥35%), headache (≥33%), induration (≥28%), nausea (≥18%), and arthralgia (≥13%)
  • Vaccination with BEXSERO may not provide protection against all meningococcal serogroup B strains
  • Vaccination with BEXSERO may not result in protection in all vaccine recipients

AAP issues meningococcal B vaccine ( Trumenba & Bexsero)  guidelines for adolescents
Trumenba and Bexsero have both been approved for the prevention of serogroup B meningococcal disease in individuals aged 10 through 25 years by the American Academy of Pediatrics Committee on Infectious Diseases.

Please Click the link below to read the entire post:

http://www.healio.com/internal-medicine/vaccination/news/online/%7B9d42e15b-0c08-477d-8b1e-f28a59c545ea%7D/aap-issues-meningococcal-b-vaccine-guidelines-for-adolescents

Pfizer heads back to school with Trumenba vaccination campaign

Please click the link below to read the entire post:

http://www.fiercepharma.com/marketing/pfizer-menb-vaccination-campaign-for-trumenba-gears-up-for-back-to-school

Teaching kids to share is usually a parental goal, but a new ad from Pfizer may have some parents rethinking the parameters.

The first campaign for meningococcal group B vaccine Trumenba highlights the dangers of MenB, which can be spread through habits common among teens–including kissing and sharing drinks and food.

The TV ad shows a mother in the hospital with her stricken son, asking “how did we get here?” The ad then goes back through events earlier in evening showing the son sharing food and drinks with several different friends at a party and kissing a girl.

“The campaign was designed to reach parents of teens and young adults during the summer and back-to-school season, when many parents are thinking about steps they can take to help protect their child’s health, including vaccination,” she said.

Trumenba is one of two vaccinations to protect against MenB, along with GlaxoSmithKline’s Bexsero. But last year, the CDC’s Advisory Committee for Immunization Practices (ACIP) stopped short of granting the pair universal recommendation. The vaccines are recommended for young adults ages 16 to 23, with a preferred age of 16 to 18, which means that doctors decide on an individual basis whether to vaccinate their patients against MenB.

watch the ad on iSpot.tv

https://www.ispot.tv/ad/ARCj/trumenba-meningitis-b

Frank Magliochetti is Managing Partner for Parcae Capital.

  • North Andover, Massachusetts

This column of posts is directed at the Healthcare Industry.  Frank plans to release a new site dedicated to the industry.  He currently assists companies who are building, restructuring, transforming and resurrecting there business’s. An example of his client base are, Xenetic Biosciences , IPC Medical Corp, Just Fellowship Corp, Environmental Services Inc., Parsons Post House LLC, ClickStream Corporation as well as having a business talk radio show; The Business Architect on the URBN network.

frankmagliochetti_ParcaeCapital