Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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Flu Vaccine May Provide NO PROTECTION AT ALL from H3N2 Virus, the Dominant Strain This Year

Canadian influenza researchers reported Thursday in the online journal Eurosurveillance that the first reckoning of how well the flu vaccine is protecting against H3N2 viruses this year in North America has a dismal answer: not very.

 

Their midseason estimate, based on data from the four provinces where roughly 80 percent of Canadians live, suggested that the H3N2 component of the vaccine is 17 percent effective at preventing infection. Last year it was estimated at 37 percent in Canada and 34 percent in the U.S.

 

In working-age adults, the estimated protection is lower still: 10 percent. That is in line with the protection level Australia saw in its harsh winter 2017 flu season.

 

And in the case of the assessment of the H3N2 component, the confidence intervals cross zero, which means the researchers cannot rule out the possibility there was no benefit from that part of the vaccine.

 

The report does not estimate how well this year’s vaccine protects against H1N1 viruses. Skowronski said there has simply been too little H1N1 disease in Canada so far this winter to make that calculation. 

 

Whatever the reason, the findings confirm the fact that people who’ve been vaccinated are among those contracting flu this season.

“This is low protection. And the overall message is: People who have been vaccinated should not consider themselves invincible against this H3N2 virus that’s circulating,” said Dr. Danuta Skowronski, lead author of the report and an influenza epidemiologist at the British Columbia Center for Disease Control.

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Why Flu Vaccines Are Not as Effective as They Should Be

Why Flu Vaccines Are Not as Effective as They Should Be | Pharmaguy's Insights Into Drug Industry News | Scoop.it

People grumble a lot about the shortcomings of the flu vaccine, which some years offers less protection than expected. (Warning: This year may be one of them.) What they may not know is that the source of at least some of the problems is a common item found in all grocery stores and many fridges.

 

The egg.

 

The overwhelming majority of flu vaccines are made from viruses grown in eggs. This production process is inexpensive and time-tested; flu vaccines have been made this way as long as flu vaccines have been made.

 

But the process is not ideal — and it leads to issues that can undermine the vaccine’s effectiveness. Increasingly, experts are questioning whether the pros of egg production are worth putting up with the cons.

 

“We need to do a lot to improve existing vaccines. And getting away from eggs would be very valuable,” said Dr. Kanta Subbarao, director of the World Health Organization’s influenza collaborating center in Australia.

 

Further Reading:

  • “Academic Research Goes Where No Pharma was Willing to Go: Develops a Universal Flu Vaccine”; http://sco.lt/5kHIOn
  • “Your Next Flu Vaccination May Not Be as Effective as You Think”; http://sco.lt/9CKgl7 
  • “Flu Shot Doesn't Work as Well as #pharma Clinical Data Suggests”; http://sco.lt/4pRtTd 
  • "Everything You Wanted to Know About Vaccine Marketing, PR, Earned Media, Lobbying, and 'Anti-Vaxxers'"; http://bit.ly/29H0UOL 
  • “Pharma Needs to Step Up & Help Develop a Universal Flu Vaccine"; http://bit.ly/PMBalbum012913 
  • “Adults Only Really Catch the Flu About Twice a Decade, Study Suggests: Another Good Reason Not to Get Flu Vaccine”; http://sco.lt/7yRU9J 
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Baby Boomers Make Fools of Themselves in Patti LaBelle "Prank" to Promote Pfizer's Pneumonia Vaccine

Baby Boomers Make Fools of Themselves in Patti LaBelle "Prank" to Promote Pfizer's Pneumonia Vaccine | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Pfizer has tapped a legendary singer to raise awareness about the risk of pneumococcal pneumonia for older adults. In an online video, Patti LaBelle plays judge for a fake backup singer audition. Baby boomer singers take the stage to perform, but there's one catch: The microphones have been rigged to make it sound like the singers have pneumococcal pneumonia, with coughing and wheezing overtaking their songs.

 

LaBelle clues in the singers with an “I got you,” while a voiceover explains the risk for people over 65 and encourages them to get a “new attitude”—one of LaBelle’s most popular songs—and talk to their doctor about vaccination.

 

The awareness effort is called “All About Your Boom,” and it will appear online at the campaign website allaboutyourboom.com as well as on social channels, including Facebook and YouTube.

 

Pfizer chose LaBelle, 73, because “she embodied what it means to be a boomer. … She wants to remind fellow boomers that a big part of staying healthy that is often overlooked is staying up-to-date on CDC-recommended adult vaccinations,” the Pfizer spokeswoman said.

 

The campaign comes as flu season begins, a time when many people aged 65 and older go to their doctor for a flu shot, so the reminder to ask about the pneumonia vaccine is meant to coincide with that, she said.

 

Pfizer’s vaccination for pneumococcal pneumonia is Prevnar 13, which in branded TV advertising has tallied $30.3 million in national spending so far this year, according to data from real-time TV ad tracker iSpot.tv. The bulk of that was spent in the first four months of the year, with a break for the summer, and ads just recently came back on the air at the beginning of September.

 

Further Reading:

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Why Isn’t Pharma Working Harder & Smarter to Develop a Better Flu Vaccine?

Why Isn’t Pharma Working Harder & Smarter to Develop a Better Flu Vaccine? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

This year’s flu vaccine is offering moderate protection against the main family of viruses causing illness, data released Thursday by the Centers for Disease Control and Prevention show (here: http://bit.ly/2kTmrGx).

 

Overall, getting a flu shot cut one’s risk of contracting flu and needing to see a doctor (my emphasis) by 48 percent this season, when the effectiveness of the various components of the vaccine were assessed together, according to the report published in the CDC’s online journal Morbidity and Mortality Weekly Report.

 

Far and away the most common cause of influenza so far this year is the influenza A virus family known as H3N2. [The vaccine is only 43% effective against illness caused by influenza A] Seasons in which H3N2 viruses dominate are typically harsh because the virus is especially hard on older adults. Older adults also get less benefit from flu vaccines than healthy younger people.

 

“Forty percent to 50 percent is a lot better than zero, but what it really begs the question is: Why are we not working hard to get new and better flu vaccines?” said Michael Osterholm, director of the University of Minnesota’s Center for Infectious Diseases Research and Policy and a long-time advocate for the development of more effective flu vaccines.

 

“Last year we spent over a billion dollars researching new HIV vaccines — an amount that I think is an important investment. But the best estimate we can come up with is we only spend about $35 million globally on … research on new game-changing flu vaccines.’’

 

[Read “NIH Study Leads the Way for #Pharma to Develop a More Effective Flu Vaccine”; http://sco.lt/5fNcXJ and “One Step Closer to Universal Flu Vaccine”; http://sco.lt/7yOawr]

 

Last week Canadian researchers reported they are seeing about 42 percent protection from the H3N2 component of the vaccine north of the border. And European scientists reported vaccine effectiveness of 38 percent for H3N2 on Thursday.

 

Jacqueline Katz, deputy director of the CDC’s influenza division, said a theory behind the poor performance of the H3N2 component of the vaccine relates to the way flu vaccine is produced.

 

Most influenza vaccine is produced in hen’s eggs; the viruses have to adapt to grow in eggs. That’s true of all families of flu but for some reason the H3N2 viruses adapt in ways that introduce important differences. In essence, the viruses produced in the eggs are different from the viruses circulating in people and don’t adequately prime immune systems to recognize and fend off those viruses. In some years those differences are more pronounced than others.

 

Further Reading:

 

  • “Millions of patients given flu drugs with little or no benefit, study finds”; http://sco.lt/93x12P
  • “Adults Only Really Catch the Flu About Twice a Decade, Study Suggests: Another Good Reason Not to Get Flu Vaccine”; http://sco.lt/7yRU9J
  • “Does the Flu Vaccine Work? What 62% ‘Effective’ Really Means”; http://bit.ly/1duC2Cx
Pharma Guy's insight:

The effectiveness of flu vaccines is a disgrace! Use of old technology to develop the vaccine is partly to blame. I've been writing about this for a long time. Read, for example, “Does the Flu Vaccine Work? What 62% ‘Effective’ Really Means”; http://bit.ly/1duC2Cx

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Want to Avoid Toxins in Your Flu & Other Vaccines? "Good Luck," Says Cleveland Clinic Wellness Doctor

Want to Avoid Toxins in Your Flu & Other Vaccines? "Good Luck," Says Cleveland Clinic Wellness Doctor | Pharmaguy's Insights Into Drug Industry News | Scoop.it

I, like everyone else, took the advice of the Centers for Disease Control (CDC) - the government - and received a flu shot. I chose to receive the preservative free vaccine, thinking I did not want any thimerasol (i.e. mercury) that the "regular" flu vaccine contains.

 

Makes sense, right? Why would any of us want to be injected with mercury if it can potentially cause harm? However, what I did not realize is that the preservative-free vaccine contains formaldehyde.

 

WHAT? How can you call it preservative-free, yet still put a preservative in it? And worse yet, formaldehyde is a known carcinogen. Yet, here we are, being lined up like cattle and injected with an unsafe product. Within 12 hours of receiving the vaccine, I was in bed feeling miserable and missed two days of work with a terrible cough and body aches.

 

My anger actually stems from a constant toxic burden that is contributing to the chronic disease epidemic.

 

Why do I mention autism now twice in this article. Because we have to wake up out of our trance and stop following bad advice. Does the vaccine burden - as has been debated for years - cause autism? I don't know and will not debate that here. What I will stand up and scream is that newborns without intact immune systems and detoxification systems are being over-burdened with PRESERVATIVES AND ADJUVANTS IN THE VACCINES.

 

The adjuvants, like aluminum - used to stimulate the immune system to create antibodies - can be incredibly harmful to the developing nervous system. Some of the vaccines have helped reduce the incidence of childhood communicable diseases, like meningitis and pneumonia. That is great news. But not at the expense of neurologic diseases like autism and ADHD increasing at alarming rates.

 

When I was in medical school in the late 1980s, the rate of autism was 1 in 1,000 children. For those born in the 1950's and 60's, do you recall a single student in your grade with an Individualized Education Program (IEP) for ADHD or someone with a diagnosis of autism? I do not.

 

As of 2010, the rate of autism in the U.S. escalated to 1 in 68 children. The deniers will simply state that we do a better job of diagnosing this "disorder". Really? Something (s) are over-burdening our ability to detoxify, and that is when the problems begin.

 

So let me be clear - vaccines can be helpful when used properly. But the vaccination timing and understanding one's epigenetics (how your genes interact with the environment) are all critical to our risk of developing chronic disease. Please talk to your doctor about the optimal timing of vaccinations for your children, and therefore reduce your risk of raising a child with a neurologic complication.

 

For those who want to dive in further, help me understand why we vaccinate newborns for hepatitis B - a sexually transmitted disease. Any exposure to this virus is unlikely to happen before our second decade of life, but we expose our precious newborns to toxic aluminum (an adjuvant in the vaccine) at one day of life.

 

And when they actually need the protection, many who have received this three-shot series in the first year of life will lack antibody protection--as immunity may not last. Perhaps delaying the series until the immune system is more mature would reduce the risk of neurologic complications.

 

[The Clinic responded by doubling down on its disavowal of Neides' column, saying that the health system is "fully committed to evidence-based medicine," and promising to take disciplinary action against Neides.

 

 

The Clinic's full statement reads:

"Cleveland Clinic is fully committed to evidence-based medicine. Harmful myths and untruths about vaccinations have been scientifically debunked in rigorous ways. We completely support vaccinations to protect people, especially children who are particularly vulnerable. Our physician published his statement without authorization from Cleveland Clinic. His views do not reflect the position of Cleveland Clinic and appropriate disciplinary action will be taken."]

 

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On Twitter, HPV Vaccination is Viewed Positively

On Twitter, HPV Vaccination is Viewed Positively | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Background: Human papillomavirus (HPV) is the most common sexually transmitted infection in the United States. There are several vaccines that protect against strains of HPV most associated with cervical and other cancers. Thus, HPV vaccination has become an important component of adolescent preventive health care. As media evolves, more information about HPV vaccination is shifting to social media platforms such as Twitter. Health information consumed on social media may be especially influential for segments of society such as younger populations, as well as ethnic and racial minorities.


Objective: The objectives of our study were to quantify HPV vaccine communication on Twitter, and to develop a novel methodology to improve the collection and analysis of Twitter data.


Methods: We collected Twitter data using 10 keywords related to HPV vaccination from August 1, 2014 to July 31, 2015. Prospective data collection used the Twitter Search API and retrospective data collection used Twitter Firehose. Using a codebook to characterize tweet sentiment and content, we coded a subsample of tweets by hand to develop classification models to code the entire sample using machine learning procedures. We also documented the words in the 140-character tweet text most associated with each keyword. We used chi-square tests, analysis of variance, and nonparametric equality of medians to test for significant differences in tweet characteristic by sentiment.


Results: A total of 193,379 English-language tweets were collected, classified, and analyzed. Associated words varied with each keyword, with more positive and preventive words associated with “HPV vaccine” and more negative words associated with name-brand vaccines. Positive sentiment was the largest type of sentiment in the sample, with 75,393 positive tweets (38.99% of the sample), followed by negative sentiment with 48,940 tweets (25.31% of the sample). Positive and neutral tweets constituted the largest percentage of tweets mentioning prevention or protection (20,425/75,393, 27.09% and 6477/25,110, 25.79%, respectively), compared with only 11.5% of negative tweets (5647/48,940; P<.001). Nearly one-half (22,726/48,940, 46.44%) of negative tweets mentioned side effects, compared with only 17.14% (12,921/75,393) of positive tweets and 15.08% of neutral tweets (3787/25,110; P<.001).


Conclusions: Examining social media to detect health trends, as well as to communicate important health information, is a growing area of research in public health. Understanding the content and implications of conversations that form around HPV vaccination on social media can aid health organizations and health-focused Twitter users in creating a meaningful exchange of ideas and in having a significant impact on vaccine uptake. This area of research is inherently interdisciplinary, and this study supports this movement by applying public health, health communication, and data science approaches to extend methodologies across fields.

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After Long Battle with MSF, Pfizer Drops Price of Prevnar Vaccine to Humanitarian Groups

After Long Battle with MSF, Pfizer Drops Price of Prevnar Vaccine to Humanitarian Groups | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Seeking to defuse a nasty row, Pfizer has lowered the price of its pneumococcal vaccine to non-governmental organizations that supply poor countries.

 

The company will sell the newest version of its Prevnar 13 vaccine for $3.10 a dose, which means the three-dose treatment to vaccinate a child will cost $9.30. This is the same price that Gavi, an international public-private partnership, has paid since last year. Gavi acts as a bridge between drug makers and philanthropic groups in negotiating supplies for 57 poor and developing countries.

 

Until now, though, Pfizer had not made the same offer to non-governmental organizations or civil society groups. And the price drop comes after a protracted dispute with Doctors Without Borders, in particular. The nonprofit has repeatedly criticized Pfizer for failing to lower its price and make it more widely available to humanitarian organizations that work in poor and developing countries (read “Doctors Without Borders to Pfizer: We Don't Want Your "Free" Vaccines. We Want Lower Prices!”; http://sco.lt/5qcfGT).

 

Doctors Without Borders has aggressively pushed Pfizer to cut its price to $5 per child, arguing the company was overcharging both donors and developing countries for a vaccine that has generated billions of dollars in sales in wealthy nations. In the first nine months of this year, the Prevnar vaccine generated about $4.3 billion in sales.

 

Pharma Guy's insight:

Also read, “Vaccines Are Path to Better Revenue Growth for Some #Pharma Companies”; http://sco.lt/582wTZ

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Adults Not Vaccinated Against Flu Account for 70% of the Economic Burden Caused by All Anti-Vaxxers!

Adults Not Vaccinated Against Flu Account for 70% of the Economic Burden Caused by All Anti-Vaxxers! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Vaccines save thousands of lives in the United States every year, but many adults remain unvaccinated. Low rates of vaccine uptake lead to costs to individuals and society in terms of deaths and disabilities, which are avoidable, and they create economic losses from doctor visits, hospitalizations, and lost income. To identify the magnitude of this problem, we calculated the current economic burden that is attributable to vaccine-preventable diseases among US adults. We estimated the total remaining economic burden at approximately $9 billion (plausibility range: $4.7–$15.2 billion) in a single year, 2015, from vaccine-preventable diseases related to ten vaccines recommended for adults ages nineteen and older. Unvaccinated individuals are responsible for almost 80 percent, or $7.1 billion, of the financial burden.

 

Sixty-five percent of the estimated annual economic burden, equivalent to $5.8 billion (plausibility range: $2.0–$11.6 billion), resulted from influenza alone—a vaccine-preventable disease that causes substantial numbers of hospitalizations and morbidity each year.

 

It should be noted that this study examined a static annual estimate of the unvaccinated cohort, and therefore not all cases in this group are necessarily preventable by increased vaccination because of less than 100 percent vaccine efficacy.

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Zika Vaccine: A Blockbuster Opportunity for Pharma Thanks to Tourists

Zika Vaccine: A Blockbuster Opportunity for Pharma Thanks to Tourists | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Though still years out, an effective Zika vaccine could beat a path to blockbuster sales, thanks to demand from travelers to endemic areas--which include some common tourist destinations. That's a key difference from the limited market prospects in other mosquito-borne diseases.

 

That blockbuster potential, plus an urgent medical need, has prompted a burst of R&D in the field, Reuters reports.

 

A Zika vaccine could reel in more than $1 billion in sales from “just a portion” of U.S. travelers, Inovio CEO J. Joseph Kim told the news service. And that's a conservative estimate, he said. Unlike residents of Zika-affected countries, who'd need vaccinations en masse, travelers would be able to pay a high price for protection, and thus are viewed as the most attractive market for a prospective shot.

 

Though other mosquito-borne diseases can lead to hospitalizations and death, the thousands of microcephaly cases caused by Zika have served to raise the alarm on the virus, quickly boosting vaccine development efforts.

 

So far, Sanofi, GlaxoSmithKline, Takeda and dozens of smaller companies and organizations have committed to Zika vaccine R&D. The National Institutes of Health and Inovio are in clinical trials with their candidates.

 

 

Pharma Guy's insight:

As Reuters notes, vaccines against malaria and West Nile virus--which have been around for decades--haven’t seen the same interest from pharma.

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Struggling Vaccines From Novartis Turn Into Sales Boon for Glaxo

Struggling Vaccines From Novartis Turn Into Sales Boon for Glaxo | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Outbreaks of the meningitis B disease in the U.S., along with the social-media frenzy that followed the death of a British toddler, have helped propel sales of GlaxoSmithKline Plc’s vaccine well past initial projections for its use.

 

The U.K. drugmaker is poised to deliver nine times the 2016 sales Novartis AG had forecast for vaccines including the meningitis B shot Bexsero, said Thomas Breuer, chief medical officer at Glaxo’s vaccines division. Glaxo acquired the business in March 2015, and revenue for vaccines last year was five times what Novartis had estimated, Breuer said.

 

Glaxo negotiated a price with the U.K. that paved the way for the world’s first infant immunization program using Bexsero last year. Fresh efficacy and safety data from that program are set to be presented next month at a conference in Manchester, England. That may persuade the U.S. and other countries to start their own mass vaccination campaigns against the rare but serious infection.

 

“When this new evidence becomes available, public health agencies will re-evaluate,” Breuer said. “But I don’t want to make any predictions.”

 

Meningitis B infection can cause devastating effects in children and young adults including brain damage and loss of limbs. There have been seven college outbreaks in the U.S. since 2009, with one this year at Rutgers University in New Jersey. The death of a British girl in February and the photographs of her that went viral spurred public demand for wider vaccination in the U.K.

 

In the U.S., where the majority of meningitis B cases occur in older teenagers and young adults, the vaccine is approved for people ages 10 to 25. In Europe, it’s approved for use in children aged two months and older. The U.K.’s National Health Service covers vaccination for infants under 1.

 

Glaxo is exploring ways to expand the use of the vaccine, including a large study to test whether Bexsero can prevent carriage of meningitis B in teenagers, who frequently have the bacteria in the backs of their nose and throat.       

Pharma Guy's insight:

Also read, “Vaccines Are Path to Better Revenue Growth for Some #Pharma Companies”; http://sco.lt/582wTZ

 

Meanwhile, Pfizer is attempting to encroach on GSK’s Meningitis B territory with its own vaccine, Trumenba. For more on that, read “Branded as Well As Unbranded Vaccine Ads Are the Scariest!”; http://sco.lt/5TxJPl 

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CDC Infographic Summarizes the Global Impact of Vaccines

CDC Infographic Summarizes the Global Impact of Vaccines | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Part of CDC’s Updated #VaxWithMe Social Media Campaign: http://sco.lt/8bQcuv

Pharma Guy's insight:

Meanwhile, more U.S. Parents Refuse Vaccination for Their Kids; http://sco.lt/8pIo65

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CDC’s #VaxWithMe Social Media Campaign has been updated

CDC’s #VaxWithMe Social Media Campaign has been updated | Pharmaguy's Insights Into Drug Industry News | Scoop.it

In an effort to promote all vaccinations as an important prevention method for protecting against serious, and even deadly diseases, CDC has updated its #VaxWithMe social media campaign to encourage individuals to be aware and up-to-date on recommended vaccines for themselves and their family for every stage of life.

The new #VaxWithMe campaign seeks to drive visibility of vaccination across a person’s lifespan, spark engagement around the importance of vaccination for all ages, and generate a movement that encourages individuals to be aware of recommended vaccinations for all ages, lifestyles, jobs, travels, and health conditions.

CDC encourages individuals to join the campaign  by sharing messages, post, tweets, photos, and videos with the hashtag #VaxWithMe on social media to promote their support and participation in getting recommended vaccinations.

Learn more about the new #VaxWithMe campaign here!

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How Sanofi Pasteur & U.S. Gov't Collaborate to Develop Zika Vaccine

How Sanofi Pasteur & U.S. Gov't Collaborate to Develop Zika Vaccine | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Sanofi and its vaccines global business unit Sanofi Pasteur announced today a Cooperative Research and Development Agreement with the Walter Reed Army Institute of Research (WRAIR) on the co-development of a Zika vaccine candidate. According to the terms of the agreement, WRAIR will transfer its Zika purified inactivated virus (ZPIV) vaccine technology to Sanofi Pasteur, opening the door for a broader collaboration with the U.S. government.

 

The agreement also includes Sanofi Pasteur's production of clinical material in compliance with current GMP (Good Manufacturing Practices) to support phase II testing, optimization of the upstream process to improve production yields, and characterization of the vaccine product. Sanofi Pasteur will also create a clinical development and regulatory strategy.

 

WRAIR will share data related to the development of immunologic assays designed to measure neutralizing antibody responses following natural infection and vaccination with ZPIV, biologic samples generated during the performance of non-human primate studies, and biologic samples generated during the performance of human safety and immunogenicity studies using ZPIV. WRAIR, the National Institute of Allergy and Infectious Diseases (NIAID) - part of the U.S. National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA) - part of the Health & Human Services (HHS) Office of the Assistant Secretary of Preparedness and Response - have been coordinating pre-clinical development of the candidate encouraged by new, pre-clinical research conducted by WRAIR and the Beth Israel Deaconess Medical Center[1]. NIAID will sponsor a series of phase 1 ZPIV trials while the technology transfer process is occurring.

Pharma Guy's insight:

Also read: "When Does It Makes Economic Sense for #Pharma Industry to Develop Vaccines vs Drugs?"; http://sco.lt/7adpSb

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Drug Makers Signal Lack of Interest in Developing Vaccines During Crises

Drug Makers Signal Lack of Interest in Developing Vaccines During Crises | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Every few years an alarming disease launches a furious, out-of-the-blue attack on people, triggering a high-level emergency response. SARS. The H1N1 flu pandemic. West Nile and Zika. The nightmarish West African Ebola epidemic.

 

In nearly each case, major vaccine producers have risen to the challenge, setting aside their day-to-day profit-making activities to try to meet a pressing societal need. With each successive crisis, they have done so despite mounting concerns that the threat will dissipate and with it the demand for the vaccine they are racing to develop.

 

Now, manufacturers are expressing concern about their ability to afford these costly disruptions to their profit-seeking operations. As a result, when the bat-signal next flares against the night sky, there may not be anyone to respond.

 

A number of flu vaccine manufacturers were left on the hook with ordered but unpaid for vaccine during the mild 2009 H1N1 flu pandemic. By the time the vaccine was ready — after the peak of the outbreak — public fear of the new flu had subsided. Many people didn’t want the vaccine, and some countries refused to take their full orders. GSK, Sanofi Pasteur, and Novartis — which has since shed its vaccines operation — produced flu vaccine in that pandemic.

Pharma Guy's insight:

Maybe if vaccines were more effective and delivered on time, it would be a different story

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Academic Research Goes Where No Pharma was Willing to Go: Develops a Universal Flu Vaccine

Academic Research Goes Where No Pharma was Willing to Go: Develops a Universal Flu Vaccine | Pharmaguy's Insights Into Drug Industry News | Scoop.it

A UK company has started trialling a new universal influenza vaccine that would avoid the annual scramble to guess the most likely strains to be circulating in the following flu season.

 

The vaccine - developed by University of Oxford spin-out Vaccitech - will be tested in around 500 National Health Service (NHS) patients in a study supported by the National Institute for Health Research (NIHR). It is thought to be the first trial of such a vaccine and will extend over the 2017-18 and 2018-19 flu seasons.

 

The need for a more effective flu vaccine was starkly revealed last winter. The recommended vaccine was around 40% effective overall, but hardly provided protection at all to the over-65s who are most at risk of severe complications and death from the infection, despite being a good match for circulating strains of the virus.

 

The NIHR notes that flu affects about a billion people worldwide a year with 250,000 to 500,000 annual deaths, mainly in the over-65 age group. About 10,000 over 65s registered at six GP practices will be asked to take part in the trial in Berkshire and Oxfordshire this winter.

 

The new vaccine is designed to offer greater protection against flu because it targets the core proteins of the virus, which stay constant, while current vaccines target surface proteins (haemagglutinin and neuraminidase) that are constantly changing.

 

Further Reading:

Pharma Guy's insight:

I was involved tangentially in research to develop a universal flu vaccine way back in the early 80s (see further reading). The image shown here is of a molecular model I built of the core protein of the flu virus.

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Another Reason for Seniors to Skip Zostavax Vaccine for Shingles: Serious Side Effects Claim Attorneys

Another Reason for Seniors to Skip Zostavax Vaccine for Shingles: Serious Side Effects Claim Attorneys | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Merck & Co. could have a growing Zostavax problem on its hands. After several plaintiffs filed lawsuits claiming the drugmaker’s shingles vaccine caused serious injury and death, attorneys say more cases are on the way.

 

Plaintiffs have sued in state and federal courts in Pennsylvania alleging that Merck’s Zostavax—used to prevent shingles, the painful complication of varicella infection—caused serious side effects, including death.

 

“I think Merck has failed terribly … to warn about the very serious side effects and the failure of the vaccine to do what they claim it does,” attorney Marc Bern told FiercePharma.

 

Bern, founding partner at Marc J. Bern & Partners, said his firm has “thousands of complaints” yet to be filed in Philadelphia, with the injuries running “the gamut from contracting shingles as a result of the vaccine all the way to serious personal injuries such as blindness in one eye, individuals who have serious paralysis in their extremities, brain damage, all the way to death.”

 

In a statement, Merck said it “stands behind the demonstrated safety and efficacy” of the shot, which is licensed in 50 countries.

 

Further Reading:

Pharma Guy's insight:

Seniors have bee avoiding getting vaccinated for shingles even though the Affordable Care Act requires private insurers to cover Zostavax without co-pays for people older than 60 (read “Early Shortages, Delayed Marketing, High Prices, Other Health Priorities, Among Reasons Why Seniors Skip Shingles Vaccine”; http://sco.lt/4wT9NZ Perhaps the side effects mentioned in this article is a bigger reason.

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Trump Picks Vaccine Critic Robert F. Kennedy Jr. to Chair Vaccine Panel

Trump Picks Vaccine Critic Robert F. Kennedy Jr. to Chair Vaccine Panel | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Outspoken vaccine critic Robert Kennedy Jr. (read“Off The Grid: Robert F. Kennedy Jr. Says Vacines are Pay Dirt’ for #Pharma”; http://sco.lt/6smHDt) said Tuesday that he had accepted a position in Donald Trump’s administration as chair of a panel on vaccine safety and scientific integrity, in what would be the clearest sign yet of the president-elect’s suspicions about vaccines.

 

Kennedy’s remarks followed his meeting with the president-elect at Trump Tower and immediately sparked outrage from scientists, pediatricians, and public health experts, who fear the incoming administration could give legitimacy to skeptics of childhood immunizations despite a huge body of scientific research demonstrating that vaccines are safe. Many of those skeptics believe vaccines are a cause of autism.

 

Hours later, Trump spokeswoman Hope Hicks said in a statement that the president-elect was “exploring the possibility of forming a commission on Autism,” but said “no decisions have been made at this time.”

 

Kennedy was unequivocal about an offer when speaking to reporters at Trump Tower in New York after the meeting. He also said Trump has doubts and questions about current vaccine policies.

 

“His opinion doesn’t matter but the science does matter and we ought to be reading the science and we ought to be debating the science,” Kennedy said. “And that everybody ought to be able to be assured that the vaccines that we have — he’s very pro-vaccine, as am I — but they’re as safe as they possibly can be.”

 

Further Reading:

  • “Off The Grid: Robert F. Kennedy Jr. Says Vaccines are Pay Dirt’ for #Pharma”; http://sco.lt/6smHDt
  • “Vaccines Are Path to Better Revenue Growth for Some #Pharma Companies”; http://sco.lt/582wTZ
  • “When Does It Makes Economic Sense for #Pharma Industry to Develop Vaccines vs Drugs?”: http://sco.lt/7adpSb
  • “Want to Avoid Toxins in Your Flu & Other Vaccines? ‘Good Luck,’ Says Cleveland Clinic Wellness Doctor”; http://sco.lt/4gmHXl
  • “CDC’s #VaxWithMe Social Media Campaign has been updated”; http://sco.lt/8bQcuv
  • “Intelligent, High Income People Refuse Vaccinations”; http://sco.lt/67gVs1
  • "Everything You Wanted to Know About Vaccine Marketing, PR, Earned Media, Lobbying, and 'Anti-Vaxxers'"; http://bit.ly/29H0UOL
  • “Discredited Anti-Vaxxer Researcher Is “Very Positive” He Has an Ally in Trump”; http://sco.lt/76R4xF
  • “Better to Keep Vaccine Adverse Event Reports Secret, Concludes Study”; http://sco.lt/4gkjhJ
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Up Until Now, GSK Bet on Vaccines Rather than Trendy Immuno-Oncology Cancer Treatments

Up Until Now, GSK Bet on Vaccines Rather than Trendy Immuno-Oncology Cancer Treatments | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Bucking biopharma’s trend in 2014, GlaxoSmithKline CEO Andrew Witty swapped off his oncology assets to Novartis, building his company’s position in vaccines and consumer healthcare instead.

 

Fast-forward to the future. After taking flak from prominent investors, Witty continues to defend the logic—and in recent quarters, he's had the numbers to back up that contention. He continues to make the case that high-priced treatments don't make business sense in the long run.

 

Consider immuno-oncology. Speaking Tuesday at the opening of GSK’s Rockville, Maryland, vaccine research site, Witty said that he doesn’t see pricey immunotherapies for cancer, now biopharma’s hottest field, as a “cost-effective … global healthcare solution.”

 

To back up his point, Witty said the number of patients treated by the last 20 top-selling pharma products has dropped “catastrophically” in recent decades.

 

“A blockbuster drug of the '80s probably treated tens or hundreds of millions. In the '90s it was tens of millions, and now you are into tens of thousands," he said. "Vaccines are going the other way.”

 

Witty said believes the returns to shareholders are “very similar” for vaccines and pharmaceuticals. What’s different is the shape of the return curves.

 

 

With vaccines, a business with high barriers to entry driven by volume on a lower price point, companies can eke out similar profits, the CEO said.

 

By focusing on vaccines and consumer healthcare, Witty bet GSK’s future on lower-margin businesses in a move that so far seems to have paid off. Pricing pressure has taken a toll on the pharmaceutical industry, and GSK’s vaccines have outperformed other units in the second and third quarters this year.

Pharma Guy's insight:

Witty said that he doesn’t see pricey immunotherapies for cancer, now biopharma’s hottest field, as a “cost-effective … global healthcare solution.”

 

It's interesting that Witty used "global" to qualify his remark. In the U.S. a pharma company can usually charge what the market will bear. Therefore, I don't see GSK giving up that lucrative market especially after the 21st Century Act has been signed into law.

 

Related article: “When Does It Makes Economic Sense for #Pharma Industry to Develop Vaccines vs Drugs?”: http://sco.lt/7adpSb

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Early Shortages, Delayed Marketing, High Prices, Other Health Priorities, Among Reasons Why Seniors Skip Shingles Vaccine

Early Shortages, Delayed Marketing, High Prices, Other Health Priorities, Among Reasons Why Seniors Skip Shingles Vaccine | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Seniors have been particularly slow to take advantage of the shingles vaccine. The Food and Drug Administration approved it a decade ago, and the C.D.C. recommends it for those over 60, including those who’ve already had shingles.

 

Coverage has climbed steadily, but in 2014 had still reached only 31 percent of those over 65. As with nearly all of these vaccines, older whites were more likely to have been vaccinated than blacks, Hispanics or Asians.

 

Seniors and their caregivers should request vaccinations; the C.D.C. publishes guidelines and a quiz that explain which ones are recommended. Zostavax, the current shingles vaccine, reduces the risk of the disease in adults over 60 by half, and the incidence of postherpetic neuralgia by two-thirds.

 

(Quick primer: Shingles results from the same virus that causes chickenpox, which nearly all older Americans have had. The virus typically remains dormant for decades, but the odds of its reactivation rise steeply after 50 as the immune system weakens. The lifetime risk of shingles is one in three, rising to one in two for those over 85.)

 

The vaccine’s underuse can be blamed, in part, on supply shortages in its early years until about 2012. The manufacturer, Merck, and the C.D.C. didn’t increase media campaigns until vaccine supplies were sufficient; such campaigns had just started when Ms. Abate became ill. It’s not surprising that she was only vaguely aware of Zostavax.

 

Cost remains a barrier to getting Zostavax and some other adult vaccines.

 

In a study published this past summer, researchers reported that nearly 40 percent of the time, patients over 50 who requested a prescription for Zostavax at a pharmacy chain chose not to receive the vaccine; out-of-pocket costs were most frequently the reason.

 

The Affordable Care Act requires private insurers to cover Zostavax without co-pays for people older than 60, and many cover it for policyholders over 50. But Medicare beneficiaries find that, unlike the flu and pneumococcal vaccines, which are covered under Part B and often administered in physicians’ offices, Zostavax and Tdap are covered under Part D.

 

Physicians can’t easily bill for Part D reimbursement, so they often send patients to pharmacies, which can. But because Part D involves a welter of different plans and formularies, some requiring patients to pay for the vaccine and then seek reimbursement, the cost and co-pays can discourage use. Zostavax, at about $200 a dose, is the most expensive adult vaccine.

 

This landscape could change drastically in a year or so. In October, the pharmaceutical giant GlaxoSmithKline submitted a new shingles vaccine for F.D.A. approval.

 

International studies indicate that the newcomer, Shingrix, is far more effective than the current vaccine, reducing the incidence of shingles by 90 percent. Moreover, the effectiveness doesn’t appear to decrease among older age groups, as Zostavax’s does.

 

Shingrix has its own drawbacks. For one, it requires a second injected dose several months after the first; some people won’t follow up. The manufacturer has yet to set a price, and unless Congress changes the law, any new vaccine will face the same Part D billing complications.

 

But if the F.D.A. approves it, and the C.D.C. recommends its use (which triggers insurance coverage), Shingrix may also prevent a lot of shingles cases — but only if older adults are actually vaccinated.

 

They don’t have a great track record.

Pharma Guy's insight:

Meanwhile, Merck is now ramping up its promotion of Zostavax in anticipation of the entrance of GSK’s Shingrix to the market (read “Merck Uses Humor & Fear to Promote Zostavax Shingles Vaccine”; http://sco.lt/6IjHSD). Shingrix appears to be much more effective and GSK expects it to be a "major market disrupter" for Merck's Zostavax.

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Merck Uses Humor & Fear to Promote Zostavax Shingles Vaccine

Merck Uses Humor & Fear to Promote Zostavax Shingles Vaccine | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Are you the type of consumer motivated by fear? Or are you more likely to take action based on advice from a humorous celeb? Doesn't matter--Merck & Co., in a push to boost vaccine sales before new competition arrives, has a shingles commercial for you.

 

The company is currently airing two ad types that couldn't be more different from one another. In one--dubbed "Surprise Door Knock"--NFL analyst and former quarterback Terry Bradshaw barges into the home of a trio of adults to explain with gusto the nasty effects of shingles and caution them to ask their doctors for more info.

 

"We all in?" he asks, as they pile their hands atop each other's with a rousing chorus of "yes!" "Good--'cause if not, we're gonna watch highlights of my career 12 hours straight. I know--talk about pain!" he says with a laugh.

 

Merck's other currently running spots are much more serious and somber. "Day #7 with Shingles" and "Day #18 with Shingles" each depict a sufferer trying to go about his daily life. One struggles through a dismal day at the office thanks to shingles pain, and the other gives up on a game of golf because of it, while a colleague and friend go one-on-one with the camera to express their concerns.

 

The one thing the ads all have in common? Graphic depictions of the condition, which can cause unsightly rashes and blistering of the skin. And, of course, pain.

 

Merck has good reason to want to reach a broad spectrum of adults with its awareness push. Fellow vaccine behemoth GlaxoSmithKline has a shingles candidate, Shingrix, coming up the pipeline, and when it's finally ready to roll, the British company expects it to be a "major market disrupter" for Merck's Zostavax.

 

Pharma Guy's insight:

I updated my "Gallery of Scary Pharma Industry Advertising" PPT on Slideshare to include these ads (see  http://bit.ly/ScaryPharmaAds).

 

Which brand name is more memorable:  Zostavax or Shingrix? It seems to me that consumers are not likely to remember either name - not that it matters much if there is not much difference in effectiveness. 

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Doctors Without Borders to Pfizer: We Don't Want Your "Free" Vaccines. We Want Lower Prices!

Doctors Without Borders to Pfizer: We Don't Want Your "Free" Vaccines. We Want Lower Prices! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

By Jason Cone, Executive Director of Doctors Without Borders in the United States

 

I recently had the difficult task of telling Ian Read, Pfizer’s CEO, that Doctors Without Borders/ Médecins Sans Frontières (MSF) is rejecting the company’s offer to donate a significant number of pneumonia vaccine (PCV) doses for the children we serve. This is not a decision that we took lightly, since our medical teams working in the field witness the impact of pneumonia every day.

 

Pneumonia claims the lives of nearly one million kids each year, making it the world’s deadliest disease among children. Although there’s a vaccine to prevent this disease, it’s too expensive for many developing countries and humanitarian organizations, such as ours, to afford. As the only producers of the pneumonia vaccine, Pfizer and GlaxoSmithKline (GSK) are able to keep the price of the vaccine artificially high; since 2009, the two companies have earned $36 billion on this vaccine alone. For years, we have been trying to negotiate with the companies to lower the price of the vaccine, but they offered us donations instead.

 

You might be wondering, then, why we’d rather pay for the vaccine than get it for free. Isn’t free better?

 

No. Free is not always better. Donations often involve numerous conditions and strings attached, including restrictions on which patient populations and what geographic areas are allowed to receive the benefits. This process can delay starting vaccination campaigns, which would be an untenable situation in emergency settings, or grossly limit who you’re able to reach with the vaccine.

 

Donations can also undermine long-term efforts to increase access to affordable vaccines and medicines. They remove incentives for new manufacturers to enter a market when it’s absorbed through a donation arrangement. We need competition from new companies to bring down prices overall — something we don’t have currently for the pneumonia vaccine.

 

Donations are often used as a way to make others ‘pay up.’ By giving the pneumonia vaccine away for free, pharmaceutical corporations can use this as justification for why prices remain high for others, including other humanitarian organizations and developing countries that also can’t afford the vaccine. Countries, which continue to voice their frustration at being unable to afford new and costly vaccines such as PCV, need lower prices as well to protect children’s health.

 

Critically, donation offers can disappear as quickly as they come. The donor has ultimate control over when and how they choose to give their products away, risking interruption of programs should the company decide it’s no longer to their advantage. For example, Uganda is now facing a nationwide shortage of Diflucan, an essential crytpococcal meningitis drug, in spite of Pfizer’s commitment to donate the drugs to the government. There are other similar examples of companies’ donation programs leaving governments and health organizations in a lurch without the medical tools they need to treat patients.

 

To avoid these risks and to limit the use of in-kind medical products donations, the World Health Organization (WHO), and other leading global health organizations such as UNICEF and Gavi, the Vaccine Alliance, have clear recommendations against donation offers from pharmaceutical corporations.

 

Donations of medical products, such as vaccines and drugs, may appear to be good ‘quick fixes,’ but they are not the answer to increasingly high vaccine prices charged by pharmaceutical giants like Pfizer and GSK.

 

Pfizer should lower the price of its lifesaving pneumonia vaccine for humanitarian organizations and all developing countries to $5 per child. Only then, will we have a meaningful step towards saving children’s lives both today and in the future.

 

To Mr. Read, I hope to hear soon from you that Pfizer is reducing the price of the vaccine for the millions of children who still need it.

Pharma Guy's insight:

The probable answer from Ian Read: "Sorry, Jason. We got to focus on imperatives: Return on Capital." See the meme here: http://sco.lt/87r9bF 

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Flu Vaccination Rates Among Many Helthcare Workers are as Low as 45%

Flu Vaccination Rates Among Many Helthcare Workers are as Low as 45% | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The Advisory Committee on Immunization Practices recommends annual influenza vaccination for all health care personnel to reduce influenza-related morbidity and mortality among both health care personnel and their patients (1–4). To estimate influenza vaccination coverage among U.S. health care personnel for the 2015–16 influenza season, CDC conducted an opt-in Internet panel survey of 2,258 health care personnel during March 28–April 14, 2016.

 

Overall, 79.0% of survey participants reported receiving an influenza vaccination during the 2015–16 season, similar to the 77.3% coverage reported for the 2014–15 season (5).

 

Coverage in long-term care settings increased by 5.3 percentage points compared with the previous season.

 

Vaccination coverage continued to be higher among health care personnel working in hospitals (91.2%) and lower among health care personnel working in ambulatory (79.8%) and long-term care settings (69.2%).

 

Coverage continued to be highest among physicians (95.6%) and lowest among assistants and aides (64.1%), and highest overall among health care personnel who were required by their employer to be vaccinated (96.5%). Among health care personnel working in settings where vaccination was neither required, promoted, nor offered onsite, vaccination coverage continued to be low (44.9%).

 

An increased percentage of health care personnel reporting a vaccination requirement or onsite vaccination availability compared with earlier influenza seasons might have contributed to the overall increase in vaccination coverage during the past 6 influenza seasons.

Pharma Guy's insight:

“GSK's Whooping Cough Vaccination Campaign Needlessly Demonizes Wolves & Grannies! “; http://sco.lt/52JoCf The REAL “villains” may be healthcare workers!

 

Related stories:

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rosywills's comment, September 30, 2016 8:19 AM
Opportunity Analysis- H1N1 (Swine Flu) Vaccination Market Future Opportunities
Download Free PDF Brochure @ http://bit.ly/1tI5CiY
Curative drugs such as Tamiflu were introduced in the initial phase of the H1N1 pandemic. The latter phase would require drugs facilitating prevention rather than the cure. This market research report forecasts the H1N1 vaccine market for disease prevention in the unaffected population. The initial lot of vaccines will be egg-based and cell-based and first administered to priority groups such as pregnant women, chronic disease patients, and children above 6 months of age.
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Branded as Well As Unbranded Vaccine Ads Are the Scariest!

Branded as Well As Unbranded Vaccine Ads Are the Scariest! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

When STATnews reporter Rebecca Robbins (@rebeccadrobbins) interviewed me about what's behind ominous unbranded "disease awareness" ads, I opined that if you’re a drug maker, “you don’t want to attach a dark image to the brand — so you’re attaching this dark imagery to a medical condition instead,” which leaves room for a branded ad that shows “the bright side: that there’s this product that can save the day” (Read "#Pharma 'Disease Awareness' Ads: Are They 'Stealthy' Fear Mongering Set Pieces?").

That "conventional wisdom" or "rule" -- if it is one -- obviously does NOT apply to many ads for vaccines, especially lately. Take, for example, the TV ad for Trumenba - Pfizer's Meningitis B vaccine. I saw this ad for the first time last night:

As described by iSpot.tv the Trumenba ad "follows the series of events that lead up to this young man being in a hospital with Meningitis B. The source of the infection is traced back to a party where the teenager shared food, drinks and a kiss with friends. Trumenba offers a vaccine to prevent future spread of the disease." Bummer! You can't even enjoy an innocent kiss without fearing for your life! This is obviously a "dark" and scary ad aimed at the parents of teenagers for whom this vaccine is indicated (up to age 25).

Why are scare tactics the marketing strategy du jour in branded and unbranded vaccine ads?

It wasn't always this way. More...

Pharma Guy's insight:

Related article: “Merck Uses Humor & Fear to Promote Zostavax Shingles Vaccine”; http://sco.lt/6IjHSD and  “Gallery of Scary Pharma Industry Advertising”; http://bit.ly/ScaryPharmaAds

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More Parents Refuse Vaccination for Their Kids. Why? Not the Reason You Think

More Parents Refuse Vaccination for Their Kids. Why? Not the Reason You Think | Pharmaguy's Insights Into Drug Industry News | Scoop.it

More doctors are reporting encounters with parents refusing to vaccinate their kids than a decade ago, but parents’ reasons for skipping immunizations have shifted in the past decade.

A new survey published in Pediatrics on Monday reports that 87 percent of pediatricians in the United States say they encountered parents refusing to vaccinate their children in 2013. A decade earlier, 75 percent of doctors reported they had experienced vaccine refusals.

 

The proportion of doctors who had encountered autism concerns fell from 74 percent in 2006 to 64 percent in 2013. It’s the first documented drop in that concern, the authors said.

The most common reason parents gave, according to doctors? The vaccines weren’t necessary.

 

Many parents are concerned about giving their children too many vaccines in a short period of time, a nod to the idea of an alternate vaccine schedule that’s gained steam in recent years. Nearly 73 percent of pediatricians say that parents delayed vaccines because of scheduling concerns.

 

Parental Concerns About Vaccines

 

Vaccine safety

 Too many vaccines

 Development of autism

 Vaccine additives (thimerosal, aluminum)

 Overload the immune system

 Serious adverse reactions

 Potential for long-term adverse events

 Inadequate research performed before licensure

 May cause pain to the child

 May make the child sick

Necessity of vaccines

 Disease is more “natural” than vaccine

 Parents do not believe diseases being prevented are serious

 Vaccine-preventable diseases have disappeared

 Not all vaccines are needed

 Vaccines do not work

Freedom of choice

 Parents have the right to choose whether to immunize their child

 Parents know what’s best for their child

 Believe that the risks outweigh the benefits of vaccine

 Do not trust organized medicine, public health

 Do not trust government health authorities

 Do not trust pharmaceutical companies

 Ethical, moral, or religious reasons

Pharma Guy's insight:

Meanwhile, pharma executives still blame the fringe element: “Dear PhRMA CEO John Castellani: You Can't Arrest People for Being ‘Stupid!’"; http://sco.lt/6Kf51t.

 

Related stories: “The Weird History of Anti-Vaxxers”; http://sco.lt/5OGVnd and “Intelligent, High Income People Refuse Vaccinations”: http://sco.lt/67gVs1 and “Only 0.7 Percent of Children Received No Vaccines at All, Says CDC”; http://sco.lt/8w58YT and “Majority of Parents Do NOT Support HPV Vaccination School-Entry Requirement”; http://sco.lt/54kKQL

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Flu Shot Doesn't Work as Well as #pharma Clinical Data Suggests

Flu Shot Doesn't Work as Well as #pharma Clinical Data Suggests | Pharmaguy's Insights Into Drug Industry News | Scoop.it

It's the time of year when experts crunch the numbers to see how well the flu shot worked. The result? Better than last year, but still not good enough.

 

"Overall, just shy of 45 to 50 per cent," said Dr. Danuta Skowronski of the BC Centre for Disease Control, who presented the data to the Global Influenza Vaccine Effectiveness meeting at the World Health Organization last week.

 

"That's lower than we would like to see, but it's an improvement over the previous year, because it couldn't be worse, frankly"

 

Experts used to believe the annual flu shot protection was much higher, around 70 to 90 per cent. But not anymore. Those early estimates were based on industry-funded clinical trials that were extrapolated to apply across all ages and flu seasons.

 

"It was a blanket assumption that is simply not true," Skowronski said.

 

That assumption changed dramatically, after Skowronski and colleagues developed a protocol that revealed the true picture of vaccine efficacy. It's called the test negative design (TND) first piloted in Canada in 2004.

 

"The test negative design has opened our eyes to all kinds of variables that we were blind to for years. We were flying blind," said Skowronski.

 

The good news is the data is more reliable. But the bad news is that experts now realize the flu vaccine protects only about half of the time.

 

"Our public health goal is to minimize the serious health problems association with the flu," said Skowronski. "There's no use promoting a vaccine that isn't working well. The only way you can do better is to recognize the problem in the first place."

 

This year's data also shows that only about a third of Canadians got the flu shot, about five per cent less than last year.

 

"That's not a surprise coming out of a year where effectiveness was so low. That had to have an impact," said Skowronski.

Pharma Guy's insight:

The drug industry over promises the effectiveness of vaccines based on small clinical trials, but in the real world effectiveness, as in this case, is much lower than pharma marketers want us to believe. You can't fault the "anti-vaxxers" when the data suggests that marketers share some of the blame why the public may be skeptical. For more on that, read "Everything You Wanted to Know About Vaccine Marketing, PR, Earned Media, Lobbying, and 'Anti-Vaxxers'"; http://bit.ly/29H0UOL Also read “CDC Says AZ's FluMist is Ineffective Compared to Flu Shots; i.e., 3% v. 63%!”; http://sco.lt/5E9L2P

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