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.

advertisement

GSK has made a corporate decision that while it wants to help in public health emergencies, it cannot continue to do so in the way it has in the past. Sanofi Pasteur has said its attempt to respond to Zika has served only to mar the company’s reputation. Merck has said while it is committed to getting its Ebola vaccine across the finish line it will not try to develop a vaccine that protects against other strains of Ebola and the related Marburg virus.

Drug makers “have very clearly articulated that … the current way of approaching this — to call them during an emergency and demand that they do this and that they reallocate resources, disrupt their daily operations in order to respond to these events — is completely unsustainable,” said Richard Hatchett, CEO of CEPI, an organization set up after the Ebola crisis to fund early-stage development of vaccines to protect against emerging disease threats.

advertisement

Hatchett and others who plan for disease emergencies worry that, without the involvement of these types of companies, there will be no emergency response vaccines.

“The only real expertise in the world to make these vaccines in a quantity and a safety environment is in the private sector,” said Michael Osterholm, director of the Center for Infectious Diseases Research and Policy. “If the private sector isn’t fully engaged and involved, it’s a show stopper.”

Nearly all the major pharmaceutical companies that work on these vaccines have found themselves holding the bag after at least one of these outbreaks.

GSK stepped up during the Ebola crisis, but has since essentially shelved the experimental vaccine it once raced to try to test and license. Two other vaccines — Merck’s and one being developed by Janssen, the vaccines division of Johnson & Johnson — are still slowly wending their ways through difficult and costly development processes. Neither company harbors any hope of earning back in sales the money it spent on development.

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.

Dr. Rip Ballou, who heads the U.S. research and development center for GSK Global Vaccines, told STAT it’s not in the “company’s DNA” to say “no” to pleas to respond to appeals in an emergency. But the way it has responded in the past is no longer tenable.

“We do not want to have these activities compete with in-house programs,” said Ballou. “And our learnings from Ebola, from pandemic flu, from SARS previously, is that it’s very disruptive and that’s not the way that we want to do business going forward.”

GSK has proposed using a facility it has in Rockville, Md., as a production plant for vaccines needed in emergencies, but the funding commitments that would be needed to turn that idea into reality haven’t materialized.

And as Ebola and Zika recede ever further in the rearview mirror, the chances governments and philanthropy institutions will seize on this type of paradigm-shifting proposal appear to be slight. The threat of new outbreaks is still top of mind for organizations in this area, like BARDA and CEPI — the U.S. government’s Biomedical Advanced Research and Development Authority and the Oslo, Norway-based Coalition for Epidemic Preparedness Innovations. But there appears to be little discussion of the issue among governments facing perennial funding shortfalls.

“The people that are concerned about this haven’t lost focus,” Ballou said. “We’re still very concerned about it. I know BARDA hasn’t lost focus. CEPI hasn’t lost focus. But the rest of the world probably has.”

Sanofi Pasteur has also taken several enormous hits in the successive rounds of disease emergency responses. In the early 2000s, the company worked on a West Nile virus vaccine. Though the disease still causes hundreds of cases of severe illness in the U.S. every year and is estimated to have been responsible for over 2,000 deaths from 1999 to 2016, public fear abated, taking with it the prospects for sales of a vaccine. Sanofi eventually pulled the plug.

In 2016, Sanofi was the only major manufacturer to commit to trying to make a Zika vaccine on an expedited basis. But BARDA, which had been helping to fund the work, told Sanofi last year that it would not support the company’s Phase 3 trial – the large and expensive study needed to prove a vaccine works — and instead backed an effort by Takeda Pharmaceuticals.

At the same time, the company bore the brunt of a barrage of criticism for not publicly committing to a low-price guarantee for developing countries. Facing horrible PR and no sales prospects, Sanofi announced late last summer that it was out.

“It was a bruising experience,” admitted John Shiver, Sanofi’s head of vaccine research and development. “Honestly, we really were trying to be good citizens.”

As was the case with Zika, emergency vaccine development efforts are often at least partially funded from government coffers. But Hatchett said the sacrifices of pharmaceutical companies in outbreak response work are still underappreciated.

“If you look at the performance of the vaccine companies, it’s hard to think of an example going back 30 or 40 or 50 years where they haven’t stepped up to the plate. I think their record of corporate social responsibility is a story that they don’t get nearly enough credit for, given the risks and what they take on and how little they get out of responding,” he said.

Even if governments help fund vaccine work, money can dry up and costs can add up. Scientists reassigned to work on emergency vaccines have to put aside other work that their company — and its shareholders — hope will earn profits.

“There are opportunity costs, especially if you’re trying to do something fast. I mean, we put the equivalent of a couple of programs worth of people on Zika,” Shiver said. “They were all working on high-priority projects for us and we switched them off those projects. … And those programs slowed down or stopped.”

Shiver said particularly problematic for vaccine manufacturers is the fact that it is extraordinarily difficult to run the clinical trials needed to persuade regulatory agencies that emergency vaccines are safe and effective. Conducting research during a crisis is notoriously tough and, with diseases like these, after outbreaks end, there’s typically no way to mount a standard Phase 3 trial.

In an emergency, regulatory agencies may be willing to bend some rules. But once the crisis subsides, they revert to normal operating procedures — as Merck has found out as it tries to persuade regulators to accept data from an innovative ring-vaccination trial conducted on its Ebola vaccine.

“This is sort of a human nature problem. People pay attention to the burning house, and maybe not the one that’s got bad wiring, right, that’s down the street,” Shiver said.

Finding a way that allows vaccine makers to help without sustaining these kinds of operational costs is critical to the success of future disease outbreak responses, experts say. Because the reality is that even if a government or academic laboratory designs and tests a promising vaccine for a dangerous pathogen, someone has to make it — and potentially make large amounts of it.

“These repeated incidences where people were left hanging is going to make it a lot harder for companies to be able to make the case internally that they should get involved. And if that happens — which I think it is happening — the world is going to be in a much riskier place,” said Dr. Mark Feinberg, president of the International AIDS Vaccine Initiative and formerly Merck’s chief science officer.

  • For those who prefer vaccines—

    Since the flu shot is only 10% effective this year, be sure to get 10 flu shots for 100% protection… you know, for the greater good.

    Vaccine inventor Dr. Paul Offit MD says an infant can handle 100,000 shots at one time, so 10 shots for an adult should be no problem.

  • It’s funny in vaccines we see them totally differently then we do ANY other class of drug.
    I work strictly in Surgical Oncology (head and neck so VERY attuned to HPV) but as part of a team approach with my medical as well as radiation therapy teammates. At NO time do ANY of our patients expect, think, assume or even promise that ANYTHING we provide is going to cure them. Every patient knows we are doing the best we can that we are waist deep in an issue that Medicine is only on the tip of the tip of the iceberg in understanding and that EVERY approach is a risk vs benefit gamble and every side has pros and cons. Yet every patient stands in line writes letters to InsCos and PharmaCos to get access to technologies that MIGHT just MAYBE help them and that ALL have HUGE risks but they accept any of them blindly for a single chance to survive a few more moments
    In Vaccines the community is so stupidly misguided that they see vaccines as “force fields” that once given can then ignore any aspect of disease association. I have even seen nurses after getting flu vaccines modifying their own personal hygiene habits because they thought they were “immune to getting sick” (stopped wearing masks etc..)
    Seriously people time to stop watching Hollywood nonsense and realize that vaccines like ALL other drugs have huge failings but overall have FAR more positives than negative
    The RIDICULOUS article that suggested that because only 12000 women out of 170 million got cervical cancer that the likelihood was small and therefore no need to vaccinate demonstrates the authors ABSOLUTE irresponsible “fake news” approach to science and society
    He neglected to also say that of the 12000 who did get it last year that 75% won’t make it 20 months and of the similar numbers of pharyngeal oral cancer patients less than 25% of them will make it 36 months
    The suggestion that instead of vaccination of girls and boys who will get HPV instead we should spend all that money on opioid treatment facilities (that have an 85% recidivism rate)
    Come on people YES vaccines have risks as do aspirins and Tylenol. Tylenol is the NUMBER ONE cause of liver failure in the US. Tylenol overdose is the primary cause of ED visits for liver failure in the world.
    More people die from bee stings then vaccines yet I don’t hear a massive surge to find insecticides to prevent that
    We have some good technology with vaccines NO they don’t make much money for the manufacturers and yes they do have side effects but overall the globe is still here thanks to polio and smallpox vaccines. Without them, it is highly probable that most of you would not be here to read these blogs
    Wake up folks there is no panacea and no solution with risk and surely no reward without some effort
    If you actually believe the conspiracy theorists be it on your head and your life but the majority of society has done very well with the various immunities we have created thru the vaccination programs and many will do very well in future years as more are created. Stop expecting perfection and accept small steps forward being better then no steps at all.
    Dr. Dave

    • I don’t think anyone is saying that existing vaccine companies do not make a profit (the ones that don’t go out of business), but as the link states, this should not be a motivation to not be vaccinated.

    • It’s the cozy relationship between ACIP, CDC, CDC Foundation, and Pharma that makes the public suspect of approval bias. Close inspection of vaccine safety studies confirms analysis to result, confirmation bias, sanitation, non-objective model selection, unusual choices in study design and design of analysis, and, most of all, low power (for most studies) for detecting adverse events.

    • All these organizations work toward a common goal, at least in part. To some it appears as cooperation and alignment; to others, it appears as collusion (the latter term having a more sinister overtone). We can be sure that this is not a sinister plot to poison people or put people in danger. At worst, it would be confirmation bias, which researchers generally work hard to avoid. Regulations also have requirements that lead to more objective decisions. It is not perfect, though, due to the response diversity in people and the complexity of biological systems. As in political arguments, exceptions are cited as a reason to condemn the whole, and this is no different. As cited elsewhere here, they are also not zero risk, but the benefits far outweigh potential downsides.

  • I stopped at “they set aside their profit-making…” what? what? that’s what this poison flu vaccine is all about! and you show an old man who gets a double dose of “flu shot” poison! what a load! No flu shot for me since I was forced working alone at night the OFFICE of a hospital 2014! And it turned out that the hospital was offered hundreds of thousands of dollars if they got 90% “compliance” with their Flu shot. I got sick that year, but no other flu since 1967! This is disgraceful.

    • “Poison flu vaccine”?? They would not be on the market if poison due to FDA requirements. I am glad that you have not had the flu for much of your life, but others are not so lucky. BTW, a compliance inducement may have been a contractual agreement to satisfy a sample size, a health insurance driver or simply protection of others in the hospital whom are more prone to infections.

    • We’ve failed as public health educators if the myths about the fake dangers of vaccines and lies about private companies making big profits from them continues to persist as shown in your comment. I highly recommend not “stopping” and actually READ the whole, well-researched article with an open mind and learn the truth. Public health suffers when people stop reading, learning, and listening to public health experts and believe myths instead of the science and facts.

    • Yes, a lot of medical facilities get bonuses for high compliance rates on flu shots and the like but it’s not from pharmaceutical companies, it’s from medical insurance companies. The reason; if you prevent the disease from happening, it’s cheaper for them rather than paying out for ongoing medical care when someone gets sick. If there was even the slightest hint of danger that vaccinations of any kind did more harm than good, the last people to offer bonuses for the uptake of vaccination would be insurance companies.

  • @Carl, below (replies are inoperational)… vaccine makers cannot be sued. Under the The National Childhood Vaccine Injury Act (NCVIA) of 1986 (42 U.S.C. §§ 300aa-1 to 300aa-34), all cases are referred to the National Vaccine Injury Compensation Program, in which the injured (or their families) must sue the US Dept of Health and Human Services. There are 8 Special Masters that hear the cases, and fixed table of injury types allowed per vaccine. The Compensation Program has paid out close $4billion dollars in settlements since 1986. Not all injuries make it to program, because many people don’t know about it. Re: risk communicated on VISs, handing patients VISs after the shot does not count as informed consent. It counts as denial of informed consent. I was CENSORED by CDC for my comments during open comment period in Dec 2016 when they attempted to weaken the warnings on the MMR. My comments were redacted (as were others), until we informed the CDC via a lawyer of the First Amendment. Then ours, and others not yet published (withheld) were published. Re: “Antivaxxer”, that’s a slur. You clearly don’t know anything about what you’re talking about. Being vaccine risk aware, and calling for improvements to vaccines does not make on “Antivax”. Vaccine makers are not help accountable anywhere for their products, or their so-called “science”, and CDC and ACIP have rigged the system against finding safety issues with vaccines. FDA does not require dosage safety testing for anything other than proteins in individual vaccines, and FDA has nothing to say about pediatric dosing of aluminum w/2 or more shots in a single day. It’s reckless and irreponsible. Neil Miller found increased mortality and morbidity w/concurrent vaccination compared to single vaccines per day.
    Vaccine makers are aware of the contaminants like copper found in vaccines that can bind aluminum and antigens making the vaccines less effective. We need objectivity in our next phase of consideration of artificial immunization.

    • James, thanks for your reply. I do find the need to address some other points that you make in your reply. I am not aware that the CDC or ACIP has a rigged system. Regarding dosage safety testing, vaccines certainly have that, although the ranges are much broader than proteins due to the complexity and precision of the tests for them (cell based testing which is more variable that protein quantitation). Neil Miller may have come to a certain conclusion, but many others may have come to a different one. We don’t want a repeat of the Wakefield incident based on the opinion of one person. I am not implying that Miller is a fraud like Wakefield, just that science needs to be checked my others – it’s the reason scientific reviews are necessary.

    • @Carl, other may have come to different conclusions, but not based on any study of morbidity and mortality of 2+ vaccines/day/week/visit vs. 1/day/week/visit. Other than Miller’s, no such studies have been conducted. And we see no RCTs of the schedule, instead we see post-market surveillance in which parents and patients are not told they are being given new experimental vaccines (safety is presumed in so-called pharmacovigilence retrospective studies). HPV pre-licensure studies had breathtakingly brief period for adverse event detections (4 days), and long-term safety was aborted b/c all participants were vaccinated at the end of the study. Not all adverse events were reported; some were put into “new medical records”… not science. https://slate.com/health-and-science/2017/12/flaws-in-the-clinical-trials-for-gardasil-made-it-harder-to-properly-assess-safety.html

  • Good. Their out-dated technology fails on safety for some people and for efficacy (e.g., Tdap and MMR) because they are formulated with safety LAST. Many vaccines use metal toxins; Many do not screen for unsafe epitopes. We need an open market w/competition. Microneedle technology could use Vitamin E crystals as the delivery medium, hit the epithelial dendritic cells, use only proteins that do not match human proteins. Aluminum and mercury are neurotoxins, and denialism is no longer working. I’d be happy to see them move on and make room for true initiative. Otherwise we need vaccine risk biomarkers and rational screens to identify susceptible subtypes (as mandated by Congress in 1986). Either way, we need to make vaccines safer (also as mandated by Congress in 1986). Merck stands in court, accused of adding rabbit anti-mumps antibodies to the MMR to defraud the American public; Tdap is a failed vaccine that was brought into use during pregnancy w/insufficient safety data; safety studies by CDC failed to report rates of spontaneous abortion w/TdaP exposure during pregnancy. The sacred aura of vaccines is lost due to these (and other) concerns. I for one would love to see a return to objective science. CDC should have nothing to do with the next generation of public health tools. Nothing they have done is justified. We need state re-assertion of protections of informed consent in human subject studies, including vaccines. We need RCTs, not retrospective studies. We need to repeal the National Childhood Vaccine Injury Act – why should any corporation enjoy protection from liability? It’s the deaths and injuries that inform on product quality – that’s feedback to vaccine makers that should be SOUGHT after to IMPROVE their product. We are 20 years behind in improvements in artificial immunization technologies. Let new technologies compete on the proving grounds of safety. If you can’t be part of the improvements in the future, by all means, move along and get out of the way.

    • I agree with some of your points but some are a bit exaggerated. A few vaccines have been on the market for decades, so their technology is a few decades old. We are seeing improvements with the latest licensed vaccines, and the market is working (Shingrix is a good example). The NCVIA does not protect companies from liability, but it does limit liability so they do not either stop producing vaccines entirely. Not everything is shiny but vaccines have saved many lives and many are still needed.

    • Carl
      We obviously have an Anti-vaxer here so arguing is a moot point. The issues of all of the negative aspects of vaccines are well edudicated and weighed into the of pros and cons. The issues in this article are based on economics, not efficacy. If the issue is efficacy then we need to take that up with the FDA committee on vaccination and immunization. The issue is that economically none of these companies are making money on vaccines they produce and develop them as a service to society and HOPE that they can get a winner to bolster their corporate identity and maybe break even. NOT every aspect of a PharmaCo is going to hit a home run but in vaccination, they NEVER hit one. between the cost to produce and develop them coupled with the universal aspect to provide them at minimal cost to third world nations, they are in a lose-lose situation and I see why so many are bailing out. Look at the African multi-outbreak pandemics over the last 25 years. The companies stepped up some succeeded in creating vaccines and some didn’t and the ones who did sell them to WHO at a minimal profit it at all. Imagine a WHO announcement that says ABC PharmaCo refuses to sell the vaccine to starving African areas due to solo to price objections? It would be a HUGE PR nightmare. SO instead they all but gift them move on
      They earn their profits in places like the US EU and UK but if we are not exposed then they have limited incomes
      Not sure about you all but ever seen a Dengue Fever patient in your practice? NOT us! Even if we did I can’t imagine convincing Orlando Florida to vaccinate against it for the one who came over from a trip abroad with it.
      Dr. Dave

  • People are rightly suspicious of emergency vaccines brought out quickly. They have always had tons more side effects. Like the flu vaccine 1976 disaster and the 2009 pandemic flu shot had tones of problems, like many more cases of GBS and narcolepsy. Especially in Europe.
    Many also feel there are just too many vaccines now. How many is too many? More and more studies are coming out showing long term problems. I will take a once in a life time measles vaccine. But will never take a un-needed, next to useless yearly flu shot.
    I would also be suspicious of any so-called pandemic. The last 3 have been false alarms.
    Sars. Read this. SARS in the end was nothing, just, Quote, “full media freak-out” -http://www.forbes.com/2009/04/27/swine-flu-mexico-sars-business-healthcare-flu-hysteria.html
    -http://www.spiegel.de/international/world/reconstruction-of-a-mass-hysteria-the-swine-flu-panic-of-2009-a-682613.html Fake pandemic.
    http://www.nytimes.com/2005/10/23/weekinreview/lessons-from-a-plague-that-wasnt.html This is about the fake 1976 flu pandemic, and says the flu shot kill over 30 people and paralyzed over 500, before they canceled it.

    • To heck with the emergent vaccines, the ones that are taken their time with are as bad
      This year the annual flu vaccine is at BEST 28% effective. No fault of the actual vaccine but the virus that was chosen based on the algorithms is NOT the virus we actually have this year
      Each year the research community has to guess what the next year’s variations and mutations will be this year they missed it by a MILE and the UK alone has been forced to cancel over 50K elective surgeries due to not having enough bed space to see the patients since they are filled with flu patients. California is totally out of OTC flu products CVS is trucking in from other states but that will soon come back to bite them as well.
      Every hospital has EDs with patients stacked up and housed in the hallways since there are no beds left
      ALL because the process of vaccines is less science then we expect
      In the future, I suspect that vaccines will be part of a different process with individual immune responses evaluated rather than trying to create micro-organism specific ones. We will turn “up the immune system” for all types of conditions, not a virus or bacterial speciific. this is already happening in oncology so it will widen in scope as time and money are invested
      Dr. Dave

  • Thank you for the education. You have provided us Docs with yet another opportunity to pay homage to one of Medicine’s favorite apple pies, Vaccines. Like Medications, Vaccines are portrayed as no-fail /no risk solutions. So powerful is the Vaccine Lobby, that any doctor who has any reservation about their usefulness or toxicity will be branded, at the very least, as hopelessly ignorant by colleagues. Think back to a year ago, Jan 7, 2017, when Daniel Neides MD, CEO of Cleveland Clinic, dared to dissent. Even business heavy weight, Forbes, and news media giants got in on the slamming fest. Not to worry, the Vax businesses have stepped up the rate and kinds of immunizations for infants who don’t yet have their own immunity. With a little help from their friend, the CDC. The rationale is that parents don’t have to worry, come back for another shot, and sign “yes,” again. How thoughtful.
    If you’re a parent, expecting to be informed about this more efficient, new challenge to your newborn, don’t hold your breath.
    And what about the rest of us? No one asks, exactly. Just sign the papers and stop holding up the line. Now vaccines are required, meaning the LAW, for both working in a hospital, and even becoming a patient in a hospital. (If you’re comatose, you’re out of luck. You just get it.)
    So I must ask this author, how can vaccine manufacturers be hurting when they have literally captive consumers, meaning us and US, repeat customers with no competition? That sounds like a darn good business deal .

    So, no thank you, my heart does not bleed for vaccine companies.
    In fact, we Docs could use a lesson from them, not about vaccines, but how they managed such cozy deals. No one taught us THAT in medical school.
    Peggy Finston MD
    http://www.Acu-Psychiatry.

    • “Like Medications, Vaccines are portrayed as no-fail /no risk solutions.” Portrayed by whom? The pediatricians or other vaccinating MDs? The vaccine manufacturers? The CDC or ACIP? A patient or parent only has to read the Vaccine Information Statement (VIS) that should be handed out by any competent medical office to see that Section 4 lists the documented risks and Section 5 lists what adverse events to look for and what to do. The MMR VIS lists even lists “Permanent brain damage” as a possible risk even though it has been measured to occur at a rate of 0.69 times per million doses given. All of the pediatricians in our group verbally convey this information anyway during an office visit with a vaccination, so “If you’re a parent, expecting to be informed about this more efficient, new challenge to your newborn, don’t hold your breath” is true for someone, then they should seek more competent pediatricians.

      The vast majority of those promulgating that vaccines are “no-fail” (100% efficacy) and “no risk” (100% safe/0% adverse events) are those against vaccines who use that assertion as either a strawman to easily knock down (plenty of evidence to the contrary, the existence of VICP for example) or to further the false dichotomy that a <100% effective vaccine (all of them) is the same as a 0% effective vaccine.
      https://www.cdc.gov/vaccines/hcp/vis/current-vis.html

    • If you are an MD, then you should know that no medication is without risk, there is always a risk:benefit ratio, even for aspirin. Also, you do make conspiracy-like statements that appear less objective to make your point. Many vaccines do have competition – very few do not. With all due respect, having an MD specializing in psychiatry (I assume from your link) is not the same as specializing in infectious diseases.

  • This is really a pile of BS as far as I can tell. Firstly, since vaccines are supposed to be a public health measure, they should never have been privatized to begin with, and that held especially true in 1986 with the advent of the blanket immunity vaccine makers suddenly received, which gives them no impetus to bother making safe vaccines. Meanwhile, these same vaccine makers are RAKING it in with all other vaccines aside from the “emergency” ones mentioned in this article, and they have the governments in the palms of their hands, legislating vaccines to be mandatory, even Gardisil which makes no sense since HPV can NOT be contracted in a casual social setting, and the HEP B vaccine on first day of life which also makes no sense since most babies will never get hep B or come close to getting it until they’re teenagers. The government, if it had any responsibility, would pull ALL vaccines from the drug companies and make all vaccine makers public.

    • You do remember this is America, right? We like to privatize societal benefits, not the other way around. You also recognize the United States federal government doesn’t mandate anything – these are state specific school/employment rules you are referencing. There is only ONE state that has successfully ‘mandated’ the HPV vaccine for middle schoolers, and the backlash was so severe they had to create a special exemption category outside of religious and medical to satisfy people. And if you would like, I could get my labor and delivery nurse friend to explain to you why all babies receive the Hep B vaccine at birth, especially those being born to Hep B positive mothers.

    • Mike
      Not sure what you mean “casual contact” but that is EXACTLY how HPV is contracted
      When I started in H&N cancer treating arena in the early 80’s the issue was smoking and drinking now the majority of oral pharyngeal cancer are HPV based and 90% of cervical cancer is HPV based. SO much so that we don’t even bother to vaccinate after age 26 because it is assumed that everyone has by then had sex with someone that has given them HPV and they developed their own immune response
      Vaccines are all out a dead issue financially
      Even Gardisil and Prevnar have no real income potential for their respective costs. None of the PharmaCos are getting rich on vaccines they add them to their portfolios for “Good Samaritan bonus points” with their stockholders
      Add to that the failure rates and the pressure to get past otherwise generous regulators if done in a timely manner to a pandemic but otherwise ridiculous when not they are smart to back off.

      If the society REALLY wants vaccines it should have the NIH and CDC develop them and let PharmaCos bid to market and manufacture them
      I recommended that to the previous FDA chair and it went over like a lead balloon BUT Gotleib is a TOTAL different breed of cat and might just be open to it
      Dr. Dave

    • Vaccine manufacturers are interested in safety because (1) there are many caring people that do this work and have a conscience, (2) companies would be sued even more than now if they had no regard for safety, and (3) the FDA requires extensive safety studies before allowed to be put in humans.

  • This is similar to the drivers that led to the Vaccine Childhood Injury Act of 1986, which was initiated since many companies stopped efforts in the 1970s due to the high financial liability associated with vaccines. History is repeating.

    • Thanks for providing some focus on an element of current vaccine research, development and commercialization. The article provides a lot of focus on vaccine development efforts towards outbreaks, but there’s an important and larger sector of vaccine research that includes pediatric, prophylactic vaccines, which have been incredibly successful — first from a human health perspective, but also commercially (think about many years of earnings across MMRII, Recombivax, Gardasil, RotaTeq, Penumovax23, Prevnar13, etc., etcc). And, there’s a new wave of vaccines in development against infectious disease as well as for example, immuno-oncology (oncolytic viral immuno-therapies). In short, while the commercial challenges of developing a vaccine against an outbreak may be real, and the model needs to be re-evaluated, let’s not lump all of vaccine manufacturing into that category. MMRII has been on the market for >70 years in the US, and if one considers the “area under the curve”, the total commercial earnings from that product are the equivalent of an annuity investment few would mind having in their portfolio — not to mention the millions of children’s lives saved and made better because they don’t get measles, mumps, or rubella.

Comments are closed.

Sign up to receive a free weekly opinions recap from our community of experts.
Privacy Policy