FDA Licenses New Hepatitis B Vaccine Despite Big Safety Concerns

FDA Licenses New Hepatitis B Vaccine Despite Big Safety Concerns

In February 2018, the Advisory Committee on Immunizations Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) approved the recommendation for a new hepatitis B vaccine, Heplisav-B (HepB-CpG) targeting for adults over the age of 18.1 Heplisav-B is manufactured by Dynavax Technologies Corp. and the new vaccine is given in a two-dose series versus the three dose recommendation for Merck’s Recombivax hepatitis B vaccine licensed in 1986 and Glaxo Smith Kline’s Engerix-B vaccine licensed in 1989.

The U.S. Food and Drug Administration (FDA) had twice rejected Dynavax’s application for licensure for Heplisav-B in the past four years because of safety signals.2 In Dynavax’s third attempt, the FDA granted the license in November 2017, despite unresolved safety concerns. Below is the sequence of events leading to licensure of Heplisav-B.

In 2013, the FDA rejected Dynavax’s license application for Heplisav-B for the first time due to the regulatory agency’s concern that the experimental vaccine’s new adjuvant, which was designed to boost immunogenicity, could lead to development of autoimmune disorders.3 

Heplisav-B differs from other licensed hepatitis B vaccines in that it contains a new synthetic adjuvant known as cytosine phosphoguanine 1018 (CpG 1018) composed of short synthetic DNA molecules.4

Hepatitis B vaccines previously licensed in the U.S contain alum adjuvants (aluminum salts), which stimulate a general inflammatory response.3 CpG 1018 is believed to stimulate a more specific inflammatory response by producing hepatitis B surface antigen-specific antibodies against the hepatitis B virus.3

According to an article published in Medscape, the first application by Dynavax Technologies for licensure of Heplisav-B vaccine was rejected by the FDA for the following reason:

Although safety analyses showed no statistically significant differences between Heplisav and the currently licensed hepatitis B vaccine Engerix-B (GlaxoSmithKline) in local and systemic solicited adverse events or deaths, there were numerically greater numbers of patients receiving Heplisav who had evidence of autoimmunity disorders, including thyroid disorders. The increases were not statistically significant, but advisory panel members said the safety database was too small to detect rare adverse events.3

At the time, Melinda Wharton, Deputy Director of the National Center for Immunization and Respiratory Diseases at the CDC stated,  “I don’t think the safety database is sufficiently large to support a recommendation for use in the general adult population, given that this vaccine contains a new adjuvant.”3

 In 2016, the FDA rejected a second application by Dynavax for licensure for Heplisav-B vaccine. That time the agency was concerned about an increased rate of cardiovascular events and deaths in people who had been given Heplisav-B vaccine versus Engerix-B.5

In a randomized clinical trial involving approximately 8,400 subjects, 5,600 study participants received Heplisav-B and 2,800 participants received Engerix-B.6 7 During the trial, approximately 14 subjects in the Heplisav-B group had heart attacks in comparison to one subject in the Engerix-B group.6 7 Taking into account that the Heplisav-B group was twice as large as the Engerix-B group, the risk for heart attacks was seven times higher for people who had been given the experimental vaccine.6

In an attempt to minimize the significance of the increased rate of serious heart complications, Dynavax argued that the higher number heart attacks recorded in the Heplisav-B group was due to the “fewer than expected” instances that occurred with the Engerix-B group.8

According to a press release by Dynavax in 2016:

The FDA’s Complete Response Letter (CRL) seeks information regarding several topics, including clarification regarding specific adverse events of special interest (AESIs), a numerical imbalance in a small number of cardiac events in a single study (HBV-23), new analyses of the integrated safety data base across different time periods, and post-marketing commitments. In the CRL, the FDA acknowledged that it has not yet completed its review of responses received from Dynavax in early October, including those pertaining to AESIs and the numerical imbalance in cardiac events. The responses included an extensive analysis that included independent expert consultation supporting our view that the imbalance was driven by an unexpectedly low number of events in the comparator arm. It would appear the Agency could not fully assess the responses in the current review period. In the CRL, there is no request for additional clinical trials and there are no apparent concerns with rare serious autoimmune events.9

In July 2017, the FDA’s Vaccine and Related Biological Products Advisory Committee (VRBPAC) convened to re-evaluate the scientific evidence and make a decision on whether Heplisav B should or should not be approved for use in the U.S.6 A majority of the committee consisted of immunology and infectious disease professionals with only one cardiologist on the team, Milton Packer, MD, who is a Distinguished Scholar in Cardiovascular Science at the Baylor University Medical Center in Dallas, Texas.6

According to Dr. Packer, it was possible the strong inflammatory response induced by the Heplisav B vaccine’s novel adjuvant was causally related to the higher number of heart attacks in study participants who received the experimental vaccine. He said:

The advisory committee needed to consider whether it was biologically plausible for the new vaccine to cause heart attacks. The new adjuvant in the vaccine caused an inflammatory response of uncertain duration. We know that inflammation causes atherosclerotic plaques in coronary arteries to rupture—the event that triggers most heart attacks. So a causal link between the vaccine and heart attacks wasn’t out of the question. Most importantly, we needed to decide if the imbalance in heart attacks between the two groups could have been due to the play of chance. That was a great question, but one that was impossible to answer.6

Dr. Packer goes on to explain:

To know if the 7 -1 heart attack imbalance represented a real risk, we’d need comparative data in 50,000 people. The fastest way of obtaining that evidence would be through a post-marketing trial. But a post-marketing trial would be possible only if the vaccine was approved for public use.6

The FDA asked the committee to vote on whether there was reasonable evidence that Heplisav-B vaccine i safe. Twelve committee members voted in favor of the safety of the new vaccine, one voted against it and three abstained.6 Dr. Packer was one of those who abstained.6

Dr. Packer explains why he abstained:

Why did I abstain? Based on the available data, it was impossible for anyone to know if the increase in heart attack risk in the Dynavax group was real or spurious. So although the questions were fascinating and the discussions terrific, my vote wasn’t that complicated. There is a simple rule in life: if you don’t know, you should say you don’t know.6

Following the meeting, the FDA requested more information from Dynavax on its post-marketing study.6 Four months later, in November 2017, the FDA licensed Heplisav-B for use in the U.S, by adults over age 18. However, continued approval hinges on a post-marketing study that will compare health outcome results from people who have received Heplisav-B with those who have received Engerix-B.2

On the FDA website, the agency claims that, “FDA regulations for the development of vaccines ensure their safety, purity, potency, and effectiveness.”10

However, the fact that Heplisav-B vaccine was approved for public use despite clear evidence in pre-licensure clinical trials that the new vaccine is associated with development of autoimmunity, heart attacks and death calls into question the FDA’s commitment to adhering to its own regulations.


References:

1 Centers for Disease Control and Prevention. Heplisav-B (HepB-CpG). CDC.gov Apr. 28, 2018.
2
Lowes R. Heplisav-B Vaccine for Hep B Finally Wins FDA Approval. Medscape Nov. 10, 2017.
3 Tucker M. FDA Rejects Novel Hepatitis B Vaccine. Medscape  Feb. 23, 2013.
4 Dynavax Technologies Corp. Heplisav-B. FDA.gov 2017.
5 National Vaccine Support Group. Heplisav Hep B Vaccine Linked to Heart Attacks, Deaths.
6 Packer M. Is the new Dynavax hepatitis vaccine safe? I couldn’t tell — and I was advising the FDA. StatNews Aug. 4, 2017.
7 Food and Drug Administration. FDA Advisory Committee Briefing Document – Heplisav-B. FDA.gov July 28, 2017.
8 Clarke T. Dynavax hepatitis B vaccine works; raises safety issues: FDA. Reuters July 26, 2017.
9 Dynavax Innovative Immunology. Dynavax Receives Complete Response Letter from U.S. Food and Drug Administration for Biologics License Application for HEPLISAV-B. Dynavax Nov. 14. 2016.
10 FDA. Ensuring the Safety of Vaccines in the United States. July 2011.

16 Responses to "FDA Licenses New Hepatitis B Vaccine Despite Big Safety Concerns"

  1. Shawn Siegel   August 5, 2018 at 8:27 am

    Actually, it calls into question not only the FDA’s purpose, but its very existence. Values are judged by actions, not regulations.

    Reply
    • Rose   August 22, 2018 at 11:38 pm

      Shawn, I agree. Frankly, if all aliens are gone, we are safer from getting HepB, and do have to contend others with visas who bring this problem with them. I am sensitive to vaccines and this new version is scary because I already have thyroidism which started after get the 1980’s type of vaccine and I think now that it had caused this condition, and do not want to aggravate my body more. In my work I have to have HepB vaccination but I am not due again for a few years more and maybe a far better and safer HepB vaccine can be found. Why is it the pharmaceutical companies can’t come up with SAFE drugs that won’t kill you, cause you more health problems, and naturally overcharge on everything?

      Reply
  2. Robert L Wachsmuth sr .   August 5, 2018 at 9:11 am

    Doctors on a murder spree.
    Doctors in Queens New York are totally incompetent to even know vaccine injury is.
    Using vaccine injuries for I profit making scheme.
    It takes a whole day just to fill out the form. They’re not going to do that. Lazy and incompetent Insurance thieves
    a child with autism is worth nothing, a child with autism is worth 10 million dollars now which do you think the doctors would choose.

    Reply
  3. Robert L Wachsmuth sr .   August 5, 2018 at 9:14 am

    Doctors on a murder spree.
    Doctors killing off my family little by little.
    try to contact the Census Bureau to see how many families have been exterminated by the American Medical Association.

    Reply
  4. Robert L Wachsmuth sr .   August 5, 2018 at 9:16 am

    Doctors on the murder spree.
    The illusion of health care provided by the mainstream media.

    Reply
  5. Robert L . Wachsmuth sr .   August 5, 2018 at 9:36 am

    Doctors on the murder spree.
    It used to be welcome to America The Melting Pot.
    Now it’s welcome to America the human meat grinder.

    Reply
  6. Concerned   August 5, 2018 at 10:25 am

    Thanks for your great work in describing the issues with this vaccine and the behind the scenes deliberations. I’m shocked that anyone could vote yes for a vaccine with a questionable element that could cause this much damage. But that’s the world we live in. It’s sad that the public (including readers replying to today’s nytimes vaccine related article) is so schooled to react angrily (and often with their own misinformation) to any vaccine question. Most so called antivaxers just want a transparent and responsible process and a true understanding of all factors that underlie the rapid growth of neurological and autoimmune illness in this country.

    Reply
  7. Gary Mullennix   August 5, 2018 at 11:45 am

    Given that there is enough of a question that they are requiring a post marketing analysis, is it appropriate to warn Drs who prescribe this to not give to their population that is at a higher risk for cardiovascular events? I presume that would make the analysis meaningless so they won’t warn. I’ve sent to my family and my Physician to try to be sure no one I know takes the Hep B Heplisav B.

    Reply
  8. CATHERINE WHITE   August 5, 2018 at 12:42 pm

    Why do we need another one? Was the other one a failure that needs to be replaced? If that is the case then how could anyone be assured that this one is of any value (like any of them are). My answer to receiving any of these will remain NO!

    Reply
  9. Donna   August 5, 2018 at 1:58 pm

    Is HepB such a terrible thing that one might risk being injected with either aluminum etc. OR something synthetic that is supposed to mess with your genes. ? Come on now.

    Reply
  10. Jane Jones   August 5, 2018 at 2:44 pm

    You should post the video on this vote and how it was fast tracked.The video is so disgusting to watch. Those assholes have no business being on a committee that votes for any type of “healthscare”. They will now be using it and DENYING all the damages that it will cause because we all know the first rule of vaccines is #1. DENY ALL ASSOCIATED DAMAGE WITH VACCINES

    Reply
  11. PHYLLIS BALA   August 6, 2018 at 12:09 am

    Dear Dr. Packer:

    Would you give your own family members this new vaccine? Would you want it used on yourself?

    What criteria would you use to make those decisions? Thank you!

    Reply
  12. j   August 6, 2018 at 4:12 pm

    But this one’s better, because it costs more and will kill you faster, keel you keel you.
    The FDA has long been the most corrupted-absolutely Executive Branch Agency. It does NO quality-testing of its own, is merely paid to accept tests of tobacco or whatever by the highest bidder. It was brought away from guarding the ports & USDA Chemistry regulating misbranding drugs in the early days, to harass vitamin/supplement manufacturers, who interfered with the sales of dry boxed “breakfast” cereal, part of this balanced cancer. The key is to not kill people fast enough to get sued. Now we are back to where we were in the 1930s—but now the gov workers have protection. When science was that young, folks were still making their own bad ketchup, while companies were making their own bad drugs. Over time, Agency after Agency and CONgressjack after CONgressjack moved to get rich off more and more of the same. The foxes basically decided to eat the hen-house, eating out our substance, voting themselves the treasury. Even the military was willing to eat its own, with the Anthrax vaccine, but that was amateur–compared to the exempted/protected drug makers who kill the kids and families with the hardly-tested unregulated industrial chemical, and cannot be sued.
    Nothing has been done to halt, let alone punish, deceitful Vaccine makers, a couple decades now—even though CDC whistle-blowers proved THE CDC KNEW. Nothing can touch drug-makers’ huge bribes to the gov; nothing can close that effective gold-mine “ATM” they’ve opened. “Did you know they want to get rich off culling the population, i.e., kill us, Mom? Dad? Did you know?” Mom, dad, they renamed Hepatitis Not-A Not-B, into “Hepatitis C,” and the new 3-digit abbreviations makes it HCV. Is it possible YOU don’t have any of the diseases they made up, in order to sell these untested chemicals—while distracting you from vaccines for the older actual diseases, where the vaccines don’t work? Mom, dad can you please inject this straight into my blood stream, so as to bypass natural immunity protections, e.g., digestion, skin absorption, etc.? Good, that’ll be $666.
    When docs who know some chemistry fail to speak up, that’s iatrogenic: death by doc; which violates their basic oath of “first, do no harm.” Oh, unless I get rich?
    Today, we even have the better conservative Congressmen quitting, to be on TV “news” shows. YOU ARE NOT “REPRESENTED;” and in our lifetime we witnessed the government “souled-out, ” their coup against the D.J. T-Rump fueled by the leftist useful-idiot mainstream media & Hollowood. Fine young folks’ brains have been washed dumb-down, by media and the government-controlled public schools–another area where silent-majority teachers refuse to stand up and speak out against the corrupted-absolutely administration.
    IF YOU’RE NOT PART OF THE COUP, YOU’RE NOT GETTING RICH IN THE SHORT-TERM. Bob Mueller’s investigation seems to be a stall, to allow completion of the coup, by the sick Executive Branch traitors. (Remember, military is part of the E.B.) THE SNOOZE “NEWS” MEDIA WON’T SAY THE WORD “COUP.” GOV became as twisted mercenary as Hollowood and their wanna-be “news” media.
    The NRA fills their garages with ammo & Y2K supplies they will never use. Whitey will never riot.
    BUT IF YOU WOULD at least STOP PAYING YOUR DOCTOR & HOSPITAL, et al., IT WILL WAKE THEM UP. Of course, they’ll move to forced vaccinations & drugs, eventually. If so, you might finally realize it’s tyranny and the end of the Republic experiment.
    WHAT COULD YOU HAVE DONE TO STOP THAT?? Could you have ignored the lies of your TV & other media? WHAT IF you did NOT TELL YOUR DOCTOR YOU WANT THE DRUGS ADVERTISED.
    You know, all those drug ads that say tell your doc if you’ve had an infection or even in a country that has infections and T.B. Or symptoms of an infection or took a vaccine. (Because this drug will turn off your immune system, and you will die from random infections, while going bankrupt.)
    Or the drugs that say, “Don’t give this to a child under the age of six. Don’t give this to children age 6 to 18—as it may harm them.” Why don’t they say, “don’t give it to kids & teens”? They don’t mention under age six may be killed on the spot. They don’t want you to connect the testing on foreign-only children was a disaster. USA doesn’t allow its kids to be tested, so any testing is on desperate but willing 3rd-world lands. They’re not asking much, with drugs & vaccines. Only your children. C’Mon!
    NO NO, EVERYTHING IS ROSY. Look, you’ve got a squirrelly Twitter text!!

    Reply
  13. sheldon101   August 6, 2018 at 9:58 pm

    The last two paragraphs are not supported by anything in the article. Their purpose is nasty and is part of NVIC’s philosophy of taking issues on any vaccine and the FDA and expand it to all vaccines.

    Reply
  14. shell shockers   August 9, 2018 at 4:06 am

    Well, that’s a very specific vaccination against hepatitis B

    Reply
  15. Emily   August 13, 2018 at 12:02 am

    Pharmaceutical companies will continue to pump out and fast track as many “new” vaccines as possible, for one reason and one reason only, $$$$profits$$$$. Money and tgeir insatiable greed is the driving force behind new vaccine development And innovation.

    Their objectives and agendas are simple too, manipulate And brainwash the public to believe that “insert infectious disease” is a public health threat, fatal, dangerous, capable of unlimited complications, permanent effects, and death. And that this disease can only be avoided or an individual is vulnerable and susceptible to dying unless they immediately go get this “insert new vaccine or pharmaceutical company solution or treatments”

    Problem, reaction and their vaccine lucrative solution.

    Fear is the ultimate mechanism of control
    Amd pharmaceutical companies use this incessantly. They emotionally a people. Fear mongered them via the media, politicians, celebrities, medical authorities like CDC, AMA, and then influence doctors themselves, and GP or pediatric practices.

    That way they can brainwash people into thinking that they’re at risk of death from an deadly epidemic or outbreaks of whatever disease or vaccines they’re pushing, so that they can sell more vaccines.

    And there is ZERO incentive or motivation to ensure vaccine safety or effectiveness because vaccine.manufacturees are immune to any financial responsibility for any damage, reactions or deaths their vaccines cause. Not only can we not sue big pharma, but the lawsuits against vaccine injuries are all compensated with consumer accrued money in a trust fund that’s funded by vaccine recipients, by a .75 tax per disease in Vax.

    Literally, big pharma has absolutely zero reason to make safer or more effective vaccines, or to perform adequate testing, or do longitudinal studies on new vaccines because they aren’t liable if the vaccine harms or kills people. They are off the hook no matter how dangerous or worthless it is.

    So why wouldn’t they pump out as many new vaccines, and brainwash all of us into believing they all necessary, and push for federal mandates that force the skeptics to get vaccinated, and create and promote as many new vaccines as possible!?!?!

    Which is exactly what theyre doing. Their only motivation is profits. And our sold our Congress has created a system in which big pharma is off the hook for any responsibility, and has zero motivation to do anything but make as many vaccines as possible, ignore valid testing and research, fast track as many new vaccines as they can and then bribe politicians to pAas vaccine mandates that dictate individuals right to choose healthcare treatments and decisions and punish anyone who doesn’t comply. And this is working incredibly well.

    The ignorant and uninformed, dumbed down masses are constantly inundated with fear mongering lies and brainwashing so that they are inna constant state of fear and anxiety. And are stupid enough to believe that vaccines are their best protection and security. They demand as many vaccines as possible, and attack and berate and blame antivaxxers for routine vaccine failures.

    Fear and greed are the driving forces behind their entire business model, and due to corporate corruption and infiltration of our government, big pharma has zero liability or accountability and responsibility for making safe and effective vaccines. Profits trump people. And greed Trump’s necessity.

    The entire vaccine dogma and paradigm are dependent on fear, manipulation, ignorance, profits And greed.

    And so long as we continue to allow vaccine manufacturers to have total immunity to liability for tgeir products, then we can expect more vaccines to be added to the schedule, to be mandated for school and to be forced upon all of us despite any legit evidence of its benefits.

    And we can expect exponential increases in chronic illnesses, neurological, auto immune diseases, and declining health for our children and adults. We will.all continute to be sick, cancer ridden and dying prematurely.

    Reply

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