The New FDA Approved Hepatitis-B Vaccine – Trials Signal Heart Attacks

The New FDA Approved Hepatitis-B Vaccine
Trials Signal Heart Attacks

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The New FDA Approved Hepatitis-B Vaccine

Trials Signal Heart Attacks

We trust that they all know what they are doing. No one on the committee has any ties to the pharmaceutical industry. They are the absolute experts that we completely trust our lives with and would not steer us towards harm. So, of course, the new Hepatitis B vaccination is safe and effective.

They did say that about Vioxx, which ended up killing 55 plus thousand people? Some say the real numbers are more like 500 plus thousand people. They also knew that that Vioxx signaled myocardial infarction before it was approved and approved it anyway. This new Hepatitis-B vaccination HEPLISAV-B also indicates myocardial infarction.

Dynavax – Randomized trial of >8000 patients; about 5600 received the new vaccine with a new dual adjuvant. Around 2800 people received the existing standard vaccine. Why are they comparing it to another vaccine instead of a placebo we ask? The answer is the FDA does not do it that way. They do not compare it to a placebo in a double-blind control trial. Therefore, we cannot see the real effects and adverse side effects.

In the clinical trial, an acute myocardial infarction occurred in 14 people who received the new Dynavax vaccination. It happened in only one of the people receiving the conventional vaccine. The Dynavax group was twice as large. Therefore, the risk of acute myocardial infarction was seven times greater with the new vaccine in the trial.

They will say it is all just a coincidence but shouldn’t we do some further testing to know for sure? Their answer is NO. They are going to do post-vaccination monitoring and let us know later on. Will you take it and see if you have a heart attack and tell us about it afterward?

Remember the seven-year rule we discussed in other articles? Many say wait seven years to see the post-marketing results. If you waited seven years to see if Vioxx caused heart attacks, you would have been better off. Is this a coincidence or another Vioxx tragedy about to happen? They knew before the approval that Vioxx signaled myocardial infarction also. We are not assuming it is; we are just questioning why they do not try to find out before using humans as the guinea pig?

To help make a decision, it convened a public advisory committee meeting on July 28. The members of the committee consisted primarily of experts in infectious diseases and immunology. I was the only cardiologist on the committee, said Milton Packer, M.D.

If the 7-1 imbalance was due to the play of chance, then the issue of myocardial infarction risk was spurious, and the vaccine should be approved. But if the 7-1 imbalance reflected a real increase in cardiovascular risk, then approving the Dynavax vaccine would be problematic.

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.

Milton Packer, M.D., is the Distinguished Scholar in Cardiovascular Science at Baylor University Medical Center at Dallas. A version of this article originally appeared as part of his “Revolution and Revelation” column on MedPageToday.

No studies of HEPLISAV-B have been conducted in pregnant or lactating women.

So its use in women with these conditions must be weighed against the benefit. Although not an identified risk, the use of HEPLISAV-B concomitantly with another vaccine (e.g., zoster, pneumococcal) has not been studied. Dynavax plans to support a concomitant vaccine administration study postapproval.

Post Approval on pregnant women. We will let you know in seven years after the post surveillance if this will cause congenital disabilities or miscarriage.

Notable HEPLISAV Adverese Events

Notable Adverse Events in the Clinical Trials – Appendix 5

System Organ Class Preferred Term HEPLISAV-B (N = 9365)% (n) the number on the left, Engerix-B (N = 3867) % (n) the number to the right. Neither has been tested against a placebo in a clinical trial.

Subjects with at least 1 qualifying adverse event 4.8% (449) 4.8% (184)
Blood And Lymphatic System Disorders 0.04% (4) 0.08% (3)
Anaemia 0.02% (2) 0.05% (2)
Anaemia Vitamin B12 Deficiency 0 0.03% (1)
Leukocytosis 0.01% (1) 0
Microcytic Anaemia 0.01% (1) 0
Cardiac Disorders 0.63% (59) 0.54% (21)
Acute Coronary Syndrome 0.01% (1) 0
Acute Myocardial Infarction 0.17% (16) 0.05% (2)
Angina Pectoris 0.04% (4) 0.03% (1)
Angina Unstable 0.01% (1) 0.03% (1)
Atrial Fibrillation 0.07% (7) 0.10% (4)
Atrial Flutter 0.02% (2) 0.03% (1)
Bradycardia 0.02% (2) 0
Cardiac Arrest 0.03% (3) 0
Cardiac Failure 0.02% (2) 0.03% (1)
Cardiac Failure Acute 0.01% (1) 0
Cardiac Failure Congestive 0.06% (6) 0.08% (3)
Cardiac Ventricular Thrombosis 0.01% (1) 0.03% (1)
Cardio-Respiratory Arrest 0.01% (1) 0.03% (1)
Cardiogenic Shock 0.01% (1) 0
Cardiomyopathy 0.01% (1) 0.03% (1)
Coronary Artery Disease 0.09% (8) 0.08% (3)
Coronary Artery Occlusion 0.01% (1) 0.03% (1)
Coronary Artery Stenosis 0.02% (2) 0.03% (1)
Hypertensive Heart Disease 0.04% (4) 0.03% (1)
Myocardial Infarction 0.02% (2) 0.03% (1)
Myocardial Ischaemia 0.01% (1) 0
Pulseless Electrical Activity 0.01% (1) 0
Supraventricular Tachycardia 0.01% (1) 0.03% (1)
Ventricular Fibrillation 0.01% (1) 0
Ventricular Tachycardia 0.02% (2) 0
Congenital, Familial And Genetic Disorders 0.03% (3) 0.03% (1)

They say the heart attacks are probably a coincidence

And it very well may be but they will wait for observational post-marketing surveillance to find out. Be sure to report your heart attack to Vaccine Adverse Event Reporting System (VAERS) VAERS information line 1-800-822-7967

o In a single study, HBV-23, the preferred term of acute myocardial infarction was
reported in a higher proportion of HEPLISAV-B than Engerix-B recipients. A
comprehensive evaluation found:
 myocardial infarctions and MACE outcomes occurred in subjects in whom they
would be expected at rates similar to or below background;
 no evidence for theoretically plausible vaccine-induced immune etiologies;
 the most reasonable conclusion is the numerical imbalance is likely due to random
variation in small numbers of events, and
 a large, observational, post-marketing surveillance study is proposed as the most
feasible and appropriate design to confirm the safety of HEPLISAV-B.

Some of the people who experienced a heart attack after receiving the Hep-B vaccination have serious underlying medical conditions. This in itself should not automatically make it a coincidence, and we believe more studies should have been completed before the approval.

Clinical Trials

HBV-23: Myocardial infarction [Preferred Term: Myocardial Infarction]
A 47-year-old black or African American man with a relevant medical history that included
type 2 diabetes mellitus, peripheral vascular disease, gangrene left leg, left leg below knee
(b) (6)
amputation, and right leg edema experienced a fatal MI days after receiving the second
injection of HEPLISAV-B. The death certificate noted that the subject died in the hospital;
cause of death per the death certificate was an MI and the manner of death was noted as
natural. An autopsy was not performed. Medical records could not be obtained.
C5 adjudicated this as unable to determine whether it was a myocardial infarction event and
unable to determine the cause of death.

HBV-23 Subject: Acute myocardial infarction [Preferred Term: Acute Myocardial
Infarction]
A 69-year-old black or African American man with a relevant medical history that included
hypertension, congestive heart failure, abdominal aortic aneurysm, and neuropathy (b) (6)
experienced a fatal acute myocardial infarction days after receiving the second injection
of HEPLISAV-B. The subject was found dead in his home, slumped over in a chair. He was
last known to be alive 2 days prior. Resuscitative measures were not attempted. The cause of
death, per the death certificate, was acute MI due to atherosclerosis. Other factors noted as
contributing to the subject’s death were tobacco use and chronic obstructive pulmonary
disease (COPD). An autopsy was not performed.
C5 adjudicated this as a non-myocardial infarction event and as an undetermined cause of death.

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