This article has two objectives. One is to present the adverse effects of the two smallpox vaccines, JYNNEOS and ACAM2000, also used for monkeypox.
The second is to demonstrate that reporting adverse events after vaccination (like COVID-19 shots) is necessary so that the safety profile of that product can be more defined. Knowledge about adverse effects should be weighed together with the benefits when getting vaccines.
Latest Monkeypox News
As of today, BNO News tallies the monkeypox cases at 322 confirmed, 74 suspected, and zero deaths.
CBS News reports that Denmark, France, and the UK are the countries recommending smallpox vaccination for the close contacts of patients with monkeypox. CNN reports that the US is urging the same for its citizens.
The purpose of vaccinating close contacts is to prevent the spread of monkeypox by providing active immunity to the contacts. As it is called ring vaccination is a strategy that provides a buffer between a monkeypox patient and the rest of the population.
All vaccines have adverse effects, and vaccine makers must inform people. To know what these adverse events are, the number of people who develop those conditions (Adverse Events of Special Interest) is compared between the group that received the vaccine and the placebo group during the vaccine trials and after the release to the public.
Read more about AESIs at The Complete List of the Pfizer Adverse Events of Special Interest.
The image below shows the typical monkeypox rash. It is indistinguishable from smallpox.
Smallpox vaccines for Monkeypox
JYNNEOS™ and ACAM2000™ are FDA-approved vaccines for smallpox used for monkeypox since both viruses come from the Poxvirus family. Their adverse events are listed in their product inserts.
JYNNEOS™ Cardiac Adverse Events of Special Interests (AESI)
Cardiac AESIs were reported in 1.3% (95/7,093) of JYNNEOS recipients and 0.2% (3/1,206) of placebo recipients who were smallpox vaccine-naïve.
Cardiac AESIs were reported in 2.1% (16/766) of JYNNEOS recipients who were smallpox vaccine-experienced.
The numbers of JYNNEOS and placebo recipients, respectively, with troponin-I data, were:
- baseline troponin-I level (6,376 and 1,203)
- troponin-I level two weeks after the first dose (6,279 and 1,166)
- level two weeks after the second dose (1,683 and 193)
- unscheduled visit, including for clinical evaluation of suspected cardiac adverse events (500 and 60).
Comment: In medicine, the cardiac enzyme troponin I is ordered when someone has a complaint due to a heart problem like chest pain or shortness of breath. Elevated levels of troponin I may be due to heart muscle damage. Based on the number of people who got their troponin-I tested, more people given JYNNEOS complained of cardiac symptoms than the placebo group.
Among the cardiac AESIs reported, 6 cases (0.08%) were considered causally related to JYNNEOS vaccination and included tachycardia, electrocardiogram T wave inversion, electrocardiogram abnormal, electrocardiogram ST-segment elevation, electrocardiogram T wave strange, and palpitations.
Comment: EKG changes and troponin-I elevation are suggestive of myocarditis and pericarditis. However, the JYNNEOS product information does not mention if any further testing, like an MRI or echocardiogram, was done to confirm or rule out the diagnosis.
If there is no definitive evidence of myocarditis or pericarditis (MRI or echocardiogram), they can say that those conditions did not happen. Naturally, their conclusion is as follows,
None of the cardiac AESIs considered causally related to study vaccination were deemed to be serious.
Vaccine recipients should report any adverse events to their healthcare provider or the Vaccine Adverse Event Reporting System at 1-800-822-7967 and www.vaers.hhs.gov.
ACAM2000™ Adverse Events of Special Interest
From their product insert,
ACAM2000 may cause serious heart problems, including myocarditis and pericarditis. This can happen within 3 to 4 weeks after you get the vaccine.
Most people who get myocarditis and pericarditis seem to get better after a few weeks. But heart problems may last longer in some people and, in rare cases, could lead to death.
Other serious side effects include:
- swelling of the brain or spinal cord
- problems with the vaccination site blister, such as it becoming infected
- spreading of the vaccine virus to other parts of your body or another person
- severe allergic reaction after vaccination
- accidental infection of the eye (which may cause swelling of the cornea causing painful, watery eyes and blurred vision, scarring of the cornea, and blindness)
To report SUSPECTED SIDE EFFECTS (ADVERSE REACTIONS), contact Emergent
BioSolutions at 1-877-246-8472 and productinquiries@ebsi.com or VAERS at 800-822-7967 and https://vaers.hhs.gov.
Having a diagnosis is essential.
There is a difference between the adverse events of JYNNEOS and ACAM2000. JYNNEOS lists EKG abnormalities and abnormal troponin, while ACAM2000 is more forthright and open since it listed diagnosis.
Most likely, JYNNEOS has myocarditis and pericarditis as serious adverse events, but they are hidden behind the EKG and the troponin-I.
Lesson: If you develop an adverse event after vaccination or medication, insist on a diagnosis. For example, ask if the abnormal EKG is due to myocarditis. And then report to VAERS or the pharmaceutical company.
Remember: You get only symptomatic treatment if you have only symptoms but definitive treatment if you have a diagnosis.
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Related:
- The Complete List of the Pfizer Adverse Events of Special Interest
- Smallpox vaccines for monkeypox
- Germany orders 40,000 smallpox vaccines
- Did the Wuhan Virology lab mutate the monkeypox virus?
- Aerosolized Monkeypox Viruses
- The 2021 Monkeypox tabletop exercise resulted in 3.2 billion cases, 271 million dead
- Monkeypox: Time for disinfection again
- Know more about Monkeypox
- A Smallpox Epidemic is More Possible than You Think
- First cases of human cases of H5N1 influenza in the US and H3N8 in China
- Pathogens from the Pentagon BioSafety labs in Ukraine revealed
- Pentagon Bio-laboratories in Ukraine
- Bioweapons from Ukraine are now in the US
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