At the bottom of this article I have posted excerpts from the label for Jynneos and an FDA review document. In a nutshell:
1) there is no evidence to support using this vaccine in pregnancy, lactation or children. There is no information on male (as well as female) fertility effects or carcinogenicity.
2) About 2% of recipients had a serious adverse event
3) According to the label, between 1.3% and 2.1% of recipients had a cardiac event of special interest, compared to 0.2% of placebo subjects. According to the FDA review document, not mentioned in the label, there were 10% and 18% of subjects with troponin elevations in two sub-studies. This suggests that somewhere between 1 in 90 and 1 in 6 people will have a troponin elevation or EKG abnormality, indicating some degree of cardiac damage due to the shot.
4) The monkeypox virus against which the vaccine was tested is probably quite different from the monkeypox virus currently circulating.
5) Now, if you want a scarier picture of what the vaccine does to recipients, it is found in the FDA review of the documents and studies that led to Jynneos’ 2019 license, but was not included in the label.
For example on page 191 of the FDA review: 8% of those subjects who were HIV positive could not get their second Jynneos dose due to side effects from the first. 7% of the HIV positive subjects had worsening of HIV parameters. It is likely that Jynneos causes immune suppression.
Thirty-eight SAES [serious adverse events] were reported in HIV-infected subjects (17 vaccinia-naïve, 6 vaccinia-experienced) and none in HIV-uninfected controls. Most of these fell under the Infectious or Respiratory SOCs. One of these SAEs, pneumonia which occurred 2 days after the 2nd dose of MVA-BN in a 39-year-old HIV-infected, vaccinia-naïve woman, was considered possibly related to MVA-BN. [And the rest weren’t, even though you withdrew the subjects from further doses?–Nass] Of note, 1.0% of HIV infected subjects (n=6) were withdrawn from the study due to AE and 7% (n=35) of HIV infected subjects did not receive a second dose of MVA-BN due to worsening of HIV parameters (drop in CD4 count or rise in HIV viral load) after the first dose.
Doorless Carp wrote a thesis on all the issues with the Jynneos vaccine on June 3 while I only have the Cliff’s Notes here, scattered through several posts. [I give a more comprehensive presentation today, Aug 9 to Medical Doctors for COVID Ethics.]
His article is de rigeur for those who really want detailed information about this subject. It deserves a lot of attention—thanks for pointing it out! Here it is:
Now for the label:
5.1 Severe Allergic Reactions
Appropriate medical treatment must be available to manage possible anaphylactic reactions following administration of JYNNEOS.
The risk for a severe allergic reaction should be weighed against the risk for disease due to smallpox or monkeypox.
6. Adverse Reactions
Serious Adverse Events
SAEs were monitored from the day of the first study vaccination
through at least 6 months after the last study vaccination.
Among the smallpox vaccine-naïve subjects, SAEs were reported for 1.5% of JYNNEOS recipients and 1.1% of placebo recipients. Among the smallpox vaccine-experienced subjects enrolled in studies without a placebo comparator, SAEs were reported for 2.3% of JYNNEOS recipients. Across all studies, a causal relationship to JYNNEOS could not be excluded for 4 SAEs, all non-fatal, which included Crohn’s disease, sarcoidosis, extraocular muscle paresis and throat tightness.
Cardiac Adverse Events of Special Interest
Evaluation of cardiac adverse events of special interest (AESIs) included any cardiac signs or symptoms, ECG changes determined to be clinically significant, or troponin-I elevated above 2 times the upper limit of normal. In the 22 studies, subjects were monitored for cardiac-related signs or symptoms through at least 6 months after the last vaccination. The numbers of JYNNEOS and placebo recipients, respectively, with troponin-I data were: baseline level (6,376 and 1,203); level two weeks after first dose (6,279 and 1,166); level two weeks after second dose (1,683 and 193); unscheduled visit, including for clinical evaluation of suspected cardiac adverse events (500 and 60). [What happened to the rest of the people (about 70%) who should have gotten a second dose? Why are they missing followup visits?–Nass]
Cardiac AESIs were reported to occur 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 to occur in 2.1% (16/766) of JYNNEOS recipients who were smallpox vaccine-experienced. The higher proportion of JYNNEOS recipients who experienced cardiac AESIs was driven by 28 cases of asymptomatic post-vaccination elevation of troponin-I in two studies: Study 5, which enrolled 482 HIV-infected subjects and 97 healthy subjects, and Study 6, which enrolled 350 subjects with atopic dermatitis and 282 healthy subjects. An additional 127 cases of asymptomatic post-vaccination elevation of troponin-I above the upper limit of normal but not above 2 times the upper limit of normal were documented in JYNNEOS recipients throughout the clinical development program, 124 of which occurred in Study 5 and Study 6. Proportions of subjects with troponin-I elevations were similar between healthy and HIV-infected subjects in Study 5 and between healthy and atopic dermatitis subjects in Study 6. A different troponin assay was used in these two studies compared to the other studies, and these two studies had no placebo controls. The clinical significance of these asymptomatic post-vaccination elevations of troponin-I is unknown. Among the cardiac AESIs reported, 6 cases (0.08%) were considered to be causally related to JYNNEOS vaccination and included tachycardia, electrocardiogram T wave inversion, electrocardiogram abnormal, electrocardiogram ST segment elevation, electrocardiogram T wave abnormal, and palpitations.
None of the cardiac AESIs considered causally related to study vaccination were considered serious. [I guess heart attacks and myocarditis no longer count as serious when there are $Billions at stake–Nass]
All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Available human data on JYNNEOS administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy.
It is not known whether JYNNEOS is excreted in human milk. Data are not available to assess the effects of JYNNEOS in the breastfed infant or on milk production/excretion.
8.4 Pediatric Use
Safety and effectiveness of JYNNEOS have not been established in individuals less than 18 years of age.
JYNNEOS is a live vaccine produced from the strain Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN), an attenuated, non-replicating orthopoxvirus. MVA-BN is grown in primary Chicken Embryo Fibroblast (CEF) cells suspended in a serum-free medium containing no material of direct animal origin, harvested from the CEF cells, purified and concentrated by several Tangential Flow Filtration (TFF) steps including benzonase digestion. Each 0.5 mL dose is formulated to contain 0.5-3.95 x 10 to the 8th power infectious units of MVA-BN live virus in 10 mM Tris (tromethamine), 140 mM sodium chloride at pH 7.7.
Each 0.5 mL dose may contain residual amounts of host-cell DNA (≤ 20 mcg), protein (≤ 500 mcg), benzonase (≤ 0.0025 mcg), gentamicin (≤ 0.163 mcg) and ciprofloxacin (≤ 0.005 mcg).
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
JYNNEOS has not been evaluated for carcinogenic or mutagenic potential, or for impairment of male fertility in animals.
13.2 Animal Toxicology and/or Pharmacology
The efficacy of JYNNEOS to protect cynomolgus macaques (Macaca fascicularis) against a monkeypox virus (MPXV) challenge was evaluated in several studies. Animals were administered Tris-Buffered Saline (placebo) or JYNNEOS (1 x 108 TCID50 ) sub-cutaneously on day 0 and day 28.
On day 63, animals were challenged with MPXV delivered by aerosol (3 x 105 pfu), intravenous (5 x 107 pfu) or intratracheal (5 x 106 pfu) route. Across all studies, 80-100% of JYNNEOS-vaccinated animals survived compared to 0-40% of control animals[Hang on, the monkeypox virus against which the Jynneos vaccine was tested killed 60-100% of the unvaccinated monkeys. But the currently circulating monkeypox virus has not killed a single American and causes a mild, self-limited disease according to the CDC. Seems like this vaccine was tested against a very different virus. Does it work against the current strain?–Nass]