Vaccines
看完研究報告，我只能說，我選擇不給我的小孩打。
兒童疫苗研究報告，連結內有PDF：
Vaccine
COVID疫苗的問題：
https://richard2022tw.blogspot.com/2022/10/covid.html
https://www.facebook.com/share/p/15FYZosqwi/ 備用
HPV疫苗的問題：
https://richard2022tw.blogspot.com/2024/08/hpv.html
所謂的事實查核中心的爭議：
https://richard2022tw.blogspot.com/2023/09/blog-post.html
新冠疫苗對婦女、孕婦、兒童的影響：
https://richard2022tw.blogspot.com/2022/10/vaccinated-women-and-babies-in-more.html
流感疫苗有夠可怕
https://x.com/DrBenTapper1/status/1851262524815036621
https://t.co/5oKOmy8mbK
新冠疫苗：
HPV疫苗：
流感疫苗package insert：
FLUAD® QUADRIVALENT（可以看到沒有真正的DB－RCT，沒有做雙盲對造實驗）。
Unsolicited adverse events (AEs) were collected for all subjects for 21 days after vaccination. Related
unsolicited AEs were reported by 303 (9.0%) and by 261 (7.7%) of the subjects for FLUAD
QUADRIVALENT and Boostrix, respectively. For FLUAD QUADRIVALENT, injection site pain and influenzalike illness were the only unsolicited adverse reactions reported in ≥ 1% of subjects (1.7% and 1.5%,
respectively).
Serious adverse events (SAEs) and potentially immune-mediated adverse events of special
interest (AESIs) were collected up to 366 days after vaccination. SAEs were reported by 238
(7.0%) FLUAD QUADRIVALENT recipients and 234 (6.9%) comparator recipients. There
were no SAEs, AESIs or deaths in this study that were related to FLUAD QUADRIVALENT.
Study 2 (NCT03314662) was a multicenter, randomized, double-blind, comparator-controlled
study conducted during the 2017-18 Northern Hemisphere influenza season. In this study, 888
subjects received FLUAD QUADRIVALENT, 444 subjects received the licensed adjuvanted
trivalent vaccine (aTIV-1 - FLUAD® (trivalent formulation)) and 444 subjects received an
adjuvanted trivalent influenza vaccine with an alternate B strain (aTIV-2).
The mean age of subjects at enrollment who received FLUAD QUADRIVALENT was 72.5
years. Female subjects represented 56.6% of the study population and the racial distribution of
subjects was 91.6% Caucasian, 7.0% Black or African American, and ≤ 1% each for Asian,
Native Hawaiian or Pacific Islander, American Indian or Alaska Native or Other.
Solicited local and systemic adverse reactions reported within 7 days after vaccination were similar to
those reported for Study 1. Unsolicited AEs were collected for 21 days after vaccination. Related
unsolicited AEs were reported by 39 (4.4%) and by 17-19 (3.8%-4.3%) of subjects administered FLUAD
QUADRIVALENT or aTIV, respectively. For FLUAD QUADRIVALENT, injection site bruising (1.0%) was the
only unsolicited adverse reaction reported in ≥ 1% of subjects.
Serious AEs and AESIs were collected up to 181 days after vaccination. Within 6 months after
vaccination, 37 (4.2%) FLUAD QUADRIVALENT recipients and 18-28 (4.1%-6.3%) aTIV recipients
experienced an SAE. There were no SAEs, AESIs or deaths in this study that were related to the study
vaccine. There were no AEs leading to withdrawal from the study.6.2. Postmarketing Experience
In addition to the adverse reactions observed during clinical trials, the following adverse events
were reported from postmarketing surveillance in individuals 65 years of age and older for
FLUAD QUADRIVALENT and/or for FLUAD (trivalent formulation), which is relevant
because both vaccines are manufactured using the same process and have overlapping
compositions.Because these events were reported voluntarily from a population of uncertain size,
it is not possible to reliably estimate their frequency or to establish, for all events, a causal
relationship to vaccine exposure.
Blood and lymphatic system disorders:
Thrombocytopenia (some cases were severe with platelet counts less than 5,000 per mm3
),
lymphadenopathy
Immune system disorders:
Allergic reactions including anaphylactic shock (in rare cases), anaphylaxis
Nervous system disorders:
Encephalomyelitis, Guillain-Barré Syndrome, convulsions, neuritis, neuralgia, paresthesia,
syncope, presyncope, dizziness
Vascular disorders:
Vasculitis which may be associated with transient renal involvement
Skin and subcutaneous tissue disorders:
Generalized skin reactions including erythema multiforme, urticaria, pruritis or non-specific
rash, erythema, angioedema
Musculoskeletal and connective tissue disorders:
Muscular weakness, pain in extremity.
評語：沒有做雙盲對造實驗、沒有長期研究，只有短期（AE21天、SAE366天）研究時間太短。
Fluzone® Quadrivalent
與前一個流感疫苗一樣，藥廠沒有做DB-RCT人體試驗。（通常藥廠這樣做的原因是想要把嚴重不良反應藏起來，所以他們做2種藥物的相對性比較試驗）研究時間僅有28天，嚴重不足，因為很多嚴重不良反應是幾個月，甚至是數年後才會發生（病症一般都有潛伏期）。
1. 研究時間看起來只有28天。
The difference in fever rate (Group 2 minus Group 1) was 0.84% (95% CI: -2.13%; 3.80%),
meeting the prespecified non-inferiority criterion (upper limit of the 2-sided 95% CI of the
difference in fever rates <5%). Participants were monitored for unsolicited adverse events and
SAEs during the 28 days following vaccination. Unsolicited non-serious adverse events were
reported in 417 (44%) participants in Group 1 and 394 (40%) participants in Group 2. The most
commonly reported unsolicited non-serious adverse events in both groups were cough and
rhinorrhea. Ten SAEs were reported during the 28-day follow-up period: 5 (0.5%) in Group 1 and
5 (0.5%) in Group 2.
2. 針對兒童施打劑量 0.25 mL and 0.5 mL 的比較性研究（發現3人有嚴重不良反應）：
Among children 6 months through 8 years of age, unsolicited non-serious adverse events were
reported in 1360 (47.0%) recipients in the Fluzone Quadrivalent group, 352 (48.0%) recipients in
Page 10 of 40
the TIV-1 group, and 346 (48.0%) recipients in the TIV-2 group. The most commonly reported
unsolicited non-serious adverse events were cough, vomiting, and pyrexia. During the 28 days
following vaccination, a total of 16 (0.6%) recipients in the Fluzone Quadrivalent group, 4 (0.5%)
recipients in the TIV-1 group, and 4 (0.6%) recipients in the TIV-2 group, experienced at least
one SAE. Throughout the study period, a total of 41 (1.4%) recipients in the Fluzone Quadrivalent
group, 7 (1.0%) recipients in the TIV-1 group, and 14 (1.9%) recipients in the TIV-2 group,
experienced at least one SAE. Three SAEs were considered to be possibly related to vaccination:
croup in a Fluzone Quadrivalent recipient and 2 episodes of febrile seizure, 1 each in a TIV-1
recipient and a TIV-2 recipient.
3.針對成人的實驗（發現2人有嚴重不良反應）：
Unsolicited non-serious adverse events were reported in 33 (17.4%) recipients in the Fluzone
Quadrivalent group, 45 (23.7%) recipients in the TIV-1 group, and 45 (23.7%) recipients in the
TIV-2 group. The most commonly reported unsolicited non-serious adverse events were
headache, cough, and oropharyngeal pain. In the follow-up period, there were two SAEs, 1 (0.5%)
in the Fluzone Quadrivalent group and 1 (0.5%) in the TIV-2 group.
4. 針對老人的實驗（發現3人有嚴重不良反應）：
Unsolicited non-serious adverse events were reported in 28 (12.4%) recipients in the Fluzone
Quadrivalent group, 22 (9.8%) recipients in the TIV-1 group, and 22 (9.8%) recipients in the TIV2 group. The most commonly reported adverse events were oropharyngeal pain, rhinorrhea,
injection-site induration, and headache. Three SAEs were reported during the follow-up period, 2
(0.9%) in the TIV-1 group and 1 (0.4%) in the TIV-2 group.
藥物上市後，回報系統發現下列病症：
• Blood and Lymphatic System Disorders: Thrombocytopenia, lymphadenopathy
• Immune System Disorders: Anaphylaxis, other allergic/hypersensitivity reactions (including
urticaria, angioedema)
• Eye Disorders: Ocular hyperemia
• Nervous System Disorders: Guillain-Barré syndrome (GBS), convulsions, febrile convulsions,
myelitis (including encephalomyelitis and transverse myelitis), facial palsy (Bell’s palsy),
optic neuritis/neuropathy, brachial neuritis, syncope (shortly after vaccination), dizziness,
paresthesia
• Vascular Disorders: Vasculitis, vasodilatation/flushing
• Respiratory, Thoracic and Mediastinal Disorders: Dyspnea, cough, wheezing, throat
tightness, oropharyngeal pain, rhinorrhea
• Skin and Subcutaneous Tissue Disorders: Rash, pruritus, and Stevens-Johnson syndrome
• General Disorders and Administration Site Conditions: Asthenia/fatigue, pain in extremities,
chest pain
• Gastrointestinal Disorders: Vomiting
歐美關於兒童疫苗的研究資料（上色部分）
留言
張貼留言