再回複鐵背山一次，否則對您引經據典有的長文有點失敬。也引用一點信息，不過不是科學文獻，因為那得列出無數的文章，是方舟子的推文，我對免疫學的認知完全同意方的說法。前提：in general speaking，理論上講：（方舟子：“如果不考慮佐劑、載體因素，疫苗應該是成分越單一、涉及的過程越少越安全。理論上最安全的是蛋白質疫苗，其次是RNA疫苗，再次是DNA疫苗，最不安全的是減毒疫苗，其次是病毒載體疫苗、滅活疫苗。安全性最終要由臨床試驗檢驗。”
哪來的以訛傳訛滅活疫苗安全？？嗯嗯讓我們來仔細看一下：
第一，好像是WHO（世界衛生組織）以訛傳訛的哦：
根據WHO出版的報告 ‘Vaccine safety and adverse reactions’ (https://www.who.int/vaccine_safety/initiative/tech_support/Part-2.pdf):
According to the WHO: both inactivated vaccines and protein subunit vaccines are given a safety rating of ‘Excellent stability profile’
‘Inactivated whole-cell vaccines have no risk inducing the disease’
Here’s what it has to say about protein subunit vaccines （所謂的“成分單一”)
‘Rather than introducing a whole-cell vaccine (either attenuated or inactivated) to an immune system, a subunit vaccine contains a fragment of the pathogen and elicits an appropriate immune response.’
‘A weakness of [protein-based subunit vaccines] is that isolated proteins, if denatured, may bind to different antibodies than the protein of the pathogen.’
‘subunit protein-based vaccines induce only short-term immunity, it has a slow immune response, slow rise of antibody levels and no immune memory’
’They differ from inactivated whole-cell vaccines, by containing only the antigenic parts of the pathogen. These parts are necessary to elicit a protective immune response. This precision comes at a cost, as antigenic properties of the various potential subunits of a pathogen must be examined in detail to determine which particular combinations will produce an effective immune response within the correct pathway.’
‘A response may be elicited, but with no guarantee that memory will form for future responses’
According to GAVI, the vaccine alliance (https://www.gavi.org/vaccineswork/what-are-whole-virus-vaccines-and-how-could-they-be-used-against-covid-19):
‘Inactivated virus vaccines also contain the disease-causing virus, or parts of it, but their genetic material has been destroyed. For this reason, they are considered safer and more stable than live attenuated vaccines, and they can be given to people with compromised immune systems. Even though their genetic material has been destroyed, inactivated viruses usually contain many proteins which the immune system can react to.’
還不滿意？覺得世界衛生組織和疫苗聯盟是糊弄平民百姓的？
'These past events have shaped the manufacture and regulatory control of inactivated vaccines today resulting in vaccines with extremely high safety profiles which protect millions of people against a range of pathogens.'
— From ‘Vaccine Analysis: Strategies, Principles, and Control‘ by Nunnally et al., 2014
'The improved safety profile of inactivated vaccines entails that they are also suitable for the rapidly increasing group of immunocompromised individuals'
— From ‘Vaccination of immunocompromised patients’ by Ljungman P., 2012
‘However, one of the unintended consequences of RNA vaccines is that the foreign mRNA strands may elicit an unintended immune reaction (interferon type I response), leading to fevers or chills. ‘
— From ‘Basic translational science’ by Lin, Mecham and Mann, 2020)
再看看目前兩種mRNA疫苗巨大的副作用百分比。
Pfizer phase 3 clinical trails showed that 84.1% of the approximately 19,000 participants reported injection site reactions, 62.9% reported fatigue, 55.1% reporting headache, 38.3% reporting muscle pain, 31.9% reporting chills, 23.6% reporting joint pain and 14% Fever. Serious adverse reactions occurred in 0-4.6% of participants. (https://www.fda.gov/media/144245/download | https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/reactogenicity.html)
The Moderna vaccine, another mRNA candidates, reported the follower adverse reactions out of the 15,175 participants, injection site pain (91.6%), fatigue (68.5%), headache (63%), muscle pain (59.6%), joint pain (44.8%), and chills (43.4%). With severe adverse reactions occurring in 0.2% to 9.7% of participants. (https://www.fda.gov/media/144434/download)
而目前發表的滅活疫苗的副作用比例和mRNA疫苗相比非常少。
CoronaVac (developed by Sinovac Life Sciences, Beijing, China) is an inactivated vaccine candidate against COVID-19. Its phase 2 clinical trial reported 23% of the 336 participants having at least one adverse reaction within the first 7 days, with the most common injection site adverse reaction being localised pain (16%), and fever (2%). All adverse events were mild or moderate in severity and there was a higher number of systemic adverse evens in the placebo group. NO serious adverse effects were reported within 28 days following the second dose (Zhang et al., 2020)
Another inactivated vaccine candidate BBIBP-CorV has also completed a phase 2 clinical trial: in which 16% of the 336 participants reported pain, 2% Fever, 3% fatigue, 1% nausea and 1% headache. NO serious adverse reactions were reported within 28 days following the second dose (Xia et al., 2020)
A third inactivated Sars-cov-2 vaccine candidate had the following phase 2 results: within 7 days after injection, adverse reactions were reported by 48 (15.0%) of 320 participants in the trials. Specifically, the number of participants reporting adverse reactions was 5 (6.0%), 4 (14.3%), 16 (19.0%) and 5 (17.9%) in the groups who received the medium dose at days 0 and 14, alum only at days 0 and 14, the medium dose at days 0 and 21, and alum only at days 0 and 21, respectively, in the phase 2 trial. The most common adverse reaction was injection site pain (14 in phase 1 and 21 in phase 2), followed by fever (2 in phase 1 and 8 in phase 2). ALL adverse reactions were mild (grade 1 or 2), transient, and self-limiting, and did not require any treatment. No other adverse reactions were reported between days 8 and 28 after injection. (Xia et al. 2020)
接下來是最重要的部分: The inactivated vaccine was well tolerated in all dose groups under different injection procedures with no vaccine-related serious adverse events. The most common adverse reaction was injection site pain, which was mild and self-limiting. The incidence rate of adverse reactions in the current study (15.0% among all participants) was lower compared with results of other candidate vaccines. Therefore, the inactivated vaccine in the current study suggests a relatively BETTER safety profile compared with vaccines using other platforms. (Xia et al., 2020)
牛津的疫苗是一款腺病毒疫苗，安慰劑組居然有更多的參與者發現了嚴重副作用。
168 serious adverse events occurred in the 12021 participants in the vaccine group and the 11724 participants in the control group. 79 of whom received the vaccine and 89 received the placebo. （Voysey et al. 2020)
目前針對新冠的Protein subunit vaccine還沒有發表研究報告，那我們看看以往的成績是怎麽樣的。
Hepatitis B vaccine is a widely used protein subunit vaccine developed from the hepatitis B surface antigen. A review that analysed results from 22 studies in healthy adults (representing over 10,000 vaccine doses) showed that 29.3% of candidates reported soreness lasting for 1-2 days, 15.5% reported fatigue and 9.3% for headache. (André, 1989)
滅活的流感疫苗和你所讚美的抗原成分單一的蛋白質疫苗副作用的百分比基本上是一樣的。
In a US phase 3 clinical trial that investigated the safety of inactivated influenza virus vaccines, the most common solicited adverse reaction among 1684 participants was vaccination site pain (20.8%), nausea and/or vomiting (9.4%) and NO serious adverse events were assessed to be related to the vaccine. (Statler et al., 2019)
美國著名天文物理學家Neil Degrasse Tyson說過: ‘One of the great challenges in life is knowing enough to think you’re right, but not enough to know you’re wrong.’
請以後核對相關的科學文獻之後再在網上發表抨擊別人想法的評論而不要輕信自己毫無依據的 ”科學知識“。
Bibliography:
André, F.E., 1989. Summary of safety and efficacy data on a yeast-derived hepatitis B vaccine. The American journal of medicine, 87(3), pp.S14-S20.
Beasley et al., 1983; Chung et al., 1985; Francis et al., 1982; McLean et al., 1983; Szmuness et al., 1980
Diaconu, S., Predescu, A., Moldoveanu, A., Pop, C.S. and Fierbin?eanu-Braticevici, C., 2017. Helicobacter pylori infection: old and new. Journal of medicine and life, 10(2), p.112.
Lin, C.J., Mecham, R.P. and Mann, D.L., 2020. RNA vaccines for COVID-19: Five things every cardiologist should know. Basic to Translational Science.
Ljungman, P., 2012. Vaccination of immunocompromised patients. Clinical Microbiology and Infection, 18, pp.93-99.
Nunnally, B.K., Turula, V.E. and Sitrin, R.D. eds., 2015. Vaccine analysis: strategies, principles, and control.
Statler, V. A., Albano, F. R., Airey, J., Sawlwin, D. C., Alison, G. J., Matassa, V., . . . Marshall, G. S. (2019). Immunogenicity and safety of a quadrivalent inactivated influenza vaccine in children 6–59?months of age: A phase 3, randomized, noninferiority study. Vaccine, 37(2), 343-351. doi:http://dx.doi.org.virtual.anu.edu.au/10.1016/j.vaccine.2018.07.036
Voysey, M., Clemens, S.A.C., Madhi, S.A., Weckx, L.Y., Folegatti, P.M., Aley, P.K., Angus, B., Baillie, V.L., Barnabas, S.L., Bhorat, Q.E. and Bibi, S., 2020. Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK. The Lancet, 397(10269), pp.99-111.
Xia, S., Duan, K., Zhang, Y., Zhao, D., Zhang, H., Xie, Z., Li, X., Peng, C., Zhang, Y., Zhang, W. and Yang, Y., 2020. Effect of an inactivated vaccine against SARS-CoV-2 on safety and immunogenicity outcomes: interim analysis of 2 randomized clinical trials. Jama, 324(10), pp.951-960.
Xia, S., Zhang, Y., Wang, Y., Wang, H., Yang, Y., Gao, G.F., Tan, W., Wu, G., Xu, M., Lou, Z. and Huang, W., 2020. Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBIBP-CorV: a randomised, double-blind, placebo-controlled, phase 1/2 trial. The Lancet Infectious Diseases.
Zhang, Y., Zeng, G., Pan, H., Li, C., Hu, Y., Chu, K., Han, W., Chen, Z., Tang, R., Yin, W. and Chen, X., 2020. Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine in healthy adults aged 18–59 years: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial. The Lancet Infectious Diseases.
