Mabuɗin maɓalli guda biyu da alama sun riga sun faɗi daga labarin rigakafin COVID - ɗaya game da ingantaccen ingancinsu game da kamuwa da cuta da ɗayan game da kyakkyawan amincin su. Koyaya, bulo mai taurin kai da alama ya tsaya cak, wanda ya sa mutane da yawa suyi imani cewa masu haɓaka alluran rigakafin suna da ikon ba da kariya ta dogon lokaci daga rashin lafiya da mutuwa (duk da gazawarsu na kariya daga cututtuka).
Amma shin wannan tubalin da gaske ne yana da ƙarfi? Shin wallafe-wallafen kimiyya da ke akwai da gaske suna goyan bayan ra'ayin cewa nau'ikan kariya biyu masu zaman kansu ne daga juna - cewa kariyar da ake samu daga rashin lafiya mai tsanani da mutuwa ko ta yaya ya kasance mai girma yayin da kariya daga cututtuka ya ɓace?
In sabon labarin mu a Jaridar Likitocin Amurka da Likitoci, Dr. Yaffa Shir-Raz, Dr. Shay Zakov, Dr. Peter McCullough, da ni kaina da nufin amsa waɗannan tambayoyin daga mahangar kimiyya zalla. Mun gudanar da nazari mai tsauri kan bayanan wakilai daga tushe iri uku: (1) gwajin asibiti na asali na Pfizer da Moderna, (2) ƙarin nazarin zamani kan kashi na huɗu na rigakafin, da (3) shahararrun dashboards na ƙididdigar cutar.
A cikin wannan ɗan gajeren labarin (wannan yana ƙarawa bidiyon da na shirya akan wannan batu), Ba zan iya gabatar da dukkan bincikenmu ba. Koyaya, Ina fatan in ba ku ɗanɗano bitar mu ta amfani da misalai guda uku, farawa da kafa gwajin asibiti ta Pfizer.
Adadin Matattu a Gwajin Asibiti na Pfizer
Wani yana iya (a ƙarya) ɗauka cewa maɓallin tambayar da na gabatar a sama an riga an amsa shi a cikin Mataki na 3, Gwajin Sarrafa Bazuwar ta Pfizer - wacce ta ba FDA izinin ba da izinin gaggawa don amfani da allurar COVID [1].
Bayan haka, ana ɗaukar Gwajin Gudanar da Bazuwar a matsayin da ma'aunin gwal a cikin binciken ilimin halittu. Duk da haka, wannan mahimmin gwaji na asibiti bai koya mana komai ba game da iyawar alluran don karewa daga mummunan cututtuka da mutuwa. Musamman na ƙarshe, Pfizer ya ba da rahoton cewa watanni 6 bayan alluran, babu wani bambance-bambance mai mahimmanci a cikin adadin mace-mace daga duk abubuwan da ke faruwa tsakanin ƙungiyar da ta karɓi maganin alurar rigakafi da ƙungiyar kulawa da ta sami placebo [2].
Bugu da ƙari, a lokacin buɗaɗɗen lakabi na binciken su, lokacin da yanayin makanta ya ƙare kuma mahalarta masu karɓar placebo za su iya zaɓar a ba su ainihin maganin alurar riga kafi, Pfizer ya tabbatar da ƙarin mutuwar biyar kuma duk sun faru a cikin mutanen da suka dauki maganin. A wasu kalmomi, a cikin wannan mahimmin gwaji na asibiti, kimiyya ba ta goyi bayan ra'ayin cewa alluran sun kare daga mutuwa ba. A zahiri, wasu na iya jayayya cewa kimiyya ta ba da gargaɗi mai mahimmanci game da waɗannan rigakafin.
Nazarin Dubawa na Zamani game da kashi na huɗu
Ba tare da bayyananniyar shaida daga gwaje-gwajen asibiti na yau da kullun ba, ya kamata mu juya zuwa ƙarancin ƙira na bincike waɗanda suka bincika alluran a cikin saitunan rayuwa ta hanyar lura, amma ba matakan gwaji ba. Tabbas, ya kamata a fassara nazarin binciken a hankali saboda suna da rauni ga son rai na gaske, kamar matakan gwaji marasa daidaituwa wanda aka tilasta wa mutanen da ba a yi musu allurar gwajin COVID-19 ba yayin da aka keɓe mutanen da aka yi wa alurar riga kafi daga waɗannan gwaje-gwajen [3-5].
Duk da haka, mun yanke shawarar yin bitar duk binciken binciken da aka gudanar akan ingancin kashi na huɗu kuma waɗanda aka buga a kusan lokacin da FDA ta ba da izini ga wannan mai ƙarfafawa na biyu. Ba za ku yi mamakin cewa waɗannan binciken sun fito daga Isra'ila - "Labarin duniya," kamar yadda jami'an Pfizer suka kira [6]. Isra'ila ita ce ƙasa ta farko da ta amince da gudanar da wannan mai ƙarfafawa na biyu (har ma kafin izinin hukuma ta FDA) kuma Isra'ila ita ce ta farko da ta fara bincikar ingancin wannan mai haɓakawa a cikin saitunan rayuwa.
Binciken lura da aka ambata a cikin Sakin Labarai na FDA
Nazarin Isra'ila na farko da nake so in kawo anan an ambaci shi a cikin Sakin Labarai na FDA wanda ya ba da rahoton izinin su na fara amfani da kashi na huɗu na maganin [7]. A cikin wannan Sakin Labarai, FDA ta bayyana, ba tare da kiftawar ido ba, cewa kashi na hudu "yana inganta kariya daga mai tsanani COVID-19 ″ (ƙara mai ƙarfi). Ta yaya suka sani? Maganar kimiyya kawai da suka kawo don tallafawa wannan da'awar madaidaiciya ita ce wani binciken Isra'ila da Cibiyar Kiwon Lafiya ta Sheba ta yi ya yi ba samar da kyakkyawan sakamako mai inganci. Baya ga gaskiyar cewa wannan binciken bai magance rashin lafiya mai tsanani kai tsaye ba, marubutansa sun kammala cewa bincikensu ya nuna cewa mai ƙarfafawa na biyu "zai iya samun fa'ida kawai" [8]. Waɗannan maganganunsu ne ba nawa ba.
Babban binciken lura wanda ya yi iƙirarin nuna inganci akan rashin lafiya mai tsanani
Don haka menene zai iya zama shaida a bayan wannan madaidaiciyar magana ta FDA game da inganci da rashin lafiya mai tsanani? Sakin Labarai, kamar yadda aka ambata a baya, ba ya kawo ƙarin nazarin inganci don dogaro da shi, amma mun sami wani binciken Isra'ila, wanda aka buga mako guda bayan izinin FDA na kashi na huɗu [9]. A cikin wannan babban binciken, marubutan sun ba da rahoton cewa kashi na hudu ya kasance mai tasiri a kan rashin lafiya mai tsanani makonni shida daga gwamnatinsa, yayin da tasirinsa kan cututtuka ya fara raguwa a cikin kimanin mako na biyar, har zuwa mako na takwas, tasirin cututtuka ya ɓace gaba daya. A iya sanina, wannan shi ne karo na farko da masu bincike suka ba da rahoton sakamakon da masu karatu za su iya ɗauka cewa ingancin kashi na huɗu game da rashin lafiya mai tsanani ya fi ƙarfinsa a kan cututtuka.
Don bayyana wannan magana ta ƙarshe da kuma kimanta ingancinta, ina buƙatar ɗaukar matakin kimiyya baya kuma in yi magana game da mahimman ra'ayi na bincike wanda ake kira. mai yiwuwa yanayin. Maganar ka'ida, lokacin da bincike ya gano alamun cewa maganin da aka ba shi yana da tasiri cututtuka, Har ila yau, yawanci suna samun raguwar lambobi masu tsanani na rashin lafiya a cikin ƙungiyoyin maganin su, idan aka kwatanta da ƙungiyoyin kulawa. Yi la'akari, alal misali, yanayin bincike wanda mahalarta 10 daga rukunin rigakafin suka kamu da cutar, idan aka kwatanta da mahalarta 100 daga ƙungiyar kulawa.
Ana iya fassara waɗannan lambobin a matsayin alama mai kyau don babban tasiri a kan cututtuka. Koyaya, menene idan 1 daga cikin mahalarta 10 da suka kamu da cutar daga rukunin rigakafin sun kamu da rashin lafiya mai tsanani idan aka kwatanta da 10 daga cikin mahalarta 100 daga rukunin kulawa? A cikin wannan yanayin, bambance-bambance a cikin ƙananan lambobi, 1 da 10 marasa lafiya marasa lafiya, na iya zama mai ban sha'awa, amma gaskiyar ita ce, waɗannan lambobi ne kawai sakamakon tasirin maganin rigakafi game da cututtuka, kamar yadda ƙungiyoyin biyu a cikin wannan binciken na tunanin suna da kashi 10 cikin dari na cututtuka masu tsanani. daga mahalartan da samu kamuwa da cutar. Amma menene zai faru a cikin lamuran da allurar ta kasa karewa daga cututtuka - kamar yanayin da muke fuskanta a yau lokacin da tubalin farko na labarin ya riga ya lalata? Shin kariya daga rashin lafiya mai tsanani zai kasance?
Hanya daya tilo da za a tabbatar da cewa alluran rigakafin suna karewa daga rashin lafiya mai tsanani fiye da tasirin su daga kamuwa da cuta shine a nuna cewa mai yiwuwa yanayin na rashin lafiya mai tsanani a cikin rukunin alurar rigakafi (wato, yawan yawan rashin lafiya mai tsanani a cikin wadanda suka halarci taron kasance kamuwa) yana da mahimmanci ƙasa fiye da yiwuwar yanayin rashin lafiya mai tsanani a cikin ƙungiyar kulawa.
Yanzu da muka fahimci wannan mahimmancin ra'ayi na yiwuwar yanayi, za mu iya komawa don bincika cikakkun bayanai na wannan babban binciken da ya yi iƙirarin nuna ingancin alluran rigakafin cututtuka masu tsanani. Abu na farko da ya kamata mu sani game da wannan binciken shi ne, saboda wasu dalilai, tsawon lokacin rashin lafiya mai tsanani ya kasance har zuwa mako na shida daga allurar rigakafi, yayin da ciwon ya kasance tsawon makonni biyu har zuwa mako na takwas. Wannan yana nufin cewa babban da'awar wannan binciken ya iyakance ne ga ɗan gajeren lokaci na musamman, farawa daga mako na biyar lokacin da tasirin kamuwa da cuta ya fara raguwa kuma ya ƙare a mako na shida lokacin da lura da rashin lafiya ya tsaya.
Amma mafi mahimmanci, ko da mun yi watsi da wannan ƙaƙƙarfan ƙaƙƙarfan, lokacin da ni da marubutana muka bincika bayanan da aka bayar a cikin labarin, mun gano cewa mai yiwuwa yanayin na rashin lafiya mai tsanani bai bambanta da gaske tsakanin magunguna da ƙungiyoyin kulawa na wannan binciken ba. Kimanin kashi 1 cikin XNUMX na masu kamuwa da cutar, a cikin ƙungiyoyin biyu, sun kamu da rashin lafiya mai tsanani.
A bayyane yake, ba za a iya amfani da irin wannan sakamakon ba don karyata zato mai ma'ana da kai tsaye cewa raguwar tasirin allurar rigakafin cututtuka daga mako na biyar gaba ya biyo baya daidai da raguwar tasirin allurar rigakafin rashin lafiya da mace-mace - ko da wannan raguwa ya faru makonni biyu bayan haka, wanda shine matsakaicin lokacin da ake ɗaukar cutar mai tsanani don tasowa daga farkon alamun cutar.
Abin takaici, rashin lafiya mai tsanani bayan makonni biyu, wanda shine ainihin a cikin mako na bakwai, ba a kula da shi ba a cikin wannan binciken, ba tare da ambaton mako na goma ba, wanda shine ainihin lokaci mafi ban sha'awa - kamar yadda yake nuna lokacin da allurar rigakafi ba su ba da kariya daga cututtuka ba.
Kammalawa
A ƙarshe, a cikin wannan ɗan gajeren labarin, na kawo misalai guda uku waɗanda ke ƙalubalantar ra'ayin da ake ganin an yarda da shi cewa magungunan haɓaka suna iya ba da kariya ta dogon lokaci daga rashin lafiya da mutuwa. Misalai guda uku sun ƙunshi, ba shakka, kaɗan ne kawai na cikakken labarinmu kuma ina roƙon ku da ku sake nazarin duk shaidar da muka kawo. Jaridar Likitocin Amurka da Likitoci.
Da fatan za a sani cewa ba na jayayya cewa labarinmu zai iya maye gurbin cikakken nazari na tsari na duk shaidun da ke akwai. Duk da haka, a cikin maganganun kimiyya, "black swan" guda ɗaya kamar yadda Karl Popper ya kira - wani misali mara kyau wanda bai dace da ka'idar ba - na iya gurbata da'awar duniya; kuma na yi muku alƙawarin cewa labarin namu yana kwatanta irin waɗannan baƙar fata masu yawa waɗanda suka rushe wannan tubali na ƙarshe na labarin ingancin maganin.
Don fahimtarmu game da wallafe-wallafen, labarin likita a yau wanda ya nace cewa magungunan haɓaka suna hana rashin lafiya mai tsanani da mutuwa duk da rashin kariya daga cututtuka ba su da tallafin kimiyya. Don haka muna kira da a gudanar da bincike na nuna son kai game da hanyoyin yanke shawara da kuma manufofin kiwon lafiya na duniya da aka aiwatar yayin rikicin COVID, musamman idan aka yi la’akari da abin da muka sani a yau game da mummunan tasirin waɗannan manufofin da kuma yawan haɗarin rigakafin.
Bibliography
1. Polack, FP, da dai sauransu. Aminci da ingancin maganin BNT162b2 mRNA Covid-19. New England Journal of Medicine, 2020.
2. Thomas, SJ, et al. Amintacciya da Ingantacciyar rigakafin BNT162b2 mRNA Covid-19 har tsawon watanni 6. New England Journal of Medicine, 2021. 385(19): p. 1761-1773.
3. Levi, R. da A. Wohl, Damuwa game da kimanta ingancin rigakafin Pfizer's Covid-19 a cikin manyan binciken bincike guda biyu a Isra'ila.. 2021, The British Medical Journal (BMJ). An dawo da ƙarshe a ranar 9 ga Satumba, 2021, daga: https://www.bmj.com/content/372/bmj.n567/rr-0.
4. di Lego, V., M. Sánchez-Romero, da A. Prskawetz, Tasirin allurar rigakafin COVID-19 akan Adadin Kisa: Muhimmancin sa ido kan cututtukan da aka samu. Mujallar kasa da kasa na cututtuka masu yaduwa : IJID : bugu na hukuma na kungiyar International Society for Diseases, 2022: p. S1201-9712(22)00197-7.
5. Has, EJ, et al., Tasiri da ingancin rigakafin mRNA BNT162b2 game da cututtukan SARS-CoV-2 da cututtukan COVID-19, asibitoci, da mace-mace biyo bayan yaƙin neman zaɓe na ƙasa baki ɗaya a Isra'ila: nazarin lura ta amfani da bayanan sa ido na ƙasa. Lancet, 2021. 397(10287): p. 1819-1829.
6. Birnhack, M., Wanene ke Sarrafa bayanan Likitan da ke da alaƙa da Covid? Haƙƙin mallaka da bayanan sirri. IIC - Binciken Ƙasashen Duniya na Ƙirar Hannu da Dokar Gasa, 2021. 52(7): p. 821-824.
7. FDA, Coronavirus (COVID-19) Sabuntawa: FDA ta ba da izinin Kashi na Biyu na Tallafin COVID-19 ga Tsofaffi da Mutanen da ba su da rigakafi. 2022, Cibiyar Abinci da Magunguna ta Amurka, Sakin Labarai daga: Maris 29, 2022. An dawo da ƙarshe a ranar 30 ga Maris, 2022 daga: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-second-booster-dose-two-covid-19-vaccines-older-and.
8. Regev-Yochay, G., et al., Ingancin Kashi na Hudu na rigakafin Covid-19 mRNA akan Omicron. New England Journal of Medicine, 2022.
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