A ƙasa akwai wasiƙar da ta sa hannu 76 likitoci a Burtaniya, zuwa Hukumar Kula da Kayayyakin Kiwon Lafiyar Kiwon Lafiya (MHRA) da sauran jami'an Gwamnatin Burtaniya. Wannan wasiƙar ta faɗi cikakkun dalilai da yasa shawarar FDA ta kwanan nan ta ba da izinin rigakafin COVID a cikin jarirai da yara ƙanana ba dole ba ne ya faru a Burtaniya. Wasiƙar ta samo asali kuma daidai. Bari mu yi fatan cewa manyan kafofin watsa labarai a nan Amurka da Burtaniya sun ba da rahoton wannan wasiƙar cikin salon rashin son zuciya.
(wasikar ta ci gaba)
Muna rubuto muku cikin gaggawa game da sanarwar cewa FDA ta ba da izinin Amfani da Gaggawa don duka Pfizer da Moderna COVID-19 alluran rigakafin yara a makarantun gaba da sakandare.
Muna roƙon ku da ku yi la'akari sosai da matakin yin allurar rigakafi ga yara ƙanana daga SARS-CoV-2, duk da sannu a hankali amma mahimmancin rage virulence na bambance-bambancen daban-daban, ƙarar shaidar tasirin tasirin allurar da sauri, ƙara damuwa game da cutarwar rigakafin dogon lokaci, da sanin cewa yawancin wannan rukunin matasa an riga an fallasa su ga SARS-CoV-2 sosai. Don haka, ma'auni na fa'ida da haɗari waɗanda ke tallafawa ƙaddamar da allurar rigakafin mRNA ga tsofaffi da masu rauni a cikin 2021 gaba ɗaya bai dace ba ga ƙananan yara a cikin 2022.
Muna kuma kalubalantar ƙarin rigakafin COVID-19 a cikin shirin rigakafin yara na yau da kullun duk da ba a nuna buƙatu na asibiti ba, sananne da haɗarin da ba a san su ba (duba ƙasa) da gaskiyar cewa waɗannan alluran rigakafin har yanzu suna da izinin tallan sharadi kawai.
Abin lura ne cewa Takardun Pfizer wanda aka gabatar wa FDA yana da manyan gibi a cikin shaidar da aka bayar:
- An canza yarjejeniya a tsakiyar gwaji. Asalin jadawalin kashi biyu na asali ya nuna ƙarancin rigakafi tare da inganci nesa da ma'aunin da ake buƙata. An ƙara kashi na uku a lokacin da yawancin masu karɓar placebo na asali aka yi musu alurar riga kafi.
- Babu wani bambanci mai mahimmanci tsakanin placebo da ƙungiyoyin alurar riga kafi a cikin ko dai ƙungiyar masu shekaru 6-23 ko kuma masu shekaru 2-4, ko da bayan kashi na uku. Abin mamaki, sakamakon ya dogara ne akan mahalarta uku kawai a cikin ƙananan shekarun (wanda aka yi wa alurar riga kafi da placebo biyu) da kuma mahalarta bakwai kawai a cikin tsofaffi masu shekaru 2-4 (biyu da kuma placebo biyar). Lallai, ga ƙungiyar masu ƙanƙanta tazarar amincewa ta kasance daga debe-367% zuwa ƙari-99%. Mai sana'anta ya bayyana cewa lambobin sun yi ƙasa da ƙasa don zana kowane tabbataccen ƙarshe. Haka kuma, waɗannan ƙayyadaddun lambobi suna zuwa ne kawai daga yaran da suka kamu da cutar fiye da kwanaki bakwai bayan kashi na uku.
- A tsawon tsawon lokacin daga kashi na farko zuwa gaba (duba shafi na 39 Tables 19 da 20), akwai jimillar yara 225 da suka kamu da cutar a hannu da aka yi wa alurar riga kafi da 150 a hannun placebo, wanda ke ba da ƙididdige ingancin maganin alurar riga kafi kawai 25% (14% na watanni 6-23, da 33% na 2-4s).
- Ƙarin nazarin immunogenicity akan Omicron, wanda FDA ta buƙata, kawai ya ƙunshi jimlar yara 66 da aka gwada wata ɗaya bayan kashi na uku (duba shafi na 35).
Yana da wuyar fahimta cewa FDA ta yi la'akari da cewa wannan yana wakiltar isassun shaida a kan abin da za a kafa shawarar yin rigakafin yara masu lafiya. Idan ya zo ga aminci, bayanan sun ma fi sauƙi: yara 1,057 ne kawai, wasu waɗanda ba su makanta ba, an bi su tsawon watanni biyu kacal. Abin lura ne cewa Sweden da Norway ba sa ba da shawarar maganin alurar riga kafi na 5-11s kuma Holland ba ta ba da shawarar ta ga yaran da suka riga sun sami COVID-19 ba. Daraktan Hukumar Lafiya da Magunguna ta Danish ya bayyana kwanan nan cewa tare da abin da aka sani yanzu, yanke shawarar yi wa yara rigakafin kuskure ne.
Mun taƙaita a ƙasa ƙaƙƙarfan hujjoji game da wannan rigakafin.
A. Matsakaicin ƙarancin haɗari daga COVID-19 ga yara ƙanana
- A cikin duka 2020 da 2021, ba ko da yaro mai shekaru 1-9 da ya mutu inda COVID-19 shine kadai ganewar asali akan takardar shaidar mutuwa, a cewar Bayanan ONS.
- A cikakken bayani binciken A Ingila daga Maris 1st 2020 zuwa Maris 1st 2021 an gano yara shida ne kawai 'yan kasa da shekaru 18 suka mutu ba tare da kamuwa da cuta ba. Ba a sami mace-mace masu shekaru 1-4 ba.
- Yara suna share kwayar cutar mafi sauƙi fiye da manya.
- Yara suna da ƙarfi, ƙarfi, da dorewa martani na rigakafi.
- Tun zuwan bambance-bambancen Omicron, cututtuka gabaɗaya sun fi sauƙi. Wannan kuma gaskiya ne ga marasa alurar riga kafi 'yan kasa da shekaru 5.
- Ya zuwa Yuni 2022 yanzu kiyasta cewa kashi 89% na masu shekaru 1-4 sun riga sun kamu da cutar SARS-CoV-2.
- Recent bayanai daga Isra'ila yana nuna kyakkyawan rigakafi na dindindin bayan kamuwa da cuta a cikin yara, musamman a cikin 5-11s.
B. Rashin ingancin maganin rigakafi
- A cikin manya, ya bayyana a fili cewa tasirin rigakafin yana raguwa a hankali a kan lokaci, yana buƙatar masu haɓakawa a lokaci-lokaci. Musamman, ingancin maganin rigakafi ya ragu da sauri a kan sabbin bambance-bambancen Omicron.
- A cikin yara, tasirin maganin rigakafi ya ragu da sauri a cikin 5-11s fiye da na 12-17s, mai yiwuwa yana da alaƙa da ƙaramin adadin da aka yi amfani da shi a cikin ƙirar yara. Daya bincikendaga New York ya nuna inganci akan Omicron yana faɗuwa zuwa 12% kawai ta makonni 4-5 kuma zuwa ga ƙima mara kyau ta makonni 5-6 bayan kashi na biyu.
- A cikin Pfizer 0-4s fitina, inganci bayan allurai biyu sun faɗi zuwa ƙima mara kyau, yana buƙatar canji ga ƙa'idar gwaji. Bayan kashi na uku an ba da shawarar inganci daga kwanaki 7-30 amma babu bayanai da suka wuce kwanaki 30 don ganin yadda sauri wannan zai ragu.
C. Yiwuwar cutarwar allurar COVID-19 ga yara
- An sami babban damuwa game da myocarditis a cikin matasa da matasa, musamman a cikin maza bayan kashi na biyu, wanda aka kiyasta a daya cikin 2,600 a cikin tallace-tallace mai aiki. sa ido a Hong Kong. Mai tasowa shaidana rashin daidaituwa na zuciya na ci gaba a cikin samari tare da maganin myopericarditis na post-mRNA, kamar yadda MRI na zuciya ya nuna a cikin watanni 3-8, yana nuna wannan yayi nisa daga 'mai laushi da ɗan gajeren lokaci'. Yiwuwar tasirin sakamako na dogon lokaci yana buƙatar ƙarin nazari kuma yana kira ga mafi tsananin aiwatar da ƙa'idar taka tsantsan dangane da ƙanana da mafi raunin yara.
- Ko da yake bayan-alurar rigakafin myocarditis ya bayyana ya zama ƙasa da na kowa a cikin masu shekaru 5-11 fiye da yara manya, amma duk da haka, ya karu akan asali.
- A cikin Pfizer binciken, 50% na yara da aka yi wa alurar riga kafi suna da abubuwan da ba su dace ba, ciki har da fushi da zazzabi. Ganewar myocarditis shine yafi wahala a kananan yara. Babu matakan troponin ko nazarin ECG da aka rubuta. Ko da yaron da aka yi wa alurar riga kafi a cikin gwaji, asibiti tare da zazzaɓi, ciwon maraƙi da CPK mai girma, ba shi da rahoton D-dimers, anti-platelet antibodies ko matakan troponin.
- A cikin sharuɗɗan izini na Pfizer na 5-11, ana buƙatar gudanar da nazarin neman myocarditis kuma ba saboda rahoton sakamako har zuwa 2027.
- Abubuwan damuwa daidai suke, har yanzu ba a san su ba, mummunan tasiri akan tsarin rigakafi. A cikin 0-4s fitina, Yara bakwai ne kawai aka kwatanta da suna da "mai tsanani" COVID-19 - allurar rigakafi guda shida kuma an ba su placebo. Hakazalika, ga yara 12 da ke fama da ciwon kai, 10 an yi musu allurar rigakafin biyu ne kawai waɗanda suka sami placebo. Waɗannan duka ƙananan adadi ne kuma sun yi ƙanƙanta don kawar da duk wani mummunan tasiri kamar inganta abin dogara antibody (ADE) da sauran tasiri akan tsarin rigakafi.
- Har ila yau, ba a amsa tambayar ba Asalin Antigenic Zunubi. Abin lura shi ne cewa a cikin a babban karatun Isra'ila, waɗanda suka kamu da cutar bayan an yi musu alluran rigakafi sun fi waɗanda aka yi musu allurar bayan kamuwa da cuta. A cikin Moderna fitina, N-antibodies da aka gani a cikin kawai 40% na wadanda suka kamu da cutar bayan alurar riga kafi, idan aka kwatanta da 93% na wadanda suka kamu bayan placebo.
- Akwai shaidar rushewar alluran rigakafin duka biyun na halitta da daidaitawa martani na rigakafi. Yiwuwar haɓaka wani rashin aikin rigakafi zai zama bala'i ga yara, waɗanda ke da ingantaccen rigakafi, wanda ya zuwa yanzu cutar ta yaɗu ta horar da su yadda ya kamata.
- Gaba ɗaya ba a sani ba shine ko za a sami wani mummunan tasiri akan aikin T-cell wanda ke kaiwa ga wani karuwa a cikin ciwon daji.
- Hakanan, dangane da aikin haihuwa, iyakance nazarin rarraba halittun dabbobiya nuna nanoparticles na lipid suna maida hankali a cikin ovaries da testes. Manya masu ba da gudummawar maniyyi suna da ya nuna raguwar kirga maniyyi musamman na maniyyi masu motsi, faduwa da watanni uku bayan allurar da sauran tawaya a wata hudu zuwa biyar.
- Ko da ga manya, damuwa suna tashi cewa munanan abubuwan da ba su da kyau sun wuce asibiti daga COVID-19.
D. Sanarwa yarda
- Don 5-11s, JCVI, a cikin ba da shawarar "bayar da gaggawa" na rigakafin, musamman. ya lura Muhimmancin cikakken sanarwa ba tare da tilastawa ba.
- Tare da ƙarancin haɓakawa a cikin wannan rukunin shekarun, kasancewar 'karnuka far', tallace-tallace gami da hotunan jarumai da bayanai game da rigakafin yara kare abokai da iyali duk a sarari suna gudana sabanin manufar yarda, cikakken bayani kuma an ba su kyauta.
- Cikakken tsallake bayanai bayyana wa jama'a daban-daban da fasahar zamani da aka yi amfani da su a cikin alluran rigakafin COVID-19 idan aka kwatanta da daidaitattun alluran rigakafi, da gazawar sanar da rashin kowane bayanan aminci na dogon lokaci, iyaka kan rashin fahimta.
E. Tasiri kan amincewar jama'a
- Alurar rigakafin cututtuka masu tsanani, kamar cutar shan inna da kyanda. bukatar a ba da fifiko. Tura wani sabon labari, maganin alurar riga kafi ga yara ƙanana yana da matuƙar lalata amincewar iyaye a cikin gabaɗayan shirin rigakafin.
- Rashin ingancin bayanan da Pfizer ya gabatar yana haɗarin haifar da masana'antar harhada magunguna cikin rashin mutunci da masu gudanarwa idan wannan samfurin ya sami izini.
A taƙaice, ƙananan yara masu lafiya suna cikin ƙaramin haɗari daga COVID-19, musamman tun zuwan bambance-bambancen Omicron. Yawancin an yi ta kamuwa da cutar ta SARS-CoV-2, duk da haka sun kasance lafiya, ko kuma suna da gajeriyar rashin lafiya. Kamar yadda aka yi bayani dalla-dalla a sama, alluran rigakafin suna da ɗan gajeren tasiri, sun san haɗarin gajere zuwa matsakaitan lokaci da aminci na dogon lokaci da ba a san su ba. Bayanai don ingantaccen amfani na asibiti a cikin ƙananan yara ba su da yawa ko babu. A cikin manyan yara, waɗanda aka riga aka ba da lasisin rigakafin, an inganta su ta hanyar tsare-tsare masu banƙyama ga yuwuwar lahani na wasu, da mahimmanci, sassan shirin rigakafin yara.
Ga ƴan tsiraru na yara waɗanda yuwuwar samun fa'ida a fili kuma ba tare da wata shakka ba ta zarce yuwuwar cutarwa, ana iya samun sauƙin yin rigakafin ta hanyar taƙaitaccen lasisi. Ko bin ƙa'idar yin taka tsantsan ko umarni na Farko Kada Ku cutar da, irin waɗannan alluran ba su da gurbi a cikin shirin rigakafin yara na yau da kullun.
(Sa hannu):
- Farfesa Angus Dalgleish, MD, FRCP, FRACP, FRCPath, FMed Sci, Shugaba, Cibiyar Nazarin Ciwon daji & Immunotherapy (ICVI)
- Farfesa Anthony Fryer, PhD, FRCPath, Farfesa na Clinical Biochemistry, Jami'ar Keele
- Farfesa David Livermore, BSc, PhD, Farfesa Farfesa na Likita Microbiology, UEA
- Farfesa John Fairclough FRCS FFSEM mai ba da shawara na girmamawa mai ritaya
- Lord Moonie, MBChB, MRCPsych, MFCM, MSc, House of Lords, tsohon Mataimakin Sakatare na Jiha na Majalisar 2001-2003, tsohon mai ba da shawara kan Magungunan Kiwon Lafiyar Jama'a
- Dr Abby Astle, MA (Cantab), MBBChir, Shugaban GP, GP Trainer, GP Examiner
- Dr Michael D Bell, MBChB, MRCGP, Babban Likita mai ritaya
- Dr Alan Black, MBBS, MSc, DipPharmMed, Likitan Magunguna mai Ritaya
- Dr David Bramble, MBChB, MRCPsych, MD, mai ba da shawara ga likitan hauka
- Dr Emma Brierly, MBBS, MRCGP, Babban Likita
- Dr David Cartland, MBChB, BMedSci, Babban likita
- Dr Peter Chan, BM, MRCS, MRCGP, NLP, Babban Kwararren Kwararren Kwararren likita, Mai aikin likita
- Michael Cockayne, MSc, PGDip, SCPHNOH, BA, RN, Ma'aikacin Lafiya na Ma'aikata
- Julie Coffey, MBChB, Babban Likita
- John Collis, RN, Kwararre na Nurse Practitioner, mai ritaya
- Mr Ian F Comaish, MA, BM BCH, FRCOphth, FRANZCO, Mashawarcin Likitan Ido
- James Cook, NHS mai rijista, Bachelor of Nursing (Hons), Jagora na Kiwon Lafiyar Jama'a
- Dr Clare Craig, BMBCh, FRCPath, Masanin ilimin cututtuka
- Dr David Critchley, BSc, PhD a Pharmacology, 32 shekaru gwaninta a Pharmaceutical R&D
- Dr Jonathan Engler, MBChB, LlB (hons), DipPharmMedDr Elizabeth Evans, MA (Cantab), MBBS, DRCOG, Likita mai ritaya
- Dr.
- Dr Simon Fox, BSc, BMBCh, FRCP, Mashawarci akan Cututtuka da Magungunan Ciki
- Dokta Ali Haggett, aikin al'umma na kiwon lafiyar kwakwalwa, sashe na 3, tsohon malami a tarihin likitanci
- David Halpin, MB BS FRCS, Orthopedic da kuma likitan tiyata (mai ritaya)
- Dr Renée Hoenderkampf, Babban Likita
- Dr Andrew Isaac, MB BCH, Likita, yayi ritaya
- Dokta Steve James, Mai ba da shawara mai kulawa
- Dr Keith Johnson, BA, DPhil (Oxon), IP Consultant for Diagnostic Testing
- Dr Rosamond Jones, MBBS, MD, FRCPCH, mai ba da shawara ga likitan yara mai ritaya
- Dokta Tanya Klymenko, PhD, FHEA, FIBMS, Babban Malami a Kimiyyar Halitta
- Dr Charles Lane, MA, DPhil, Masanin Halittar Halitta
- Dr Branko Latinkic, BSc, PhD, Masanin ilimin Halittu
- Dr Felicity Lillingstone, IMD DHS PhD ANP, Likita, Kula da Gaggawa, Abokin Bincike
- Dr Theresa Lawrie, MBBCh, PhD, Darakta, Shaida-Based Medicine Consultancy Ltd, Bath
- Katherine MacGilchrist, BSc (Hons), MSc, Shugaba/Daraktan Bita na Tsari, Epididemica Ltd.
- Dr Geoffrey Maidment, MBBS, MD, FRCP, Likita mai ba da shawara, mai ritaya
- Ahmad K Malik FRCS (Tr & Orth) Dip Med Sport, Consultant Trauma & Orthopedic Surgeon
- Dr Kulvinder Singh Manik, MBBS, Babban Likita
- Dr Fiona Martindale, MBChB, MRCGP, Babban Likita
- Dr S McBride, BSc (Hons) Microbiology Medical & Immunobiology, MBBCh BAO, MSc a Clinical Gerontology, MRCP (UK), FRCEM, FRCP (Edinburgh). Magungunan Gaggawa na NHS & Geriatrics
- Mista Ian McDermott, MBBS, MS, FRCS (Tr&Orth), FFSEM (Birtaniya), Mashawarci Likitan Orthopedic
- Dr Franziska Meuschel, MD, ND, PhD, LFHom, BSEM, Magungunan Gina Jiki, Muhalli da Hadin gwiwa
- Dr Scott Mitchell, MBChB, MRCS, Likitan Magungunan Gaggawa
- Dr Alan Mordue, MBChB, FFPH. Mashawarci mai ritaya a Magungunan Kiwon Lafiyar Jama'a & Cututtuka
- Dr David Morris, MBChB, MRCP (UK), Babban Likita
- Margaret Moss, MA (Cantab), CBiol, MRSB, Darakta, Cibiyar Abinci da Allergy, Cheshire
- Dr Alice Murkies, MD FRACGP MBBS, Babban Likita
- Dr Greta Mushet, MBChB, MRCPsych, mai ba da shawara kan ilimin halin dan Adam mai ritaya a cikin ilimin halin dan Adam
- Dr Sarah Myhill, MBBS, GP mai ritaya da Likitan Naturopathic
- Dokta Rachel Nicholl, PhD, masanin kimiyya
- Dr Christina Peers, MBBS, DRCOG, DFSRH, FFSRH, ƙwararriyar Menopause
- Rev Dr William JU Philip MB ChB, MRCP, BD, Babban Ministan Cocin Tron, Glasgow, tsohon likita kwararre kan ilimin zuciya
- Dr Angharad Powell, MBChB, BSc (hons), DFRSH, DCP (Ireland), DRCOG, DipOccMed, MRCGP, Babban Likita
- Dr Gerry Quinn, PhD. Mai bincike na Postdoctoral a cikin microbiology da immunology
- Dr Johanna Reilly, MBBS, Babban Likita
- Jessica Righart, MSc, MIBMS, Babban Masanin Kimiyyar Kula da Lafiya
- Mr Angus Robertson, BSc, MB ChB, FRCSEd (Tr & Orth), Mashawarci Likitan Orthopedic
- Dokta Jessica Robinson, BSc (Hons), MBBS, MRCPsych, MFHom, Likitan Ƙwararrun Ƙwararrun Ƙwararru da Ƙwararrun Magunguna
- Dr Jon Rogers, MB ChB (Bristol), Babban Likitan Mai Ritaya
- Mista James Royle, MBChB, FRCS, MMedEd, Likitan Launuka
- Dr Roland Salmon, MB BS, MRCGP, FFPH, Tsohon Darakta, Cibiyar Kula da Cututtuka ta Wales
- Sorrel Scott, Grad Dip Phys, ƙwararren Physiotherapist a Neurology, 30 shekaru a NHS
- Dr Rohaan Seth, BSc (hons), MBChB (hons), MRCGP, Babban Likitan Mai Ritaya
- Dr Gary Sidley, mai ba da shawara na NHS Clinical Psychologist
- Dr Annabel Smart, MBBS, Babban Likitan Janar mai ritaya
- Natalie Stephenson, BSc (Hons) Likitan Jikin Jiki
- Dr Zenobia Storah, MA (Oxon), Dip Psych, DClinPsy, Babban Masanin ilimin halin dan Adam (Yara da Matasa)
- Dr Julian Tompkinson, MBChB MRCGP, Babban Kwararren GP mai horar da PCME
- Dr Noel Thomas, MA, MBChB, DCH, DObsRCOG, DTM&H, MFHom, likita mai ritaya
- Dr Stephen Ting, MB CHB, MRCP, PhD, Likita mai ba da shawara
- Dokta Livia Tossici-Bolt, PhD, Masanin Kimiyya na Clinical
- Dr Carmen Wheatley, DPhil, Orthomolecular Oncology
- Dr Helen Westwood MBChB MRCGP DCH DRCOG, Babban Likita
- Mista Lasantha Wijesinghe, FRCS, mai ba da shawara ga Likitan jijiyoyin jini
- Dokta Damian Wilde, PhD, (Chartered) ƙwararren Masanin ilimin halin ɗan adam
- Dr Ruth Wilde, MB BCh, MRCEM, AFMCP, Likitan Magungunan Haɗin Kai & Aiki
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Robert W. Malone likita ne kuma masanin ilimin halittu. Ayyukansa sun mayar da hankali kan fasahar mRNA, magunguna, da bincike na sake fasalin ƙwayoyi.
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