Unikāls materiāls no pirmavota!

Foto: pirmo “Pfizer” un “BioNTech” vakcīnu piegāde Valsts asinsdonoru centram sestdien, 26. decembrī (Edijs Pālēns, LETA).

8h 45min ilgušās Vakcīnu un saistīto bioloģisko produktu konsultatīvās komitejas tiešsaistes sapulces konspekts latviešu valodā. Visiem mums, kuri vēlas iedziļināties un saņemt nepastarpinātu informāciju.

Tiešsaistes sapulce šā gada 10. decembrī notika ASV Pārtikas un zāļu administrācijas (FDA – U.S. Food and Drug Administration) “YouTube” kanālā un tajā piedalījās 23 darbinieki no CDC, FDA, farmācijas kompānijas “Pfizer”.

Avots: www.youtube.com

Paldies par konspektu un tiesībām to publicēt “Vakcīnrealitāte Latvijā” ārstei, kura savu vārdu lūdza nepublicēt.

Lūdzam ņemt vērā, ka šī ir oficiālo pārstāvju sniegtā informācija plašākai auditorijai, tāpēc jāuztver kritiski.

Sapulcē dzirdētais liek secināt, cik nedrošas un nepārbaudītas ir C-19 vakcīnas. Neskatoties uz nepilnīgi veikto klīnisko izpēti un reakciju analīzes trūkumu vakcīnu “brīvprātīgajiem” saņēmējiem, tās jau tiek izplatītas un piedāvātas patērētājiem. 

Citāts no sapulces: “Ņemot vērā Sponsoru, mēs uzsveram ieguvumu, tāpēc nefokusēsimies uz drošību un efektivitāti.” (Marian Gruber, “Pfizer” viceprezidente).

Konspekts:

Vakcīnu neveiksmes dažiem (astoņiem) cilvēkiem – vai Jūs novērtējāt vīrusa tipu šajos cilvēkos, pierādījumus, vai antivielas neizstrādājas pret antigēnu?

Atbilde: Pagaidām vēl neesam analizējuši šo cilvēku imūnreakciju, uz šo brīdi mūsu rīcībā nav nepieciešamo datu. / Kathryn Jansen, “Pfizer” viceprezidente & vakcīnu nodaļas vadītāja.

Jautājums par jaunajiem modificētajiem RNS, vai tie reinkorporējas DNS, vai arī reversā transkriptāze (RT) to pārvērtīs DNS. 

Atbilde:Mums nav datu par modificēto nukleozīdu pārstrādi, mēs domājam, ka ir ļoti maza iespējamība, ka tā varētu notikt.”

  • Bella paralīze 16-17 g. veciem vakcīnu saņēmušajiem bez iepriekšējas Bella paralīzes – 3,9, 37 un 48 dienas pēc vakcinācijas.
  • Limfadenopātija izteikti vairāk vakcinēto grupā.
  • Hipersensitivitāte vairāk ziņota vakcinēto grupā (137 gadījumi vs 111 placebo grupā).
  • Ziņojumā FDA nav saņēmis nekādus datus no “Pfizer” par anafilaktisko šoku.

Brīvprātīgie pirmo deva saņēmuši 27.jūlijā, novērošana pētījumam beigta 14. novembrī.

Jautājums par papildu datiem – kopš 14. novembra “Pfizer” nav veikuši papildu datu analīzi, sola to darīt laika gaitā, nav datu, kas pētītu cilvēku stāvokli pēc 2. devas injicēšanas.

Jautājums par Bella paralīzes saistību ar imunoloģisko atbildi uz ievadīto antigēnu.

Atbilde – nav pētīts šis jautājums.

Jautājums par adaptīvo imūnatbildi. Konvalescenta plazma?

Atbilde: “38 serumu panelis – mērķis ir salīdzināt vakcīnas inducētu imūnatbildi. Tātad nevajag satraukties par adaptīvo un iedzimto imūnatbildi!”

Jautājums par sievietēm un imunizēšanu – nav vēl iegūti dati par reproduktīvo toksicitāti no dzīvniekiem, tas plānots līdz šī mēneša beigām! Nav nekādu datu, lai runātu par risku grūtniecēm vai auglim, lēmumu par vakcinēšanos ļaus pieņemt sievietēm pašām (!!!)

Jautājuma par 16-17 g.v. kā iekļaujamo grupu – likumi ASV atļauj datu ekstrapolāciju no pieaugušo populācijas uz bērnu populāciju. Viņiem lielāks risks inficēties ar Sars cov2.

19 cilvēki no pētījuma abās grupās saslima ar Covid-19 pirmajās 28 dienās. Tas ir lielāks inficēšanās risks nekā bija gaidīts: vai testēšana ir gana efektīva? 

Atbilde: šo jautājumu mēs neesam pētījuši, darīsim to vēlāk. Mēs nevaram izmantot spike proteīnu testēšanā, jo tad visi būtu pozitīvi. Vai end-proteīna pozitivitāte ir labs veids korelācijai ar slimību? Krusteniskās reakcijas uzrāda labus rezultātus.

Nav nepieciešamas papildu diskusijas par imūnatbildēm, jo tās var novirzīt no tēmas.

Balsošana par to, kā turpināt pētījumu, protokolu modifikāciju, visvairāk satrauc nevis efektivitāte, bet tieši drošība (Marian Gruber, “Pfizer” viceprezidente).

Dr. Olivia Fuller jautā: Risku izvērtēšana – nav zināms, ko cilvēka organismā dara lipīdi vieni paši. Ko tas nozīmē ilgtermiņā? Vakcīnu grupa salīdzināta ar pilnīgu placebo, nevis ar lipīdiem? 

Atbilde: Blaknes placebo bija saistībā ar mRNS un lipīdu enzīmu kombināciju.

Jautājums: Tātad iepriekš nekad nav pētīta šāda kombinācija, un to dos miljoniem cilvēku, un ir ļoti ierobežots riska izvērtējums. Vai man taisnība? 

Atbilde: vai! Es nedzirdēju jautājumu. 

Atkārto jautājumu. 

Atbilde: to varētu komentēt tā, ka “Pfizer” nav daudz pētījumu. Mēs esam pētījuši, kas notiek, ja subjekts tiek pakļauts Covid, mūsu pētījumos. Gadījumi ir daži, ir zems slimības smaguma risks. Plānots pētījumu turpināt 24 mēnešus.

Paul Offit: jautājums par to, ka nav datu par smagām alerģiskām reakcijām. Vai no pētījuma tika izslēgti cilvēki ar smagām alerģiskām reakcijām? Jo Lielbritānijas sabiedrības veselības oficiālie pārstāvji pauda, ka, ja bijusi alerģiska reakcija anamnēzē, cilvēki nedrīkstēs saņemt šo vakcīnu – ļoti vienkārši! Pasaulē šobrīd ir desmitiem miljonu cilvēku, kuriem ir dažādas alerģijas, tas ir liels skaits.

Atbilde:Jā, no pētījuma izslēdza tos, kam uz kādu iepriekš saņemtu vakcīnu bija smaga alerģiska r-ja vai alerģ r-ja pret šo vakcīnu, vai arī pēc 1. devas saņemšanas bija 1. tipa hipersensitivitātes reakcija. Pētījuma gaitā netika novērota neviena alerģiska reakcija.

Jautājums: Vai pētījumā ir dati par cilvēkiem, kam bijis anafilaktiskais šoks vai kuri līdzi nēsā “EpiPen”?

Atbilde: cik zināms, šādu cilvēku nebija. Par diviem Lielbritānijā ziņotajiem gadījumiem, konkrētajā dienā tika vakcinēti 6000 cilvēki. 1 cilvēks bez iepriekšējas alerģijas 2 min pēc vakcinācijas pilnībā atveseļojās, 2 cilvēkiem bija alerģija pret kādu medikamentu (?); 

Marian Gruber: mēs komunicējam ar Lielbritānijas regulatoriem, šobrīd gaidām papildu info. Atgādinu komisijai, ka jāskatās pazīmes, kas liecina par alerģiskām reakcijām. Instrukcijā jābūt brīdinājumam, ja bijusi kāda reakcija pret kādu no vakcīnas sastāvdaļām. Tas tiks izdarīts tuvākajās dienās (pie tā strādājam mēs, FDA un Sponsors). 

Paul Offit.: Šai vakcīnai ir, iespējams, garākais ķīmiskais sastāvs, kas jebkad redzēts, praktisks risinājums būtu brīdināt visus tos, kam ir alerģija uz zemesriekstiem, olām, lietot šīs vakcīnas, tiekot rūpīgi novērotiem, līdz mums būs labāki dati. Šis jautājums nekur nepazudīs, tādēļ mums jāizlemj.

Marianna G.: Ņemot vērā Sponsoru, mēs uzsveram ieguvumu, tāpēc nefokusēsimies uz drošību un efektivitāti. 

P.Offit: Es piekrītu. 

Cody Meisner: “Vakcinējamajam būtu jābūt gatavam anafilaktiskai reakcijai no jebkuras vakcīnas. Es nedomāju, ka alerģija pret ovalbumīnu radītu risku šai vakcīnai. Otrkārt, par grūtniecēm: manas raizes, ka grūtniecības laikā embrijā notiek ļoti daudz DNS replikāciju, grūtnieču vakcinēšana, manuprāt, jāiepauzē. Vai varētu būt, ka retrovīrusi ietekmē RT mazuļa hromosomas?

Un par 16-17 gadīgajiem: pētījumā iekļauti tikai 163 subjekti, dzirdējām, ka jaunākajiem subjektiem iekaisīgas atbildes uz vakcīnu bija vairāk nekā pieaugušajiem (vecākiem). Manuprāt, mums vajadzētu vairāk informācijas, pirms mēs visu izlemjam. Pēdējais – ir svarīgi EUA, lai būtu šī vakcīna tik ātri, cik FDA to ļauj, mums nepieciešama pūļa imunitāte. Bet jābūt vakcīnu blakņu kompensēšanas programmai, ja to rekomendē CDC. 

Kā izvērtēs turpmāko individuālo vakcīnas panesamību? 

“Pfizer” atbilde: Mēs sekojam nacionālajām rekomendācijām katrā valstī .

Patric Moore (TYM): “FDA to nav prasījusi savās vadlīnijās, “Pfizer” nav prezentējis jelkādus pierādījumus, ka vakcīna ir efektīva uz vīrusa nēsāšanu vai pārnesi (shedding), kas ir pamats pūļa imunitātei. Pat, ja vakcīnas individuālā iedarbība (efficacy) ir ļoti augsta, mums šobrīd nav nekādu pierādījumu, ka tai būs ietekme uz epidēmijas radīto sociālo dzīvi, tādēļ pirms atmaskošanas (unblinding), “Pfizer” nopietni jāpārdomā nukleīnskābju izmantošana vakcīnās un placebo, es nedomāju, ka gala izplatīšana (end-point shedding) būs gana augsta, lai redzētu būtisku atšķirību, taču tas būtu jānosaka.” 

Dr. Jensen (“Pfizer”): Atgādinu, ka mums ir dati no primātu studijām, ka vakcinācija novērš infekciju, salīdzinot vakcinētus un nevakcinētus dzīvniekus.

David Kim: Cilvēki ar HIV infekciju un citām stabilām infekcijām un vakcīna? 

“Pfizer”: mēs esam pētījuši grupas ar šādām infekcijām, 196 gadījumi. Mums nodoms iegūt vairāk informācijas par šo jautājumu.

Jautājums: Par iepriekš pozitīviem cilvēkiem, ko darīsiet ar pacientiem, kuri pētījuma laikā saslima? Vai piedāvāsiet viņiem vakcīnu? 

Pfizer atbilde: mums ir indivīdi, kas ir sero pozitīvi, tātad iepriekš bija ekspozēti uz Covid; ja pēta šo nelielo grupu – 150 cilvēku apmēram, salīdzinot ar tiem, kas nebija inficēti, izskatās līdzīgi, ar vakcīnu nav sliktāki rezultāti (smagāka slimība).

Dr. Muchael Kurillo: ja pētījumā nebūtu veselības nozarē strādājošo, kādi būtu rezultāti?

Lielākais izaicinājums, cik ātri populācija pēc plāna saņems vakcīnu pat ar 20% zudumu, būs labs pārklājums. Nākotnē labāk atbildēsim uz šo jautājumu.

James Mildreth jaut. par minoritātēm pētījumā, viņu ir ļoti maz. 

Dr. Gruber (Pfizer) atbild: jau kopš sākuma izlēmām iekļaut minoritātes, manuprāt dati demonstrē efektivitāti, cilvēku vienkārši nebija vairāk.

Dr. Ofer Levy: ja gribam drošu un efektīvu vakcīnu, vajag augstu penetranci, 60-70% imunizāciju pasaulē. Vai mēs esam reāli bez pediatriskas vakcīnas? 

Atbild Arnold Monto (chair): atbildiet pēc iespējas īsāk un ātrāk!

Atbilde no “Pfizer”: mēs esam laimīgi par to runāt! Papildus tam, ko darām ar 16-17 g.v., 100 pirmajiem 12-15 g.v. vakcinētajiem bērniem ir labi rezultāti, tad virzīsimies uz 11 gadīgajiem. Kad apstiprinās drošību šai grupai, būs labi. Jāapdomā deva. Tad virzīsimies uz vecumu zem 5 gadiem. Jāatzīst, ka iniciāli bērniem nedrīkst veikt pētījumus, bet izmantojot vakcīnas efektivitāti, tas būtu pareizi.

Būtu jāskatās arī, kādas atšķirības asinīs ir abās pētījuma grupās. (Philip R. Krause). 

“Pfizer”: jā, tam ir vērtība, to mēs noteiksim arī turpmāk.

Liels izaicinājums ir visus 44000 aicināt uz atkārtotām pieņemšanām – tās ir 88000 vizīšu, lai izvērtētu vispārējo stāvokli!

Jautājums: Mums ir droši dati, lai runātu par ilgtermiņa efektivitāti?

Pfizer atbilde: mums ir noteikts laika logs, kurā veicām novērojumus (2 mēn.), domājam, ka mēs sākumā vakcinēsim kādus 20% no populācijas. Salīdzinoši jāskatās uz jaunvakcinētajiem vs iepriekš vakcinētajiem.

Vēl 2 jautājumi, tad balsosim

Jautājums: Neredzēju prezentētajos slaidos informāciju par pret gripu vakcinētajiem.

Atbilde: Mums ir plāni attiecībā pret gripas vakcīnu, tas būtu lieliski, ja arī tā palīdzētu. Ja nē, mēs skatāmies uz abu vakcīnu vienlaicīgu saņemšanu ikgadēji. Arī CDC tam pievērsīsies.

Pfizer”: mēs turpmākajos pētījumos plānojam iesaistīt pansionātus (long term care facilities).

Chair Arnold Monto: Tagad balsosim! 

Pamatojoties uz zinātnisko pierādījumu kopumu, vai Pfizer-BioNTech Covid19 vakcīna attaisno tās iespējamos riskus lietošanā cilvēkiem, kuri sasnieguši 16 gadus un vecākiem?

Jautājums “Pfizer” par risku izvērtējumu pacientiem, lietojot vakcīnu.

Doran Fink: atkarīgs no raizēm. Ja domājams lielāks risks, tad tomēr jārekomendē izvērtēt iespējamās kontrindikācijas. 

Vai būtu jābūt brīdinājumam?

Atbilde: Ja ieguvuma risks nav lielāks, tad varētu nevakcinēt. Tipiski tā nav.

Jautājums: Dati ir limitēti dažādos jautājumos, drošības jautājums ir pētīts tikai 2 mēnešus, nav zināms par vakcīnas izraisītu slimību laika gaitā. Arī jautājums par ilgstošu drošību. Saprotu, ka tas vēl tiks darīts. Būs jāgaida uz pētījuma dalībnieku atklājumiem? Mums vajadzētu skaidrus standartus, lai sāktu izplatīt vispārējai populācijai. Līdz šim tā tika dota veselības nozarē strādājošiem un pansionātu iemītniekiem.

Atbilde: Mums ir pierādījumi, ka vakcīna pasargā pret slimības saasināšanos arī vēsturē. Noteiktos apstākļos vakcīna radīs retas blaknes, tā notiks.

Jautājums (Cody Meisner): “Ja vakcīna novērš vieglu slimību, tai būtu jānovērš smaga slimība, taču es gribu atzīmēt, ka smaga slimība ir reti. Par drošību: mēs par drošību zinām tikai 60 dienas, es izskatīju vakcīnu ievainojumus, vēsturiski bija tikai 6 – max 8 nedēļu vērojums arī par polio vakcīnu! Nevar runāt par ilgtermiņa drošību, ja tik īsu laiku vēro, taču kopumā piekrītu. Nedomāju, ka vakcīna jādod no 16 gv, bet no 18gv, jo tīņi reti slimo, maz tiek hospitalizēti”.

Komentārs no “Pfizer”: svarīgas ir blaknes, ko vakcīna nav izraisījusi, jo tās uzrādīja arī placebo grupa. Ir cilvēki, kuriem nav tūlītējas vakcīn-reakcijas, ilgtermiņā jāņem vērā, ka ne vienmēr problēmas radīs vakcīna. Svarīgi saprast, ko vakcīna neizraisa!

Chair: balsojam par 16-17 gadīgajiem!

Dr. Levy: jā, tie neslimo bieži, bet mums vajadzētu iekļaut vakcinācijas shēmā pediatrisko vakcināciju, citādi zaudēsim svarīgu ieroci pandēmijas uzveikšanā!

Jautājums: Tātad, ja tīņus neiekļaus, vakcīnas neapstiprinās? Vai tā ir?

Dr. Levy: Ja tagad to neiekļausim, vēlāk būs grūtāk pāriet uz agrīnu vecumu.

Jautājums: Bet mēs nezinām, vai ieguvums pārsniedz risku jaunākajām grupām.

Dr. M.Gans: esmu proponente pētījumiem par imunitāti, es atbalstītu neiekļaušanu.

Dr. Chatarjee: Piekrītu, man ir raizes par šo vecuma grupu, jo viņi nedrīkst paši pieņemt lēmumu par vakcinēšanos, esmu arī par 80+ nevakcinēšanu!

M.Sowjer: Es labāk atliktu vakcinēšanu uz vēlāku vecumu.

Eric Rubin: Neesmu pediatrs, bet efektivitāte te ir satriecoša! Mēs domājam, ka te būtu laba opcija!

Salīdzinot ar šiem 16-17 gadīgajiem, Amerikas indiāņi kopumā vairāk slimo.

P.Offit: Mēs sekosim drošībai. Fakts- 16-17 gadīgie var saslimt. Mums ir teorētiski riski un skaidri pierādījumi vakcīnas efektivitātei! 

K: saslimstības līmenis te ir daudz zemāks. Vai jēga dot bērniem, kuri visticamāk nesaslims?

Marian Gruber (“Pfizer” viceprezidente): domāju, kā teica dr. Finks, par datu ekstrapolēšanu jaunākajām grupām, jāapsver, kā viņi pārnes slimību. Es domāju, ka šis arguments ir spēcīgs ( ka neslimos šī grupa). Aicinu par šo jūs visus balsot! Balsosim datoros, paziņosim rezultātus. 

“Nē” balsoja:

Kurilli, Chaterjee, Fuller, Miger, Kimm. 17 balso par.

Marian Gruber: ļoti pateicos par balsošanu šajā nopietnajā jautājumā! Liels paldies!

Chair: liels paldies fda par lielu darbu. Slēdzu sapulci. Tiekamies pēc nedēļas!

Sapulces ierakstu iespējams noklausīties šeit.

The post Unikāls materiāls no pirmavota! appeared first on Vakcīnrealitāte.lv.

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