daddy-kool wrote: ↑17/09/2021 10:26
Naslovnica wrote: ↑17/09/2021 10:23
Vakcine se još uvijek testiraju. To je valjda i normalno, pogotovu uzevši u obzir brzinu kojom su izašle na tržište i način na koji su odobrene.
Ja sve to shvatam, ali ne shvatam kako neko ne razumije da se testiranja vakcine (ne spominjem faze 1, 2 i 3) još uvijek provode.
Mislim, počevši od toga da se nije znalo da li vakcinisani prenose virus ili ne, trajanja zaštite, od kojekakvih boostera kojim se uveliko rokaju, pa do miokarditisa i perikarditisa koji su naknadno dodani na listu nuspojava.
Opet kažem, meni je to jasno, jer je bio kratak vremenski period i nedovoljno ispitanika da bi se sve utvrdilo.
Ovo sada je real-time i real-life testiranje, podaci se prikupljaju na terenu i to je to.
To se sve podrazumijeva, pogotovo što se neki efekti mogu tek primjetiti kod velikih brojeva (<1 milion) jer su izuzetni rijetki. (što je btw slučaj sa svim i svačim od aspirina pa nadalje)
Ali post na koji sam ja reagovao tvrdi da nije završena 3. faza?
Ja mislim da je je 3.faza završena, a sada se provodi ovo (logično i sasvim očekivano):
Ongoing clinical trials
Ongoing clinical trials, safety monitoring, and real-world data from COVID-19 vaccination programmes worldwide provide us with useful information. This includes the long-term safety and benefits of the vaccine.
Monitoring clinical trial participants
To understand the long-term efficacy and safety of the vaccine, participants in the
clinical trials are tracked for at least two years from their second dose of the Pfizer vaccine.
Participants will:
have their health monitored
attend regular follow-up visits.
This is closely observed by Pfizer/BioNTech and an independent group of experts called the Independent Data Monitoring Committee. They decide if a clinical trial can continue.
Reviewing new data and evidence
Regulatory authorities, like Medsafe, have procedures to closely review all new data and will update their recommendations as this becomes available.
Real-world data
We’re continually reviewing new data as it’s being reported.
Medsafe is closely monitoring real-world data from the vaccination programmes across the world, in particular on the safety of the Pfizer vaccine (Comirnaty). This will add to the clinical data we receive from Pfizer/BioNTech. This includes:
the overall safety profile of the vaccine
any reported reactions (the frequency, the severity, and any previously unknown reactions)
the effectiveness of the vaccine overall and in certain groups.
https://www.health.govt.nz/our-work/dis ... nd-testing
edit: vjerovatno se ovo boldovano odnosi na 2022 i 2023 (dvije godine od druge doze). To bi se moglo nazvati Faza 4.