I support US colleagues in the request to FDA to refrain from fully approving any covid-19 vaccine, until the evidence base is mature enough to judge whether clinical benefits outweigh the risks in all populations. blogs.bmj.com/bmj/2021/06/08…
"Our petition doesn’t argue that risks outweigh benefits—or that benefits outweigh risks. Rather, we focus on methods and processes, outlining the many remaining unknowns about safety and effectiveness—and suggest the kinds of studies needed to address the open questions".
"regarding the elephant in the room: publicly raising any element of hesitation about covid-19 vaccines will be seen by some as irresponsible, stoking unfounded fears in the public’s mind and contributing to the “vaccine hesitancy” problem trumpeted every day....
.. But the alternatives—privately raising concerns or simply remaining silent—are arguably more detrimental to public trust in the long run. Staying silent is not the responsible option".

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More from @StabellBenn

11 May
Back in Denmark after >6 weeks in Africa. Time was spent on two trials close to my heart. Here a brief introduction. First, the @EDCTP funded randomised trial of BCG vaccine to health care workers, as a potential bolster against COVID and other infections. edctp.org/projects-2/edc…
It is a two-center trial at #BandimHealthProject in Guinea-Bissau and at @Manhica_CISM in Mozambique. In March, we from Bandim visited the Manhica team, led by Dr. Pedro Aide and Lidia Nhamussua, to align study procedures before the launch of the trial in Mozambique. Great days with the Manica team - Dr. Pedro Aide on my left,
In Guinea-Bissau, we have enrolled ~300 health care workers. Our analyses show that >20% have COVID-19 antibodies; most have not noticed that they were ill. Perhaps this is why many Guineans said no to the COVID-vaccines that were rolled out in April. medrxiv.org/content/10.110…
Read 6 tweets
9 Apr
NEW PAPER OUT. We investigated the effect of rabies vaccine on the mortality of Danish pigs. Why did we do that - Danish pigs do not get rabies?
Here follows an explanation and the results of the study. #NSEvac sciencedirect.com/science/articl…
Our group has found that many child vaccines have important non-specific effects #NSEvac, affecting the risk of other infections. Live vaccines have beneficial #NSEvac. Non-live vaccines, in contrast, have been observed to have harmful #NSEvac in females. thelancet.com/journals/lanin…
In 2016, analysing data from a trial of a new non-live malaria vaccine (RTS,S), we found that girls had 2-fold higher all-cause mortality if they received RTS,S vs. a control vaccine. The RTS,S group also had more cerebral malaria and meningitis. mbio.asm.org/content/7/2/e0…
Read 9 tweets
20 Mar
The statements put forward by @GVDBossche have created anxiety. @GVDBossche has invited to discussion, but few scientists seem to have replied. The lack of response seems to generate more anxiety. I have received many requests to give my take and felt obliged to do so. 1/n
First a few words on my background: I am an MD working in epidemiology/global health>27 years. Our studies show non-specific effects of vaccines on other infections #NSEvac; I therefore also did immunological vaccine studies to understand mechanisms. 2/n thelancet.com/journals/lanin…
My main interest in COVID-19 vaccines is whether these new vaccines also have #NSEvac (So far none of them have been studied for their effect on other infections). Thus, vaccine immunology is not my main area, but I do know more than most. Hence my feeling of obligation. 3/n
Read 16 tweets
13 Mar
Det mener jeg også. Studiet antager, at en person, der tester positiv så lidt som een dag efter indexcase, er smittet af indexcase. Det kan skabe falsk association ml. høj CT og smitterisiko, hvis mange bare er familie ”lilla periode” - se figur.
Jeg har spurgt forfatterne, om de vil prøve med større vindue; formodningen er, at associationen mindskes. En anden måde test er ved at se på, hvor mange sekundærcases, der kom på hospital; formodningen er, at der var meget få blandt "sekundærcases" til de med højt CT.
Studiet bekræfter fund fra England og Spanien: der er flot korrelation mellem CT-værdi og smitterisiko. Det er det eneste studie, der angiver at finde smitte ved høje CT. Det kalder på grundig undersøgelse af om der kunne være fejlkilder a la ovenstående.
Read 4 tweets
12 Mar
I @Orientering (56:29): Hvis der er god dokumentation for gavn af en Corona-anbefaling (test, isolation, etc) og man gør det praktisk muligt for folk, så vil folk følge anbefalingerne. Lad os skaffe den dokumentation ved at teste vores anbefalinger. dr.dk/radio/p1/orien…
Lad os lave masser af forsøg. Fx om der er gavn af at teste asymptomatiske i ikke-udbrudssituationer - som vi nu er i gang med i stor stil - ved at lade nogle skoler have de to gange ugentlige tests, men fritage andre fra dem. linkedin.com/pulse/et-%C3%A…
Lad os teste, om vi kan forbedre smitteopsporing ved at inddrage viden om mængden af virus i prøven, og give de folk, der har meget virus i halsen, besked om, at de kan være mulige superspredere og at det er ekstra vigtigt at informere alle kontakter.
Read 5 tweets
18 Nov 20
Jeg medvirker i denne artikel, men er ikke tilfreds med, at der er kludder i begreberne. "Falsk positive" med PCR er hvis man ikke har noget virus i halsen, men alligevel testes positiv. Det er der meget lille risiko for. 1/ tjekdet.dk/faktatjek/anal…
"Funktionelt positiv" er noget andet. Det handler om, hvorvidt man har LEVENDE virus i halsen og dermed kan smitte andre. Vi ved, at jo flere "cykler" (=jo højere "CT"), jo mindre er den statistiske sandsynlighed for, at man har levende virus i halsen. 2/ medrxiv.org/content/10.110…
SSI har ikke offentliggjort CT tallene, men baseret på andre studier er der mange "funktionelt negative", altså folk der testes positive uden at kunne smitte andre. Statistisk set er de fleste asymptomatiske med høj CT nogle, der har haft infektion. 3/ nytimes.com/2020/08/29/hea…
Read 7 tweets

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