Investigation by our @serenatinari on @BMJ_latest The @EMA_News Covid-19 vaccine leak show that some early commercial batches of Pfizer-BioNTech’s vaccine had lower than expected levels of intact mRNA, prompting wider questions about how to assess this novel vaccine platform 1/4
@EMA_news was victim of a cyberattack, the material delivered to journalists and academics. EMA was concerned about manufacturing not producing vaccines to the specifications expected, and unsure of the implications of low mRNA integrity on the vaccine safety and efficacy. 2/4
@BMJ_latest@serenatinari piece on mRNA integrity in Covid-19 vaccines raises questions about the lack of transparency. Companies and regulators said to the journal the specification limit acceptance criteria are commercially confidential @RecheckHealth 3/4
The documents offer the medical community a chance to reflect on the complexities of quality assurance for all mRNA vaccines and especially on RNA instability, one of the most important variables that has thus far received scant attention 4/4
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1/3 Just out: @RecheckHealth analysis and commentary Der seltsame Fall / le cas étrange / the Strange Case of the Swiss National COVID-19 Science Task Force @SwissScience_TF. Open access in Deutsch / Français / English. re-check.ch/wordpress/fr/s…
2/3 @SwissScience_TF is a group of scientists acting as a consultant to the Swiss authorities on #COVID19. Only his president should be talking to the media; is it really the case? And what are the rules of engagement of this very special board? @RecheckHealth
2/9 The article tracks back the approval history of the first vaccine to have been granted the FDA’s accelerated approval and fast track. @CatherineRiva and MD @gipispinosa combined published documents with DAPs and correspondence obtained with a #FOIA#Gardasil#HPV
3/9 The authors of @thejospi piece sought to understand how the evaluation criteria were selected during #Gardasil approval and the impact of the FDA experts’ choices on the quality of the available evidence about the vaccine’s efficacy. #Gardasil#HPV
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.@Doctors4Assange published in @TheLancet on behalf of 117 signatories hbs.ly/H02z580 “We are calling upon governments to end the torture of #Assange and ensure his access to the best available health care before it’s too late”
Care to kick off the New Year with a TWEETORIAL? Our humble homage to @VPrasadMDMPH will walk you through the evidence on #HPV vaccines and what @Cochranecollab made of it. Let’s first agree on one thing: RCTs are superior to observational studies
On HPV vaccines many observational studies published and hyped Randomized Controlled Trials on #Gardasil#Cervarix failed to demonstrate the expected efficacy though. It is sad, true and rarely discussed. Let’s have a closer look. @garyschwitzer@HealthNewsRevu@senseaboutsci
In 2006 @US_FDA VRBPAC Committee required @Merck to provide data and analyses on Gardasil RCTs FUTURE I and II.
Which outcome would you consider as the most relevant to assess Gardasil efficacy?