Professor, Global Health @SDU. Studying the overall health effects of vaccines in Guinea-Bissau and Denmark, discovering that they have important non-specific effects #NSEvac
Crunching numbers in the study that forms the basis for EMA's approval of Pfizer's COVID-19 vaccine ("Comirnaty") for use in 12-15-year-old children. 2260 children were randomized to vaccine or placebo and followed for 1 month after the 2nd dose. I.e. a small study, with short follow-up. EMA noted that the vaccine prevented COVID-19 infection and concluded that "the benefits of Comirnaty in this age group outweigh the risks"(https://lnkd.in/dvGPrhq). However, it appears from suppl. table 2 that in the age group 12-15 years, 7/1131 vaccinated vs. 2/1129 unvaccinated had a severe adverse event, i.e. a 3.5-fold increased risk. In the age group 16-25 years, also presented in the paper, it was 9/536 vaccinated vs. 3/561 unvaccinated. Taken together, the results indicate a relative risk of 3.28 (95% confidence interval 1.21-8.94), hence a highly significantly increased risk in the vaccinated children/young adults. In absolute numbers, 1 of 100 vaccinated child/young adult experienced a severe event, vs. 3 of 1000 unvaccinated. Given the low risk of severe COVID-19 in children - none in this study - it is not clear how EMA could determine that benefit outweighs risks. https://lnkd.in/dhU9bfi
What happened to: better safe than sorry? No use in saying sorry when its too late! Stop now.
I wish I read this 9 months ago. Cheers!
Gerben de Jong deze al gezien?
It seems we should be glad to have any trials at all before rolling out new vaccines. According to Marco Cavaleri, chair of vaccine evaluation team at the EMA. “We are working on updated guidelines, assuming that we cannot ask for large Phase III trials. This will allow us to go faster,” said Cavaleri. “We will ask for much smaller trials, with a few hundred participants, rather than 30,000 to 40,000,” https://www.reuters.com/article/us-health-coronavirus-eu-vaccines-exclus-idUSKBN2AC27T I've always had this silly idea that vaccines are first tested on animals, and that lab rats are real rats, but I must have lived under the rock for quite some time.
Christine, hats off for your efforts. A scholar with academic integrity and courage is hard to come by these days. What strikes me is that given the absolute risk reduction of 0.82% shown in the first trial published in November last year (I guess you're familiar with P. Doshi" op Ed in the bmj on Pfitzer trial) that anyone would even consider vaccination of children. In the course of this vaccination frenzy I came across a number of publications claiming both that the risk of death and the risk of being the vector of transmission of the virus in kids is 0.00007%, the latest one in a op-ed in the Washington post by Monica Gandhi.
Thanks once again Christine Stabell Benn For my understanding what were the actual adverse effects on the unvaccinated kids? Chances of kids even testing PCR positive are less than the numbers presented of them having adverse effects?
Tak Christine for at crunche meget vigtige numbers!
Chief Scientist at Avant-Gray LLC
2yhttps://www.nejm.org/doi/full/10.1056/NEJMoa2107456 Which events did you classify as severe?