1/n My 7-slide summary of the @NEJM 7 July study on safety and effectivity of #COVID19Vaccination in adolescents
Q What was the research question?
Is Covid vaccine safe and effective in adolescents aged 12-15 years of age?
2/n What did the researchers do?
In an ongoing multinational, placebo-controlled, observer-blinded trial, researchers randomly assigned 2260 adolescents to receive two injections, 21 days apart, of BNT162b2 vaccine or placebo.
3/n Was the vaccine safe, immunogenic and effective?
Yes
Yes
Yes
4/n
What are the 3 key messages from this study?
5/n
Was it effective?
Yes
Did it produce serious adverse events?
No
6/n
Point to ponder
We lack data on long term safety and effectivity in children.
7/END
What are the key implications of the study?
Adolescents and community both benefit.
Schools are colleges can re-start.
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1/n The COLCORONA clinical trial (Lancet 27 May 2021) concludes that if we treat 70 Covid positive people with colchicine for a month, we prevent 1 hospital admission or death.
How did the researchers estimate the sample size of their study?
2/n Assumptions. They assumed that 7% of those on placebo shall either die or need hospital admission. Oral colchicine shall reduce this number to 5.25.
To detect a difference between the 2 arms of the study, they needed to enrol about 6000 people in the study. Which they did.
3/n The outcome in the colchicine trial was death or hospital admission. The secondary outcome was the need for mechanical ventilation.
Outcomes that are clinically meaningful. Outcomes that matter most to patients or their family.
I cringe when Times of India reports results from a COVID19 case-series from Maharashtra- drugs are doing great. Not a word on control arm or standard of care. They should ask—and tell us—who did they compare the drug with. These numbers are confusing and distort science. 1/4
First, #Favipiravir. Maharashtra reports that 5.5% (27/495) mildly sick COVID patients on Favipiravir died. Normally, about 98% of such patients recover. Are these results “encouraging”? Or should we be worried about the association of increased mortality with Favipiravir? 2/4
Second, #Remdesivir. The NEJM RCT showed that 7.1% on Remdesivir died compared to 11.9 % on placebo. The results lacked statistical significance. In Maharashtra, 29% (89/311) patients receiving Remdesivir died. Should we call these results promising? 3/4
My quick comments on the #Favipiravir study results released by #GLENMARK in a press release.
Did Favipiravir succeed in achieving faster viral clearance? No. The difference between the two arms of the study lacks statistical significance. The 95% CIs cross 1. N/1
What about secondary endpoints? Would you pay Rs 12500 for a drug that promises to make you fever-free a day earlier?
Look at the 95% CIs again- they barely float above 1! Not impressive! And were these patients hypoxic? The data does not tell us. 2/2
#Favipiravir group tended to require oxygen late compared to the usual care group.
OK. The trouble is, we do not know, eventually how many required oxygen in each group. 95% Cis touch 1- meaning no difference between the two groups. 3/4