I don't have many followers, so this thread won't reach far, but as a Clinical Pharmacist I've read the drug product monograph for the pfeizer vaccine and am optimistic about it. (1/x)
Some points:
1. no efficacy was studied in people under 16. No parents need fear their kids must be vaccinated or they will be excluded from things. Can't expect a kid to be vaccinated if there isn't one approved for pediatric use (2/x)
2. It is two shots separated by 21 days, with efficacy proven a week after the second dose. The 95% efficacy is much more likely in the younger category (under 65) than in seniors, but it is at the worst 66% effective in seniors which is still pretty good.
Why is that good? Older people in general have a harder time generating an immune response to a vaccine, so still getting efficacy in minimum 2/3 of the population which is most at risk will save lives.
A note about efficacy here.There's no mention of testing everyone for covid after immunization by PCR and measuring asymptomatic infection rates. This vaccine is shown to prevent symptomatic infection only. Symptomatic cases are obviously the ones which strain health care systems
3. Another point of optimism is that they included testing on a wide range of ages and pre existing conditions. They didn't include immune compromised people or people who have unstable risk factors (standard for most clinical trials)
But they did include diabetes, asthma, COPD obesity, HIV, HVB, HVC and hypertension. 46% of participants had one or more of these conditions. This is more representative of our society than some trials can be.
Another note about the participants. Their numbers of different ethnic groups show mostly white participants. While they did include many ethnicities, racialized people are disproportionately affected by covid and it would be better to see more robust days for these people
4. As for side effects, they see what I'd expect in a typical immunization, which is a good sign for this new mRNA technology. Most people experienced some arm pain and redness. Other typical post immunization reactions like fever, body aches, fatigue happened to about 1/4 people
This is a good sign! The fact that it makes your immune system work and the rates are so much higher than the placebo group means it generated a meaningful immune response, even in seniors. Also important to note, serious reaction rates were very low, so it's well tolerated
There is a note that its possible 1/100 people could get swollen lymph nodes. That isn't something I typically see. That's something to keep in mind
Long term safety? The monograph includes data for 2 months post second shot for part of the participants. Health Canada gave a conditional approval, requiring pfeizer reports monthly on the long term follow up of these patients for 2 years. This tracking is safety in action
What about pregnancy? There are no safety or efficacy data for human pregnancy and no animal teratogenicity studies at all. NACI says that immunization for pregnant women should be considered but implores manufactures to obtain safety data
Will I recommend this vaccine to my patients? To people 16 and over, who are not immune compromised or medically unstable, this vaccine is shown to be safe and effective, especially if you are white and not pregnant. To all others over 16 I say it's probably safe and effective
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