Here’s a link to the Pfizer FDA report. It’s interesting and I encourage every one of us who is interested to read some of the highlights towards the end of the paper.
Known benefits:
1. The Pfizer vaccine has been shown to decrease rates of Covid-19 infection in vaccinated individuals > 7 days following dose 2
2. Decreased severe COVID-19 in individuals receiving at least one dose
Unknown Benefits/Data Gaps: (
my highlights)
1. Duration of protection - no clear evidence yet if protection lasts longer than 2 months.
Does this mean we need repeated vaccinations every few months, or each year?
2. Effectiveness in the face of a changing pandemic.
Will the vaccine be efficacious versus a variant of the S protein? It appears we don’t know, and this is now a real concern with the news of a new strain out of the UK.
3. Vaccine effectiveness against long-term sequelae of COVID-19.
“COVID-19 disease may have long-term effects on certain organs, and at present it is not possible to assess whether the vaccine will have an impact on specific long-term sequelae of COVID-19 disease in individuals who are infected despite vaccination.“
4. Effect on mortality.
“A larger number of individuals at high risk of COVID-19 and higher attack rates would be needed to confirm efficacy of the vaccine against mortality.”
5. There is currently no definitive evidence vaccination reduces transmission of Covid.
Unknown risks:
It’s not known if the vaccine is safe in pregnant individuals, pediatric patients younger than 16, and immunocompromised individuals.
It doesn’t appear the vaccine poses any vaccine enhanced risk, but the FDA cautions that this cannot be definitively determined if this will hold true over time.
The study participants will be re-evaluated after 18 months (or two years, I wasn’t sure) to more definitively assess for safety.
If the pandemic changes and becomes more devastating than it already is, maybe my opinions change and I decide to vaccinate. It’s all fluid. As things currently stand, I won’t fault any provider from wanting to wait at least 2 years for a more definitive safety assessment. A caveat, this is only for the Pfizer vaccine.