Pfizer and partner BioNTech’s COVID-19 vaccine meets expectations on agency guidance and is enough to spur an agency review, according to staff of the U.S. Food and Drug Administration.
However, one thing of note in the ‘risk’ section includes:
The vaccine has been shown to elicit increased local and systemic adverse reactions as compared to those in the placebo arm, usually lasting a few days…
The most common solicited adverse reactions were injection site reactions (84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), fever (14.2%)
…
Severe adverse reactions occurred in 0.0-4.6% of participants, were more frequent after Dose 2 than after Dose 1 and were generally less frequent in older adults (>55 years of age) (<2.8%) as compared to younger participants (≤4.6%). Among reported unsolicited adverse events, lymphadenopathy occurred much more frequently in the vaccine group than the placebo group and is plausibly related to vaccination.
The experimental vaccine, BNT162b2, is on track to be the first shot to get an emergency authorization in the US.- READ MORE
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