Pfizer/BioNTech COVID-19 Vaccine (BNT162b1) is the first mRNA vaccine to be approved by a regulatory body outside of China. In this case， the European Medicines Agency. We are in Phase 3 studies for safety and efficacy as well as long term follow ups on the BNT162b1 vaccines that were manufactured at Pfizer's facility using an established manufacturing process.
In order to address safety concerns from other countries about vaccine production we have developed risk mitigation strategies around key elements of our manufacturing pipeline with oversight from independent experts across all areas of operation， including quality management system assurance and product tracking systems. With over $8 billion being invested into these activities so far it would appear those measures will pay off if they haven’t already. You can check out some of my prior work here on the topic
For example there has been one reported adverse event where someone experienced acute allergic reactions after receiving the second dose. The reaction was managed appropriately but further investigation uncovered something called polyethylene glycol (PEG) allergy that might play a role. PEG allergies are common. One study found nearly half of Americans who had taken medicines containing Polyethylene Glycol reported side effects such as stomach pain， diarrhea or nausea. It turns out though when used in pharmaceutical compositions like the covid shots there appears to be no significant problem associated because of how the PEG molecules are protected inside the composition.
The CDC states “There is currently no evidence that suggests that vaccines contain harmful substances， and available data demonstrate their safety”
