Published: 2020-12-15 18:10
Last Updated: 2021-05-18 19:04
Monday, Jordan issued an emergency use license for the Pfizer-BioNTech vaccine against COVID-19. While the vaccine is 95 perfect effective, the US Food and Drug Administration (FDA) announced it also has seven side effects commonly experienced by trial participants.
According to the FDA briefing document on the Pfizer-BioNTech COVID-19 vaccine, safety data from approximately 38,000 participants (who either took the vaccine or a placebo) over the age of 16, were monitored upon vaccination administration for two months after the required second dose was taken.
According to the FDA, no specific safety concerns were identified that would preclude issuance of an Emergency Use Authorization (EUA).
Additionally, available safety data from all participants enrolled through the Nov. 14 data cut-off (which includes late enrollment of additional adolescent and adult participants), was consistent with the safety profile for the approximately 38,000 participants and did not raise concerns.
The most common solicited adverse reactions by participants were injection site reactions (84.1 percent); fatigue (62.9 percent); headache (55.1 percent); muscle pain (38.3 percent); chills (31.9 percent); joint pain (23.6 percent); and fever (14.2 percent).
Notably, Britain, the first country to authorize the use of the Pfizer-BioNTech vaccine asked individuals to avoid the vaccination if they are prone to allergic reactions from medicines, food or vaccines, after two National Health Service (NHS) nurses experienced adverse reactions after receiving the first dose.