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COVID-19 Booster Shots: Pfizer Presents Data of Side Effects to the US FDA

The FDA discusses the request for authorization of Pfizer’s boosters. In documents posted available online, FDA noted conflicting data about the booster shots. Pfizer presented data to the FDA that details the side effects of the boosters.

Side Effects of Pfizer’s Booster Shot

Pfizer required trial participants to keep an electronic journal of their symptoms. The result showed that on-site injection pain was the most prevalent side effect. Extreme adverse effects were rarely recorded, but they included severe exhaustion and muscle soreness. The participants in the study who were between the ages of 18 and 55 were the most likely to report any negative effect.

Chills and new or worsened joint pain were two less common side effects. However, Pfizer said most side effects only lasted up to two days.

Vials of the Pfizer-BioNTech COVID-19 Vaccine (Photo: Getty Images)

Pfizer said in new data submitted to the Food and Drug Administration as it seeks approval to distribute COVID-19 vaccine booster shots across the United States that side effects are similar to those experienced after the second dose and are more likely to afflict younger people.

Results of Pfizer’s Phase 3 Booster Trial

Pfizer’s phase three vaccination booster dose trial indicated that 63.7 % felt fatigued, 48.4% had headaches, and 39.1% had muscle soreness after receiving their booster doses. The majority of booster reactions were mild or moderate, according to a 52-page company report issued Wednesday. Co-developer BioNTech is asking the FDA for special permission to give third doses of its vaccine to persons over 16 across the U.S.

Pfizer previously studied 2,682 second-dose patients aged 16 to 55 and found that 61.5 % had fatigue, 54% experienced headaches, and 39% felt muscle pain. Among 306 booster participants, 44 experienced at least one unanticipated side effect. Lymph node inflammation was reported by 16 of the participants.

According to the report, no occurrences of anaphylaxis, hypersensitivity, Bell’s palsy, appendicitis, myocarditis, or pericarditis were observed among phase three participants. Pfizer also stated that no new adverse medication responses have been discovered as a result of the booster.

President Joe Biden has stated that booster shots will be made available last September 20, but the FDA declined to support Pfizer’s Covid boosters. According to an FDA report, the government has not yet independently evaluated the data and findings from trials on the effectiveness of Pfizer’s boosters.