In this photo illustration a Johnson & Johnson logo is seen in front of a medical syringe and a vial with coronavirus vaccine.
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Headaches, fatigue and muscle pain were some of the most common side effects among people who received Johnson & Johnson‘s one-shot coronavirus vaccine in clinical trials, according to a U.S. Food and Drug Administration report published on Wednesday.
In the report, the FDA staff endorsed J&J’s one-shot coronavirus vaccine for emergency use authorization, and, if approved, it would become the third vaccine given authorization in the U.S. behind Pfizer–BioNTech and Moderna.
Side effects following vaccination are common, doctors say, and they typically are indications that it’s helping build protection against the disease. The FDA said it determined that the clinical trial results and safety data were “consistent with the recommendations set forth in FDA’s guidance Emergency Use Authorization for Vaccines to Prevent COVID-19.”
The most frequent, least severe “local” adverse reaction among those who were vaccinated was injection site pain, which was reported by nearly half of vaccine recipients, compared with roughly 17% in the placebo group, according to the report. Skin redness, or erythema, and swelling were reported less frequently, the FDA said.
The most frequent “systemic” adverse reactions, which typically occur less frequently than local reactions but are slightly more severe, included headache and fatigue, according to the report. Nearly 40% of people who received the vaccine reported experiencing a headache and just over 38% reported feeling fatigued.
More than 33% of vaccinated people reported feeling muscle pain, roughly 14% reported nausea and under 10% had a fever, according to the report. Most of the adverse reactions were reported in younger people age 18 to 59, the FDA said, though most age groups reported similar rates of nausea.
The report found a “balanced” number of Bell’s Palsy cases, a condition that causes half of your face to droop. The FDA had previously said the condition would be monitored among recipients of other vaccines, noting that it’s not necessarily a side effect but is worth watching out for.
J&J first submitted its Covid vaccine data to the FDA on Feb. 4. While the vaccine’s level of protection varied by region, the company said the vaccine prevented 100% of hospitalizations and deaths.
— CNBC’s Berkeley Lovelace Jr. contributed to this report.