Pfizer Inc. has submitted new data of side effects from its COVID-19 vaccine booster doses to the U.S. Food and Drug Administration (FDA), saying they have similar effects to the second shots and are more likely to affect younger people.
CNBC reported that the data covered the biotechnology corporation’s Phase 3 study of its booster doses, finding that 63.7% of the participants experienced fatigue after getting their COVID-19 vaccine boosters.
The study, conducted on a group of about 300 participants from 18 to 55 years old, also indicated that 48.4% had headaches, and 39.1% felt muscle pain.
The majority of reactions to Pfizer’s booster shots were mild or moderate in severity, the firm said in a 52-page report released by the FDA on Wednesday, Sept. 15.
The New York City-based company submitted the data seeking emergency approval from the FDA to distribute its third dose to those Americans aged 16 and over across the United States.
In its previous study phase, Pfizer evaluated side effects on 2,682 second-dose recipients ages 16 to 55. The results found that 61.5% of the participant developed fatigue, 54% suffered headaches, and 39.3% dealt with muscle pain.
The new study also found that 29.1% of booster recipients experienced chills, while 25.3% felt joint pain. However, fever cases fell by half between the second and third dose, from 16.4% to 8.7%.
There were no cases of anaphylaxis, hypersensitivity, Bell’s palsy, appendicitis, myocarditis, or pericarditis among the phase three participants, CNBC citing the study reported.
In August, the Biden administration announced that it plans to begin distributing the booster shots for COVID-19, by Pfizer-Moderna, by Sept. 20. Accordingly, the adult Americans who have completed their first round of immunization from the two shots Pfizer-Moderna vaccine are recommended to seek their third shot at least eight months after their last vaccination.
According to CNBC, the FDA on Wednesday declined to take a stance on supporting Pfizer’s Covid boosters, while it has also not yet independently verified the data and conclusions from studies on the effectiveness of Pfizer’s boosters.
Professor Sarah Gilbert, the leading scientist behind the creation of AstraZeneca’s COVID-19 vaccine, said last week that most people don’t have to get the vaccine boosters at the moment because the first two-dose regimen is providing lasting protection in most cases.
The Oxford University professor stressed that the first COVID-19 vaccine dose was the most crucial for immunity.