More than 100 Adverse Events and 4 Deaths Reported to CDC Within Days of New COVID Booster Rollout

The Centers for Disease Control and Prevention (CDC) on Friday released new data showing 106 adverse events and 4 U.S. deaths had been reported to the Vaccine Adverse Event Reporting System (VAERS) attributed to the new bivalent COVID-19 booster shots by Pfizer-BioNTech and Moderna.

VAERS is the primary government-funded system for reporting adverse vaccine reactions in the U.S.

The bivalent COVID boosters — labeled “COVID-19-2” in the VAERS system — received emergency use authorization on Aug. 31. The latest VAERS data showed reports received by the system as of Sept. 9, just 10 days after the rollout.

Of the 106 reported adverse events, 16 cases were classified as “serious.” A 20-year-old female from Washington was diagnosed with pericarditis, an 83-year-old female experienced severe hypoxia requiring transfer to the hospital, a 68-year-old female and 20-year-old male also experienced pericarditis, a 67-year-old female and 79-year-old man died, and a 70-year-old male and 65-year-old woman developed blood clots.

The U.S. Food and Drug Administration authorized modified booster shots without any human clinical trials  to determine their safety or efficacy.

Because the Biden administration bypassed the regulatory process to push for a fall booster campaign to begin in September, Pfizer/BioNTech and Moderna “didn’t have time” to conduct proper safety studies of the reformulated boosters in people. Instead, they relied on tests in mice.

The new boosters target both the original Wuhan strain that emerged more than 2 years ago and is no longer circulating in the U.S and Omicron BA.4 and BA.5 subvariants, which are now the dominant variants in the U.S.

Pfizer’s new booster is authorized for people aged 12 and older, while Moderna’s is authorized for adults 18 and older. Older versions of the COVID-19 vaccines will still be given as the primary series, but will not be given as booster doses, according to the FDA.

According to the latest VAERS data, between Dec. 14, 2020, and Aug. 19 a total of 1,407,409 reports of adverse events following COVID-19 vaccines were submitted between Dec. 14, 2020, and Sept. 9, 2022. The data included 30,935 reports of deaths and 257,227 serious injuries, including deaths, during the same time period.