Large US Study Examines First 6 Months of COVID-19 Vaccine Safety Data

During the first 6 months of the US COVID-19 vaccination campaign, most adverse events reported to surveillance systems were mild and short-lived, researchers from the Centers for Disease Control and Prevention reported in The Lancet Infectious Diseases. The study examined safety data collected through the new v-safe surveillance system and the Vaccine Adverse Event Reporting System (VAERS).

Nearly 300 million mRNA vaccine doses were administered in the US between December 14, 2020, and June 14, 2021, of which about 167 million were BNT162b2 (Pfizer-BioNTech) and 132 million were mRNA-1273 (Moderna).

The VAERS received 340 522 reports during this time: 92.1% were classified as nonserious; 6.6% as serious, not resulting in death; and 1.3% were deaths. The most common serious reports aside from deaths were shortness of breath, fever, fatigue, and headache.

COVID-19 vaccines were administered under Emergency Use Authorization (EUA) during the study period, and providers were required to report all serious postvaccination adverse events, including deaths, even if they were unlikely to have been associated with vaccination. The most common causes of death were heart disease and COVID-19, according to death certificates and autopsy reports that were available for about 18% of 4471 deaths. The authors noted that they “found no unusual patterns in cause of death among the death reports received.”

For v-safe participants, transient reactions were more common after mRNA-1273 than BNT162b2 and were more frequent after the second dose than the first dose of either vaccine. Following their second dose, about 21% of v-safe participants who received BNT162b2 and about 33% of those who received mRNA-1273 reported they were unable to do normal activities. There were more reports of reactions and health effects involving females and people younger than 65 years than males and older people.

The researchers concluded that the findings from both surveillance systems were consistent with the pre-EUA vaccine clinical trials.

https://jamanetwork.com/journals/jama/fullarticle/2790957?guestAccessKey=e062f7f5-b033-4d5e-81c1-0b7a7ffbbadc&utm_source=fbpage&utm_medium=social_jama&utm_term=6758679449&utm_campaign=article_alert&linkId=160597275&fbclid=IwAR2ZEXWjGGvb3Pnio1OQkVRDahk8rz4sp-x9c09DF7FRGqIRY6mviLaPpTU

Créditos: Comité científico Covid