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COVID-19: Vaccine Safety Profiles; Testing Expansion

A Centers for Disease Control and Prevention (CDC) Morbidity and Mortality Weekly Report (MMWR) early release published Feb. 19 shows promising vaccine safety profiles for the Pfizer and Moderna COVID-19 vaccines during the first month of administration.

From Dec. 14, 2020, to Jan. 13, 2021, more than 13 million COVID-19 vaccine doses were administered in the United States. The report analyzes data from the Vaccine Adverse Event Reporting System (VAERS), a national passive surveillance system used by health care providers, vaccine manufacturers, and the public, for spontaneous reporting of adverse events.

VAERS received 6,994 adverse events, 90.8 percent of which were classified as nonserious and 9.2 percent of which were considered serious. The most frequently reported symptoms after receiving either vaccine were:

  • headache, reported by 22.4 percent of recipients;
  • fatigue, reported by 16.5 percent of recipients; and
  • dizziness, reported by 16.5 percent of recipients.

VAERS shows 62 reports of anaphylaxis and 113 deaths, 78 of which were recipients in long-term care facilities.

The report also synthesizes data from V-safe, an active surveillance system, during the initial implementation phases of the COVID-19 national vaccination program. V-safe enrollees receive daily text messages that link to web-based surveys for the first seven days after vaccination, followed by weekly surveys through six weeks postvaccination and follow-up surveys at three, six, and 12 months.

V-safe enrollees reported more reactions on the day after vaccination than on any other day. Reactions to the Pfizer vaccine were more frequent after the second dose than the first. The agency encourages providers to promote V-safe enrollment to vaccine recipients.

Pfizer Requests Update to Vaccine EUA

Pfizer and BioNTech on Feb. 19 requested an update to the emergency use authorization (EUA) for its vaccine after submitting new data demonstrating the vaccine’s viability at higher temperatures than the initial data submitted with the EUA request. If approved, the request would enable the vaccine to be stored at temperatures from 25 to 15 degrees below Celsius (minus 13 to 5 degrees Fahrenheit), temperatures more commonly found in pharmaceutical refrigerators and freezers.

Federal Action to Expand COVID-19 Vaccination and Testing

The White House COVID-19 Response Team will open five federally supported vaccination centers, Acting Centers for Medicare & Medicaid Services (CMS) Administrator Andy Slavitt announced in a Feb. 19 press briefing. Four Florida centers in Orlando, Miami, Jacksonville, and Tampa each will have the capacity to administer 2,000 vaccines a day, and each site will have two small, mobile satellite sites that will administer 500 vaccinations per day in underserved areas. The remaining center, at the Pennsylvania Convention Center, in Philadelphia, will have the capacity to deliver 6,000 doses a day. These sites were selected using a CDC and Federal Emergency Management Agency framework that targets vaccinations to the most vulnerable, using CDC’s Social Vulnerability Index.

President Biden on Feb. 17 announced new initiatives to expand COVID-19 testing and surveillance. The Department of Health & Human Services (HHS) will partner with the Department of Defense (DOD) to provide $640 million to expand testing at kindergarten through eighth grade schools and in congregate settings, including homeless shelters. The agencies also will provide regional coordinating centers to organize testing supply distribution and partnerships with labs.

HHS and DOD also announced $815 million to support domestic manufacturing of testing supplies and raw materials. Additionally, CDC will invest nearly $200 million to use genome sequencing to discover, monitor, and mitigate emerging SARS-CoV-2 strains.

Visit the America’s Essential Hospitals coronavirus resource page for more information about the pandemic.

Contact Senior Director of Policy Erin O’Malley at eomalley@essentialhospitals.org or 202.585.0127 with questions.

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About the Author

Emily Schweich is a senior communications associate for America's Essential Hospitals.

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