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Additional Clinical Issues and Guidance

AP Analysis of CDC Data Shows Nearly All COVID-19 Deaths in the U.S. Are Now in Unvaccinated Individuals

Posted June 29, 2021

The Associated Press (AP) recently released an article on their analysis of Centers for Disease Control and Prevention data on the current rate of deaths related to COVID-19 and found that nearly all recent deaths are in individuals who are not vaccinated. In May, approximately 150 of the more than 18,000 COVID-19-caused mortality in the U.S. occurred in fully vaccinated people, which amounts to a mortality rate of less than .1 percent in this population. This data lends more evidence that currently available COVID-19 vaccines are extremely effective in preventing mortality and underscores how important it will be to increase vaccination rates in the areas of the country that still have low immunization rates.

Read the full AP article.

COVID-19 and Vaccine Update: Breakthrough Infections after Vaccination

by Kenneth W. Sharp, MD, FACS, ACS Regent | Posted June 1, 2021

The vaccination campaign for prevention of COVID-19 is going smoothly, even if not as rapidly as many health care professionals would desire. As of April 30, 2021, approximately 101 million persons in the U.S. have received full vaccination against COVID-19. Read the Centers for Disease Control and Prevention report

The Centers for Disease Control and Prevention has reported a total of 10,262 SARS-CoV-2 breakthrough infections as of the same date—a very small fraction of those vaccinated (though this certainly is an underestimate of the true number, as asymptomatic cases are not likely to be captured accurately). The patients reported were a median age 58 and 63 percent female. Many infections were asymptomatic and 10 percent (995) were hospitalized. A total of 160 (2 percent) died—median age 82 and 28 (18 percent) of those who died were asymptomatic or died from causes unrelated to COVID-19. There were 555 cases for which genetic sequencing data were available and 356 (64 percent) of those were reported to be variants of concern. These included B.1.1.7 (56 percent, the “U.K.” variant), B.1.429 (25 percent, the “California” variant), B.1.427 (8 percent, the other “California” variant), P.1 (8 percent, the “Brazilian” variant) and B.1.351 (4 percent, the “South Africa” variant). These variants account for approximately 70 percent of COVID-19 cases occurring in the period March 29–April 10 in the U.S., so these are not variants with an unusually high prevalence for breakthrough infections after vaccination. 

The CDC began reporting only COVID-19 cases resulting in hospitalization or death on May 1, 2021. These are the cases of highest importance for public health, as asymptomatic cases are not accurately captured and have less clinical significance. The CDC will continue to collect reports of all breakthrough COVID-19 cases to continually monitor vaccine effectiveness. 

Current FDA authorized vaccines (under the Emergency Use Authorization) are recommended for all persons 12 years old or older. Fellows of the ACS and their patients should be reassured that the currently available COVID-19 vaccines are effective and safe. 

FDA Expands Emergency Use for Pfizer COVID-19 Vaccine to 12 to 15 Year Olds

Posted May 11, 2021

The U.S. Food and Drug Administration (FDA) May 10 expanded the emergency use authorization of the Pfizer COVID-19 vaccine in adolescents age 12 to 15 years of age. With the recent increase in the number of adolescents who are diagnosed with COVID-19, the expanded age range is an important step forward in reducing the rate of infection in the U.S. 

According to acting FDA Commissioner Janet Woodcock, MD, the May 10 action “allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic. Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations.”

Read the FDA press release for more information on the agency’s decision, as well as its evaluation of available safety and effectiveness data.

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