COVID-19 Updates: Breakthrough Case Rate Impacted by Age and Vaccine Type, FDA Grants EUA for Pfizer Vaccine Among Children Ages 5-11

nurse puts oxygen mask on elderly woman patient lying in hospital bed, wearing protective gloves and visor medical mask, coronavirus breakthrough case rate concept

At least 247.8 million cases of coronavirus (COVID-19) have been diagnosed worldwide as of Monday evening, Nov. 1, 2021, including more than 5 million deaths. Healthcare officials in the United States have reported more than 46.8 million positive COVID-19 cases and more than 767,000 deaths. Source: www.worldometers.info/coronavirus

At least 7.07 billion individual doses of COVID-19 vaccine have been administered worldwide as of Monday evening, including at least 422 million in the United States. Source: GitHub

Related Webinar Course: COVID-19 Vaccines: What You Need to Know

Breakthrough case rate impacted by age and vaccine type, data says

While people of all age groups who have been vaccinated against COVID-19 have seen similar rates of breakthrough infections, death rates have varied and have been primarily determined by age.

According to data gathered by the U.S. Centers For Disease Control and Prevention (CDC), unvaccinated seniors are the most likely to die from COVID of any group, but age has been the top risk factor overall – so much so that vaccinated people aged 80 and older have had higher death rates than even unvaccinated people who are under age 50. Data includes reports from Alabama, Arizona, Arkansas, Colorado, Florida, Georgia, Idaho, Louisiana, Massachusetts, Michigan, Nebraska, New Mexico, Utah, and Wisconsin, as well as New York City and Seattle.

The data shows that immunosenescence, the weakening of the immune system over time, has a significant impact on disease severity, according to a report by The New York Times.

Additionally, among the three brands of vaccines administered in the United States, the Johnson & Johnson patients had slightly higher rates of breakthrough cases and related deaths, followed by those receiving the Pfizer-BioNTech shot and then those who received Moderna. The CDC includes insight into early September, although data from New York and California show similar patterns through October, the Times report states. All data, which excludes partially vaccinated people, also suggests that the vaccines are working to protect against the most severe outcomes.

Related Webinar Course: Moving from COVID-19 Pandemic to COVID-19 Endemic

FDA grants Emergency Use Authorization for Pfizer vaccine among children ages 5-11

The U.S. Food and Drug Administration (FDA) has authorized the Pfizer Inc./BioNTech vaccine for emergency use in children ages 5-11 years of age, the first COVID-19 vaccine authorized in the U.S. for this age group.

The vaccine is to be administered in a two-dose regimen of 10-µg doses given 21 days apart, according to Pfizer and BioNTech officials. The 10-µg dose level was selected based on safety, tolerability, and immunogenicity data.

“This is a day so many parents, eager to protect their young children from this virus, have been waiting for,” said Albert Bourla, chairman and chief executive officer at Pfizer, in a prepared statement. “With this FDA authorization, we have achieved another key marker in our ongoing effort to help protect families and communities, and to get this disease under control.”

The FDA reportedly based its decision on data from a Phase 2/3 randomized, controlled trial that included some 4,500 children. Results from the trial were reviewed by the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) after the vaccine demonstrated a favorable safety profile, robust immune responses, and a vaccine efficacy rate of 90.7% in participants without prior infection. The Data Monitoring Committee for the study has reviewed the data and has not identified any serious safety concerns related to the vaccine, according to Pfizer and BioNTech officials.

As a next step, the CDC Advisory Committee on Immunization Practices (ACIP) will meet to discuss a potential recommendation for the use and rollout of the vaccine to children. Pediatric vaccinations are anticipated to start, subject to, and after, CDC endorses the ACIP recommendation, said Pfizer and BioNTech officials.

The companies have also submitted requests for authorization of their COVID-19 vaccine in this age group to other global regulators, including the European Medicines Agency.

“Today’s emergency use authorization is supported by clinical data showing a favorable safety profile and high vaccine efficacy in children, underlining its potential to address a current public health need,” said Ugur Sahin, MD, CEO, and co-founder of BioNTech. “As children 5 through 11 get reacclimated to the new school year, both in and out of the classroom, our goal is to help keep them safe and protected and get them back to normalcy.”

In individuals 12 years of age and older, a third primary series dose may be administered at least four weeks after the second dose to individuals who are determined to have certain kinds of immunocompromise.

Related CE Courses: Pediatric Specialty Courses for Nurses

Depression drug possibly effective against COVID-19?

Fluvoxamine, a selective serotonin reuptake inhibitor (SSRI) antidepressant that has been typically used to treat depression and obsessive-compulsive disorder, has been found in one study to reduce the need for hospitalization among high-risk adults with COVID-19.

According to a recent study, researchers tested the drug because it was known to reduce inflammation and showed promise in previous studies.

Nearly 1,500 patients who were recently infected with coronavirus who were also at risk of severe illness because of other health problems were involved in the research. About half took the antidepressant at home for 10 days while others took placebo. Patients were tracked for four weeks to see who was admitted to the hospital or spent extended time in an emergency department when hospitals were full.

In the group that took the drug, 11% needed hospitalization or an extended ED stay, compared to 16% of those on placebo. The results have reportedly been shared with the U.S. National Institutes of Health.

U.S. cases continue to trend downward

As of Oct. 27, new daily coronavirus cases in the United States have fallen nearly 60 percent since the Delta variant peaked in mid-September, according to a report by USA TODAY.

With the current pandemic wave easing in the United States, travel restrictions that barred entry from 33 countries will reportedly be lifted, according to a report by the Washington Post.

Stay up-to-date on the latest coronavirus news developments. Visit our Resource Center each week for new COVID-19 updates—plus a variety of other resources for healthcare professionals.

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