Close up of gloved hands holding a bottle of covid-19 vaccine and syringe before injection to adolescent female patient. Vaccine for kids 12-17 concept.

COVID-19 Updates: FDA Delays Decision on Moderna Vaccine for Kids 12-17, Pfizer’s COVID Antiviral Shows Promising Study Results

Close up of gloved hands holding a bottle of covid-19 vaccine and syringe before injection to adolescent female patient. Vaccine for kids 12-17 concept.

At least 251 million cases of coronavirus (COVID-19) have been diagnosed worldwide as of Monday evening, Nov. 8, 2021, including more than 5.07 million deaths. Healthcare officials in the United States have reported more than 47.4 million positive COVID-19 cases and more than 776,000 deaths. Source: 

At least 7.28 billion individual doses of COVID-19 vaccine have been administered worldwide as of Monday evening, including at least 431 million in the United States. Source: GitHub

FDA delays decision on Moderna vaccine for kids 12-17

The U.S. Food and Drug Administration (FDA) is reportedly postponing a decision on the authorization status of the Moderna vaccine for adolescents until at least January.

According to officials at Moderna, the FDA has notified the company that it will require additional time to complete its assessment of an emergency use authorization (EUA) request for the use of the vaccine at the 100µg dose level in adolescents 12-17 years of age.

The FDA has informed Moderna officials that the agency requires additional time to evaluate recent international analyses specifically of the risk of myocarditis after vaccination. Officials at Moderna said the company is fully committed to working closely with the FDA to support the review.

An increased risk of myocarditis has been described for COVID-19 vaccines, including the Moderna COVID-19 vaccine, particularly in young men following the second dose. The U.S. Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO) have stated that myocarditis following vaccination with mRNA vaccines has been rare and generally mild.

It is estimated that more than 1.5 million adolescents have received the Moderna COVID-19 vaccine to date, with the observed rate of myocarditis reports in those younger than 18 years of age in Moderna’s global safety database not high enough to suggest an increased risk of myocarditis in this population, officials said.

Related webinar course: COVID-19 Vaccines: What You Need to Know

Pfizer’s COVID antiviral shows promising study results

The investigational novel COVID-19 oral antiviral candidate PAXLOVID™ has been proven to significantly reduce hospitalization and death, according to data recently released by Pfizer Inc.

The results are based on an interim analysis of a Phase 2/3 Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients, a randomized, double-blind study of non-hospitalized adult patients diagnosed with COVID-19 who are said to be at high risk of progressing to severe illness.

The scheduled interim analysis reportedly showed an 89% reduction in risk of COVID-related hospitalization or death from any cause compared to placebo in patients treated within three days of symptom onset compared to 7% of patients who received placebo and were hospitalized or died.

Similar reductions in COVID-related hospitalization or death were observed in patients treated within five days of symptom onset. In the overall study population through Day 28, no deaths were reported in patients who received PAXLOVID as compared to 10 deaths in patients who received placebo.

“Today’s news is a real game-changer in the global efforts to halt the devastation of this pandemic,” said Albert Bourla, chairman and chief executive officer at Pfizer. “Given the continued global impact of COVID-19, we have remained laser-focused on the science and fulfilling our responsibility to help healthcare systems and institutions around the world while ensuring equitable and broad access to people everywhere. These data suggest that our oral antiviral candidate, if approved or authorized by regulatory authorities, has the potential to save patients’ lives, reduce the severity of COVID-19 infections, and eliminate up to nine out of ten hospitalizations.”

If approved or authorized, PAXLOVID would be the first oral antiviral of its kind, a specifically designed protease inhibitor that could be prescribed more broadly as an at-home treatment to help reduce illness severity, hospitalizations, and deaths, as well as reduce the probability of infection following exposure among adults.

It has also reportedly demonstrated potent antiviral in vitro activity against circulating variants of concern, as well as other known coronaviruses, suggesting its potential as a therapeutic for multiple types of coronavirus infections, according to Pfizer officials.

The Phase 2/3 study began enrollment in July 2021.

COVID causes life expectancy to plummet in the U.S.

The COVID-19 pandemic caused the United States to have the second-largest decline in life expectancy among high-income countries during 2020, according to multiple reports.

Only Russia saw a bigger overall trend, cites a study recently published by The BMJ journal, which assessed premature death in 37 countries, comparing observed life expectancy in 2020 with what would have been expected for the year based on historical trends from 2005-2019. Life expectancy dropped in 31 of these countries during the pandemic, the study found.

Specifically, men in the U.S. saw life expectancy fall by nearly 2.3 years, from about 76.7 to 74.4. Women lost more than 1.6 years of life expectancy, from about 81.8 to 80.2. The drop in life expectancy in the U.S. was said to be driven by the deaths of young people.

The measurements provide one of the most comprehensive views of the human cost of the pandemic and illuminates its effects on different age groups and genders, according to a report by NBC News.

Related webinar course: Moving from COVID-19 Pandemic to COVID-19 Endemic

FDA approves iHealth rapid test

Another over-the-counter COVID-19 test has been authorized by the U.S. Food and Drug Administration (FDA). An emergency use authorization (EUA) has been issued for the iHealth COVID-19 Antigen Rapid Test, an antigen diagnostic test that delivers results in 15 minutes. The company anticipates producing 100 million tests per month, with capacity increasing to 200 million per month in early 2022, the FDA has announced.

The test can be used as a single test for COVID-19 symptoms, a serial test for those without symptoms, those ages 15 years and older with a self-collected nasal swab sample, and those ages 2 years or older when an adult collects the nasal swab sample.

iHealth is based in Mountain View, CA.

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