Roundup: FDA Approves Pfizer Vaccine for Kids 5-11; ‘Brain Fog’ Persists in COVID Patients for Months; and More

FDA Clears Way for Final CDC Approval of Pfizer Vaccine for Kids Ages 5 to 11

The U.S. Food and Drug Administration (FDA) authorized the emergency use of Pfizer-BioNTech’s COVID-19 vaccine to include children, ages 5 through 11 years. The FDA said today that its authorization was based on “thorough and transparent evaluation of the data” from its independent advisory committee of experts who voted in favor of making the vaccine available to this age group.

An advisory committee to the U.S. Centers for Disease Control and Prevention (CDC) will meet next week to discuss further clinical recommendations. The CDC is expected to follow the FDA in giving its approval to the lower-dose Pfizer vaccine for kids 5-11.

The FDA provided these “key points” for parents and caregivers. Immune responses of children 5 through 11 years of age were comparable to those of individuals 16 through 25 years of age, the FDA said. In addition, the vaccine was found to be 90.7 percent effective in preventing COVID-19 in children 5 through 11.

The vaccine’s safety was studied in approximately 3,100 children, age 5 through 11 who received the vaccine and no serious side effects have been detected in the ongoing study, the FDA stated.

The Biden administration said earlier this month that it has procured enough vaccine to vaccinated all 28 million 5- to 11-year-olds in the U.S., and will distribute the vaccine with smaller needles for pediatricians and pharmacists to administer to kids. Parents should consult with their pediatricians if they have any questions about the vaccine — once it becomes fully authorized.

Study: Even Those Not Hospitalized with COVID-19 Showed ‘Brain Fog’ Symptoms for Months

Cognitive impairment — known as “brain fog” when linked to COVID-19 — can linger for months in COVID patients, even among those whose symptoms were moderate and did not require hospitalization, concludes a new study from the Mount Sinai Health System in New York.

Nonetheless, the majority of brain fog cases were among those hospitalized because of COVID-19, according to the research, published in the journal JAMA Network Open.

“In this study, we found a relatively high frequency of cognitive impairment several months after patients contracted COVID-19,” the study’s authors state. “Impairments in executive functioning, processing speed, category fluency, memory encoding, and recall were predominant among hospitalized patients.”

The U.S. Centers for Disease Control and Prevention (CDC) “brain fog” on its list of “new or ongoing symptoms” tied to COVID-19. “Unlike some of the other types of post-COVID conditions that tend only to occur in people who have had severe illness, these symptoms can happen to anyone who has had COVID-19, even if the illness was mild, or if they had no initial symptoms,” states the CDC.

In the new study from Mount Sinai, data was collected from April 2020 through May 2021 on 740 COVID-19 patients with “no history of dementia.” The average age of patients was 49.

Among other impairments, the researchers found that 15 percent of the patients demonstrated deficits in phonemic fluency in their speaking. Additionally, 16 percent showed a deficit in a set of mental skills referred to as “executive functioning;” 18 percent were found to have deficits in their cognitive processing speed; 20 percent in their ability to process categories or lists; 23 percent had issues with memory recall, and 24 percent showed impairments in memory encoding, which refers to initial learning of information.

CDC: Those Vaccinated Against COVID-19 are Less Likely to Die From Any Cause

People who have been vaccinated against COVID-19 may have an additional advantage beyond the vital one of being much less likely to be hospitalized or die from COVID. Newly published research by the U.S. Centers for Disease Control and Prevention (CDC) concludes that people who have been vaccinated against COVID are also less likely to die from any cause in the months following vaccination.

The research team, which included researchers the CDC and healthcare groups from seven states, found these results while studying the safety of the three authorized COVID-19 vaccines.

“During December 2020–July 2021, COVID-19 vaccine recipients had lower rates of non–COVID-19 mortality than did unvaccinated persons after adjusting for age, sex, race and ethnicity, and study site,” the CDC stated in its Morbidity and Mortality Weekly Report.

Researchers reviewed date on 11 million people, including 6.4 million people who had been vaccinated against COVID-19 and 4.6 million people who had received flu shots over recent years — but had not gotten a COVID-19 vaccine. The team filtered individuals who had died from COVID-19 to determine the non-COVID deaths.

Here’s the breakdown from the CDC by vaccine: Those who received two doses of the Pfizer-BioNTech vaccine were 34 percent less likely to die from non-COVID causes in the months after vaccination, compared to those unvaccinated against COVID. Those who received two doses of the Moderna vaccine were 31 percent less likely to die as unvaccinated people. And those who received the one-shot Johnson & Johnson vaccine were 54 percent likely to die.

“There is no increased risk for mortality among COVID-19 vaccine recipients,” the CDC said. “This finding reinforces the safety profile of currently approved COVID-19 vaccines in the United States.”