Healthcare worker wearing mask, visor, and gloves injects Covid-19 vaccine in male child 5-11 years old.

COVID-19 Updates: FDA and CDC to Mull Vaccines for Children Ages 5-11, Cognitive Impairment Persists Among Recovered COVID-19 Patients

Healthcare worker wearing mask, visor, and gloves injects Covid-19 vaccine in male child 5-11 years old.

At least 244.7 million cases of coronavirus (COVID-19) have been diagnosed worldwide as of Monday evening, Oct. 25, 2021, including more than 4.96 million deaths. Healthcare officials in the United States have reported more than 46.3 million positive COVID-19 cases and more than 757,000 deaths. Source:

At least 6.87 billion individual doses of COVID-19 vaccine have been administered worldwide as of Monday evening, including at least 414 million in the United States. Source: GitHub

FDA and CDC to mull vaccines for children ages 5-11

The White House has announced plans to distribute vaccines to children ages 5-11 in the near future if health regulatory bodies give a green light.

According to a recent report by the Washington Post, the vaccinations for this age group will begin when federal health officials approve a reduced dose of the Pfizer-BioNTech vaccine, which could happen next week.

The plan would impact 28 million children at more than 25,000 pediatricians’ and doctors’ offices, hospitals, pharmacies, community health centers, and school- and community-based clinics.

A group of expert advisers to the U.S. Food and Drug Administration (FDA) will meet about the vaccine’s safety and efficacy prior to making any recommendations. The FDA will then decide whether to authorize its use. If the FDA provides approval, a vaccine advisory panel to the U.S. Centers for Disease Control and Prevention (CDC) is scheduled to meet Nov. 2-3 to consider a recommendation for use, the report states. The vaccine could be administered to children in early November.

Cognitive impairment persists among recovered COVID-19 patients

New research indicates that cognitive impairment can remain a problem for several months for many people who are diagnosed with COVID-19, including those who otherwise fully recover.

A study based on patients who had been treated at Mount Sinai in New York found as many as 24 percent of people who have recovered from the virus continue to experience cognitive difficulties, such as problems with memory, multitasking, processing speed, and focusing, say researchers at the Icahn School of Medicine at Mount Sinai. The results of the study have been published in JAMA Network Open.

The research tested 740 patients who had signed up to be part of a registry between April 2020 and May 2021. Participants were ages 18 or older, spoke English or Spanish, and had no history of dementia. Results showed a relatively high rate of cognitive impairment nearly eight months after contracting the disease.

The most common cognitive deficit found was a problem with storing new memories, which reportedly affected nearly one in four patients. Issues with memory recall were next on the list. Other problems reported were deficits in processing speed and executive functioning, including the ability to initiate, plan, organize, and make judgments.

Hospitalized patients were more likely to have cognitive impairments.

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CDC expands eligibility for COVID-19 booster shots

A recommendation by an Advisory Committee on Immunization Practices’ (ACIP) to allow for a booster shot of COVID-19 vaccines in certain populations has been endorsed by the director of the U.S. Centers for Disease Control and Prevention (CDC).

For individuals who have received a Pfizer-BioNTech or Moderna vaccine, the following groups are eligible for a booster shot at six months or more after their initial series:

  • Those ages 65 years and older
  • Those ages 18 and older who live in long-term care settings
  • Those ages 18 and older who have underlying medical conditions
  • Those ages 18 and older who work or live in high-risk settings

For the nearly 15 million people who got the Johnson & Johnson COVID-19 vaccine, booster shots are also recommended for those who are 18 and older and who were vaccinated two or more months ago, according to a recent announcement from Rochelle P. Walensky, MD, MPH and the CDC.

There are now booster recommendations for all three available COVID-19 vaccines in the United States. Eligible individuals may choose which vaccine they receive as a booster dose.

Available data show that all three of the COVID-19 vaccines approved or authorized in the United States continue to be highly effective in reducing risk of severe disease, hospitalization, and death, including against the Delta variant.

“These recommendations are another example of our fundamental commitment to protect as many people as possible from COVID-19,” Walensky said in a prepared statement. “The evidence shows that all three COVID-19 vaccines authorized in the United States are safe – as demonstrated by the over 400 million vaccine doses already given. And, they are all highly effective in reducing the risk of severe disease, hospitalization, and death, even in the midst of the widely circulating Delta variant.”

Moderna announces positive data for vaccine in children ages 6-11

Data from a Phase 2/3 study have produced positive interim results for administering the Moderna vaccine to children ages 6-11 years of age. The interim analysis showed a robust neutralizing antibody response after two doses at the 50 µg dose level with a favorable safety profile, according to Moderna officials. Results will reportedly be submitted to the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and other global regulators.

“We are encouraged by the immunogenicity and safety profile of [the vaccine] in children aged 6 to under 12 years and are pleased that the study met its primary immunogenicity endpoints,” said Stéphane Bancel, chief executive officer at Moderna. “We look forward to filing with regulators globally and remain committed to doing our part to help end the COVID-19 pandemic with a vaccine for adults and children of all ages.”

The study, KidCOVE, is a randomized, observer-blind, placebo-controlled expansion study to evaluate the safety, tolerability, reactogenicity and effectiveness of two 50 µg doses given to healthy children 28 days apart. The study population is divided into three age groups (6 to <12 years, 2 to <6 years, and 6 months to <2 years).

The 6 to <12 years cohort enrolled 4,753 participants. In the trial, the neutralizing antibody geometric mean ratio (GMR) comparing the response in children to the response in young adults from a Phase 3 study was 1.5 with a seroresponse rate of 99.3%, representing a difference of 0.6%  to the Phase 3 benchmark. These results demonstrate strong immune response in this cohort of children one month after the second dose and met the co-primary immunogenicity endpoints for 6 to <12 years olds in KidCOVE, according to Moderna officials.

The vaccine was generally well tolerated with a safety and tolerability profile generally consistent with the Phase 3 study in adolescents and adults. The majority of adverse events were mild or moderate in severity. The most common solicited adverse events were fatigue, headache, fever, and pain at the injection site.

Safety data continue to accrue, and the study continues to be monitored by an independent safety monitoring committee. All participants will be monitored for 12 months after their second injection to assess long-term protection and safety. The Phase 2/3 study continues to enroll children ages 6 months to under 6 years of age. The Company has enrolled approximately 5,700 pediatric participants in the U.S. and Canada in the trial as a whole.

The study is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services. The identifier is NCT04796896.

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