FDA Authorizes Moderna and Pfizer-BioNtech COVID-19 Vaccines for Children Down to 6 Months of Age

On June 17, 2022 the U.S. Food and Drug Administration authorized emergency use of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 to include use in children down to 6 months of age.

• For the Moderna COVID-19 Vaccine, the FDA amended the emergency use authorization (EUA) to include use of the vaccine in individuals 6 months through 17 years of age. The vaccine had been authorized for use in adults 18 years of age and older.
• For the Pfizer-BioNTech COVID-19 Vaccine, the FDA amended the EUA to include use of the vaccine in individuals 6 months through 4 years of age. The vaccine had been authorized for use in individuals 5 years of age and older. 

FDA and ACIP Expand Eligibility for Pfizer-BioNTech COVID-19 Vaccine Booster Dose to Children 5 through 11 Years:

On May 17, 2022, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine, authorizing the use of a single booster dose for administration to 1 COVID-19 Vaccine Information Brief May 20, 2022 individuals 5 through 11 years of age at least five months after completion of a primary series with the Pfizer-BioNTech COVID-19 Vaccine. Following the meeting of the Advisory Committee on Immunization Practices’ (ACIP), CDC is expanding eligibility of COVID-19 vaccine booster doses to everyone 5 years of age and older.

CDC now recommends children ages 5 through 11 years should receive a booster shot 5 months after their initial Pfizer-BioNTech vaccination series. In addition, CDC is strengthening its recommendation that those 12 and older who are immunocompromised and those 50 and older should receive a second booster dose at least 4 months after their first. Over the past month there has been steady increases in cases, with a steep and substantial increase in hospitalizations for older Americans. While older Americans have the highest coverage of any age group of first booster doses, most older Americans received their last dose (either their primary series or their first booster dose) many months ago, leaving many who are vulnerable without the protection they may need to prevent severe disease, hospitalization, and death.

Patients who experience recurrence of symptoms after taking Paxlovid should isolate again:

Reuters (5/24, Mishra) reports, “Patients who experience recurrence of COVID-19 symptoms after completing treatment with Pfizer’s drug Paxlovid should isolate again for five days, the U.S. Centers for Disease Control and Prevention said in an advisory issued on Tuesday.” The agency “said...that case reports suggest that recurrence results in mild symptoms, and there have been no reports of severe disease so far.” The CDC “still continues to recommend the oral antiviral drug as a treatment.”

However, NBC News (5/24, Bendix) says that the agency “has not yet determined if patients with COVID rebounds are more or less likely to spread the virus than they were during their initial illness.”

CDC study examines rates of “post-COVID” symptoms in U.S. seniors, adults:

CBS News (5/24, Tin) reports, “As many as one in four seniors and one in five adults under 65 experienced ‘long COVID’ or ‘post-COVID’ symptoms after surviving a coronavirus infection, a new study from the Centers for Disease Control and Prevention reported Tuesday.” The researchers “found 38.2% of COVID-19 survivors ‘experienced at least one incident condition’ – a list that includes heart, lung, kidney and gastrointestinal problems, pain, fatigue, loss of smell or taste, mental health issues, and more – in the months after their infection.” These findings were published in the CDC’s Morbidity and Mortality Weekly Report.