Roundup: Pfizer Booster Approved for Kids 12-15, and at Shorter Interval for All; Major Study Affirms Vaccine Safety in Pregnancy; and More

FDA, CDC: Pfizer Booster Shots for Kids 12-15, and Less Time Between 2nd and 3rd Shots for Everyone

The U.S. Food and Drug Administration (FDA) and the U.S. Centers for Disease Control and Prevention (CDC) have approved the Pfizer-BioNTech COVID-19 booster dose (third shot) for children ages 12 to 15. The agencies also shortened the time period for everyone over the age of 12 to qualify for Pfizer’s third shot — from six months to five months after the second shot

The booster interval recommendations for people who received the Johnson & Johnson vaccine (two months) or the Moderna vaccine (six months), have not changed.

The two actions come as the much more transmissible Omicron variant is spreading rapidly across the U.S., and causing a surge in pediatric patients hospitalized with confirmed and suspected COVID-19.

The “recommendations ensure people are able to get a boost of protection in the face of Omicron and increasing cases across the country, and ensure that the most vulnerable children can get an additional dose to optimize protection against COVID-19,” said CDC Director Rochelle Walensky, M.D., in a statement.

Before deciding to shorten the time between second and third Pfizer shots, the FDA said it reviewed “real-world data from Israel” — including safety data from more than 6,300 individuals, 12 through 15 years of age, who received a booster dose of the vaccine at least 5 months following completion of the primary two-dose vaccination series.

The FDA and CDC are also allowing a third shot for “certain immunocompromised children 5 through 11 years of age.”

Children 5 through 11 years of age, “who have undergone solid organ transplantation, or who have been diagnosed with conditions that are considered to have an equivalent level of immunocompromise,” may not respond adequately to the two-dose primary vaccination, the FDA.  A third shot, or booster, has now been authorized for this group.

“A booster dose of the currently authorized vaccines may help provide better protection against both the Delta and Omicron variants,” said Peter Marks, M.D., director of the FDA’s Center for Biologics Evaluation and Research, in a statement. “In particular, the omicron variant appears to be more resistant to the antibody levels produced in response to the primary series doses (first and second shots) from the current vaccines.”

CDC Study: COVID-19 Vaccines Safe in Pregnancy, Not Linked to Complications at Birth

A new, large-scale study involving more than 40,000 expectant women has reaffirmed the safety of COVID-19 vaccines during pregnancy, according to the U.S. Centers for Disease Control and Prevention (CDC), which published the study this week.

Researchers concluded that vaccination against COVID “was not associated” with preterm births (or births before 37 weeks) and small-for-gestational-age births (or babies whose birth weight was at the 10th percentile or lower), compared to unvaccinated women.

Many pregnant women with COVID-19 are at increased risk for severe illness and adverse birth outcomes, yet many remain reluctant to be vaccinated. As of December, about 40 percent of pregnant women in the U.S. were vaccinated against the coronavirus, according to CDC data.

The women involved in the study had become pregnant between May and October of 2020, before vaccines were available. Nearly all of them who were vaccinated got their shots in their second or third trimester of pregnancy. Some 96 percent of them had received at least one dose of an mRNA vaccine from either Pfizer-BioNTech or Moderna. The rest received the single-shot vaccine from Johnson & Johnson.

The CDC states: “These data support the safety of COVID-19 vaccination during pregnancy. CDC recommends COVID-19 vaccination for women who are pregnant, recently pregnant, who are trying to become pregnant now, or who might become pregnant in the future.”

NIH Study: COVID-19 Can Spread Widely to Other Organs, Linger for Several Months

A new study by scientists at the National Institutes of Health (NIH) found that COVID-19 can spread from the respiratory tract to virtually every other bodily organ — and then linger for a long period of time.

The researchers said the study represented the “most comprehensive analysis to date” of COVID’s ability to spread and linger in the body. Autopsies were performed on 44 patients who died either from COVID-19 or with the infection present at time of death. 

“Our results collectively show while that the highest burden of COVID-19 is in the airways and lung, the virus can disseminate early during infection and infect cells throughout the entire body, including widely throughout the brain,” researchers stated in findings released this month.

Scientist concluded that Ribonucleic acid (RNA), a molecule similar to DNA from the virus — was found in patients up to 230 days after symptom onset.

The study’s authors said the coronavirus can spread widely inside the body initially, even in patients who do not require hospitalizations. “Replication can occur early in COVID-19, even in asymptomatic or mild cases,” they stated.