Moderna Expanding Kids Vaccine Study to Better Assess Safety

July 27, 2021by Matthew Perrone and Linda A. Johnson, Associated Press
In this March 29, 2021 file photo, a worker readies syringes with the Moderna COVID-19 vaccine in Metairie, La. Moderna plans to expand the size of its study in younger children to better detect rare side effects. The company said Monday, July 26, 2021 it is in talks with the Food and Drug Administration to enroll more patients in its study of the vaccine in children under 12 years old and younger. (AP Photo/Gerald Herbert, File)

WASHINGTON (AP) — Moderna said Monday it plans to expand the size of its COVID-19 vaccine study in younger children to better detect rare side effects, such as a type of heart inflammation recently flagged by U.S. health authorities.

The company said it is in talks with the Food and Drug Administration to enroll more study participants under age 12. It had intended to test the vaccine in about 7,000 children, with some as young as 6 months. The Cambridge, Massachusetts-based company said via email it hasn’t decided on how many kids might be added. 

The announcement comes as U.S. COVID-19 cases are rising and schools prepare to welcome students back to classrooms. At the same time, regulators continue to review cases of a rare type of heart inflammation called myocarditis that has been reported in a small number of teenagers who got the Moderna or Pfizer shots.

Pfizer said on Monday that if it makes changes to its vaccine testing in children, it will provide an update then. The New York-based company is testing its vaccine in up to 4,500 children in the United States and Europe.

The FDA said in a statement it could not comment on its discussions with companies, but added “we do generally work with sponsors to ensure the number of participants in clinical trials are of adequate size to detect safety signals.”

The news was first reported by the New York Times.

U.S. officials and independent medical experts said last month the benefits of the vaccines far outweigh the risks of the side effect, which has been reported in several hundred people younger than 30. But any vaccine safety issues could slow uptake, particularly among parents wary of taking any health risk with their children.

Currently, Pfizer has the only U.S. vaccine authorized for children 12 years and up, while Moderna is expecting an FDA ruling on its application in the coming days.

While teens receive the same dose as adults, younger children may need smaller doses. That additional complexity adds time to drugmakers’ research and application timelines.

Moderna said Monday it expects to have enough data to apply for FDA authorization in younger kids by late this year or early 2022. 

Pfizer has previously said it expects to apply in September for children ages 5 through 11. Results for two younger age groups that began testing a little later should be available by October or November, according to the company.

___

 Johnson reported from Fairless Hills, Pennsylvania.

___

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

Health

FDA Panel Takes Up Tough Questions on J&J COVID-19 Boosters

WASHINGTON (AP) — U.S. health advisers on Friday tackled who should get boosters of Johnson & Johnson's single-shot COVID-19 vaccine... Read More

WASHINGTON (AP) — U.S. health advisers on Friday tackled who should get boosters of Johnson & Johnson's single-shot COVID-19 vaccine and when — and whether using a competing brand for the second dose might provide better protection. The push for boosters kicked off last month after... Read More

FDA Panel Endorses Lower-Dose Moderna COVID Shot for Booster

U.S. health advisers said Thursday that some Americans who received Moderna's COVID-19 vaccine should get a half-dose booster to bolster... Read More

U.S. health advisers said Thursday that some Americans who received Moderna's COVID-19 vaccine should get a half-dose booster to bolster protection against the virus. The panel of advisers to the Food and Drug Administration voted unanimously to recommend a booster shot for seniors, adults with other... Read More

Nursing Schools See Applications Rise, Despite COVID Burnout

STORRS, Conn. (AP) — Nurses around the U.S. are getting burned out by the COVID-19 crisis and quitting, yet applications... Read More

STORRS, Conn. (AP) — Nurses around the U.S. are getting burned out by the COVID-19 crisis and quitting, yet applications to nursing schools are rising, driven by what educators say are young people who see the global emergency as an opportunity and a challenge. Among them... Read More

FDA Spells Out Lower Sodium Goals for Food Industry

NEW YORK (AP) — Food companies are coming under renewed pressure to use less salt after U.S. regulators spelled out... Read More

NEW YORK (AP) — Food companies are coming under renewed pressure to use less salt after U.S. regulators spelled out long-awaited guidelines aimed at reducing sodium levels in dozens of foods including condiments, cereals, french fries and potato chips. The voluntary goals finalized Wednesday for 163... Read More

October 13, 2021
by Alexa Hornbeck
Gene Editing Treatment Used in Human Subjects With Rare Genetic Blindness

WASHINGTON — New data presented by researchers from Editas Medicine, a leading genome editing company, reveals that gene editing treatments... Read More

WASHINGTON — New data presented by researchers from Editas Medicine, a leading genome editing company, reveals that gene editing treatments are not only safe in humans, but may hold promise of treating a rare retinal disease that leads to blindness. “We believe these findings validate the... Read More

October 13, 2021
by Alexa Hornbeck
How Telehealth is Helping Address Veteran Food Insecurity

WASHINGTON -- The COVID-19 pandemic has impacted veterans' access to food, leading to greater food insecurity, and according to officials... Read More

WASHINGTON -- The COVID-19 pandemic has impacted veterans' access to food, leading to greater food insecurity, and according to officials from the United States Department of Veterans Affairs, telehealth is now helping to combat the issue.  “The COVID-19 pandemic certainly has been impactful for many Americans,... Read More

News From The Well
Exit mobile version