A new study funded by Pfizer found its COVID-19 vaccine didn’t help children under five much..The 33-page study was published September 15 in the Journal of the American Medical Association and examined children six months to four years of age..Three doses did little to minimize emergency room visits, outpatient visits, or needs for urgent care, the study found..Pfizer-funded researchers analyzed records from Kaiser Permanente Southern California. This included patients who tested for COVID-19 at an emergency department, urgent care or outpatient setting, along with being diagnosed with acute respiratory infection between July 23, 2022 and May 19, 2023..Comparisons were made between those with positive test results and others who had tested negative and showed no signs of prior infection in the previous 90 days..Children were only counted as vaccinated if they received a second or third shot two or more weeks before exposure to COVID-19. Children were excluded if they had just one dose, or received a shot from a different company, or failed to follow the recommended dosing schedule..After adjusting for age and sex, researchers estimated just 12% effectiveness against medically-attended encounters for children who received three doses. However, it was 44% for children who only received two doses..Researchers thought the reason might be that more immune-evasive virus variants dominated in the United States by the time children received a third dose.."Updated vaccines will likely be needed to maintain protection against contemporary Omicron strains in young children," they wrote..A Pfizer clinical trial for children aged six months to five years pegged the efficacy at 80.3% overall — 82.3% for children aged two to five and 75.5% for kids six months to two years..However, those estimates were declared "not to be reliable due to the low number of COVID-19 cases that occurred in study participants," the Food and Drug Administration (FDA) said in a statement on June 17, 2022..The FDA cleared Pfizer's shot by comparing antibody levels in children after vaccination with levels in adults after vaccination. An official August 2022 complaint said the FDA violated its own standards with the clearance..By a 13-1 vote, the FDA cleared new vaccines from Pfizer and Moderna for children. The only trial data was from 50 people aged 12 or older who received Moderna's shot..On September 12, the U.S. Centers for Disease Control and Prevention (CDC) recommended the shots to all people aged six months and older, despite weak results for young children..One dose of Pfizer's vaccine provided just 8% protection against urgent care and emergency room visits beyond 13 days. Two doses provided a peak of 44% protection. A third dose provided 71% protection between 14 and 59 days, but this dropped to 16% after two months..A two-shot primary series of Moderna's shot initially provided 46% protection. That shielding dropped to 24% beyond 60 days..The World Health Organization considers 50% as adequate effectiveness for vaccines..A single dose of a bivalent shot, introduced in the fall of 2022, boosted protection to 61%. However, this was based on just eight vaccinated patients who tested positive.."This imprecision indicates that the actual [effectiveness] could be substantially different," the CDC said.
A new study funded by Pfizer found its COVID-19 vaccine didn’t help children under five much..The 33-page study was published September 15 in the Journal of the American Medical Association and examined children six months to four years of age..Three doses did little to minimize emergency room visits, outpatient visits, or needs for urgent care, the study found..Pfizer-funded researchers analyzed records from Kaiser Permanente Southern California. This included patients who tested for COVID-19 at an emergency department, urgent care or outpatient setting, along with being diagnosed with acute respiratory infection between July 23, 2022 and May 19, 2023..Comparisons were made between those with positive test results and others who had tested negative and showed no signs of prior infection in the previous 90 days..Children were only counted as vaccinated if they received a second or third shot two or more weeks before exposure to COVID-19. Children were excluded if they had just one dose, or received a shot from a different company, or failed to follow the recommended dosing schedule..After adjusting for age and sex, researchers estimated just 12% effectiveness against medically-attended encounters for children who received three doses. However, it was 44% for children who only received two doses..Researchers thought the reason might be that more immune-evasive virus variants dominated in the United States by the time children received a third dose.."Updated vaccines will likely be needed to maintain protection against contemporary Omicron strains in young children," they wrote..A Pfizer clinical trial for children aged six months to five years pegged the efficacy at 80.3% overall — 82.3% for children aged two to five and 75.5% for kids six months to two years..However, those estimates were declared "not to be reliable due to the low number of COVID-19 cases that occurred in study participants," the Food and Drug Administration (FDA) said in a statement on June 17, 2022..The FDA cleared Pfizer's shot by comparing antibody levels in children after vaccination with levels in adults after vaccination. An official August 2022 complaint said the FDA violated its own standards with the clearance..By a 13-1 vote, the FDA cleared new vaccines from Pfizer and Moderna for children. The only trial data was from 50 people aged 12 or older who received Moderna's shot..On September 12, the U.S. Centers for Disease Control and Prevention (CDC) recommended the shots to all people aged six months and older, despite weak results for young children..One dose of Pfizer's vaccine provided just 8% protection against urgent care and emergency room visits beyond 13 days. Two doses provided a peak of 44% protection. A third dose provided 71% protection between 14 and 59 days, but this dropped to 16% after two months..A two-shot primary series of Moderna's shot initially provided 46% protection. That shielding dropped to 24% beyond 60 days..The World Health Organization considers 50% as adequate effectiveness for vaccines..A single dose of a bivalent shot, introduced in the fall of 2022, boosted protection to 61%. However, this was based on just eight vaccinated patients who tested positive.."This imprecision indicates that the actual [effectiveness] could be substantially different," the CDC said.