Pfizer COVID Vaccines Safe And Effective For Small Children, FDA Staff Say
The FDA reviewers said in briefing documents published on Sunday evening that their evaluation did not reveal any new safety concerns related to the use of the vaccine in young children.
The FDA analysis of data from Pfizer’s trial was published ahead of a Jun 15 meeting of its outside advisers. Recommendations from the external advisers will determine the FDA’s decision on the vaccines.
“Available data support the effectiveness of the Pfizer-BioNTech COVID-19 Vaccine 3-dose primary series in preventing COVID-19 in the age group of 6 months through 4 years,” FDA staff said in the review.
An early analysis of data from Pfizer-BioNTech’s vaccine based on 10 symptomatic COVID-19 cases identified when the omicron coronavirus variant was dominant suggested a vaccine efficacy of 80.3% in the under-5 age group.
COVID-19 shots for children under the age of 6 are yet not approved in most parts of the world. It remains unclear how many parents will get their young ones vaccinated as demand has been low for kids aged 5 to 11.
US President Joe Biden’s administration expects vaccinations for young children to begin in earnest as early as Jun 21 if the FDA and the Centers for Disease Control and Prevention approve the vaccines.
Government officials say pre-orders for use in the under-6 age group has been low but demand is expected to pick up once the vaccines gain authorisation.
The FDA on Friday released a staff review of Moderna Inc’s COVID-19 vaccine which said the doses were safe and effective for use in children aged 6 months to 17 years old.
Murder Inquiry After Girl, 9, Shot In Liverpool
A nine-year-old girl has been shot dead in Liverpool and two other people are in hospital with gunshot injuries. Officers...
California To Protect Health Benefits For Young Immigrants
SACRAMENTO, Calif. — About 40,000 low-income adults living in the country illegally won't lose their government-funded health insurance over the...
Elon Musk Subpoenas Twitter Founder Jack Dorsey As Legal Dispute Over $44BN Purchase Continues
Elon Musk has sued his friend and former Twitter CEO Jack Dorsey amid the ongoing legal battle over his $44...
NYT: Trump Kept Over 300 Classified Documents On His Estate
Former US President Donald Trump kept at least 300 secret documents on his estate in Mar-a-Lago. Trump handed over about...
Donald Trump Sues Justice Department Over Mar-A-Lago Search
Former US President Donald Trump has asked a judge to freeze the justice department's investigation of files seized from his...
Britain’s Channel 4 Announces Satirical Musical About Prince Andrew’s 2019 BBC Interview On Jeffrey Epstein
Prince Andrew will be the subject of a satirical TV musical that will "re-imagine" a disastrous 2019 interview discussing his...