FDA clears emergency use of Pfizer COVID-19 vaccine for children ages 5-11


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The United States Food and Drug Administration on Friday cleared emergency use of the Pfizer-BioNTech COVID-19 vaccine for children aged 5 to 11.

The Centers for Disease Control and Prevention must approve the vaccines before they can be distributed, but it could start as early as this week. The CDC’s advisory committee on immunization practices will meet on Tuesday to discuss new clinical recommendations, the FDA said.

The vaccine will be given in two doses, three weeks apart. Each represents one third of the dose used for people 12 years of age and older.

The clearance was based on the evaluation of the data which included input from independent experts on the advisory committee who voted overwhelmingly in favor of making the vaccine available to children in this age group, the FDA said.


Vaccinating young children against COVID-19 brings the United States closer to returning to a sense of normalcy, said Acting FDA Commissioner Dr. Janet Woodcock.

The vaccine is 90.7% effective in preventing COVID-19 in children 5 to 11 years old, according to the FDA. The immune responses of children in this age group are comparable to those of individuals aged 16 to 25 years.

The safety of the vaccine has been studied in approximately 3,100 children aged 5 to 11 years and no serious side effects have been detected.

In the United States, cases of COVID-19 in children aged 5 to 11 represent 39% of cases in people under the age of 18. According to the CDC, about 8,300 cases of COVID-19 in children aged 5 to 11 have resulted in hospitalization.

As of October 17, 691 deaths from COVID-19 have been reported in the United States in people under the age of 18, with 146 deaths in the 5 to 11 age group.

The FDA has determined that based on the body of available scientific evidence, the known and potential benefits of Pfizer vaccine in individuals up to 5 years of age outweigh the known and potential risks.


Reluctance to vaccinate in the United States remains a concern for health officials seeking to achieve herd immunity against the coronavirus.

An estimated 57.8% of the population, as of October 26, is fully vaccinated, according to the Mayo Clinic.

Regarding all the COVID-19 vaccines available, serious adverse events after vaccination are rare but can occur, depending on the CDC, report Oct. 26. These include anaphylaxis; Thrombosis with Thrombocytopenia Syndrome (TTS) after Johnson & Johnson vaccination; Myocarditis; and pericarditis.

Reports of deaths after COVID-19 vaccination are rare. More than 414 million doses of COVID-19 vaccines were administered in the United States from December 14, 2020 to October 25. Meanwhile, the Vaccine Adverse Event Reporting System (VAERS) – which is a self-reporting system – has received 9,143 death reports (0.0022%) among people who have received a COVID-19 vaccine.

The FDA requires healthcare providers to report any deaths after COVID-19 vaccination to VAERS, even though it is not clear whether the vaccine was the cause. Reports of adverse events to VAERS after vaccination, including deaths, do not necessarily mean that a vaccine caused a health problem, the CDC said.


“The FDA is committed to making science-driven decisions that the public and the healthcare community can trust,” said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. “We are confident in the safety, efficacy and manufacturing data behind this authorization. As part of our commitment to transparency around our decision-making, which included our meeting of our Public Advisory Committee earlier this week, Today we released documents to support our decision and more information detailing our assessment of the data will be released soon, and we hope this information will help build the confidence of parents who decide to have their children immunized. ”

Twitter: @SusanJMorse
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