May 10, 2021 – The FDA on Monday approved the emergency use of the Pfizer coronavirus vaccine for children ages 12-15.
The much-anticipated decision increases the likelihood that schools in the US will reopen fully in the fall – a goal of both the Biden and Trump administrations.
Acting FDA Commissioner Janet Woodcock, MD, described the decision as “a significant step” in “returning to a sense of normalcy”.
“Today’s action is making it possible to protect a younger population from COVID-19, which brings us closer to returning to a sense of normalcy and ending the pandemic,” she said in a statement. “Parents and guardians can be assured that the agency has carried out a rigorous and thorough review of all available data, as we have done with all of our COVID-19 emergency vaccine approvals.”
The Pfizer adolescent vaccine is still ongoing.
Next, the CDC’s Advisory Committee on Immunization Practices will decide whether to recommend the use of the vaccine in this age group, CNN reported. This group is supposed to meet on Wednesday. Thereafter, CDC Director Rochelle Walensky, MD, will decide whether to give the green light to the vaccine to be given to this age group.
The FDA action on Monday changes the December 11th emergency approval that allowed the Pfizer vaccine to be given to people aged 16 and over. Pfizer was the first to receive an EEA for its adult vaccine and the first to receive approval for its adolescent vaccine. Pfizer also conducts clinical studies on much younger children.
Moderna and Johnson & Johnson vaccines are approved for use by people aged 18 and over. Moderna has also started clinical trials in children.
Most health professionals have said that the United States must vaccinate children before the COVID pandemic can really be brought under control. The 12 to 15 year old group represents 17 million people, about 5% of the population. To date, 58% of adults in the US have had at least one dose of vaccine, and 34.8% of Americans are fully vaccinated.
Lee Savio Beers, president of the American Academy of Pediatricians, praised the agency’s decision, calling it a “critical step in offering life-saving vaccines to children and adolescents,” Beers said in a statement. “Our youngest generations have put themselves under severe stress over the past year, and the vaccine is a hopeful sign that they will be able to experience all of the activities that are so important to their health and development.”
Last week, President Joe Biden announced a new vaccination expansion strategy with vaccination of 12-15 year olds being a key component. He said the government is ready to ship the youth vaccine direct to pharmacies and pediatricians to speed up the vaccination rate.
In March, Dr. Anthony Fauci to a Senate committee: “We don’t really know what this magical point of herd immunity is, but we know that we will be fine if we vaccinate the overwhelming population.” Form. … We want and must ultimately bring children into this mix. ”
Pfizer submitted data to the FDA in late March showing its mRNA vaccine was 100% effective in preventing COVID-19 infection in children ages 12-15 in clinical trials.
Although most children have milder symptoms when infected with the coronavirus, approximately 1.5 million cases were reported to the CDC between March 1, 2020 and April 30 of this year in children between the ages of 11 and 17, it said in the FDA press release.
Albert Bouria, CEO of Pfizer, tweeted, “Today it brings very encouraging news for families and youth across the United States.”
“Although this is a significant step forward, we are still at a critical stage in the fight against # COVID19 worldwide. We hope to continue receiving approvals from global regulators in the coming weeks to support the global vaccination effort.
“I would like to thank all of the brave participants who selflessly raised their hands to take part in our clinical trial. Without them – and their families and carers – this milestone would not be possible. “
WebMD Health News
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FDA: “Coronavirus (COVID-19) Update: FDA Approves Pfizer-BioNTech’s COVID-19 Vaccine for Adolescent Emergency as Another Important Measure in Combating Pandemics.”
CNN: “The US FDA approves Pfizer’s Covid-19 vaccine for people ages 12 to 15.”
Twitter.com: @AlbertBourla, May 10, 2021.
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