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Pfizer Asks FDA To Approve COVID-19 Vaccine For Children 12-15 Years Old

On Friday, Pfizer asked the Food and Drug Administration to expand its emergency use authorization to include children between the ages of 12-15 in the United States. The company is working to be approved to distribute the vaccine to children around the world.

“These requests are based on data from the pivotal Phase 3 trial in adolescents 12 to 15 years of age with or without prior evidence of SARS-CoV-2 infection, which demonstrated 100 percent efficacy and robust antibody response after vaccination with the COVID-19 Vaccine,” Pfizer said in a statement.

The Pfizer vaccine is only approved for people that are 16 and over. Johnson & Johnson and Moderna’s vaccine is only authorized for emergency use in individuals 18 and over.

According to the Centers for Disease Control and Prevention, over 66 million people in the United States have been fully vaccinated. 112 million have received at least one dose.

“It’s almost a race between getting people vaccinated and this surge that seems to want to increase,” Dr. Anthony Fauci, the Director of the National Institute for Allergy and Infectious Disease, said.

The UK variant of the virus reigns supreme in the United States.

“I wish we had another three or four months before this B.1.1.7 variant surge started to occur,” Dr. Michael Osterholm, Director for the Center for Infectious Disease Research and Policy at the University of Minnesota, said.

Health officials are pushing for Americans to get vaccinated, but many are skeptical. The long-term effects of the virus are still unknown. Kristen Nordlund, a Centers for Disease Control and Prevention spokesperson, spoke to CNN about the adverse reactions that some Americans have had after taking the Johnson & Johnson one-dose vaccine.

“CDC is aware of several incidents of vaccine recipients experiencing dizziness, lightheadedness, feeling faint, rapid breathing, and sweating (vasovagal or anxiety-related) symptoms following COVID-19 vaccines in Iowa, Colorado, Georgia, and North Carolina,” Nordlund said.

The Johnson & Johnson vaccine was temporarily paused because of the adverse reactions that 11 people experienced. The individuals received their vaccine at the Dick’s Sporting Goods Park vaccination site in Colorado.

“After reviewing each patient’s symptoms, analyzing other vaccinations from the same lot of the vaccine and speaking with the CDC to confirm our finding, we are confident in saying that there is no reason for concern,” Dr. Eric France, Chief Medical Officer with CDPHE.

The National Institutes of Health are conducting clinical trials to determine whether people who are highly allergic or have mast cell disorder are more likely to experience a reaction to the Moderna and Pfizer vaccines.

“The public understandably has been concerned about reports of rare, severe allergic reactions to the Moderna and Pfizer-BioNTech COVID-19 vaccines,” Dr. Fauci said. “The information gathered during this trial will help doctors advise people who are highly allergic or have mast cell disorder about the risks and benefits of receiving these two vaccines. However, for most people, the benefits of COVID-19 vaccination far outweigh the risks.”

 

About RavenH

Raven Haywood is a journalist for 10+ years. Graduate from Howard University.

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