WASHINGTON DC – Pfizer on Thursday asked the US government to allow the use of its COVID-19 vaccine in children ages 5 to 11 – and if regulators agree, the shots could start in a matter of weeks. can be.
Many parents and pediatricians are struggling to protect children under the age of 12, cutting the age for vaccines made by Pfizer and its German partner BioNTech today. Not only can youth sometimes become seriously ill, but keeping them in school can be a challenge, as the coronavirus is still rampant in poorly vaccinated communities.
Pfizer announced in a tweet that it has formally filed its application with the Food and Drug Administration.
– Pfizer Inc. (@pfizer) October 7, 2021
Earlier this month, Pfizer presented preliminary research health canada On the effectiveness of its COVID-19 vaccine in children aged five to 11 years. Hopefully it will ask for authorization soon.
Currently, Health Canada only approves vaccines for people 12 years of age and older in the country, but may approve the shot for younger children if it is satisfied that the data is safe and effective.
South of the border, the FDA must decide whether there is enough evidence that the shots are safe and will work for young children just as they do for teens and adults. An independent expert panel will publicly debate the evidence on 26 October.
One big change: Pfizer says its research shows that young children should now get a third of the dose given to everyone else in the US, after their second dose, to fight the virus in children ages 5 to 11. The stronger the level of fighting antibodies became. As teens and young adults get from regular-power shots.
In Canada, a small portion of the population has received a third dose. Many provinces have begun giving a third to people who are in immunosuppressant or long-term care, which studies suggest the vaccine may not be as effective in those people.
Some provinces are offering a third dose to meet international travel requirements that prevent people with mixed doses from entering the country.
Delta cases on the rise
While children have a lower risk of serious illness or death than older people, COVID-19 sometimes kills children and cases among youth have skyrocketed as the extra-infectious delta variant swept across the US and Canada . This is prompting growing concerns for uninfected children.
“It makes me so happy that I’m helping other kids get vaccinated,” said 8-year-old Sebastian Priebol of Raleigh, North Carolina. He is enrolled in Pfizer’s study at Duke University and does not yet know whether he has received the vaccine or the dummy shot.
“We want to make sure it’s absolutely safe for them,” said Sebastian’s mother, Brittany Pribol, Sebastian’s mother. But she said she would be “very happy” if the FDA approves the vaccine.
Pfizer conducted a low-dose study in 2,268 of children ages 5 to 11 and said there were no serious side effects. The study isn’t close enough to detect any extremely rare side effects, such as heart swelling that sometimes occurs after a second dose of the regular-strength vaccine, mostly in young men.
If the FDA authorizes the emergency use of a child-sized dose, there is another hurdle before vaccination can begin in this age group. Advisors from the Centers for Disease Control and Prevention will decide whether to recommend the shots for youth, and the CDC will make the final decision.