Pfizer’s COVID vaccine is safe and generates strong immune response in children 5-11 years old

Pfizer's COVID vaccine is safe and generates strong immune response in children 5-11 years old

Pfizer and BioNTech’s COVID-19 vaccine is safe and has produced a “strong” immune response in a clinical trial in children aged 5 to 11, the drugmakers said in a press release Monday.

The companies tested a two-dose regimen of 10 micrograms – about a third of the dose used for adolescents and adults – given three weeks apart. He said the injections were well tolerated and produced an immune response and side effects comparable to those seen in the study in people aged 16 to 25.

According to the Centers for Disease Control and Prevention, common side effects in teens and adults are fatigue, headache, muscle aches, chills, fever, and nausea.

The data, which included more than 2,200 children, would be submitted “as soon as possible” to the Food and Drug Administration and other health regulators, the companies said.

“We look forward to extending the protection offered by the vaccine to this young population, subject to regulatory authority, especially as we follow the spread of the delta variant,” said Pfizer CEO Albert Boerla, in a press release. And this is a substantial danger to children. .

The new data comes as many parents say they are eager to get their children vaccinated, especially as schools reopen and the highly contagious delta variant continues to spread. Stress has led to an increase in hospitalizations in the United States, including young children who are not currently eligible for the vaccine.

So far, the Pfizer-BioNTech coronavirus vaccine has been approved by the FDA for people under the age of 12, while the vaccines from Moderna and Johnson & Johnson are licensed for adults.

The FDA is expected to make a decision this week on which groups are eligible to receive a third dose of the Pfizer vaccine, or a booster injection. On Friday, an FDA advisory committee unanimously recommended Pfizer booster shots for people 65 and older and other vulnerable Americans.

Baurla said last week that Pfizer could collect data on children aged 5 to 11 by the end of this month.

Additionally, Pfizer plans to release clinical trial data on the effectiveness of its COVID vaccine in children aged 6 months to 5 years by the end of October.

The statement released on Monday did not mention whether any of the children in the trial had suffered from myocarditis, a rare heart disease seen in a small number of adolescents and young adults.


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