Pfizer Covid vaccine is safe and generates robust immune response in children aged 5 to 11

Pfizer and BioNTech’s Covid-19 vaccine is safe and generates a “robust” 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. The injections were well tolerated and produced an immune response and side effects comparable to those seen in a study in people aged 16 to 25, they said.

Common side effects in teens and adults include fatigue, headaches, muscle aches, chills, fever, and nausea, according to the Centers for Disease Control and Prevention.

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

“We look forward to extending the protection offered by the vaccine to this younger population, subject to regulatory approval, especially as we follow the spread of the Delta variant and the substantial threat it poses to them. children, “said Albert Bourla, CEO of Pfizer, in a statement. .

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. The strain has led to an increase in hospitalizations in the United States, including among young children who are not currently eligible for the vaccine.

So far, the Pfizer-BioNTech coronavirus vaccine has been cleared by the FDA for people as young as 12 years old, while Moderna and Johnson & Johnson’s vaccines have been cleared for adults.

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

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

In addition, Pfizer plans to publish clinical trial data on the effectiveness of its Covid vaccine in children aged 6 months to 5 years as early as the end of October, he said.

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.