Pfizer says its Covid vaccine is safe and generates robust immune response in kids ages 5 to 11

Pfizer and BioNTech‘s Covid-19 vaccine is secure and generates a “sturdy” immune response in a scientific trial of children ages 5 to 11, the drugmakers introduced in a press launch Monday.

The businesses examined a two-dose routine of 10 micrograms — a few third the dosage used for teenagers and adults — administered three weeks aside. The pictures had been properly tolerated and produced an immune response and uncomfortable side effects similar to these seen in a examine of individuals ages 16 to 25, they mentioned.

Frequent uncomfortable side effects for teenagers and adults embody fatigue, headache, muscle ache, chills, fever and nausea, in accordance with the Facilities for Illness Management and Prevention.

The information, which included greater than 2,200 youngsters, can be submitted to the Meals and Drug Administration and different well being regulators “as quickly as potential,” the businesses mentioned.

“We’re keen to increase the safety afforded by the vaccine to this youthful inhabitants, topic to regulatory authorization, particularly as we observe the unfold of the Delta variant and the substantial risk it poses to youngsters,” Pfizer CEO Albert Bourla mentioned in a launch.

The brand new knowledge comes as many mother and father say they’re anxious to get their youngsters vaccinated, particularly as colleges reopen and the extremely contagious delta variant continues to unfold. The pressure has led to a surge in hospitalizations throughout the U.S., together with among young kids who’re at present ineligible to get the pictures.

Thus far, the Pfizer-BioNTech coronavirus vaccine has been cleared by the FDA for individuals as younger as 12, whereas Moderna‘s and Johnson & Johnson‘s vaccines have been approved for adults.

The FDA is predicted to problem a choice someday this week on which teams are eligible to get a 3rd dose, or booster shot, of the Pfizer vaccine. An FDA advisory committee on Friday unanimously recommended Pfizer booster pictures to individuals age 65 and older and different susceptible Individuals.

Bourla said last week that Pfizer may submit knowledge on youngsters from ages 5 to 11 by the tip of this month.

Moreover, Pfizer expects to launch scientific trial knowledge on how properly its Covid vaccine works in youngsters as younger as 6-months-old to five years previous as early as the tip of October, he mentioned.

The discharge shared Monday did not point out whether or not any of the youngsters within the trial skilled myocarditis, a uncommon coronary heart situation seen in a small variety of adolescents and younger adults.

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