Pfizer and BioNTech’s Covid-19 vaccine is secure and generates a “strong” 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 photographs have been properly tolerated and produced an immune response and unwanted side effects similar to these seen in a research of individuals ages 16 to 25, they stated.
Frequent unwanted side effects for teenagers and adults embrace fatigue, headache, muscle ache, chills, fever and nausea, based on the Facilities for Illness Management and Prevention.
The information, which included greater than 2,200 youngsters, will likely be submitted to the Meals and Drug Administration and different well being regulators “as quickly as doable,” the businesses stated.
“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 stated in a launch.
The brand new knowledge comes as many dad and mom say they’re anxious to get their youngsters vaccinated, particularly as faculties 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 amongst younger youngsters who’re at present ineligible to get the photographs.
To date, 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 difficulty 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 advisable Pfizer booster photographs to individuals age 65 and older and different susceptible People.
Bourla stated final 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trial knowledge on how properly its Covid vaccine works in youngsters as younger as 6-months-old to five years outdated as early as the tip of October, he stated.
The discharge shared Monday did not point out whether or not any of the children within the trial skilled myocarditis, a uncommon coronary heart situation seen in a small variety of adolescents and younger adults.