First Findings of Expected Studies on the Effectiveness of Pfizer—BioNTech COVID vaccination Children aged 5-11 are released today and the first results seem promising.
In the second of the three phases, the pharmaceutical giant enrolled 2,268 participants aged 5-11 in the United States, Finland, Poland and Spain. Patients 12 years and older received a dose of 30 µg (micrograms), while patients in the new study received a dose level of 10 µg in a double-dose regimen.
The study showed a strong immune response in a group of children one month after the second dose. This is used as a control group in the analysis and is often compared (or “not inferior”) to the results seen in participants aged 16 to 25 years who received a 30 µg double dose regimen. The vaccines are well tolerated even in the younger group, and side effects are generally comparable to those observed in participants aged 16 to 2 years, the two companies said.
Related story
This study is designed to test children’s “safety, tolerability, and immunogenicity.” The two companies will share the findings with the US Food and Drug Administration, the European Medicines Agency, and other regulatory agencies as soon as possible.
The news comes when millions of children across the country and the world return to school in the fall semester.
Albert Bourla, Chairman and Chief Executive Officer of Pfizer, said: “We extend the protection provided by the vaccine to this young population, subject to regulatory approvals, especially in tracking the spread of delta variants and the substantial threat they pose to children. Since July, the number of pediatric cases of Covid-19 has increased by about 240% in the United States, emphasizing the need for public health vaccination. It will provide a strong basis for seeking vaccine approval for 11-year-old children and will be urgently submitted to the FDA and other regulatory agencies. “
Dr. Ugur Sahin, CEO and co-founder of BioNTech, said: “We are pleased to be able to submit data to the regulatory agencies of this group of school-aged children before the start of the winter season. Safety profiles and immunogenicity in low-dose vaccinated children aged 5-11 years. Sexual data are consistent with those observed with the vaccine at high doses in other elderly populations. “
Pfizer Vaccine Seems Safe for Children 5-11 Years Old, Findings – Deadline
Source link Pfizer Vaccine Seems Safe for Children 5-11 Years Old, Findings – Deadline
The post Pfizer Vaccine Seems Safe for Children 5-11 Years Old, Findings – Deadline appeared first on Illinois News Today.
No comments:
Post a Comment