Pfizer/BioNTech Claims Vaccine Is Safe And Protects Children Age 5-11

ILLUSTRATION/UNSPLASH

JAKARTA - Pfizer and BioNTech say their COVID-19 vaccine triggers a strong immune response in children aged 5-11 years.

They plan to seek approval as soon as possible so that the vaccine can be used in this age group in the United States, Europe and other countries.

The two companies said the Pfizer/BioNTech two-dose vaccine produced an immune response in children aged 5-11 years in phase II and III clinical trials.

These results are in agreement with the results observed in previous clinical trials in the 16-25 year age group.

The resulting safety indicators were also generally comparable to that of the older age group, they said.

"Since July, cases of COVID-19 in children have increased by about 240 percent in the US, which underscores the importance of vaccination in public health," said Pfizer President Director Albert Bourla in a statement.

"The results of this clinical trial provide a solid foundation for seeking approval for the use of our vaccine in children 5 to 11 years of age, and we plan to submit it to the FDA and other regulators as soon as possible," Bourla said.

The Pfizer/BioNTech vaccine has received approval in the US for use in people 12 years of age and older, including last week's full approval from the US Food and Drug Administration, the FDA for use in people 16 and older.

Top US health officials believe regulators will make decisions about the safety and effectiveness of the Pfizer/BioNTech vaccine for younger children within three weeks of applying for clearance.

Rapid clearance will help reduce the potential for a spike in cases this fall as schools begin to open across the US.

Acting FDA Commissioner Janet Woodcock said as soon as the permit application was submitted, the FDA would look into whether the vaccine was safe and effective for children.

"We're going to look at the clinical data and make sure that the children are responding to the vaccine as we expect," Woodcock said.

The Pfizer/BioNTech vaccine is one of three vaccines approved for use in the US alongside vaccines from Moderna and Johnson & Johnson.