By Dhirendra Tripathi
Investing.com – Pfizer stock (NYSE:) rose 0.4% on Monday after it said its Covid-19 vaccine was found to be safe for children aged 5 to 11 years.
Its German partner, BioNTech (NASDAQ:), traded 4.4% weaker.
“In participants 5 to 11 years of age, the vaccine was safe, well tolerated and showed robust neutralizing antibody responses,” the company said in a note.
The companies tested a two-dose regimen of 10 micrograms that was administered three weeks apart. The note said the companies plan to submit data to the Food and Drug Administration and other regulators “as soon as possible.”
For the U.S., the companies expect to include the data in a near-term submission for emergency use authorization as they accumulate the safety and efficacy data required to file for full FDA approval in this age group, they said.
Results in children under 5 years of age are expected as soon as later this year, the companies said.