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BioNTech Jumps on EU Drug Regulator's Review of Covid Vaccine for Kids

The European Medicines Agency said a committee will carry out an accelerated assessment of data submitted by BioNTech and Pfizer for use of their vaccine in 12-to-15 year olds.

U.S.-listed shares of BioNTech  (BNTX) - Get BioNTech SE Report jumped Monday after the European Union's drug regulator said it was evaluating the company's two-shot coronavirus vaccine, jointly developed with Pfizer  (PFE) - Get Pfizer Inc. Report, for use in children between the ages 12 to 15.

Shares of the Mainz, Germany, company were rising 7.82% to $203 at last check while shares of Pfizer rose 2.5% to $39.60.

On Monday, the European Medicines Agency said its human medicines committee will carry out an accelerated assessment of data submitted by Pfizer and BioNTech.

Last week, the two companies requested authorization for their COVID-19 vaccine to be used in the European Union in children ages 12 to 15.

If the vaccine is authorized for the age group, these children will take one step closer to being back to school in the fall.

The pharmaceutical companies also plan to ask other drug regulators worldwide for clearance to use the vaccine for children in this age range, they said in a statement.

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They similarly sought authorization with the U.S. Food and Drug Administration in early April, after trials determined that the vaccine was 100% safe for adolescents aged 12 to 15.

The trials “demonstrated 100% efficacy and robust antibody response after vaccination with the COVID-19 vaccine,” the companies added.

The vaccine may be authorized in the U.S. for 12- to 15-year-olds by mid-May, Rochelle Walensky, director of the U.S. Centers for Disease Control and Prevention, told ABC News in April.

Pfizer is also in discussions with the Indian government seeking an "expedited approval pathway" for its COVID-19 vaccine, Pfizer CEO Albert Bourla said on LinkedIn on Monday, announcing a donation of medicines worth more than $70 million, Reuters reported.

Separately, shares of Moderna  (MRNA) - Get Moderna Inc. Report advanced Monday after the drugmaker struck a deal to provide 500 million COVID-19 vaccine doses to low- and middle-income countries through a United Nations-backed program.