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Pfizer-BioNTech announced Monday that three shots of their COVID-19 vaccine provided strong protection for children under the age of 5.
"We are pleased that our formulation for the youngest children, which we carefully selected to be one-tenth of the dose strength for adults, was well tolerated and produced a strong immune response," Pfizer CEO Albert Bourla said in a statement.
Bourla added that the companies are looking forward to "completing our submissions to regulators globally with the hope of making this vaccine available to younger children as quickly as possible, subject to regulatory authorization."
The U.S. Food and Drug Administration is set to meet in June to decide whether to authorize the shots for children.
The FDA has already begun evaluating data from Moderna, which says its low dose, two-shot vaccine offers protection for young children.
Meanwhile, World Health Organization Director Tedros Adhanom Ghebreyesus said Sunday at the 75th World Health Assembly that the COVID pandemic is "most certainly not over."
His warning comes as some countries are rescinding their COVID mandates, just as cases are on the rise again. "Reported cases are increasing in almost 70 countries in all regions," Tedros said. "This virus has surprised us at every turn - a storm that has torn through communities again and again, and we still can't predict its path, or its intensity."
The WHO chief said that while more than 6 million global coronavirus deaths have been reported, the U.N. agency estimates the worldwide tally is much higher at "almost 15 million deaths."
Tedros called on countries to do all they can to eradicate COVID, including vaccinating 70% of their population, which would include 100% of people over 60 years old; 100% of health workers; and 100% of people with underlying conditions.
The WHO leader warned, "The pandemic will not magically disappear. But we can end it ... Science has given us the upper hand."
The Johns Hopkins Coronavirus Resource Center reported Monday more than 525 million global COVID infections and more than 6 million global coronavirus deaths.