Regulators urging drugmaker to apply for emergency authorization of 2-dose regimen of shot for kids aged 6 months to 5 years old while awaiting data on 3-dose course

'The public can be assured that this vaccine was approved in keeping with the FDA’s rigorous scientific standards,' says senior regulator

Officials say shorter wait time could help as US struggles with Omicron surge, call vaccination 'our best defense against COVID-19'

Conflicting reports as to whether officials expect manageable number of severe cases or huge jump; surging cases force reliance on potentially unreliable rapid tests

Agency's vaccine chief says third dose for kids 12 and over 'may help provide better protection against both the Delta and Omicron variants'

AstraZeneca's Evusheld okayed for those 12 and older who didn't respond adequately to vaccines or who have history of severe allergic reactions to shots

US follows Israel's lead and places emphasis on those aged 50 and above, urging older populations to get extra shot; expansion makes tens of millions more Americans eligible

Decision still needs CDC approval for Pfizer and Moderna vaccines, with panel to meet later Friday, amid rising cases and fears of a fresh virus wave in winter

Drug company CEO Albert Bourla says it is 'moving as quickly as possible' to get the treatment into the hands of patients

FDA says review could last until January; pharma company also delays filing authorization request for lower dose of the vaccine for 6- to 11-year-olds