December 20th – U.S. Food and Drug Administration (FDA) Director Hahn said that Pfizer and Modena can distribute coronavirus vaccines by themselves without waiting for FDA approval for quality control tests for each batch of vaccines.
Hahn said on his social media Twitter account that under the Emergency Use Authorization (EUA) rule, distribution of COVID-19 vaccines do not require FDA authorization approval.
Authorization conditions require pharmacist to submit an analytical certificate for each batch at least 48 hours before the vaccine is distributed, after which the vaccine can be distributed without waiting for FDA approval.
It is understood that after Pfizer vaccine, Modena has become the second coronavirus vaccine approved by the United States.
The United States reportedly plans to distribute about 5.9 million doses of vaccine to 64 states, territories and major cities across the United States next week.
By the end of December this year, Modena will deliver about 20 million doses of vaccine.