The Food and Drug Administration (FDA) voted Thursday to approve the Pfizer-BioNTech coronavirus vaccine for emergency use and mass distribution.
Shipments of the vaccine shown 95 percent effective in large-scale phase three clinical trials could begin within hours following the FDA’s decision, pending final review from officials within the Center for Biologics Evaluation and Research.
The FDA advisory committee dictating authorization voted 17-4 to greenlight the Pfizer vaccine’s approval with one member abstaining. According to Fox News, some raised issue over limited evidence related to use in 16 and 17-year-olds.
The FDA’s decision to approve the vaccine under the White House initiative led by President Donald Trump, Operation Warp Speed, comes after Canada, the United Kingdom and Bahrain similarly approved Pfizer’s product for emergency use.
An advisory panel at the Centers for Disease Control voted at the start of the month to prioritize health care workers and nursing home patients first, considering older patients are at higher risk of serious complications from infection. Trump signed an executive order at a White House vaccine summit this week ordering American vaccine makers to prioritize U.S. citizens first, threatening to invoke the World War II-era Defense Production Act to ramp up production if necessary. However, Operation Warp Speed’s top scientist Dr. Moncef Slaoui was unsure how enforcement of the law in the pandemic context could work.
While the first round of Pfizer vaccines will be limited, another vaccine could soon be granted FDA approval. Biotechnical company Moderna’s vaccine has shown to be 94.5 percent effective in large-scale trials. A third vaccine developed by AstraZeneca and Oxford University was shown up to 90 percent in providing immunization from the novel coronavirus.