Some health officials said the Food and Drug Administration needs to give full approval for the Pfizer/BioNTech and Moderna coronavirus vaccines in order to convince hesitant Americans to get vaccinated.
Are COVID-19 vaccines approved by the FDA?
Per CNN, the current COVID-19 vaccines from Moderna, Pfizer and Johnson & Johnson were all approved for emergency use authorization — meaning they could be used to treat the public health emergency. But they don’t have full approval from the FDA.
- “Progressing from authorized to approved would allow manufacturers to market and directly distribute their vaccines. It could also have an impact on vaccine mandates — and perhaps sway skeptics hesitant to get the vaccines now,” according to CNN.
Dr. Jerome Adams, who worked as the U.S. surgeon general during the Trump administration, wrote in an opinion article for The Washington Post that full approval would convince some skeptics to get vaccinated.
- “The individuals who got vaccinated early on were generally high risk and willing to take a vaccine authorized for emergency use. But many people who are lower risk understandably ask if the benefits justify taking a medication that has not received the full and traditional FDA stamp of approval,” he wrote. “As vaccine manufacturers complete further studies, which will eventually lead to expanded eligibility among minors, it will help show skeptics that the authorized COVID vaccines are safe.”
When will FDA give full approval?
It’s unclear. According to NBC Chicago, the FDA goes through “a rigorous and structured process” in order to approve a drug in full. Data about the drug will need to be approved by the Center for Drug Evaluation and Research, too, which will determine if benefits outweigh the risks.
Dr. Anthony Fauci, one of the country’s top infectious disease experts, told CNN that the FDA will need time to approve the drug in full.
- “When you’re getting a formal approval you have to have a certain amount of time just observing predominantly the safety — and obviously the safety looks really, really good in well over 140 million people having been vaccinated with at least a single dose,” Fauci said on CNN.
- “I hope they do it quickly,” he added.