Rochelle Walensky (director of the Centers for Disease Control and Prevention) gave a clear message to Americans in August: Get immunized. CNN interviewer Rochelle Walensky said that vaccines “are working extraordinarily well.” They continue to be effective for [the delta variant]They prevent severe illness or death. They keep it from happening.”
Anthony Fauci (President Joe Biden’s chief medical advisor) reiterated this message. He has also expressed his support for mandating public school teachers be immunized. The Food and Drug Administration (FDA) also echoed the sentiment. This agency regulates vaccines and has to approve any widespread use.
Janet Woodcock is the FDA’s acting Commissioner. She stated, “Getting more of this population vaccinated it critical to moving forward” and “passing this pandemic.” Woodcock stressed the fact that vaccines were thoroughly reviewed by the FDA, which found them to be safe and effective.
Regulatory reality was a more important factor for much of the year. The FDA had yet to give formal approval for any COVID-19 vaccinations as of mid-August. They were instead administered using “emergency usage authorizations,” which is a provisional status that suggests the FDA wasn’t certain about their safety.
According to FDA officials, safety data was being collected. Although Woodcock made clear that the vaccines were effective and safe, the real goal of the FDA was to expedite the drug approval process. Even though this meant confusing the public and possibly costing them lives, the delay and effort could not be ignored.
Pfizer’s vaccine was approved by the FDA in August. However, two other Pfizer vaccines remain unapproved and are not authorized for immediate use. This means that it is likely that young children will need to be vaccinated in the future.
After the clinical trial results were reviewed, FDA took weeks before provisionally approving the vaccines. The FDA could have acted sooner to stop the devastating winter wave and likely saved many lives. The FDA is not proving that the vaccines are working. However, the FDA doesn’t agree.