Lack of context : The claims do not mention that FDA approval is not finalized yet. They also overlook the fact that Emergency Use Authorization of a vaccine is based on different and more tolerant standards than a standard approval.
AFFIRMATION COMPLETE: 'FDA panel backs Moderna’s COVID-19 vaccine'
On 17 December 2020, the claim began circulating that the U.S. Food and Drug Administration (FDA), the federal agency responsible for authorizing drugs and vaccines in the U.S., authorized the COVID-19 vaccine developed by the U.S. biotech company Moderna.
This is accurate, as the FDA held a meeting on 17 Dec. 2020 where an advisory panel positively reviewed Moderna’s COVID-19 vaccine. According to the FDA, the panel included leading experts in the fields of vaccines and infectious diseases.
The panel discussed results from the clinical trials with Moderna’s COVID-19 vaccine, which showed a 95% reduction in the number of symptomatic cases of COVID-19 among people who took the vaccine compared to the control group and a reduction of 60% in asymptomatic cases. Several points regarding the vaccine’s safety and potential side effects were discussed in the presence of Moderna representatives. At the end of the meeting, the panelists validated the vaccine with 20 votes in favor and 1 in abstention.
Contrary to what is being claimed on social media, the FDA has not formally approved the vaccine yet. Although the advisory committee provided a positive review, the official authorization has not happened yet. According to the FDA, approval for Moderna’s COVID-19 vaccine should ensue shortly, as a result of the committee’s meeting.
Many posts also lack context. The FDA is considering issuing an Emergency Use Authorization (EUA) for the Moderna vaccine against COVID-19, which differs from a standard FDA approval. For instance, a standard approval generally requires two clinical trials instead of one, as it is the case for EUA. This system is designed to fast track a treatment in the context of an ongoing health crisis where no approved treatment exists. Given the existing health threat, the amount of efficacy and safety data required for an EUA is less than that required for a standard FDA approval. For a standard approval, the proponent must present substantial evidence of efficacy. For an EUA, on the other hand, the FDA must assess whether the available data at the time is sufficient to reasonably believe that the treatment will prove efficient. Whereas a standard approval demands a complete proof of safety, an EUA requires that the benefits from the treatment outweigh its potential risk. Asked about this “benefits versus risks” balance, the FDA advisory committee responded to this question with a clear “yes”.
