FULL CLAIM: There are no FDA-approved COVID-19 vaccines on the U.S market as of May 2023
REVIEW
COVID-19 vaccine distribution began in the U.S. on 14 December 2020, following the authorization by the U.S. Food and Drug Administration (FDA) earlier that month. Almost two and a half years later, in May 2023, participants in an Arizona Senate hearing claimed that there was no FDA-licensed and approved COVID-19 vaccine on the market. However, this is inaccurate and contradicted by the FDA’s own press releases.
The Arizona Novel Coronavirus Southwestern Intergovernmental Committee, chaired by Republican State Senator Janae Shamp, officially aims to “solicit information from experts, and the public regarding federal, statewide, and local public health departments, and healthcare systems (non-profit and private) COVID-19 response”.
However, the committee sparked controversy when it held a meeting on 25 and 26 May 2023 with speakers who have spread COVID-19 and vaccine disinformation in the past, including critical care physician Pierre Kory and cardiologist Peter McCullough.
During the meeting, McCullough claimed that there were no FDA-approved COVID-19 vaccines on the U.S. market. In response to Shamp’s statement that “We do not have a vaccine currently on the market for Covid-19 that is licensed and FDA approved”, McCullough answered, “that’s correct”, validating the claim.
However, this is inaccurate. FDA press releases, which are publicly available online, show that the Pfizer-BioNTech COVID-19 vaccine was approved for people over 16 on 23 August 2021. It was later approved for individuals between the ages of 12 and 15 on 8 July 2022. The FDA also approved the Moderna COVID-19 vaccine for individuals over 18 on 31 January 2022.
The vaccine rollout in the U.S. began in December 2020, after the COVID-19 mRNA vaccines received Emergency Use Authorization (EUA). EUAs are a way to fast-track the distribution of clinically tested drugs to the population in case of a public health threat. In contrast to full approval, an FDA-issued EUA requires less documentation and a shorter clinical trial follow-up.
In situations like pandemics or bioterrorist attacks that pose a serious public health threat, being able to rapidly provide effective medical interventions like vaccines or drugs to the population is vital, thereby justifying an accelerated release process. Because the COVID-19 pandemic was declared a public health emergency, this permitted COVID-19 vaccines to be made available under EUAs.
EUAs for an intervention are issued for specific populations and purposes. Therefore, an EUA being issued for a vaccine doesn’t necessarily mean that the vaccine can be given to everyone. In the case of the COVID-19 vaccines, a new EUA had to be issued to allow the vaccines to be given to children and adolescents or when the vaccines were intended to be used as boosters as opposed to primary vaccination. As time went by and scientists gathered more data about the vaccines’ safety and effectiveness in more and more people, there was eventually sufficient evidence to support full FDA approval forCOVID-19 vaccines.
One might think that the end of the COVID-19 public health emergency in May 2023 voided the existing COVID-19 vaccines EUAs. This isn’t the case. In a health emergency, the Secretary of the U.S. Department of Health and Human Services (HHS) can release “EUA declarations” that enable the FDA to issue specific EUAs to address the ongoing crisis. For the FDA EUAs to end, the HHS Secretary must first terminate the related EUA declarations, which hasn’t been done for COVID-19.
In summary, two COVID-19 vaccines are FDA-approved: the Pfizer-BioNTech vaccine for people aged 12 or older and the Moderna vaccine for people aged 18 or older. Claims stating the opposite are therefore false. These vaccines and others are also authorized for use in other age groups or as booster shots under EUA. It is important to note that EUAs still require clinical trials demonstrating the effectiveness and safety of vaccines. Vaccines authorized under EUAs thus aren’t experimental.
