We must have realistic expectations of how much influence FDA approval will have on vaccine hesitant populations, says Peter Hotez
The announcement of the Food and Drug Administration’s (US FDA) full regulatory approval of the Pfizer-BioNTech covid-19 vaccine is an important development for the US vaccination programme.
The US FDA is often considered the world’s most stringent national regulatory authority, with an extraordinary track record of approving safe and effective products for medical use. Among these products, the bar is especially high for vaccines because of the simple reality that they are mostly administered to well people in order to prevent them from becoming sick. That the US FDA has now signed off on the Pfizer-BioNTech covid-19 vaccine is in itself a milestone in efforts to halt the spread of covid-19.
Full vaccine approval also helps to validate the strength of the emergency use authorization process. Last year, the US FDA was under tremendous pressure to quickly release covid-19 vaccines to a nation losing thousands of Americans lives daily. However, the agency remained committed to expediency without sacrificing vaccine safety or efficacy. In this way, formal approval confirmed that an emergency use authorization (EUA) for a vaccine can work and be achieved with integrity.
The most immediate impact of full regulatory approval will be vaccine mandates. Several large US companies will now require their employees to be fully vaccinated, while the federal government will now mandate vaccines for those enlisted in the US military. Approval would have likely advanced school vaccine requirements had it included the 12-15 year old age group. The full approval is for people aged 16 years and older. The emergency use authorisation will continue for 12-15 year olds. But, potentially secondary schools and certainly colleges and universities will also soon mandate covid-19 vaccinations.
What’s much less clear is the impact of vaccine approvals on individual decisions and choices. Since the beginning of 2021, and even before, we have heard that many Americans did not trust the EUA process or thought it was rushed. The hope was that formal approval would make many vaccine reluctant Americans feel comfortable accepting a covid-19 vaccine. However, many of us felt that the impact of approval would be modest at best. The reason requires a better understanding about the basis for anti vaccine attitudes or vaccine resistance in America. Yes, questioning the rigor of the EUA was a major talking point among the unvaccinated, but the reality is that there are at least a dozen reasons offered ranging from reasonable skepticism around vaccine safety, to a range of government conspiracies.
Expecting regulatory approvals to convert a substantial proportion of the 80 million unvaccinated Americans into reversing their position is naïve. Such expectations ignore the depth and breadth of anti vaccine sentiment in the US, and fail to understand its political dimension. Years ago, as we began debunking links between vaccines and autism, the American anti vaccine movement needed to re-energize and did so by connecting with far right political ideologies. By espousing health or medical freedom slogans and beliefs, it attached itself to the funding and mounting political strengths of the Republican Tea Party. This occurred initially in Texas, but later accelerated nationally during the years of the Trump Administration.
A new NBC News poll on the 24 August 2021 confirms the dominant influence of politics and far right ideologies. Only 46% of people identified as “Republicans who support Trump” have been vaccinated, the lowest among all demographic groups surveyed, followed by 50% of “Trump voters in 2020 general election.” In contrast, 91% of Biden voters have been vaccinated. This sharp partisan divide also extends to regional differences in vaccine uptake, now the lowest in the Southern US, where delta transmission is consequently the worst. States such as Mississippi and Louisiana have the highest covid-19 incidence rates globally and tens of thousands are being admitted to hospital.
Therefore, while vaccine mandates should help to close a piece of the gap on the estimated 80 million unvaccinated Americans, there will need to be more concerted outreach to resistant groups now driven by political identities. Paramount will be a continued cultivation of influential leaders, but also heightened efforts to reduce or damp down the sources of disinformation. Taking on the social media platforms will not be adequate. There is urgency to find mechanisms to identify and dissolve the disinformation sources. They include the “three-headed monster” of 1) right wing extremists groups, 2) propaganda amplifying anti vaccine and anti science tenets, and 3) the top non-governmental groups recently identified by the Center for Countering Digital Hate as the “disinformation dozen.”
In the meantime, the recent vaccine approval is a welcomed development and hopefully will be followed by others for the Moderna and Johnson & Johnson vaccines. But, we must have realistic expectations about their usefulness as instruments of advocacy.
Peter Hotez, Texas Children’s Center for Vaccine Development, Department of Pediatrics and Molecular Virology and Microbiology, National School of Tropical Medicine, Baylor College of Medicine, Houston TX, USA
Competing interests: PH is an inventor on a covid-19 vaccine technology owned by Baylor College of Medicine that was licensed non-exclusively to several companies, including Biological E in India and ImmunityBio in South Africa for producing a low-cost recombinant protein vaccine. He is also an inventor on non-revenue generating patents for parasitic disease vaccines. PH is an author on four books (published by Johns Hopkins University Press and American Society of Microbiology ASM Press) related to the geopolitics of emerging and neglected diseases.