In the United States, it became clear very early on that the vaccines would be the only sustainable way for the country to emerge from the emergency phase of the COVID-19 pandemic. This realization resulted in the creation of Operation Warp Speed and a tremendous government and industry effort to develop and administer safe vaccines in the fastest manner possible.
When the vaccines were tested and it was clear they were safe and efficacious in rigorously designed and executed clinical trials, an emergency use authorization (EUA) was issued by the Food and Drug Administration (FDA). This was a cause for celebration. In an emergency, like this one, time equals lives. In the past, the EUA pathway — without controversy — facilitated access to intravenous antivirals during the 2009 H1N1 pandemic and diagnostics for Zika.
During the COVID-19 pandemic, it was not until a vaccine was available that a substantial and sustained decline in deaths occurred. If the vaccines were not available under and EUA, more people would die or be hospitalized, and more economic losses would be sustained. In fact, we would still be waiting for a vaccine and the strides we’ve made in decoupling cases from hospitalizations would be non-existent if we didn’t have an EUA.
However, in this pandemic, the achievement of the EUA — and having multiple safe vaccines available — has become something held against the vaccines by some Americans. This is because a concerted misinformation campaign is underway describing the vaccines as “experimental” or akin to a large clinical trial. Nothing could be further from the truth. The “experiments” — if one can describe meticulously monitored clinical trials in this manner — have been completed in adults and children above the age of 12. Billions of doses have gone into the arms of people worldwide. The evidence of the efficacy and safety demonstrated unequivocally in the trials is evident.
The lack of full FDA licensure has become a misleading talking point for those opposed to the vaccine. Surveys of the unvaccinated have shown that this strategy has unfortunately been successful in dissuading people from improving and saving their lives through vaccination. The lack of licensure has also made many organizations reticent to mandate vaccination as a condition of employment of participation (although they are well within their abilities to do so under EUA).
Pfizer has filed for full approval after having accrued the six months of data necessary for the FDA to begin the evaluation process. The FDA has granted Pfizer priority review status meaning they have six months to tender a decision (versus the usual 12-month period) although the decision to fully approve the Pfizer vaccine is expected to occur within weeks. Moderna has also begun the process.
It is valuable to assure the public that no corners have been cut, no steps have been skipped and no irregularities have occurred with these crucial life-saving vaccines and be very deliberate and transparent with each step of the vaccine evaluation process. However, this progression, as it has played out thus far, has been used to increase vaccine hesitancy because, despite the overwhelming proof of vaccine safety and efficacy, there is still no fully FDA-licensed COVID-19 vaccine. The FDA process is being used in a misinformation campaign that must be challenged. Considering the data available showing the safety of these vaccines and the critical nature of increasing the speed of vaccinations as Delta circulates widely, the FDA should act expeditiously – today – and disarm the anti-vaccine activists. We need full approval.
Amesh Adalja, M.D., is an infectious disease physician and a senior scholar at the Johns Hopkins Center for Health Security. Follow him on Twitter: @AmeshAA.