Editor’s Note: Ali S. Khan, MD MPH is a professor and dean of the College of Public Health at the University of Nebraska Medical Center. He is a former assistant surgeon general and senior CDC director of Preparedness and Infectious Diseases. He serves on the Executive Steering Committee for the WHO’s Global Outbreak Alert and Response Network. The views expressed here are those of the author. View more opinion articles on CNN.
The United States’ commitment to develop, manufacture and distribute safe and effective Covid-19 vaccines for all Americans started with Operation Warp Speed and was ramped up even further by the Biden Administration.
The nation put resources and manpower behind the mission before even knowing if the vaccines would work. Less than a year after the first known cases of Covid-19 reached this country, the US had developed and authorized the first Covid-19 vaccines for emergency use.
This is not the typical development process for vaccines, which usually undergo a lengthy US Food and Drug Administration approval process. But the urgency of the pandemic called for a deviation from the norm, as the nation in crisis waited for vaccines that would mean a new, hopefully brighter chapter for the country and the world. And so, instead of applying for traditional FDA approval, Pfizer, Moderna, and a few months later Janssen, applied for emergency use authorization (EUA) from the FDA.
The FDA’s emergency use authorization, a process that has been used many times before, allowed effective and rigorously tested Covid-19 vaccines to be widely administered to millions of Americans during a pandemic that has killed more than 580,000 people in the US. Anyone who may have been hesitant to get the vaccine due to the lack of full FDA approval should rest assured vaccine developers were required to take additional safety measures. And now that the vaccine has been successfully rolled out, states and private companies should think outside the box and help incentivize vaccinations while focusing on expanding access to all Americans.
The FDA’s emergency use authorization of drugs, biological products, and devices was specifically created after the 9/11 terrorist attacks to ensure that in emergency situations, potentially lifesaving medical products could be available quickly without lengthy approval processes. The EUA’s authority has been used extensively during previous public health emergencies – including 22 products such as antivirals, respiratory protection devices, and diagnostic tests in response to 2009 H1N1 pandemic – and the current pandemic to ensure expedited access to diagnostic tests and treatments like remdesivir, which now has full FDA approval.
The FDA’s Office of Vaccines and Research Review knew early on that it needed to maintain the public’s trust as it worked with vaccine developers to expedite the availability of vaccines. They knew that the EUA should not be a shortcut to vaccine availability. As such, each vaccine was to be evaluated for safety and efficacy in rigorous, large, and diverse randomized clinical trials. Furthermore, they added the provisions that at least half of the vaccine recipients in the last phase of clinical trials have at least two months of follow-up to collect safety data.
Readers may remember the political turmoil around the decision of these extra safety requirements since it guaranteed that a Covid-19 vaccine would not be authorized prior to the November elections. The review process itself was also as meticulous as ever, including the usually required manufacturer’s independent data monitoring safety board, followed by independent evaluation by FDA advisers, and external FDA & US Centers for Disease Control and Prevention advisory committees.
The only unusual twist in the otherwise usual process was the profound transparency from sharing study protocols to livestreamed committee meetings.
As part of their EUA, the manufacturers were expected to continue their clinical trials after receiving their authorization to obtain additional safety and effectiveness information before applying for approval – which typically includes at least 6 months of safety data. Pfizer/BioNTech initiated this process in early May, making them the first Covid vaccine developers to seek full approval from the FDA. Moderna recently followed suit, announcing its initiation of the application process on Tuesday.
Also, manufacturers were required to actively monitor for safety to inform ongoing deliberations on the benefit and risks of the vaccines. These systems have proven to be been extremely sensitive – enough to identify a rare event such as the blood clots with low platelets occurring among Johnson & Johnson vaccinated individuals at a rate of less than 5 per million. Real-world experience after over 230 million doses of the mRNA vaccines has also confirmed the study trial data of greater than 94% effectiveness in preventing hospitalization among the fully vaccinated, even among the elderly. Severe breakthrough infections have been rare.
The exceptional risk-benefit profile of the US vaccines is now firmly established, and vaccination has been extended to those 12-to-15-year-olds this week with more opportunity to broaden community protection. Unfortunately, the new challenge in the US is no longer a limited supply of vaccines but a diminishing demand for vaccines is attributed, largely, to a lack of vaccine confidence and continued challenges for access. As of April, 55% of adults have received at least one dose of vaccine but 26% say they will definitely not get vaccinated or only if required. States are also still lagging in vaccinating Black and Hispanic people, despite a greater supply of vaccines across the country.
The question now is how to improve vaccine confidence and access, along with other public health measures, in order to crush the pandemic and regain our collective freedoms. This is especially important since increasing vaccine rates can decrease daily preventable deaths to near zero. Confronting this challenge will require new tools, incentives, and strategies to address simple hesitancy, misinformation, and outright lies being communicated by bad actors, like Russia’s disinformation campaign, or “Plandemic” – a debunked “documentary.” No, Microsoft co-founder Bill Gates is not engaged in a decadeslong conspiracy to control the world through vaccines including creating the SARS-CoV-2 virus in a lab and spreading it. And, no, the vaccine does not have a tracking microchip, does not cause infertility, nor does it make you a mutant. It also does not cause menstrual irregularities in the unvaccinated who are in contact with those who are vaccinated.
In fact, getting vaccinated prevents death, makes you a good citizen, and allows you to safely visit your elders, socialize with your vaccinated friends, travel, and remove your mask in numerous settings.
We are already seeing creative incentives to get people vaccinated including the offer of saving bonds, gift certificates, subway passes, baseball tickets, and free rides to vaccine appointments. Ohio is also setting up a statewide lottery for those who have been vaccinated, with a prize of up to $1 million or a full, four-year college scholarship for those under the age of 18. Companies should also step in and make it easier to get vaccinated by providing paid leave or child care options.
States should also establish mobile clinics to meet people where they are and improve access to vaccines by markedly expanding access points throughout the entire health care system so people can get vaccinated at any pharmacy or clinic – even when they visit the dentist, podiatrist or chiropractor, for example.
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And, getting the vaccines officially approved by the FDA will also pave the way for mandated vaccination programs to facilitate school-based and workplace health programs.
The vaccines are powerful. Get vaccinated now and, till then, mask on!
This article has been updated to indicate that Moderna has initiated its application for full FDA approval of its Covid-19 vaccine.
