Headlines as of late have painted a grim picture of the immediate public health landscape,
Headlines as of late have painted a grim picture of the immediate public health landscape, with Covid-19 cases spiking across the nation and some cities and states forced to implement new regulations in an attempt to stymie the spread of disease. But amid the bad news, there has been a glimmer of hope. Last week, Pfizer and BioNTech announced that early data on their vaccine candidate showed it was more than 90% effective in trial participants, before announcing on Wednesday that a final analysis of the vaccine’s Phase 3 trial found it was 95% effective. And on Monday, Moderna reported that early data from its vaccine candidate shows it is over 94% effective.
These promising news, however, are likely to raise some eyebrows, as they come along side skepticism that any Covid-19 vaccine developed on an expedited timeline may not be as thoroughly vetted as traditional vaccines. Emergency use authorization (EUA) can indeed be granted by the FDA to allow a vaccine to bypass some of the time-consuming approval processes that would delay its availability to the public. Pfizer CEO Albert Bourla announced this week that the company is preparing to file for EUA on Friday.
Some of this concern is warranted; it is critical that a vaccine is proved to be safe and effective before it is publicly available to assure it will reduce the disease burden and not cause undue harm. However, if a vaccine candidate is proved to be safe and beneficial to the public, it becomes imperative that it is widely administered.
So, what can be done now to instill public confidence in a vaccine if and when it proves to meet public health standards and scientific muster?
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Developing a vaccine and making it available for public use is a major undertaking. First, substantial preclinical work is needed to determine what is a likely protective immune response for the virus in question and then how to induce it. Once the preclinical work is done, three major stages of clinical trials traditionally follow before licensure is possible. By the time a vaccine makes it through these trials, thousands or even tens of thousands of volunteers may have received it and data on the clinical effectiveness of the vaccine in reducing the incidence of illness compared to a placebo typically provides proof of its efficacy. So far, both the Pfizer/BioNTech and Moderna vaccine trials have included tens of thousands of individuals, divided into groups of those receiving the vaccine and those getting a placebo.
But these companies may soon deviate from the traditional vaccine approval process by filing for an EUA from the US Food and Drug Administration to make their vaccines available to the public as soon as possible. Given this expedited timeline, the authorization process must be transparent and clearly communicated to the public to instill confidence that no shortcuts were taken that could result in harm to those who get vaccinated. To facilitate this, investments should be made in developing appropriate communications materials to help explain the vaccine trial and approval process to the public and to health care provider groups.
Committee meetings in a public forum
To ensure vaccine safety and provide an opportunity for the public to observe the data being discussed, vaccine trials should be reviewed by independent committees of experts in a public forum prior to vaccine approval and as administration programs are considered. Opportunities for public comments to the committees should also be prioritized. By doing this, concerned individuals will be able to hear firsthand the safety considerations that went into the critical decision making regarding the vaccine.
There are two major committees that need to be involved in this process: The Vaccines and Related Biological Products Advisory Committee (VRBPAC), which consists of experts in a variety of fields who can help in evaluating data to determine whether the vaccines should be approved for public use; and the Advisory Committee on Immunization Practices (ACIP), which makes recommendations for vaccine use once the FDA has approved the vaccine. Information on the ACIP and the ability to listen and provide comments at meetings can be found online.
The right message, the right messenger, the right communication channel
To be sure, there is still work to be done to make sure the current vaccine candidates meet US standards. There are many questions that are not yet answered by the early data made public. But the past weeks have been a major step in the right direction; we now have proof of principle — that Covid-19 can be prevented by a vaccine. And the reported data suggest the vaccines are relatively safe.
Fortunately, there are many more vaccines in clinical trials, so we may eventually have choices of vaccines and assure supplies are available to vaccinate large proportions of the population to induce both individual and community protection. But at the end of the day, vaccines don’t save lives. Vaccinations save lives. A vaccine dose that remains in the vial is 0% effective regardless of the results of the clinical trials.
Therefore, it is critical to assure the public that the vaccine benefits far exceed any risks. To do that, we need the right message, delivered by the right messenger through the right communications channel.
What is particularly important is that the messengers have the trust of the public. Whether it is Dr. Anthony Fauci, Dr. Deborah Birx or any other health official who becomes a household name as we get closer to a vaccine’s rollout, they must speak honestly in terms the public can understand, and deliver the message through trusted channels, such as national and local news outlets.
It will also be important for national health officials to provide critical information to primary care providers to help them in discussing risks and benefits with their patients, as these physicians are often the most trusted sources of information.
With rampant misinformation proliferating on social media, it is incumbent upon health officials at all levels to be intentional and transparent with the information they share about these vaccines. Only then, with the trust of the public and a widespread vaccination effort underway, can we embark upon the beginning of the end of the coronavirus pandemic.