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Pfizer news is great — tempering enthusiasm is not the same as erasing

Pfizer news is great — tempering enthusiasm is not the same as erasing
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When the polio vaccine was announced, church bells rang, ticker-tape parades ensued. As the Pfizer-BioNTech preliminary results were announced yesterday, there is a temptation to have that same feeling — indeed, the stock market did. However, while it is appropriate to be very enthusiastic about this development, it must be tempered to some degree. 

It is clear no one expected to see a first-generation COVID19 vaccine achieves a 90 percent+ success rate in preventing infection. Many of us in public health believed this first batch of vaccine candidates would be instrumental in preventing hospitalization or death but have a more modest ability to prevent infection in the 50-60 percent range. 

So Pfizer’s news is generating a lot of enthusiasm. Of course, we need to see the full data set in a peer-reviewed journal publication to understand the nuances of this efficacy fully, but 90 percent is beyond most people’s expectations. We know with small numbers and sample size, these statistics need to be carefully scrutinized, which will be done when the data are available. 

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Additionally, there is still a need for robust safety data, which will be forthcoming. Vaccines are given to healthy people; therefore, a rigorous risk-benefit calculation must be made in which individuals can be counseled about the risks the vaccine entails and the benefits. Based on earlier clinical trial data, it appears the Pfizer-BioNTech has a favorable short-term safety profile in trial participants. 

This data will be key to any emergency use authorization from the Food and Drug Administration (FDA). It will also be important to continue studying vaccinated individuals to develop any longer-term side effects. We should expect when hundreds of millions are eventually vaccinated, very real side effects, too rare to be detected in smaller trials, may emerge and need to be integrated into risk calculations. This is normal in the vaccine development process. 

If everything goes perfectly with this vaccine, there is still a Herculean vaccine distribution task that lies ahead. This vaccine, and several other candidates, are two-dose vaccines that require both doses for full effect. Any vaccine, especially in an emergency vaccination situation that needs more than one dose, is a challenge as compliance with the second dose typically falls. 

This vaccine candidate's storage conditions are also extremely challenging as it requires an extreme cold chain (negative 70-80 degrees Centigrade) for the vaccine to be viable. The vaccine cannot be kept at ordinary refrigerator temperatures for very long, so there will be a need — as Operation Warp Speed is addressing — to ensure that all communities have storage facilities up to the task. 

Lastly, there is concern that the population will not accept the vaccine in high enough numbers to change the pandemic's trajectory. During 2009, the H1N1 pandemic, less than a quarter of all Americans, accepted a rather routine flu vaccine against the pandemic strain. Polling suggests the same lack of public confidence exists for this vaccine and will pose a major obstacle to vaccine uptake. It is not surprising that this sentiment exists given the prior politicization seen with hydroxychloroquine and convalescent plasma decisions. We, as public health and infectious disease professionals, need to listen to communities around the country about any potential concerns or hesitation and will need to be very transparent of the risks and benefits of the vaccine and explain the rapid development process (which many of us knew was possible with programs like Operation Warp Speed and new vaccine technologies) did not compromise safety. 

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In addition to the work ahead with vaccine distribution, it is important to realize that it will be months before the general public has access to a vaccine despite the successes we've seen. The priority groups for vaccination will be healthcare workers and high-risk individuals. I suspect it will not be until at least summer 2021 before the general public has a high level of access to this vaccine as production will not be instant. In the interim, we will have to continue to behave in a manner reflecting the pandemic’s presence. Being mindful of our contacts, social distance, face coverings, and avoiding crowded situations will be the norm for some time. 

Tempering enthusiasm is not the same as erasing it and, make no mistake; the news today is great. It is great not only for COVID-19 but for a proof-of-concept of how a vaccine development process can be accelerated by programs such as Operation Warp Speed (though the Pfizer vaccine’s relationship with Operation Warp Speed is on delivery, not development). Indeed, this program should be expanded to other infectious disease threats that are on the horizon. The demonstration that new vaccine technologies, such as the Pfizer vaccine's mRNA platform, can significantly accelerate vaccine development is an impressive feat. This type of vaccine platform holds great promise and may become a platform of choice for rapid response. The COVID-19 pandemic, as disastrous as it has been, offers the prospect of galvanizing the world never to allow such an event to occur again, and today’s news furthers that goal.

Dr. Amesh Adalja, an infectious disease physician, is a senior scholar at the Johns Hopkins Center for Health Security. Follow him on Twitter at @AmeshAA.