December 3, 2020Key points:
- Two COVID-19 vaccines are likely to be available in the United States before the end of December 2020 but there will not be sufficient doses in the coming months for all who are eligible for vaccination.
- Expert advisory groups have made recommendations about who should be the first to receive scarce COVID-19 vaccines, including medical personnel and residents of long-term care facilities, but ultimately states will decide how vaccine doses are allocated.
- Continued expansion of vaccine manufacturing capacity, as well as the availability of other COVID-19 vaccines, are needed to ensure that all people in the United States and globally have access to life-saving COVID-19 vaccines.
The Emergency Use Authorizations (EUAs) for the Pfizer and Moderna COVID-19 vaccines, which will likely be issued by the U.S. Food and Drug Administration by Christmas, bring high expectations from a weary public – the clinical trials of these mRNA (messenger RNA) vaccines indicate nearly complete protection from severe COVID-19 disease. The recent surge of COVID-19 cases throughout the U.S., the continued alteration in our daily lives, and the increase in hospitalizations and the COVID-19 death rate all hopefully counterbalance vaccine hesitancy with a desire to be protected from this sinister virus. Wanting an effective vaccine during an ongoing pandemic is, from a public health point of view, a “good” perspective. Unfortunately, however, the demand for COVID-19 vaccines will markedly outstrip their supply, at least for the next four to five months, which seems like an eternity given the distressing trends we are now seeing. Vaccine scarcity will be in the news for the next several months until one or two additional vaccines meet the requirements for an EUA and become widely available. How does this happen, that two effective vaccines are found but we can’t deliver them to everyone? What has happened in the battle against this virus is that the pace of vaccine development has been unbelievably quick; quicker than anyone ever expected. This remarkable scientific accomplishment has outstripped the existing manufacturing supply chain. The conceptual framework of a victory against the virus exists but, in order to proclaim victory, we need mass vaccine manufacturing, distribution, and real uptake. Making and distributing safe and effective vaccines is a complex process. There are many steps, and each step requires detailed quality control measures to ensure that each and every vial contains the right dose and right substance. To think of it in a more personalized way, what goes into every arm – including yours and mine – needs to meet manufacturing standards. This is not an easy task; it takes specialized facilities and highly trained personnel, beyond what currently exist. When we look at the number of doses being made versus what we need, it’s a daunting thought: between Pfizer and Moderna we expect only 40 million doses in December; another 30 to 40 million in January and February; and 60 million per month in March and April. Because each vaccine requires two doses per person, even if we reach 200 million doses, that’s 100 million people vaccinated at best – only half of the U.S. adult population. As I’ll describe below, these doses may not even cover the populations we feel most need the vaccine.So, who’s in line for this scarce resource and who decides who gets vaccinated first? We knew that vaccine scarcity would be inevitable since the beginning of the Operation Warp Speed (OWS) program, so independent groups and other experts have been evaluating how to define and develop an equitable national vaccine access strategy. The National Academies of Science, Engineering, and Medicine, the country’s independent group of scientists and medical policy makers, was commissioned by the National Institutes of Health (NIH), CDC, and OWS to evaluate this issue. This group of experts divided access to effective vaccines into and estimated the number of people in each of these categories. In the first phase, they prioritized health care workers and the elderly in high density communities, such as nursing homes, followed by the elderly that have comorbidities. They classified essential workers as the second group. In both situations, they stressed the importance that economically disadvantaged communities be given equal access in all situations. The second group of experts enlisted was the Advisory Committee on Immunization Practices (ACIP), which is the CDC’s arm for making vaccine recommendations for the country. For over 50 years, the ACIP has defined populations recommended for vaccination, and its advice is linked to public health-funded programs and insurance coverage for vaccines. ACIP has been discussing this issue for many weeks in open meetings, and on December 1 suggested that health care personnel and residents of long-term care facilities should be the to receive a vaccine. Essential workers comprise group 1B, for example grocery store workers and meatpackers, and the third priority group (1C) is the elderly and those people with comorbidities. These 3 groups alone comprise well over 150 million people, which is much higher than the estimated 90 million people we will have enough vaccine for by April 2021.How does one handle this scarcity when a case for vaccination exists for a very large segment of our adult population? How does one choose between a healthy frontline worker with no comorbidities – who has a lower risk of death but a higher exposure rate (and the potential consequences of being in quarantine and unavailable for their duties) – and an elderly person with comorbidities who has a much higher risk of death but could perhaps self-protect more by limiting exposure? Is there a right answer to who gets vaccinated first? Or do we have to consider some principles of equity and patience and, in the end, do what we can to make sure that everyone who wants a vaccine has access to one as quickly as possible? Both groups – the National Academy of Medicine and the ACIP – are advisory. They make recommendations to the public and executive branches of state governments, but we don’t have a national plan. We have national guidelines, but each state will make its own decision about allocation, so we will see differences in distribution by locale. Understanding and communicating these differences to the public will be challenging and some will call it confusing. I’m sure there will be some disagreement about who should get the vaccine and when. One principle should be upheld: we should use every available vial. Nothing should be wasted. The only real solution to overcome vaccine scarcity is, of course, to remove scarcity, and move toward full vaccine availability for all who choose to be vaccinated. This means that additional vaccines will need to be made available. So, the AstraZeneca vaccine that you’ve heard about – which reports a 70% effectiveness – the one-dose Johnson & Johnson vaccine and others must be studied and continue to be evaluated. We are hopeful that answers about how these additional vaccines perform in the U.S. will be known by late January 2021 – only two months away. For the time being, we need to get used to this reality of vaccine scarcity. However difficult it may be, we must have tolerance until more manufacturing capacity for the mRNA vaccines exists, or more likely, other types of vaccines become available for all of us.