by Rachel Perkins, ICS Policy Research Intern The COVID-19 pandemic has upended all aspects of…
By Megan Carolan, Director of Policy Research; Alexis Herschkowitsch, Innovation Associate; Rachel Perkins, Policy Research Intern
With recent news from drug companies about early success in COVID-19 vaccine clinical trials, the world is buzzing with what this could mean for going back to “normal.” In the 8 months since the spread of the virus reached official pandemic status and turned daily life in the U.S. and globally upside-down, families, schools and our society at large have scrambled to adapt to a new way of life to slow the spread. Will a vaccine mean we can go back to business as usual? When could relief realistically be in sight?
First, it is important to remember that while the clinical trial successes are a major victory, it does not mean you should expect to pick up a shot at your doctor’s office any day now. As media reports reflect, these are preliminary results on the shots as a prevention strategy – additional analyses will be released down the line to allow for further study. The Food and Drug Administration (FDA), the regulatory body that must approve a vaccine, has indicated that at least one of the COVID-19 vaccine candidates is likely to receive “emergency use authorization” by the end of 2020. From there, the challenges move out of the laboratory and into the work it will take to produce and distribute millions to a billion doses. Health care workers will receive priority for the shots, in order to protect both their own health and ensure that the health care system is able to meet the needs of patients until immunity is widespread; USA Today reports “scientists have predicted [the COVID-19 vaccine] won’t be available to the general public until summer or fall of 2021.”
In addition to priority for health care workers, other factors will go into determining who receives the vaccines. Notably, the clinical trials thus far have focused on the enrollment of healthy adults to test safety and efficacy – a standard practice for testing out vaccinations, but one that means we do not yet know about its use for children or for pregnant women, and cannot know until these populations are enrolled in clinical trials. The American Academy of Pediatrics (AAP) has written a letter to federal officials calling for the inclusion of children in clinical trials of the vaccine, noting in particular the disparities in which children have been most seriously impacted:
“…in the United States alone, more than 587,000 COVID-19 cases have been reported in children, representing approximately 10 percent of all cases. Among the children who have acquired COVID-19, 109 have died from the virus, with more than two-thirds being Black and Latinx children. Beyond the direct impact of the infection, children have been greatly affected by the pandemic…Children must be included in vaccine trials to best understand any potential unique immune responses and/or unique safety concerns. Questions about unknown safety concerns will not be answered by posing questions, but only through carefully designed trials which include children.”
In addition, it is important to note that the current data released on vaccine trials has primarily focused on symptomatic COVID-19 cases – that is, individuals who became sick and demonstrated symptoms. Data so far does not discuss asymptomatic cases, which can still represent a significant portion of “carriers” of the virus to others. The CDC notes that some studies have found that up to 45 percent of children with COVID-19 are actually asymptomatic – so until vaccine producers can confirm that vaccines also prevent asymptomatic cases, as well as approve children to receive the vaccine, we will continue to need precautions like social distancing and mask-wearing to reduce transmission.
Similarly, it is routine not to include pregnant women in clinical trials unless both safety and effectiveness have been more fully determined, based on concern for both patients themselves, as immune systems respond differently during pregnancy, as well as fetal health. As a result, pregnant women are unlikely to receive the vaccine in its first wave of distribution and more research will need to be done in 2021. Experts say that if the virus presents major risks to pregnant women – as is the case with seasonal flu – it is possible that pregnant women might be offered a vaccine sooner. Data at this time suggests that while pregnant women who contract COVID-19 may experience more severe impacts, they are not more likely to contract the virus than are their non-pregnant counterparts. As we wrote in the spring, little is known about the long-term impacts on babies whose mothers contract COVID-19 in utero, though the stage of pregnancy does impact the treatments that are available.
Additionally, pregnant people may be well-represented in frontline workers. According to women’s news outlet The 19th,
“ ‘A significant number of health workers are women. Within that there are always, at any given time, a substantial number who are pregnant,’” said Ruth Faden, a bioethicist at Johns Hopkins University who focuses on immunizations for pregnant people. “ ‘What’s the right ethics stance towards a pregnant health worker?’”
Without good data, it’s difficult to know what the implications are for giving pregnant people either vaccine. But the mechanism underlying both vaccines — a new messenger ribonucleic acid (RNA) technology that helps the body develop antibodies to fight the coronavirus — has not been shown to cause harm during pregnancy…”
And of course, vaccines only work if people receive them the way they were intended! While the vaccine for COVID-19 will be brand new, health professionals have decades of research on how to make vaccination campaigns effective – annual flu shot outreach is a good example we can learn from. From this research, the Centers for Disease Control and Prevention recommends encouraging flu vaccination through use of the SHARE campaign which can be adapted to the current COVID-19 pandemic:
Public health departments, governments and health care providers will need to focus particularly on building public trust–because the development of this vaccine has been closely followed in media and discussed by politicians of all parties, individuals have developed their own presumptions and biases about it, some of which may not be grounded in fact. As of September, the U.S. was split down the middle regarding adults who definitely or probably would get a vaccine versus adults who definitely or probably would not get vaccinated at this time. This constitutes a 21% drop in overall intent to get a COVID-19 vaccine since May. We do not have new polls yet to demonstrate how trust may have changed in light of two encouraging reports from vaccine developers, Moderna and Pfizer, both of whom recently reported having about a 95 percent efficacy rate in the trials of their respective COVID-19 vaccines. This is encouraging news; for context, a mere 50 percent efficacy rate is considered roughly accurate most years for the flu vaccine.
When children are approved for the vaccine, it likely will not be a one-size fits all approach. Teenagers are more likely to be approved before young children, based on the fact that they seem to process the virus similarly to adult bodies and how they will be included in trials. The Pfizer trial does have FDA approval to include children as young as age 12 in their trials; they have enrolled 16- and 17-year-olds but will not add any other children until they have more fully analyzed the results of these older teens. Interestingly, teenagers have some of the lowest rates of flu vaccination each year, often borne of a belief that the flu is not as dangerous, and due to inconvenience; whereas younger children visit the doctor more frequently for well-child visits, teenagers only go annually for well-visits or for acute care needs, which means that their visit might not happen to coincide with the ideal timing for influenza vaccination. Experts estimate though that it could be several years before the impact and efficacy for children is understood well enough to warrant widespread vaccination for children for the prevention of COVID-19.
Finally, public health experts in each state are already working on vaccine distribution plans based on the particulars of these vaccines, including possible challenges for cold-enough storage, accessing rural areas with the right quantities for their needs, and preparing supplies and personnel to administer the vaccine. It will be an all-hands-on-deck effort to reach all those who are eligible for the vaccine when it is ready.
Vaccinating children for other illnesses has been a tremendously successful public health strategy in the past. Vaccinated children tend to produce stronger immune responses than adults do, which confers better long-term immunity. Additionally, parents are inclined to comply with the recommended vaccination schedule for young children, thanks to a trusting relationship with health care providers as well as easy access to vaccines through frequent check-ups and insurance coverage of vaccines. The completion rates for recommended childhood vaccinations run from 80-90 percent (CDC), versus less than 50 percent of U.S. adults who get their recommended vaccinations for flu, hepatitis, shingles, etc. However, many children have fallen behind on these regular vaccinations as parents held off on pediatric visits out of health concerns. In our report on pediatric health in South Carolina, more than 80 percent of providers reported having fewer vaccination visits since the pandemic started; in a recent survey of families nationwide, the Rapid Assessment of Pandemic Impact on Development Early Childhood (RAPID EC) team found that 12 percent of parents with children under 5 reported missing a vaccine for their child since the spring and nearly a third had missed a check-up. Additionally, fall has brought with it the flu season, which experts worry could lead to a “twindemic” in which health care systems are overwhelmed by COVID and flu cases, which have similar symptoms and can both be deadly. While none of these shots will prevent COVID itself, regular and seasonal vaccines are essential for protecting our communities from the spread of other harmful illnesses that could further overwhelm our already worn-down health care system.