It is nearing the end of September and there are numerous updates in the world of COVID-19. Information comes rapidly from the government, from the media, and from the scientific community. As you look to the weekend and the start of next week, here are some of the issues we think you will find helpful. As always, if there are topics you would like to see covered, don’t hesitate to send us an email.
1. Face Masks May Reduce Severity
A letter in the New England Journal of Medicine suggests that face masks may play a role in increasing the number of asymptomatic cases. The author suggests that use of face masks reduces the amount of virus a person is initially exposed to, resulting in a much milder disease and a higher number of people being asymptomatic. More study is needed to support the theory but it provides support for universal mask use. This letter has been incorrectly interpreted as “face masks giving people immunity to COVID-19” by some media outlets. That is not what the letter is saying, only that face masks may result in milder or asymptomatic disease when infected.
2. Changing Age Distribution
The CDC has published new data Sept 23rd regarding the age distribution of COVID-19 cases over the past few months. Since June, the 20-29 age group has had the greatest incidence of new cases. This is a change from earlier in the pandemic when older adults made up the bulk of cases. Though the younger group now has more new cases, the bulk of emergency department visits for COVID-19 remains in adults over age 40. This supports previous evidence that younger adults have better outcomes than older adults with COVID-19. It also mirrors a similar trend seen in Europe. noted by the WHO in August. Additionally, the analysis by the CDC noted that the increase in cases in the 20-29 age group preceded an increase in adults over age 60 by 4-15 days, concluding that more cases among the young have consequences in the community for the elderly and others at higher risk.
3. School Survey Data
A new national survey was published Sept 23rd. It is a cooperative effort between multiple organizations including: The School Superintendents Association; the National Association of Secondary School Principals; the National Association of Elementary School Principals; Brown University Professor of Economics Emily Oster; and Qualtrics. The goal of the survey is to collect information regarding the mitigations strategies schools have used and the number of COVID-19 cases they see. Ideally, with enough participation, the survey will be able to present data regarding the most effective measures for schools and the number of COVID-19 cases that schools experience in students and teachers. Though still in its infancy, the survey has over 500 schools nationwide reporting. We will continue to track the information contained in the survey and let you know if any conclusions can be drawn from the information.
4. Addition Of Vaccine Q&A
Vaccine development continues to progress quickly and numerous questions are being asked about the process. We are happy to announce the addition of a vaccine category to our questions and answers page. You can read them here (login required).
5. Vaccine Testing In Children
An article in Clinical Infectious Disease this month draws attention to the lack of vaccine testing in children. Though there are multiple phase 3 trials currently in progress, the article notes that none of them are currently enrolling children. The author also suggests that when a vaccine is approved, further testing will have to occur in children before it gains FDA approval for those under age 18. This would further delay vaccination in this population, potentially to late 2021. Though it is critically important to have sufficient testing in children prior to applying for FDA authorization for vaccine use in this population, we are unlikely to see companies begin testing vaccines on children until the adult studies are complete. It remains very likely that children will have to wait much longer to obtain COVID vaccination.
6. How Is A Vaccine Approved?
The governor of New York announced that a committee of scientists would be assembled to review all information related to any vaccine approved by the FDA, before he would allow it to be used on citizens in his state. This decision echos concerns we have heard elsewhere, that the U.S. government may be pressuring its own offices to approve a vaccine without sufficient evidence and placing the lives of citizens at risk. As multiple vaccine candidates progress through phase 3 trials, I felt it important to review how a vaccine is approved by the FDA and what subsequent steps are required for it to be added to the recommended immunization schedule.
- A vaccine has to progress through the clinical trial phases (1-3) and be approved by the FDA for use.
- Manufacturers of the vaccine then must test all lots to make sure they are safe, pure and potent. The lots can only be released once the FDA reviews their safety and quality.
- The FDA performs regular inspections of vaccine production facilities.
Once in production, the Advisory Council on Immunization Practices (ACIP) reviews all available data about the vaccine from clinical trials and other studies to develop recommendations for its use. This council is comprised of a group of medical and public health experts. Members of the American Academy of Pediatrics (AAP) and American Academy of Family Physicians (AAFP) are among some of the groups that also bring related immunization expertise to the committee. The ACIP continues to monitor vaccine safety and effectiveness data even after the vaccine has been added to the schedule, and may change or update recommendations based on that data. The group considers these questions:
- How safe is the vaccine when given at specific ages?
- How well does the vaccine work at specific ages?
- How serious is the disease this vaccine prevents?
- How many people would get the disease the vaccine prevents if we didn’t have the vaccine?
The ACIP recommendations are not official until the CDC Director reviews and approves them and they are published. These recommendations then become part of the United States official immunization schedule. Once added to the immunization schedule, further monitoring is performed on an ongoing basis by:
- The Vaccine Adverse Event Reporting System (VAERS) which collects and analyzes reports of adverse events that happen post vaccination. Anyone can submit a report, including parents, patients and healthcare professionals.
- The Vaccine Safety Datalink (VSD) which analyzes healthcare information from over 24 million people. This actively monitors vaccine safety.
- The Post-Licensure Rapid Immunization Safety Monitoring (PRISM) which analyzes healthcare information from over 190 million people. This also actively monitors vaccine safety.
- The Clinical Immunization Safety Assessment Project (CISA), a collaboration between the CDC and 7 medical research centers. This group consists of vaccine safety experts who assist U.S. healthcare providers with complex vaccine safety questions about their patients, and conducts clinical research studies to better understand vaccine safety and identify prevention strategies for adverse events following immunization.
The CDC has a good chart of this process available for download here.
7. Risk Factors In Adults 18-34
A new research letter published this month in the Journal fo the American Medical Association examined 3222 hospitalizations in young adults age 18-34 with COVID-19. They concluded that young adults “experienced substantial rates of adverse outcomes: 21% required intensive care, 10% required mechanical ventilation, and 2.7% died.” They also noted that these rates were lower than those reported for older adults with COVID-19. Common risk factors associated with higher severity of illness included: morbid obesity, hypertension, and diabetes. They also noted that young adults with more than one of these conditions had higher risks of severe illness. Lastly, they found that “more than half of these patients requiring hospitalization were Black or Hispanic, consistent with prior findings of disproportionate illness severity in these demographic groups”. Though we know that people in this age range do better than most, this study provides good information about those who are at higher risk.
8. What Happens When Someone With Symptoms Does Not Get Tested?
The CDC and most local health departments recommended that people with symptoms of COVID-19 get tested, and we strongly agree. There have been some cases of symptomatic students in our member schools not getting tested due to parental choice. This choice has repercussions beyond the immediate family. A student can bypass a test and be assumed to have COVID-19, remain out of school for the 10 days recommended by the CDC, and return after that period when symptom free. However, this complicates matters for the classroom. Contact tracing and quarantine of exposures is important for the community and school, and in this case, those exposed would be asked to quarantine for 14 days because of a “presumed” case. Due to the mandatory 14 day quarantine for exposed individuals, we strongly recommend that symptomatic students get tested in order to reduce the possibility of an unnecessary quarantine for an entire classroom due to a non-COVID illness. To date, there are no physical examination findings or symptoms that are diagnostic of COVID-19 (sufficient to be certain of the diagnosis). This makes testing imperative. The CDC recommendations on this topic can be found here, in the section titled Testing and Recommendations for Isolation. It is important to note that children in low disease transmission areas, like New York State, have the option to present a note from a healthcare provider stating the illness is not due to COVID-19. However, for communities with high disease transmission, it is recommended that testing for COVID-19 be performed.
9. CDC Exposure & Testing
Last month, the CDC changed its guidelines to suggest that people who have been exposed to someone with COVID-19 but are not displaying symptoms, may not require testing. This change was highly criticized by numerous organizations. This month, the CDC has reversed that change and once again recommends that “People who have had close contact (within 6 feet of an infected person for at least 15 minutes) with someone with confirmed COVID-19” be tested. We support this return to recommended testing. For students being sent home due to a positive case in a classroom or employees being sent home because of a case at work, we continue to recommend everyone be tested regardless of symptoms. Testing in this situation detects both symptomatic and asymptomatic disease. Though a negative test does not obviate quarantine for exposure, a positive test would change the case from exposure to infection and require further contact tracing.
10. What we do.
I am often asked what Admin EM does for our clients. In short, we serve as a COVID-19 filter and resource. We track new developments in science and regulation, and then we interpret them through the lens of medical training. There is an ocean of continuously published scientific research, coupled with an urgent need for reliable treatments, and a contentious political atmosphere. It is difficult enough to run a school or business and be responsible for the education of children or the financial success of your business. Adding that responsibility to your daily duties can feel like drowning. That is where we step in. If you are in need of assistance with reopening a school or business, dealing with decisions about illness or testing, or performing your contact tracing alone, reach out to us and let us show you how we can help.