Hope on the Horizon for COVID-19 Prevention
It has been both good news and yet more uncertainty recently in the effort to keep COVID-19 from becoming a pandemic.
On the upside, pharmaceutical manufacturer Moderna announced that clinical trials for its experimental coronavirus vaccine would begin in April. The Cambridge, MA,-based company said trials of mRNA-1273 would begin phase I testing and be evaluated on a few dozen healthy patients to determine safety and immune response. Moderna’s facility has the technical expertise in mRNA therapies and manufactures the company’s mRNA development candidates, both vaccines and therapeutics. The vaccine candidate was delivered in just 42 days through cooperation with the National Institutes of Health’s National Institute of Allergy and Infectious Diseases (NIAID) and funding from the Coalition for Epidemic Preparedness Innovations (CEPI).
Additionally, The NIH has enrolled the first patient in a mid-stage trial to assess Gilead's remdesivir in patients with COVID-19, caused by the novel coronavirus. The trial, sponsored by NIAID, will be based at Omaha’s University of Nebraska Medical Center and aims to enroll 394 patients.
On the downside, the first case of community-acquired infection in the U.S. occurred in a California individual who does not appear to have any relevant travel history or exposure to someone known to be infected with the new coronavirus.
The Virus: What We Know
COVID-19 is the moderately infective coronavirus related to SARS that originated in an outdoor market in Wuhan, China, last fall. Coronaviruses are a large family of viruses that are common in many different species of animals, including camels, cattle, cats, and bats. This latest infection has its origin in bats as with the MERS-CoV and SARS-CoV before it.
According to the CDC, the sequences from U.S. patients are similar to the one that China initially posted, suggesting a likely single, recent emergence of this virus from an animal reservoir. The virus has sickened nearly 85,000 people in at least 49 countries and is responsible for more than 3,000 deaths. Major outbreaks have spread to Italy, Iran and South Korea and new cases are being reported from individuals traveling from Italy and Iran. The World Health Organization (WHO) has not yet called the outbreak a pandemic, but as this week closes, it has increased its assessment of the risk of spread and the risk of impact of COVID-19 to “very high” at a global level. WHO is issuing daily situation reports with detailed maps showing cases and collaborative efforts to contain the virus’s spread. The reports can be accessed at: https://www.who.int/emergencies/diseases/novel-coronavirus-2019/situation-reports/.
Reactions (and Overreactions)
Markets are reacting sharply to the economic impact of the shutdowns, cancellations and other measures related to the coronavirus, including the impact on manufacturing due to production in China. The market is “re-pricing the likelihood of slower growth,” according to my analyst. He went on to say, “The fear is palpable, and the equity market may get worse before it improves or stabilizes.” Even while writing this, I saw dozens of headlines about how low the market is expected to go.
People have been and are becoming increasingly more concerned about the virus in my experience working at the pharmacy these past few weeks. I have started getting calls from friends asking me to purchase over-the-counter medications and immune boosters for them before there is a “run” on these items. People are asking about masks and protections at all the pharmacies where I have worked and all have been out of stock. Pharmacists and other employees are trying to keep hysteria from creeping into these conversations, much like the messaging among news outlets and global health organizations. Markets have experienced the effects of global disease outbreaks before and have recovered. They will do so again. It is imperative that we remind people of actions they can take to reduce their chances of contracting the virus.
The CDC has set up a special section on COVID-19 on its website with information on the signs and symptoms, preventative measures, travel information, situation updates, and numerous other resources. The information is accessible at: https://www.cdc.gov/coronavirus/2019-ncov/summary.html.
The signs and symptoms of COVID-19 infection are similar to the flu: fever, cough, and shortness of breath. The CDC is urging those who may have symptoms and who have traveled to areas where outbreaks have occurred to seek medical advice and to be sure to tell health providers about their travel history. Advising patients to get vaccinated for influenza is also important so that, in the event they develop symptoms, the flu could potentially be ruled out. Since the outbreak, we are seeing an increased number of flu shot requests across the pharmacies where I have practiced.
Good preventive measures can also help keep people healthy, and we are reminding patients about good hand-washing techniques and other preventive practices:
- Wash your hands often with soap and water for at least 20 seconds, especially after going to the bathroom; before eating; and after blowing your nose, coughing, or sneezing
- Avoid touching your eyes, nose, and mouth with unwashed hands
- Stay home when you are sick
- Cover your cough or sneeze with a tissue, then throw the tissue in the trash
These practices are critical in the efforts to keep the virus from spreading. While I’m hopeful a vaccine candidate will emerge in the coming months, prevention is key right now. When that vaccine does emerge, pharmacists will be on the front lines in efforts to immunize, as I noted in last month’s blog about the important role they play as “flu fighters.”
Not Immune to Protests
Not everyone agrees, however. Last week was Minnesota Pharmacy Day at the Capitol when we advocate for expanded patient access to pharmacist-provided clinical services as well as adequate reimbursement. We shared our day with an anti-vaccine parental rights group, who were lobbying for expanded choice in whether to vaccinate their children. We were prepared to have a respectful conversation and had a genuine interest to listen to their concerns without judgment and to share the Capitol’s halls with respect. Unfortunately, the other group was not as respectful. They gave us wide berth and refused to engage in any conversation, but they had no issues “photobombing” our picture on the Capitol steps with their placards and signs and shouting negative statements at us for our role in providing immunizations.
In many of our meetings with legislators, the elected officials expressed concern about the group’s lobbying and messaging and thanked us for being there and for our support of public health. They showed us the primary talking points from the anti-vaccine group, including their concern about the rigorousness of the vaccine approval process, the inability to directly sue vaccine manufacturers, and the slowness of seeking relief through the Vaccine Injury Compensation Program (VICP). The VICP is a federal "no-fault" system designed to compensate individuals or families of individuals who have been injured by covered childhood vaccines, whether administered in the private or public sector. The protesters have abandoned arguments about vaccines and autism because of the scientific evidence that has emerged showing no links between them, so they have substituted other arguments in its place. Our impression from legislators and our lobbying team in Minnesota is that expanding immunization exemptions for parents is unlikely to happen in our state, especially in light of the continued occurrence of measles cases and now the coronavirus outbreak.
In the U.S., all states require most parents to vaccinate their children against some preventable diseases, including measles, mumps, rubella, and whooping cough, in order to attend public school. These laws often apply to those in private schools and daycare facilities as well. There are often medical exemptions, and the majority of states also allow exemptions for religious reasons. Seventeen states permit other exemptions — allowing families to opt out of school vaccination requirements for personal or philosophical reasons. California, Mississippi and West Virginia prohibit nearly all exemptions.
Given the recent COVID-19 outbreak and the related health risks, it makes me wonder, where is the balance between the protection of public health (and herd immunity) and personal liberty? The courts have repeatedly held that when a public health intervention is necessary to safeguard the majority of the populace, individuals generally can be required to give up some personal liberty, particularly if that liberty is tied to a government benefit like school.
I wonder how the anti-vaccine parental rights group will react if and when Minnesota experiences its first case of COVID-19? Stay tuned.
Marsha K. Millonig, MBA, BPharm, is president and CEO of Catalyst Enterprises, LLC, and an Associate Fellow at the University of Minnesota College of Pharmacy’s Center for Leading Healthcare Change.
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