By Karen Kier
Pharmacist on behalf of the ONU HealthWise team
"The Final Countdown" is a song released by the group Europe on February 14, 1986. The song performed by the Swedish rock band reached number 8 on the US Billboard Hot 100. The song is often played at sporting events to rally the crowds.
On January 30, 2023, President Biden announced the administration’s intent to end both the national emergency and the public health emergency for COVID-19. These emergency declarations have to be renewed every 90 days and are set to expire on May 11, 2023. Experts have some significant concerns about the changes the final countdown will bring to medical services.
In late January 2020, a public health emergency was declared with the federal power established by the Public Health Services Act. President Trump in March of 2020 declared a national emergency with the authority provided by the National Emergencies Act.
The Secretary of Health and Human Services declared an emergency in February 2020 through the Federal Food, Drug, & Cosmetic Act. This action allowed the Food and Drug Administration (FDA) to provide emergency use authorization (EUA) for countermeasures to COVID-19. Interestingly, this declaration is not set to expire on May 11, 2023.
Even though the COVID-19 public health and national emergencies are set to expire, the COVID-19 virus is still around. So, it makes sense that the EUA for countermeasures to the virus responsible for the pandemic will remain in place after May 11, 2023. The science and research relating to COVID-19 continues and numerous articles evaluating data and new therapies are being published.
As an example, the FDA provided EUA to a new drug on March 4, 2023. Vilobelimab is the first of its kind chimeric monoclonal IgG4-kappa antibody to help the most critically ill COVID-19 patients. During clinical studies, vilobelimab reduced the risk of death from COVID-19 in patients placed on life support.
On March 14, 2023, the FDA approved the Pfizer-BioNTech COVID-19 vaccine, bivalent as a single booster dose for children 6 months to 4 years if it has been at least 2 months since completing a 3-dose primary series of the monovalent vaccine.
An FDA advisory committee recommended the FDA change the EUA for nirmatrelvir and ritonavir tablets known as Paxlovid to an approved drug product. The committee made the recommendation on March 16, 2023. The FDA has not acted on this proposal to date.
The European Centre for Disease Prevention and Control and the United Kingdom have already authorized a second bivalent COVID-19 booster. The US has not made a specific recommendation to date, but The Washington Post on April 3, 2023 reported the FDA will be proposing a second bivalent booster. This recommendation would be for those over the age of 65 who have already received the first bivalent booster and could include those under the age of 65 if they have a health condition, which would make them more vulnerable to a serious infection.
Research continues to evaluate the safety and effectiveness of the various vaccines including both the flu and COVID-19. An April 6, 2023 research letter published in the Journal of the American Medical Association (JAMA) evaluated the risk of death associated with COVID-19 versus the seasonal flu. The study reported a death rate of 6% with COVID-19 compared to a 3% rate with the seasonal flu. The risk increased with age (average was 73 years) and the risk decreased if the individual had been vaccinated with a COVID-19 vaccine series.
A study published in the New England Journal of Medicine on April 4, 2023 evaluated the risk of stroke, heart attacks and blood clots to the lungs associated with the COVID-19 bivalent vaccine. The study compared the rate of adverse effects of the bivalent vaccine to the previous monovalent vaccine. The researchers evaluated data in nearly 1 million participants and determined the bivalent vaccine to be as safe as the monovalent COVID-19 vaccine with no increased risk of stroke.
As research improves our understanding, there is some concern as to the impact of the expiration of the emergency orders on May 11th. The COVID-19 vaccines have been purchased by the government and administered free of charge. Some anticipate the free vaccines may last for a period of time, but there could be a cost associated with the commercially available COVID-19 vaccines.
Other changes will involve Medicaid beneficiaries who were provided protection through the Families First Coronavirus Response Act. Those protections ended April 1st and states may now disenroll participants who do not meet the eligibility requirements.
Some measures such as Medicare telehealth may still remain for beneficiaries to consult with a provider from home. However, the use of telehealth for access to medications for pain, attention deficit disorder, and opioid addiction may not be as readily available after May 11th.
COVID-19 infections are still occurring with the Ohio Department of Health reporting 84.7 cases per every 100,000 people in the state over a 2-week period of time. So, the final countdown for ending the declared emergencies may be on, but the science does not stop!
Talk to your healthcare professional to stay up to date on COVID-19.
ONU HealthWise is offering COVID-19 vaccines as well as flu shots Monday-Friday from 10:00 a.m.-5:00 p.m. Bivalent COVID-19 vaccines are available. Clinics are Monday-Friday from 4:00-6:00 p.m. Please call the pharmacy for information.
ONU HealthWise Pharmacy
419-772-3784
