You may remember one of the lines from the 1987 movie The Princess Bride. The movie debuted on October 9 of that year. The 98-minute movie won the 1988 Hugo Award for Best Dramatic Presentation, as well as being named in the top 100 greatest love stories by the American Film Institute. In the movie, Miracle Max and Valerie, played by actors Billy Crystal and Carol Kane, had the famously repeated line of “have fun storming the castle.” In the movie, they are using the term literally by indicating that Inigo Montoya, Fezzik, and Wesley were going to storm Prince Humperdinck’s castle to save Princess Buttercup. Rob Reiner directed the movie screenplay, written by William Goldman, that still remains a favorite.
Experts believe that this phrase actually started in the 1600s when enemies would attack by storming the castle of their opponents. Since the 1987 movie, this phrase has become a way to send off a friend when they are leaving. Metaphorically, it can be used to indicate a political or professional attack by someone. Who is storming the castle this week and how does this apply to COVID-19?
The Food and Drug Administration (FDA) has been stormed with applications for evaluation for COVID-19 therapies. The FDA approved the Pfizer COVID-19 vaccine (Comirnaty®) for first and second doses for those 16 years and up. The other uses for Pfizer’s vaccine are still only under the Emergency Use Authorization (EUA). The booster shot is still a EUA for those eligible, as well as first doses for those 12 years and up. Pfizer did submit data for FDA review on September 14 for a lower dose vaccine for children 5-11 years of age. The FDA is slated to act on this information on October 26.
Moderna applied to the FDA for full approval of their COVID-19 vaccine for first and second doses for those 18 years and up. Moderna also applied on September 1 for EUA for a booster third dose that is half of the original dose. Johnson & Johnson applied for a booster dose to follow the EUA of their first dose COVID-19 vaccine. The FDA is to review these requests on October 14 and 15.
The National Institute of Allergy and Infectious Diseases (NIAID) submitted evidence to the FDA for review of studies completed this summer that involved the mixing and matching of different COVID-19 vaccines including Pfizer, Moderna, and J&J.
Merck plans to submit data to the FDA soon for EUA for their antiviral drug that has activity against SARS-CoV-2. The drug name is molnupiravir and it reduces hospitalization and death from COVID-19 by about 50%. It is important for the public to note that this antiviral drug’s effectiveness is less than the COVID-19 vaccines, as well as the monoclonal antibodies that have EUA from the FDA. The Department of Health and Human Services has a website to locate facilities that have the monoclonal antibodies available for those that have COVID-19 symptoms for less than 10 days or who have had an exposure and are at high risk of serious complications from a COVID-19 infection (https://protect-public.hhs.gov/pages/therapeutics-distribution). Several area hospitals and pharmacies have the monoclonal antibodies available for those that qualify based on EUA criteria. The FDA has a big storm of data to evaluate in the next several months that can have a profound effect on COVID-19 vaccines and therapies.
Some health systems and pharmacies are being overwhelmed with requests for the COVID-19 booster vaccines. There are two major concerns that are being reported in the news. One is whether facilities have the staffing to adequately supply the booster shots to those who are eligible. The second concern is the storming of the castle for those who want the booster but may not be eligible or understand that right now it is only approved (EUA) for those who received the Pfizer shot at least six months ago. While over 2.8 million Americans have gotten a third dose, the priority is still on improving the vaccination rates for the prevention of COVID-19 infections with first and second doses. Mutations derive from humans that are infected with the virus. The best way to halt mutations is to stop active infections with preventive measures. It is important to make sure that mutations do not storm our country again and cause cases to rise.
Feel free to call the ONU HealthWise Pharmacy or talk to your health care professional. ONU HealthWise is offering walk-ins for COVID-19 and flu vaccines and booster doses for Pfizer. We still want to take calls and provide the best information possible. Please call the pharmacy to get more information on getting vaccinated.
ONU HealthWise Pharmacy
419-772-3784
www.onuhealthwisepharmacy.com
