In addition to AstraZeneca, the Pfizer and Moderna‘s vaccines have proven to be effective in their clinical trials. The most pressing question is now when and how the vaccine will be available and distributed.
On November 9, 2020, Pfizer announced that its vaccine is 90% effective, causing a jump in the stock market with the Dow (INDU) gaining 1,610 points in a day. On November 16, 2020, Moderna announced that its vaccine is 94.5% effective. Two days later, Pfizer updated its vaccine effectiveness at 95%. If Pfizer vaccine can be store for up to 5 five days at a temperature of -75C/-103F, Moderna’s can be for up to 30 days at a temperature of -20C/-4F. This makes Moderna’s vaccine in a comparative advantage over Pfizer’s. First, it can be stored for a longer time. Second, pharmacies and doctor’s offices are more likely to have refrigerators able to store at a temperature closer to that required for Moderna’s vaccine. According to the World Health Organization (WHO), there are several vaccines under clinical trial; of 48 vaccines tracked by WHO, 11 are in stage 3 of development.
The real question is how the vaccine will be distributed. The U.S. Department of Health and Human Services is partnering with the Biomedical Advanced Research and Development Authority (BARDA), the Centers for Disease Control and Prevention (CDC), National Institute of Health (NIH), and Department of Defense (DoD) within the so-called Operation Warp Speed (OWS). OWS has the intent to develop, produce, and distribute the vaccine against COVID-19 by the end of January 2021. To manufacture 300 million doses, OWS will become crucial in making sure that vulnerable groups first, and the rest of the population later, will receive an effective and safe vaccination.
Pfizer and Moderna have both submitted the emergency approval request for their vaccine to the U.S. Food and Drug Administration (FDA). Under section 564 of the Federal Food, Drug, and Cosmetic Act, the FDA Commissioner can approve medical products or devices to diagnose, prevent, or treat life-threatening illness when other medications or devices are either not available or not effective. The emergency approval can only be requested when an emergency is declared. Pfizer would have the capability of producing about 50 million doses by the end of 2020 and allocate half of them in the United States. Similarly, Moderna would produce 20 million doses. Considering that both vaccines require two shots of administration, up to 25 million people in the US would receive the vaccine by the end of 2020. First doses will be given to first responders, frontline and healthcare workers, employees of critical industries, and residents of nursing homes. With the announcement on December 8th, 2020, that the FDA doesn’t find any issue with the efficacy or safety of the Pfizer’s vaccine, it is likely to become readily available in the US for people 16 and older.
With the approval of the Medicines and Healthcare products Regulatory Agency (MHRA), the United Kingdom’s medicines regulator, of the Pfizer’s vaccine on December 2, 2020, the 90 years old Margaret Keenan received her first dose of the vaccine on December 8, 2020.
The CDC is playing a crucial role in elaborating the vaccine distribution plan. CDC is closely working with state and local entities to identify which stakeholders will distribute the vaccine. The CDC’s role is to provide recommendations while state and local authorities are in charge of the practical distribution. CDC also identifies which are the groups that first will receive the vaccine. These include college/universities’ faculties, staff, and students. Here some considerations.
- Which entity will distribute the vaccine to college/university faculties, staff, and students?
Main campuses have their health services which may be able to distribute the vaccine. However, some of them may not be equipped with refrigerators suited to storage the vaccine. Rural campuses may not have health services at all. These may also be located far from cities, thus far from other potential centers of distribution. Health services, when present, play an important role in providing well-being and primary care. To have an effective distribution of the vaccine, part of the health services personnel and spaces should be devoted to the vaccine’s distribution with minimal compromise of primary care services.
2. Will the vaccine be free of charge?
Another important unanswered question is whether the vaccine will be free of charge. According to CDC, the vaccine is likely to be free but there may be associated costs such as those for the injection. If many college/university health centers offer primary care service at no or low cost to the campus population, those campuses without a health center may see their students and employees unable to get the vaccination if they cannot afford the vaccine’s associated cost, especially if they are uninsured.
3. Will be there a subcategorization?
Are faculties, staff, and students in at-risk categories going to receive the vaccine first? What about enrolled students attending in-person vs. online classes? Will the vaccine be available for both domestic and international students attending a U.S. college/university? These still not answered questions should drive the distribution plan of college/universities to make sure that a safe and effective vaccine is distributed but also, efficiently and promptly. This will ultimately ensure a wide immunization while increasing the campus’ safety.
Among the challenges in vaccine distribution at both the state and local level, there is the necessary training that healthcare professionals will need to administrate the vaccine to patients. With the personal protection equipment shortage of the first weeks after the pandemic outbreak, governments at all levels, are now encourage in finding solutions to make sure that the supplies for the vaccine administration will be readily available.
Featured Image Credits: Reuters / Dado Ruvic