The COVID-19 vaccine will require two doses within about one month of each other. | Stock Photo
The COVID-19 vaccine will require two doses within about one month of each other. | Stock Photo
As the Pfizer COVID-19 vaccine nears its final approval, there are a few things that Michigan residents need to be aware of.
An advisory committee for the U.S. Food and Drug Administration (FDA) recently recommended approval for the vaccine. Doran Fink, the FDA's deputy director of vaccines and related products applications, explained the FDA’s emergency use authorization approval process and said that, although the vaccine was fast-tracked in the interest of the public health, it still must meet a “high bar for efficacy” and the process must be “transparent, scientifically sound and data driven,” according to Bridge Michigan.
Critics point out that there is only two months of data, and they wonder how safety can be guaranteed to the elderly, pregnant women and those who have have HIV or severe allergies.
Others find the limited safety data acceptable in light of a virus that has killed more than 1.5 million people worldwide.
Michigan officials have received word that the state will receive 250,000 total vaccine doses from Pfizer and Moderna, but state health spokesperson Lynn Sutfin warns that estimates have fluctuated in the past. She also added that the projected distribution network will include approximately 300 sites where people will be receiving the vaccine.
Pfizer company officials say that vaccines are ready to be shipped “within hours” of final approval by the FDA and that the company expects to supply more than 33 million U.S doses by the end of the year and 100 million for national distribution by spring.
Criteria including age, underlying health conditions and exposure risk to individuals with COVID-19 will determine priority for receiving the vaccine.
Health advisors have also recommended that health care workers and nursing home residents receive top priority. The state’s vaccination plan prioritizes other vulnerable populations, including members of racial and ethnic minority groups and tribal communities, inmates of correctional institutions, the homeless, teachers and those living in rural communities.
Those who do not fall into those categories will likely have to wait several months before receiving a vaccine.
Studies have so far excluded children, and it's unclear how they may react to the doses recommended for adults.
What is known is that children have reacted differently to the COVID-19 virus, with some children developing Multisystem Inflammatory Syndrome (MIS-C), which can cause organ failure. The majority of MIS-C cases have been reported in children under the age of 14, according to the most recent data by the Centers for Disease Control and Prevention. Some committee members have said they would recommend vaccine approval only for those 18 and older.
Robert Gordon, the Michigan Department of Health and Human Services director, told Michigan lawmakers that the vaccine will not be mandatory. However, it is unclear whether employers may require workers to take the vaccine in order to continue their employment.