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On Monday, Pfizer announced preliminary results from the phase 3 trial of the vaccine that it has developed with German company BioNTech, suggesting that it may be up to 90% effective at preventing Covid-19 with no serious safety concerns. The vaccine, which represents a new way to make a vaccine, might be ready for an Emergency Use Authorization from the FDA by the end of the year.
BioNTech’s vaccine is an mRNA (as in “messenger RNA,” which might ring a faint bell from high school biology class) vaccine, similar to one being developed by Boston-based Moderna as well as Translate Bio, which is partnered with pharmaceutical giant Sanofi. This type of vaccine has been in the works for other diseases, including the flu, but none have been approved for use by any regulatory body yet. Success with this platform has the potential to accelerate the development of vaccines for new diseases, a process which can typically take close to a decade.
Here’s what you need to know.
Traditional vaccines are made from dead or weakened versions of an infectious virus. This new type of vaccine is different. To develop it, the genes of the SARS-CoV-2 virus, which causes Covid-19, were first analyzed to locate the part that codes its “spike” protein, which is what enables the virus to infect people. The codes for that protein are then isolated and copied as mRNA fragments, which is what cells use as instructions for making proteins. Those fragments are packaged up into special molecules, then injected into the patient’s cells.
Within the cells, the mRNA comes into the body’s protein factories, called ribosomes. The ribosomes “read” the mRNA, and follow its instructions to make copies of the spike protein. Those copies of the spike protein can’t, by themselves, cause harm. But they’ll trigger the body to make antibodies against the virus. Those antibodies, in turn, will protect patients from a Covid-19 infection. At least, that’s the idea.
Before the vaccine can be distributed, it has to first be approved by appropriate regulatory bodies. In the United States, that’s the FDA. Pfizer has said that it intends to seek an Emergency Use Authorization from the FDA to enable distribution and administration of the vaccine in late November, at which point the company will have an average of two months’ worth of safety data for each patient. That’s because most bad reactions to vaccines happen shortly after infection. Additionally, Pfizer will continue to monitor the patients in its study for two years after the vaccine administration.
Although one advantage of mRNA vaccines is that they’re potentially faster to develop than traditional vaccines, their administration and distribution is scads more complicated. For example, the Pfizer vaccine is currently being tested on a two-dose schedule, 21 days apart, unlike the single dose of a typical vaccine for diseases like the flu. The 21-day separation has raised some concerns about the patient compliance needed for vaccines to work.
For long-term storage, the vaccine has to be kept at very cold temperatures—around –70° Celsius (–94° Fahrenheit), which requires a specialized freezer. (Flu vaccines, by contrast, can usually be stored in a refrigerator.) The company has developed a specialty thermal shipping container, which can be kept cold with dry ice and be used to store the vaccine doses for up to 15 days. If long-term storage isn’t required, Pfizer’s vaccine can be stored in a refrigerator, but only for up to five days.
Several companies, such as Moderna, have received federal funding and support for the development of their vaccines and treatments through the research and development process. Pfizer opted out of that, choosing instead to spend $1 billion of its own money to move the vaccine forward. “A billion dollars is not going to break us,” CEO Albert Bourla told Forbes earlier this year.
That said, BioNTech did receive a $442 million grant from the German government to help develop the vaccine. And in July, the two companies signed an agreement to sell at least 100 million doses to the U.S. Department of Health and Human Services (HHS) for $1.95 billion. The country of Spain has initially secured 20 million doses of the vaccine as well.





Detroit Medical Center is laying off employees, and its parent company, Dallas-based Tenet Healthcare, is planning to sell or close four urgent care centers in the Detroit area, according to Crain’s Detroit Business.
Detroit Medical Center officials told Crain’s layoffs have occurred, but they declined to disclose the number of employees affected. Sources told Crain’s several hundred DMC employees have been laid off with more expected this year. Clinical staff, administrative assistants and employees at the management level were reportedly affected by the layoffs.
“Like many health systems locally and nationally, we continually evaluate and review our staffing needs, which have decreased due to reduced patient demand during the pandemic,” DMC said in a statement to Becker’s Hospital Review. “Our goal is to ensure we are strongly positioned to provide the highest quality and safest care to our patients while making the best use of our resources.”
Tenet is also planning to sell or close its four remaining MedPost urgent care centers in the Detroit area. Tenet has reached agreements to sell three of the urgent care centers in Bloomfield, Livonia and Southfield, Mich., to First Choice Urgent Care, a company spokesperson told Becker’s Hospital Review.
“We expect all employees in good standing to be offered positions to remain at the facilities upon completion of the sale, which we anticipate occurring in December,” the spokesperson told Becker’s.
The MedPost urgent care center in Rochester Hills, Mich., will close in December, the spokesperson said. Tenet may convert it to a physician office or other type of healthcare facility.
“We are committed to providing our full support and assistance to employees through the close, and facilitating opportunities for open roles at local Tenet facilities,” the spokesperson told Becker’s.
Tenet, a 65-hospital system, operated nine MedPost urgent care centers in the Detroit area at the beginning of the year. It closed five of the centers in April due to challenges linked to the COVID-19 pandemic. The MedPost urgent care centers are not part of DMC.