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What You Need To Know About Pfizer’s Covid-19 Vaccine
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.
Pfizer’s vaccine is based on a new kind of technology
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.
The vaccine still needs to be approved by the Food and Drug Administration
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.
Distributing this vaccine is more complicated than for a typical vaccine
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.
Pfizer footed the bill for its own part of vaccine development
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.
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Tenet to lay off workers in Detroit, shed 4 urgent care centers
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.
Biden’s 7 point plan for the pandemic
President-elect Joe Biden and Vice President-elect Kamala Harris have released a seven-point plan regarding the COVID-19 pandemic.
The Biden administration’s seven pandemic plans:
1. Ensure all Americans have access to regular, reliable and free testing by doubling the number of drive-thru testing sites, investing in next-generation testing, developing a pandemic testing board to produce and distribute tests, and establishing a U.S. Public Health Jobs Corps.
2. Provide all states, cities, tribes and territories with critical supplies. Efforts will include full use of the Defense Production Act, building American-sourced and manufactured capabilities.
3. Provide clear, consistent and evidence-based guidance for how communities should navigate the pandemic. Planned resources will be tailored to the needs of schools, small businesses and families.
4. Plan for effective and equitable distribution of treatments and vaccines. The administration intends to invest in a $25 billion manufacturing and distribution plan to guarantee every American can receive the vaccine for free. The administration also said it will work to ensure that politics won’t play a role in determining the safety and efficacy of vaccines.
5. Protect older Americans and other high-risk groups. Efforts will include establishing a COVID-19 racial and ethnic disparities task force and a nationwide pandemic dashboard that can be checked in real-time to gauge local transmission.
6. Rebuild and expand defenses to prevent and mitigate pandemic threats, including the restoration of the White House National Security Council Directorate for Global Health Security and Biodefense and the nation’s membership with the World Health Organization.
7. Implement nationwide mask mandates.
How a conservative Supreme Court could save the ACA
Even a solidly conservative Supreme Court could find a pretty easy path to preserve most of the Affordable Care Act — if it wants to.
The big picture: It’s too early to make any predictions about what the court will do, and no ACA lawsuit is ever entirely about the law. They have all been colored by the bitter political battles surrounding the ACA.
- Even so, a handful of factors — the specifics of this case, the court’s recent precedents, even a few threads from Amy Coney Barrett’s Supreme Court confirmation hearings — can at least help draw a roadmap for a conservative ruling that would leave most of the ACA intact.
How it works: There are two steps to the current ACA case. First, the justices will have to decide whether the law’s individual mandate has become unconstitutional. If it has, they’ll then have to decide how many other provisions have to fall along with it.
- The real action is in the second step — whether the mandate is “severable” from the rest of the law.
“If you picture severability being like a Jenga game — it’s kind of, if you pull one out, can you pull it out while it all stands? Or if you pull two out, will it still stand?” Barrett explained during Wednesday’s questioning.
- “The presumption is always in favor of severability,” she said.
Severability is a question of congressional intent — whether Congress still would have passed the rest of a law if it knew it couldn’t have the piece the courts are striking down. And conservative judges make a point of relying only on a law’s text when determining congressional intent.
- That should make the current case easy, the blue states defending the ACA argue: Congress zeroed out the mandate and left the rest of the law intact — a pretty clear sign that it intended for the rest of the law to operate in the absence of the mandate.
- “It is abundantly clear that Congress wanted to keep the hundreds of other ACA provisions … without an enforceable minimum coverage provision, because that is the scheme Congress created,” Democratic attorneys general said in a brief.
The other side: The red states challenging the law, on the other hand, get further away from straight textualism.
- They say the courts should instead look to Congress’ initial belief, when it passed the ACA in 2010, that the mandate was inextricably tied to protections for pre-existing conditions.
What we’re watching: Barrett acknowledged in this week’s hearings that the law has changed since it was first passed — a potentially encouraging sign, if you’re an ACA defender hoping the conservative justices will look at legislative text Congress wrote in 2017 instead of expert statements from 2010.
- “Congress has amended the statute since” the 2012 Supreme Court ruling upholding the ACA, Barrett said Wednesday. “It has zeroed out the mandate, so now California v. Texas involves a different provision.”
A case from earlier this year — tied to another big-ticket Obama policy — might also help illuminate the current court’s approach to severability.
- The court’s conservative majority ruled in June that the leadership structure of the Consumer Financial Protection Bureau was unconstitutional.
- But a combination of four liberals and three conservatives then held that the whole agency didn’t have to be struck down because of it.
Yes, but: None of this means that the threat to the entire ACA, or to its protections for people with pre-existing conditions, has been exaggerated.
- The Republican attorneys general who brought the case are asking the court to invalidate the entire statute. So is the Justice Department.
- A federal judge ruled that the entire law had to fall. An appeals court couldn’t decide how much to strike, but said it would probably need to be more than just the mandate — and protections for pre-existing conditions would be next in line.
The bottom line: The ACA’s allies may not be able to save the remains of the individual mandate, but that’s a loss they can live with. And there is at least a clear path to a ruling, even from a conservative court, that would leave the rest of the law intact.
Genesis Healthcare warns of possible bankruptcy
Kennett Square, Pa.-based Genesis Healthcare, one of the largest post-acute care providers in the U.S., warned that bankruptcy is possible if its financial losses continue.
“The virus continues to have a significant adverse impact on the company’s revenues and expenses, particularly in hard-hit Mid Atlantic and Northeastern markets,” Genesis CEO George V. Hager Jr., said in a Nov. 9 earnings release.
Mr. Hager said government stimulus funds the company received in the third quarter of this year fell nearly $60 million short of the company’s COVID-19 costs and lost revenue.
Genesis said it has taken several steps to help offset the financial damage linked to the pandemic, including delaying payment of a portion of payroll taxes incurred through December.
But the company warned that bankruptcy is possible if its financial losses continue.
“Even if the company receives additional funding support from government sources and/or is able to execute successfully all of its these plans and initiatives, given the unpredictable nature of, and the operating challenges presented by, the COVID-19 virus, the company’s operating plans and resulting cash flows, along with its cash and cash equivalents and other sources of liquidity. may not be sufficient to fund operations for the 12-month period following the date the financial statements are issued,” Genesis said. “Such events or circumstances could force the company to seek reorganization under the U.S. Bankruptcy Code.”
Genesis ended the third quarter of this year with a net loss of $62.8 million, compared to net income of $46.1 million in the same period a year earlier.
HENRY KOTULA 