What's up with Pfizer and the Supreme Court?

Just another week, and more healthcare news. Here we go:

1.     Pfizer vaccine – what should I know? This week Pfizer, which co-developed the vaccine with German drug company BioNTech, announced some preliminary results from the trial of their vaccine. In order to keep the process scientific and unbiased, Pfizer does not actually see the results, but relies on an independent monitoring board. So far, 38,955 out of an anticipated 44,000 volunteers have received either two doses of the vaccine or two doses of placebo. Their own statistical analysis states that the trial will continue until 164 persons have developed Covid-19. The Pfizer vaccine, like the Cambridge, MA Moderna vaccine, leverages so-called messenger RNA to stimulate human cells to produce a Covid-like protein which then signals the immune system to produce protective antibodies and activated T cells. Patients will require two vaccinations three weeks apart. The vaccine also must be stored and maintained at super cold temperatures (-112F) until it is administered, complicating potential rollout on a large scale. It remains unknown how durable the positive immune response will be, opening the door to the possibility that people will require an annual booster.

The independent monitoring entity reported that 94 people developed Covid-19. They did not say how many of those people had received the actual vaccine or the placebo. However, we can infer from their conclusion that the vaccine was 90% effective that most of the sick patients received the placebo. In additional good news, no significant adverse events or safety issues have arisen. Pfizer intends to ask the FDA for an emergency use authorization to go forward with the vaccine earlier than scheduled. The company reports it will have 40 million doses ready by the end of December – enough to vaccinate 20 million people. The European Union is contracting for 300 million doses of the Pfizer vaccine.

I don’t think you have to have a degree in statistics to appreciate that determining the overall value of a vaccine cannot be based on results in just 94 people. We should be very pleased about these good preliminary results, but maintain a healthy dose of skepticism until more data is logged in.

Currently 11 vaccines are in late phase trials, with 4 of those in the United States. Pfizer pointed out that they took no money from the U.S. government to develop their vaccine and are not directly part of Operation Warp Speed. Pfizer has, however, agreed to accept $1.95 billion to produce 100 million doses of the vaccine for distribution by the Federal government. By my calculation, that comes out to $19.50 per dose! Great deal if it works… Dr. Fauci today expressed his expectation that vaccines will be available for most of us by April 2021.

I am very hopeful that the combination of an effective vaccine with renewed efforts with mask wearing and social distancing will mark the beginning of the end of this pandemic.

2.    What’s going on with the Affordable Care Act (ACA) and the Supreme Court? The ACA was signed into law on March 23, 2010 by President Obama. Currently, 20 million Americans rely on the ACA for their health insurance. Republicans have attempted more than 60 times to overturn or at least reduce the ACA, generally relying on the philosophy that there is “too much government in healthcare”. That argument is usually countered with the fact that Medicare and Medicaid --governmental programs -- provide coverage to 140 million Americans. Despite countless challenges, the courts have left protection of pre-existing conditions in place. Medicaid expansion which now exists in 38 states has increased coverage substantially. The Supreme Court ruled in 2012 that states could opt out of the Medicaid expansion provision of the ACA. The individual market for healthcare via the ACA has also survived challenges to date.

One piece of the ACA, the individual mandate, required individuals to have health insurance or pay a fine. In 2012, Chief Justice Roberts cast the key vote in a 5-4 decision holding that the law's individual coverage mandate was valid. Subsequently, the federal tax penalty for violating the individual mandate of the ACA was rescinded by President Trump through the Tax Cuts and Jobs Act of 2017, starting in 2019.

In December 2019, the Fifth Circuit ruled that the individual mandate was unconstitutional. Today the U.S. Supreme Court took up that case and sent a signal via comments from Justices Roberts and Kavanaugh that the Court will not entertain a wholesale revocation of the ACA, and rather conceives of the ACA belonging more in the hands of Congress to shape as it will. Stay tuned for the final ruling!


Sylvia Quatrale

RN Case Manager at Beth Israel Deaconess Medical Center

4 年

Thank you Rich for this information and making it understandable for everyone; stay well!

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Dr. Laurence J. Stybel

Adding”Success" to Successful Careers.

4 年

Love the articles you send, Rich.

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Patricia Stock RPH

Associate Director at Willis Towers Watson

4 年

Excellent update, thanks so much! Did you get a chance to see the 60min special on Operation Warp Speed? They are ready to go :) https://www.cbsnews.com/news/covid-19-vaccine-distribution-60-minutes-2020-11-08/

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Thanks for the clear and concise updates.

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