Thursday Miscellany

Photo by Juliane Liebermann on Unsplash

OPM has posted an announcement about the beginning of the Federal Benefits Open Season which kicked off last Monday and the NIH Director Dr. Francis Collins offers guidance on how to celebrate the upcoming holidays with exposing yourself to COVID-19.

To illustrate that the Pfizer COVID-19 game in town vaccine is not the only game, Fierce Healthcare offers articles on two candidate which offer greater pre-administration stability, one by CureVac and the other by Johnson & Johnson.

Leaning on its years of experience, the drugmaker is well on its way to producing 1 billion doses of its COVID-19 vaccine in 2021 and is looking ahead to 2022, said Paul Lefebvre, VP of strategic initiatives and COVID-19 vaccine supply chain at J&J’s Janssen unit, in an interview. 

J&J’s shot could have a storage and distribution edge over the likes of those from Pfizer and BioNTech, Lefebvre thinks. 

“In our plans, we will bring our product at -20° C into the J&J warehouses around the world,” he said.

J&J’s shot is expected to remain stable for up to two years at that temperature, about -4° Fahrenheit. Once it goes out to distributors and customers, it can be kept stable at 2 to 8° Celcius (a range of about 35.6° to 46.4° Fahrenheit) for up to three months, not much colder than your average refrigerator, Lefebvre said. 

As previously noted, the COVID vaccine manufacturers will seek emergency use authorization (“EUA”) from the Food and Drug Administration follow the completion of the phase III trial. Phrma, the drug manufacturer trade association, provides readers with an understanding of FDA EUA.

The FDA may issue an EUA, when, among other things, the agency determines that based on all of the available scientific evidence, the known and potential benefits of the vaccine outweigh the known and potential risks. To underscore this, FDA Commissioner Stephen Hahn has said repeatedly in recent weeks and months that the agency would only consider an EUA if it felt the risks associated with the vaccine were “much lower than the risks of not having a vaccine and the potential benefit of having a vaccine.”

The agency has further taken steps to ensure the robust vaccine candidate review process by engaging the Vaccines & Related Biological Products Advisory Committee (VRBPAC) to discuss the development and potential authorization of vaccines to prevent COVID-19 after issuing guidance on FDA’s recommendations for an EUA submission for a COVID-19 vaccine.­

The Department of Health and Human Services announced today its partnerships with chain and independent pharmacies to administer the COVID vaccines as the vaccines received EUA and are made available to the public under the government allocation plan, which kicks off with first responders.

In prescription drug benefit news,

  • Drug Channels is offering its “annual deep dive into employer-sponsored coverage for prescription drugs,” and
  • Good Rx unveils the 2021 changes in popular CVS Health and Express Script formularies.

Finally, the FEHBlog wants to call attention to Katie Keith’s excellent analysis of last Tuesday’s Supreme Court argument in the California v. Texas case. Although Ms. Keith does not project an outcome, the FEHBlog is comfortable stating that the Supreme Court will preserve the Affordable Care Act for the third time, except perhaps for the zeroed out individual shared responsibility provision, which already is a dead letter.