COVID Vaccine Distribution: A four-phase plan
Pfizer, in cooperation with German based BioNTech, crossed an historic milestone this week when they submitted to the Food and Drug Administration an emergency use authorization (EUA) for a COVID-19 vaccine. The data will quickly be analyzed by FDA and then submitted to an independent advisory panel in early December for approval, which then also will receive a necessary ‘green light’ from the Centers for Disease Control, particularly regarding the rollout process for Pfizer/BioNTech’s vaccine on a prioritization scale.
Early next week, Moderna is also expected to submit its request for an EUA from FDA. Both Moderna and Pfizer’s vaccines are boasting around a 95% efficacy, and both employ similar cutting edge genetic engineering by utilizing messenger RNA to ‘trick’ the immune system into producing antibodies to the coronavirus. Both vaccines require two shots — three weeks apart for Pfizer, four for Moderna.
However, many closely involved with the vaccine development process don’t think most Americans will be eligible to access either vaccine until the late spring or early summer of 2021. The good news is that once the FDA advisory panel approves Pfizer’s vaccine, distribution could begin immediately because the pharmaceutical giant has been manufacturing millions of doses under assumption its vaccine formulation will work, which it believes it has demonstrated in Phase III clinical trials involving thousand of participants. Pfizer also has received nearly $2 billion in Operation Warp Speed funds for manufacturing the vaccine.
The CDC’s Advisory Committee on Immunization Practices will decide how the vaccine will be disseminated, and who — based on a number of factors — will get it first.
A likely rollout scenario based on a number of sources will be based on the following criteria:
Phase I/Part I: Health care personnel — especially those on the front lines. First-responders would also be included in this group.
Phase I, Part II: Individuals with life-threatening diseases such as cancer or heart disease. Also, senior citizens living in nursing homes, shelters for the homeless, and jails and prisons.
Phase II: Everyone else 65 and older. This phase would also make eligible people under 65 in detention facilities This group would also include educators, people under 65 with moderate-risk health issues, and essential workers unable to avoid exposure to COVID-19 such as transit workers, or those involved in the food supply chain.
Phase III: Other individuals, regardless of age, working in higher education positions, and employees of hotels and motels, banks, gyms, and certain factories.
Phase IV: Essentially, everyone else.
No established timetable as yet is in place for any of the vaccines in development, but Anthony Fauci believes one or more COVID-19 vaccines should be widely available to there public beginning as early as April and as late as July.
Until President-elect Joe Biden takes office, Donald Trump’s policy of allowing states to determine distribution plans for any of the vaccines. In Ohio, Gov. Mike DeWine has established ten vaccine locations across his state once FDA grants the EUA. DeWine said this week those citizens with highest medical risks, frontline health care employees, and residents of congregate care facilities will be first to receive other vaccine. The Mayo Clinic in Minnesota has announced it will be ready to begin vaccinations by late December.
Pfizer’s vaccine will almost certainly be the first to receive the all-important FDA approval, and it is also working to complete applications for approval in more than 60 countries.
Other vaccines are in the pipeline as well. Astra Zeneca and Oxford are wrapping up their Phase III trial data, which included an announcement this week that their vaccine is particularly well tolerated in older adults. Johnson & Johnson is also expected to report results of its clinical trials in a few weeks. Keep in mind that an EUA is not quite the same as a complete approval. The EUA permits the drug — or in this case a vaccine — to be granted because of an urgent health crisis or life-saving capabilities. It usually takes years to create, develop and win approval for a vaccine, but the global COVID pandemic has permitted fast tracking of the vaccines now seeking quick OK from FDA.