The COVID-19 Vaccine. Who Gets it First?

It is impossible to overstate the significance of the announcements by Pfizer, Moderna and AstraZeneca that their COVID-19 vaccines proved more than 90% effective in clinical trials.

If and when those, and most likely other, vaccines receive approval, we will be far closer to vanquishing COVID-19 and saving millions of lives around the world. But that milestone is not an endpoint. It raises a host of urgent questions, including how the vaccine should be distributed and who should get it first.

Vaccines are one of the great achievements of medicine. They protect us from a host of diseases that have taken more lives in human history than any wars – including measles, mumps, smallpox, chickenpox, tetanus, hepatitis and influenza. An effective vaccine for COVID-19 is essential for halting this global pandemic.

Historically, vaccine development and testing has been a multi-year effort, at best. And for some illnesses, effective vaccines were never developed. The vaccines developed by Pfizer, Moderna and AstraZeneca are just two of more than 50 different COVID-19 vaccines that are being tested in clinical trials. Even more are in pre-clinical development. If we have an approved vaccine less than a year after we identified the coronavirus, it will be one of the great achievements of modern medicine.

I am looking forward to that day when I can roll up my sleeve and get the protection. The decision last month by AstraZenaca and Johnson & Johnson to briefly pause their vaccine trials to investigative health issues in some test subjects shows that safety is not being sacrificed for speed.

But approval is only one giant step in the process. The world has a total of 7.8 billion people and the U.S. alone more than 328 million. It will then take many months, if not years, to manufacture enough doses to meet the needs world-wide, not to speak of the logistics of vaccinating this large population.

Distribution plans depend on supply. Assuming it will not be limitless from the start, the National Academies of Sciences, Engineering, and Medicine recommends that front-line health care workers should be in the first group to receive the vaccine for COVID-19 when it is approved.

This may sounds like common sense but this recommendation is controversial.

To begin with, the National Academies include hospital workers and employees of nursing homes and other facilities as frontline workers. The risk in these settings varies. Hospitals are tightly controlled institutions run by medical experts that have effective protocols for caring for the stricken. Nursing homes, by contrast, provided long-term care for people who are not necessarily sick.

The safeguards hospitals have in place have greatly reduced the risk of COVID-19 transmission. Like facilities across the country, the University of Michigan health care system provides all of our nurses, physicians and other employees who come in contact with COVID-19 patients with a full range of personal protective equipment (PPE) – including face masks and shields, gloves, goggles and gowns. We issue appropriate PPE to our support staff and require everyone to wear a mask. In addition, we segregate patients infected with COVID-19 in special units. As a result, at our hospital and many across the country the transmission rate in the hospital is now close to zero.

Although hospital administrators still work hard to find the PPE we need, our facilities have not been affected by the problems more commonly encountered in some nursing homes. Indeed, on Oct. 14 AARP published an analysis of federal data collected in August and September which found that nearly half of nursing homes had staff infected with COVID-19 and that more than a quarter of such facilities reported shortages of PPE.

These safety records must inform decisions if the initial supplies of a vaccine are relatively small.

A related question is whether health care providers should be required to be vaccinated for COVID-19 as a condition of employment.

Such mandates are common.  For example, except in rare cases, children are required to get a range of immunizations to attend public schools. The CDC recommends that healthcare workers receive a range of vaccines to “to reduce the chance that you will get or spread vaccine-preventable diseases,” including influenza, Hepatitis B, measles, mumps and rubella.

During the H1N1 pandemic in 2009 the U.S. Labor Department's Occupational Safety & Health Administration (OSHA) said that employers can require vaccinations. In 2015 we mandated that everyone who works at Michigan Medicine must receive influenza vaccination.

Like health care institutions around the world the one I lead, Michigan Medicine, has assembled a committee to consider approaches to prioritize COVID-19 vaccination here and make recommendations.

At the end of the day, though, we may have little discretion in how we prioritize vaccine administration. The federal government will deliver vaccines to hospitals, some of which will serve as regional distribution centers. Vaccines will be likely have Emergency Use Approval but not FDA approval, at least initially so how it is used and to whom it is given to will be very tightly regulated.

Michigan Medicine will be a regional distribution center and, as such, we will be responsible not only for our employees but for health care providers in our area, including EMTs, home health nurses and others providers.

More urgent questions and issues will certainly arise in the next few weeks and months. As we work to answer them, with fingers crossed that the vaccines developed by Pfizer, Moderna and AstraZeneca will earn approval, we should allow ourselves a moment to marvel at the apparent the achievement and celebrate the first glimpses of light at the end of COVID-19’s dark tunnel.

Marschall S. Runge, MD, PhD, is Executive Vice President for Medical Affairs and Dean of the Medical School for the University of Michigan.  He serves on the Board of Directors for Eli Lilly and Company.