Even as we cautiously await the health implications of the millions of Americans who traveled during the Thanksgiving holiday in the midst of the ongoing national surge of coronavirus cases and hospitalizations, we can be buoyed by the news from Pfizer / BioNTech, Moderna, and AstraZeneca/Oxford of the efficacy of their Covid-19 vaccines and the imminent availability of the initial doses of those vaccines. The trials for each of the vaccines from these innovative companies have demonstrated an efficacy level of 90% or more and we can expect approval - assuming no unexpected negative findings - of the Pfizer/BioNTech and Moderna vaccines by the FDA under its Emergency Use Authorization shortly which means the first vaccine shipments for hospital personnel, nursing home residents and essential workers can be made available in late December.

But, this light at the end of the COVID-19 tunnel should neither cause people to become less vigilant and attentive to the safety measures necessary to prevent further spread of the virus nor to dismiss the uncontrolled surge in hospitalizations across the country or the plight of the many Americans continuing to suffer from the shattering economic impacts of the virus.

Here, I want to address some of the complications remaining in the response to the virus and the effective and equitable distribution of the vaccines in the months ahead.

First, a few reference points:
  • As of this writing, the United States has nearly 13,950,000 cases and over 273,000 deaths. The daily average of coronavirus cases nationwide this past week exceeded 170,000. Hospitalizations have now surpassed 100,000, the first time the figure has been that high since July. As of this writing only Hawaii was not experiencing an increase in new coronavirus cases.
  • Over the last two weeks, there has been a 28% increase in child Covid-19 cases and children now account for more than 11% of all confirmed coronavirus cases in the US, according to the American Academy of Pediatrics. About 144,145 new cases among children 17 and under were reported from November 5 to 19, AAP said.
  • Here in Massachusetts, despite careful restrictions imposed by Governor Baker and Mayor Walsh, we have witnessed alarming increases in the number of infections and hospitalizations and growing COVID patients in our ICUs.
  • The death rate today was the highest since the pandemic began. And, most of these results have were reported before the tens of millions of people traveled for the Thanksgiving holiday. The COVID-19 health implications of that travel will not likely be known until the second week in December.

What should we anticipate as the next steps concerning the promise of vaccines and their distribution to hospital personnel, essential workers and the general public?

As reported recently in the New York Times, over the next few months, we have to pay attention to the “effectiveness” of these vaccines versus their efficacy. Efficacy is a measure of a vaccine’s ability to reduce the risk of disease in a vaccinated person compared to someone who is not vaccinated. The term is usually applied to data in the context of a highly controlled environment, like a clinical trial. That’s the data that the companies have so far reported. Vaccine effectiveness, on the other hand, is a measure of how the vaccine performs in the real world, when those controlled variables are subject to life’s practical circumstances. This is the information that’s still to come and will be the real test of the vaccines’ immediate effectiveness as it is administered and as we determine how long it will be effective and/or control spread.

The good news here is that all of the vaccine candidates seem to have taken the real world difference into account during their trials given that they all enrolled diverse populations with a range of health conditions in the trials. This offers the potential that vaccine efficacy will translate into actual clinical benefit when millions of doses are deployed.

As mentioned above, Pfizer has already filed its data with the U.S. FDA requesting an Emergency Use Authorization (EUA) for its vaccine and Moderna and AstraZeneca/Oxford plan to do so shortly. Assuming favorable action in mid-December by the FDA on the applications, each company expects to then deploy millions of doses no later than the end of The month to priority populations. In fact, some shipments of the Pfizer vaccine have already been flown to the United States even while awaiting final Emergency Use Authorization. It is also worth noting that AstraZeneca claims that its vaccine can be produced quickly in large volumes, will require no special storage or transportation conditions and will cost significantly less than the other two candidate vaccines thereby enabling distribution to many disadvantaged populations worldwide.

Despite company and government claims of well-coordinated systems for vaccine distribution once approved, questions do remain concerning how millions of doses of vaccines from different companies will get delivered expeditiously to hospitals and other facilities, stored safely, and ultimately administered effectively and in a timely manner in the doses required to patients (the Pfizer vaccine requires two doses three weeks apart; Moderna’s vaccine requires two doses at a four week interval; AstraZeneca/Oxford will require two doses)? Even a perfect vaccine will be useless unless it can be delivered and administered to the people at risk of infection and disease. As President-elect Biden has underlined, vaccines don’t save lives, vaccinations saves lives.

Here is another point of departure between the Pfizer vaccine pathway to recipients and the Moderna and AstraZeneca/Oxford routes.

Moderna and AstraZeneca/Oxford are companies that have partnered with the U.S. government through Operation Warp Speed (OWS). Pfizer, on the other hand, has indicated that it will not utilize the OWS infrastructure. Instead, it is planning to embark on the largest ever vaccination campaign and will use partners such as FedEx Corp., United Parcel Service Inc., and DHL International GmbH to fly the vaccine from designated cold storage centers to locations close to the point of vaccine administration, like hospitals or vaccination centers. Whether the storage temperature of this vaccine (-94 F) will persist, remains to be seen. The Moderna and AstraZeneca/Oxford vaccines can be stored in a common refrigerator thus extending their useful life well beyond the Pfizer vaccine which requires administration in a significantly shorter time frame.

Developing these vaccines in record time is a monumental and remarkable scientific achievement. But, overcoming the complexities of developing a Covid-19 vaccine, coordinating the storage and shipping obstacles, and now determining who gets the vaccine in a fair and equitable way, means little if we are unable to convince a sufficient number of Americans to take the vaccine. The vaccine will only be the blessing many have hoped for if it is utilized. Recent polling has indicated that Americans are reluctant to be inoculated, with only around 55-60% even willing to take a vaccine that demonstrates 90% plus efficacy. That’s likely not enough to generate the herd immunity necessary to reverse the spike in the pandemic curve, so the public health communications campaign to overcome the suspicions raised by what appeared to be a political effort to fast track the vaccine development process and bypass safety protocols will have to be comprehensive, persistent and rapid.

One other point to make about the complexities surrounding the distribution of vaccines is underscored by the differences in refrigeration and transportation requirements for the Pfizer, Moderna and AstraZeneca/Oxford vaccines. These demonstrate how critical it is that there be seamless coordination between the federal government and the states and other distribution channels for the system to work effectively. The fact that in its waning days, the Trump Administration has deliberately obstructed the transition of power and the free flow of vital information necessary for this distribution process to work smoothly is likely to impede life saving activity. This is not hyperbole. This is real and only confirms the self-serving nature of a national Administration that has been focused exclusively on its own political survival during this entire health crisis in blind disregard of the well-being of millions of Americans. As Dr. Fauci has commented recently: “The vaccines are effective. We want to get it approved as quickly as we possibly can. We want to get doses to people starting in December, and then we want to really get the ball rolling as we get into January, February and March,” Dr. Fauci added. “We want a smooth process with that and the way you do that is by essentially having the two groups speak to each other and exchange information.”

Final thoughts about the holidays

My kids and grandkids are in Colorado and Oregon. My wife and I miss them greatly. I’m sure there are parents and grandparents across Massachusetts and the country who are in the same boat. But, with the virus surging across this nation and with hospitalizations increasing and with the infections now affecting all age groups, the danger of contracting the virus is great. As Dr. Philip J. Landrigan, who directs Boston College’s Program for Global Public Health and the Common Good, said after a meeting of health professionals and mayors at the Massachusetts State House last week: “There’s the real possibility that if people don’t take great precautions in the next month, we could see a fairly explosive increase. I’m not saying it will happen, but there is a real risk that it could.” Vaccines are now in reach and will be available for large portions of the population in a few months. We’ve held out this far. We can’t lower our guard. We should be cautious for a few more months and continue to adhere to all safety guidelines, avoid gatherings where the virus can spread, wear masks, and stay home if possible. Our family will have virtual holidays. It won’t be the same. But, it will make the day in May or June when we can all get together that much sweeter. Be safe!