Pfizer-BioNTech Covid-19 Vaccine Receives Emergency Use Authorization & ACIP Use Recommendation for People age 16 and older

On Friday, December 11, 2020, the U.S. Food and Drug Administration (FDA) issued its first Emergency Use Authorization (EUA) for a Covid-19 Vaccine developed by Pfizer-BioNTech. According to the FDA:

The totality of the available data provides clear evidence that Pfizer-BioNTech COVID-19 Vaccine may be effective in preventing COVID-19. The data also support that the known and potential benefits outweigh the known and potential risks, supporting the vaccine’s use in millions of people 16 years of age and older, including healthy individuals.

An EUA is not the same as an FDA approval — also known as licensure — of a vaccine.  As the FDA states,

In determining whether to issue an EUA for a product, the FDA evaluates the available evidence and assesses any known or potential risks and any known or potential benefits, and if the benefit-risk assessment is favorable, the product is made available during the emergency. Once a manufacturer submits an EUA request for a COVID-19 vaccine to the FDA, the agency then evaluates the request and determines whether the relevant statutory criteria are met, taking into account the totality of the scientific evidence about the vaccine that is available to the FDA.

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The FDA also expects manufacturers whose COVID-19 vaccines are authorized under an EUA to continue their clinical trials to obtain additional safety and effectiveness information and pursue approval (licensure).

The CDC’s Advisory Committee on Immunization Practices (ACIP) voted on Saturday to recommend the Pfizer-BioNTech vaccine for persons 16 years of age and older, in accordance with the FDA’s Emergency Use Authorization. As the ACIP’s report in the December 13, 2020 issue of MMWR states,

ACIP determined that COVID-19 is a major public health problem and that use of the Pfizer-BioNTech COVID-19 vaccine is a reasonable and efficient allocation of resources. Whereas there might be uncertainty in how all populations value the vaccine, it was determined that for most populations, the desirable effects outweigh the undesirable effects. The vaccine is probably acceptable to implementation stakeholders and feasible to implement in spite of difficult ultracold-chain storage and requirements for handling and administration. These requirements could limit the availability of the Pfizer-BioNTech COVID-19 vaccine to some populations thereby negatively impacting health equity. Therefore, efforts should be made to overcome these challenges and advance health equity.

A limited supply of the vaccines (approximately 2.9 million doses) have begun shipping to a preliminary set of 145 sites across all 50 states, Washington DC, and U.S. territories. They will arrive Monday, December 14, and the first recipients will begin receiving their first of the two dose vaccinations soon thereafter. Shipments will begin arriving at another 450 sites across all 50 states Tuesday and Wednesday.

Because of the supply limits, and because this vaccine will have special storage and handling needs (due in part to requiring ultracold temperatures to ship and store), the ACIP recommends prioritizing first the vaccination of health care providers (broadly defined), especially those working in acute care settings, and residents of long term care facilities. This, according to the ACIP, is in accordance with their “ethical principles for allocating initial supplies of COVID-19 vaccine, namely to maximize benefits and minimize harms, promote justice, and mitigate health inequities.”

Indiana has followed a similar approach, recommending that the first doses be given to “healthcare workers and residents of long term care facilities.”

The logistics of shipping, receiving, and delivering the vaccines are daunting.

Track developments related to the vaccine delivery process at this Washington Post web site.

Track information about Indiana’s COVID-19 Vaccine planning at the state health department site.

“No Quick Fix” To The Pandemic

The first vaccine’s arrival is an important development in the nation’s response to the epidemic. However, it is important to recognize that states and hospitals across the nation currently are dealing with record levels of positive cases, and the vaccine will not result in the rapid end of the need for containment efforts, including limits on gatherings, mask wearing, and the like. Remember: Hands (wash), Face (covered), Space (between you and others) & Replace (the air with ventilation). As Dr. Rochelle Walensky, President-Elect Biden’s nominee for CDC Director, stated last week, “If I have a cup of water, I can put out a stove fire. But I can’t put out a forest fire, even if that water is 100% potent. That’s why everyone must wear a mask. As a nation, we’ll recover faster if you give the vaccine less work to do when it’s ready.”

There also is concern about vaccine uptake being slowed by some public hesitancy about the vaccines.

Here is a good explainer on the hurdles we must clear before reaching herd immunity.

Toward this end, a NY State legislator has proposed empowering the state’s health department with authority to mandate vaccination for most healthy individuals for whom the vaccine is authorized if, after a certain period of time, not enough people are voluntarily getting vaccinated. The New York State Bar Association also has passed a resolution supporting such an effort, pointing out the importance of conducting widespread community engagement and public education efforts, as well as taking steps to minimize inequitable distribution of the vaccine. These steps appear to be in line with recommendations my colleagues and I made in our recent New England Journal of Medicine article, “Ensuring Uptake of Vaccines Against SARS-CoV-2.”

Indiana Faces Collision of Food, Unemployment, Eviction Crises

The vaccine also does not offer relief from a major, impending economic and social crisis facing Indiana in the coming weeks, as federal emergency assistance programs and protections are due to end well before the public health crisis does. The Indianapolis Star reports that, absent Congressional action by Christmas, federal CARES Act-related unemployment insurance programs would expire, resulting in more than 325,000 Hoosiers losing unemployment benefits, “the worst one-month shock to personal income in state history.”

Thousands of Indianapolis-area families have been threatened with eviction since state protections against such actions expired in August. Without action between now and December 31, when the CDC’s Eviction Moratorium is expected to expire, between an estimated 100,000 and 268,000 Indiana households will be at risk of eviction or foreclosure, leading one housing policy expert to state, “We can foresee the worst-case scenario, en masse evictions with a homeless crisis” in the new year.

Running parallel to these two crises is a “food cliff,” as food pantries have seen massive rises in use over the pandemic, will likely see even more demand should the above protections expire, and the U.S. Department of Agriculture is set to cut food bank support in half in the new year.

Other COVID-19 Law & Ethics News

• Domestic Violence: How Companies Can Protect Remote Working Employees
• Pregnancy: The COVID-19 Pandemic has raised unique concerns for many pregnant workers
• Emergency Powers: Massachusetts Supreme Court Upholds Governor’s continued use of Emergency Orders to respond to the COVID-19 pandemic, stating that legislative authorization is not needed at this time. South Carolina Supreme Court stops governor from spending COVID-19 aid on private schools.
• Jails: COVID-19 Cases and Testing in 53 Prison Systems (new research). Orange County, California judge orders 50% census reduction at local jails due to COVID-19
• Colleges & Universities: An interesting article on the ability of colleges and universities to recoup some of their COVID-19-related losses via their insurance providers