Emergency Measures to Manage the Flu Vaccine Shortage

Other orders collected by the CDC Public Health Law Program / NACHO

Also see: Vaccine Law /Emergency Administrative Orders and Regulations

The sudden flu vaccine shortage raises the legal issue of the authority of the state, through the public health department, to issue emergency orders and regulations to control the use and distribution of the remaining vaccine stocks. The United States Constitution and the state constitutions give administrative agencies dealing with the public health and safety broad powers to act in emergencies. These include the power to order the seizure and/or destruction of property without a prior hearing (North American Cold Storage), and the right to issue emergency rules with the same effect as statutes without having to go through the usual notice and comment rule making process. These rules must be based on pre-existing statutory or state constitutional authority, however. (See Police Power) While all health departments had such powers historically, some states limited these powers by statute out of fears of overreaching by public health departments. Most states have restored these powers in the wake of the 9/11 attacks. (See MSEHPA)

Emergency orders and regulations require that the agency set out statutory or constitutional authority for the action, the nature of the emergency, why the proposed action is necessary, and, if known, the duration of the emergency regulation or order. If the duration of the order or regulation is more than a short period, especially if it is permanent, the agency may need to have a hearing on an order or go through the notice and comment process if it is a regulation. (For the standards, see: Emergency Administrative Orders and Regulations)

The most difficult legal issue posed by the flu vaccine shortage is whether it is an emergency at all. The current strain of flu is not seen as particularly nasty, as opposed to the fears surrounding Swine Flu. Since the flu season has not started, it is difficult to argue that the risk of flu justifies emergency action. While there is only 50% of the expected vaccine, there is still plenty of vaccine by historical standards. The only issue that might rise to emergency status is vaccine allocation and the fear that vaccine stocks will be used up before persons at high risk are vaccinated. It is unlikely that significant additional vaccine can be obtained outside the US before the flu season is underway. Thus the only way to assure that persons at high risk receive vaccine is to force the centers with more vaccine than is needed for high risk persons to share it with those that do not have enough. Since the vaccine may be used up quickly, this might justify an emergency action such Oregon has taken, as set out below. The strongest legal argument for the Oregon order is the broad power to regulate health care workers, which would support an order controlling who they could immunize. The harder legal question is whether Oregon or other states can prevent vaccine owners from moving the vaccine out of state or out of the country and selling into the vaccine spot market.

Ironically, the Washington State Nurses Association filed suit just before the shortage was announced to block a hospital plan to require manditory immunizations for the nursing staff. This highlights an ironic problem in the midst of the hysteria over access to flu vaccine: many health care worker who should be vaccinated for their own and their patient's protection have historically refused the flu and other vaccinations.