The flurry of Covid-19 vaccine administration that marked the mid spring to early summer resulting in millions of doses administered daily has given way to a steady stream of approximately 700,000 doses of vaccine administered daily, according to some analysis of CDC data.
But now that August has arrived so has the need for regularly scheduled pediatric vaccines to be administered as schools open up again. Also, next month marks the beginning of flu season and its flood of vaccine requests. All of this demand for vaccine administration could threaten to overwhelm some of the pharmacies that have typically been a destination for quick and easy vaccine administration.
On August 4, the HHS officially amended the PREP Act declaration on medical countermeasures against Covid-19 in an effort to stave off any bottle-necking at pharmacies that administer flu vaccines. The declaration amendment, which took immediate effect and last until the end of the public health emergency officially included qualified pharmacy technicians and interns as “qualified persons” permitted to administer seasonal influenza vaccines to adults age 19 and older. Additionally, the amendment officially identifies the same techs and interns as authorized to administer the Covid-19 vaccine as well as pediatric vaccines that are on the Advisory Committee on Immunization Practices (ACIP) schedule.
The authorization does come with limitations. A licensed pharmacist has to be available to supervise and the technicians and interns have to be licensed or registered by the state board of pharmacy. There are also training requirements.
Last October, the Office of the Assistant Secretary of Health issued guidance that identified qualified pharmacy technicians and state-authorized pharmacy interns as covered persons for the purposes of the PREP Act declaration. That guidance authorized pharmacy techs and interns to administer Covid-19 vaccines and pediatric vaccines on the ACIP schedule. However, the current amendment not only makes that authorization officially part of the declaration, it also adds the seasonal flu vaccine to the authorization.
The Public Readiness and Emergency Preparedness Act, or PREP Act, was passed in 2005 as part of the Department of Defense, Emergency Supplemental Appropriations to Address Hurricanes in the Gulf of Mexico, and Pandemic Influenza Act, Pub. L. No. 109-148. It shields certain covered individuals from liability arising out of their efforts to deploy identified countermeasures to combat a pandemic or any other public health emergency.
In March 2020, the HHS issued a declaration under the PREP Act immunizing certain individuals from liability as a result of deployment of covered countermeasures designed to fight the spread of SARS-CoV-2 and the disease caused by the virus, Covid-19.
HHS has amended the declaration now eight times to expand either the countermeasures or the qualified persons covered by the declaration. This most recent amendment was made with the upcoming flu season in mind.
For more on the PREP Act in general and its use during the coronavirus pandemic in particular, please see posts from Health Industry Washington Watch and in the Drug and Device Law Blog.
Reed Smith will continue to track the progress of this regulation and other related information. Should you have any questions related to this, please do not hesitate to reach out to the health care attorneys at Reed Smith.