Statement on Emergency Use Approval for Moderna, Pfizer-BioNTech Omicron Booster Vaccines

By Soumi Saha, PharmD, JD, Senior Vice President, Government Affairs

Today’s FDA approval of the reformulated COVID-19 boosters that target the BA.4 and BA.5 Omicron sub variants can be a game changer for getting ahead of an evolving virus that continues to infect tens of thousands of Americans.

However, it’s critical that we don’t repeat some of the same problems that plagued COVID-19 vaccination efforts during the early pandemic response. As a national convener of hospital and non-acute vaccination sites across the nation, Premier recognized early on that a mass COVID-19 vaccination effort would be the biggest logistical challenge of the pandemic.

The COVID-19 fall booster campaign requires a cohesive national rollout and distribution plan with clear guidance from the Centers for Disease Control and Prevention (CDC) on vaccine allocation and eligibility for priority populations, including high-risk patients as well as those who have not yet received a booster.

Our nation also continues to lack information on the supplies needed to provide both COVID-19 and monkeypox treatment, all with the 2022 flu season on the horizon. It’s critical that the U.S. be aware of exactly where vaccine doses are being held and in the exact quantities – and it’s well past time we modernize the U.S. supply chain data infrastructure for greater data and transparency on supply availability and allocation methods. Additionally, vaccinators need detail on any ancillary kit that may accompany COVID-19 boosters and what products (i.e., needles syringes, nitrile exam gloves) may be included within. Casting further uncertainty over the rollout is the fact that government funding for the U.S. vaccine effort could run out as soon as January without additional support from Congress.

Overall, some public health experts are calling into question the speed of the booster authorization and rollout given unknowns around risk to vaccine effectiveness in humans. It’s vital that our public health vaccination approach is grounded in science – and we encourage the expeditious release of data and evidence from human trials that demonstrates booster efficacy. This is also key to helping overcome remaining hesitancy and further improve COVID-19 vaccination rates.