August 10, 2022

On Jan., 1, 2020, the Trump Administration declared COVID-19 a Public Health Emergency, and the FDA was permitted to grant emergency use authorizations (EUA) to address the massive need for COVID-19 vaccines. This led to rapid vaccination development and a national implementation effort that is still in effect.  Shortly thereafter, states across the country filed emergency waivers and SPAs with CMS, seeking approval to waive certain federal regulatory requirements.   Last year, the Biden Administration stated that it would give the public 60 days notice of its’ intent to end the (federal) COVID-19 Public Health Emergency.  In July, the Administration extended the COVID 19 PHE through October 15, 2022.  That means that the next key date to watch is August 15 (60 days before the October 15 end date mentioned above).   We will keep our eyes peeled for any indication the federal PHE is ending.

In related news… Monkeypox has so far infected over 9,000 people in the U.S. State health officials reported a total of 2,104 confirmed orthopoxvirus/monkeypox cases as of Tuesday.  The vast majority of those cases — 1,965 — were in New York City. Westchester, Suffolk and Nassau counties.

New York continues to lead the nation in monkeypox cases, accounting for nearly a quarter of the 9,493 total cases reported to the U.S. Centers for Disease Control and Prevention as of Tuesday.  California and Florida trailed New York, reporting 1,310 and 976 cases, respectively.

To address the growing outbreak, yesterday the Biden Administration issued a PHE under the Public Health Service Act, but the situation is different from what we experienced at the beginning of the COVID-19 outbreak. For a variety of reasons beginning with a shortage of vaccines, the Biden administration has decided to stretch the country’s supply of monkeypox vaccines five-fold by allowing providers to use a new injection method, the administration announced yesterday.  The FDA has issued emergency use authorization (EUA) that enables providers to give a smaller amount of the vaccine injected between layers of skin, instead of the previously-used larger amount given under the skin. This kind of administration requires a different type of needle. The CDC will be conducting training and outreach with clinicians to make sure they know how to administer doses moving forward.

Rest easy knowing we are following all of this for/with you.
More to follow.