Important pharmacy news and late-breaking industry information updated daily.
Despite expectations that CDC’s Advisory Committee on Immunization Practices (ACIP) would make its COVID-19 vaccine allocation recommendations once one or more vaccines received FDA emergency use authorization (EUA)—the traditional timeline—the group will vote Tuesday, December 1, on a “Phase 1a” distribution strategy. ACIP convened the 2:00 pm ET December 1 emergency meeting to ensure its advice is available before FDA approves any EUAs; the agency is slated to consider the first application on December 10. U.S. Department of Health and Human Services Secretary Alex Azar has said that Operation Warp Speed will begin shipping COVID-19 vaccines to states within 24 hours of their approval.
Roughly 750 participants tuned in for 2 days of virtual education, video chats, networking events, and more at the Joint Federal Pharmacy Seminar (JFPS) 2020 Virtual, held on November 13 and 14.
Moderna announced Monday it has applied to FDA for emergency use authorization of its candidate COVID-19 vaccine. If approved, the company said, vaccinations could begin in the United States as soon as December 21. Moderna reported that complete data from a large study indicated the vaccine was 94.1% effective, confirming earlier estimates.
Supermarket pharmacies are gearing up to become major providers of COVID-19 vaccinations. Grocery stores say they are well-positioned to provide the vaccines because a large share of the population lives near one of their stores, and their pharmacies regularly offer vaccinations for other illnesses.
CDC’s Advisory Committee on Immunization Practices (ACIP) has published its 2020 recommendations for meningococcal vaccination, which cover use of the three quadrivalent conjugate vaccines—meningococcal serotypes A, C, W, and Y (MenACWY)—and two available meningococcal serogroup B (MenB) vaccines. The recommendations call on shared clinical decision making for the MenB vaccine for adolescents and young adults ages 16 to 23 years and highlight the importance of these vaccines for patients at increased risk.
APhA and several other leading pharmacy groups issued a statement Tuesday on the Trump administration's new final rule on prescription drug rebates.
The U.S. Department of Health and Human Services (HHS) released three new drug pricing policies late last week. Two of the policies are based on executive orders President Trump signed in July; the last, a surprise revocation of guidances related to FDA’s Unapproved Drugs Initiative (UDI), was out of the blue. The policies’ release was announced on Friday, November 20, 2020, at a White House briefing.
Starting Friday, November 27, 2020, pharmacies must buy and sell only products with a required “product identifier” on their packages. This requirement is part of the phased-in implementation of the Drug Supply Chain Security Act of 2013 (DSCSA), also known as the “track-and-trace” law. By Friday, dispensers should be familiar with this requirement and know what to do if a product identifier is not on the package when they receive products that require it. The product identifier is on most drug packages in both human-readable format and on a machine-readable 2D data matrix barcode.
The rollout of a COVID-19 vaccine will likely target health care workers and residents of long-term care facilities during Phase 1a, essential workers during Phase 1b, and older adults as well as men and women with comorbidities during Phase 1c.
On Saturday, FDA issued an emergency use authorization (EUA) for a combination monoclonal antibody treatment—casirivimab and imdevimab (Regeneron Pharmaceuticals)—to be administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients aged 12 years and older weighing 88 pounds with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressing to severe COVID-19.