What We're Reading: Vaccines in EUA Process; Alkermes Receives CRL; California Tightens Restrictions

November 17, 2020
AJMC Staff

The FDA will move rapidly to clear Pfizer's and Moderna’s coronavirus disease 2019 vaccines for emergency use; approval of Alkermes' ALKS 3831 is pending; California's governor is tightening restrictions for 94% of the state’s residents.

HHS Secretary Says FDA Will Rapidly Move to Clear Vaccine Candidates

Appearing yesterday on CNBC’s “Squawk Box,” HHS Secretary Alex Azar said the FDA will move as quickly as possible to clear Pfizer's and Moderna’s vaccine candidates against coronavirus disease 2019 (COVID-19) for emergency use. Azar’s statement comes amid interim results from Moderna, which announced yesterday that its COVID-19 vaccine was more than 94% effective in preventing the virus. Pfizer’s vaccine candidate was additionally shown to be 90% effective, with Azar noting that both authorization applications are currently being completed.

Alkermes Issued Complete Response Letter for Manufacturing of ALKS 3831

Today, Alkermes plc announced it received a Complete Response Letter from the FDA on its New Drug Application for ALKS 3831 (olanzapine/samidorphan) for the treatment of adults with schizophrennia and adults with bipolar I disorder. The FDA stated that approval of ALKS 3831 is pending resolution of certain conditions related to the tablet coating process at the company’s facility, which Alkermes noted has been resolved with sufficient data available to address these observations.

California Tightening COVID-19 Regulations Amid Record Surge in Cases

Yesterday, California Governor Gavin Newsom said that 41 of the state’s 58 counties will be put into the most restrictive “purple” tier due to widespread virus transmission, going into effect today, according to The Hill. Noting that California is pulling the “emergency brake” and tightening restrictions for 94% of the state’s residents, Newsom additionally stated that counties will be reassessed multiple times during the course of a week and will be unable to move forward until cases of infection improve and the state deems it safe.