�������ýҕ�l

Hospitals will be able to purchase remdesivir, Gilead Sciences' antiviral drug used to treat hospitalized COVID-19 patients, directly from distributor AmerisourceBergen, federal authorities announced Thursday. Supplies of remdesivir, which is the only antiviral drug with emergency use authorization to treat hospitalized COVID-19 patients, have increased over the past several weeks as demand has waned and production has expanded. As a result, HHS will no longer oversee distribution via state health departments as planned. (Kacik, 10/1)

Researchers at the University of Oxford will begin studying AbbVie's drug, Humira, as a potential treatment for COVID-19 patients, the university announced Sept. 30. The trial will enroll up to 750 people from nursing home settings in the U.K. The university said nursing home patients were particularly hard hit by COVID-19 there and in other countries. In the U.S., 40 percent of nationwide deaths have been from nursing homes. (Anderson, 10/1)

The Food and Drug Administration (FDA) has reportedly broadened its investigation into a serious illness suffered by a patient participating in AstraZeneca's COVID-19 vaccine testing trials. Reuters reported Thursday that FDA officials will seek data from Oxford University, AstraZeneca's testing partner, regarding trials of vaccines for other diseases unrelated to COVID-19 in the hopes of determining whether patients in those trials developed similar side effects. (Bowden, 10/1)

AstraZeneca Plc said on Friday clinical trials of its experimental COVID-19 vaccine resumed in Japan, while adding that it was in talks with regulators on data needed to restart studies in the United States, where they remain halted. Several global trials of the vaccine, AZD1222, were put on hold last month after an unexplained illness in a study participant. While most trials have resumed, U.S. trials are still on pause as regulators widened their probe, Reuters reported on Wednesday. (10/2)

Just a day after President Trump said the nation was only “weeks away” from a coronavirus vaccine, the head of Moderna reportedly said his company will not be able to apply for authorization from the Food and Drug Administration (FDA) until late November at the earliest.“ November 25 is the time we will have enough safety data to be able to put into an EUA file that we would send to the FDA – assuming that the safety data is good, i.e. a vaccine is deemed safe,” Stephane Bancel, Moderna CEO, told the Financial Times on Wednesday. (Hein, 10/1)

The CEO of Pfizer — one of the frontrunners in the coronavirus vaccine race — said in a staff memo Thursday that the company wouldn’t cave to political pressure to rush its vaccine to market, while at the same time decrying "those who argue for delay." “Tuesday night I joined the millions of Americans who tuned in to the Presidential debate. Once more, I was disappointed that the prevention for a deadly disease was discussed in political terms rather than scientific facts,” Albert Bourla said in an internal memo obtained by POLITICO. (Owermohle, 10/1)

The European Medicines Agency has started a “rolling review” process for the COVID-19 vaccine being developed by Oxford University and AstraZeneca, a move it hopes will speed any eventual approval. In a statement Thursday, the EU regulator said instead of waiting for all of the required vaccine data to be submitted before beginning its assessment, the EMA has begun analyzing the preliminary information from scientists on the Oxford vaccine. (Cheng, 10/1)

A major non-profit health emergencies group has set up a global laboratory network to assess data from potential COVID-19 vaccines, allowing scientists and drugmakers to compare them and speed up selection of the most effective shots. Speaking to Reuters ahead of announcing the labs involved, Melanie Saville, director of vaccine R&D at the Coalition for Epidemic Preparedness Innovations (CEPI), said the idea was to “compare apples with apples” as drugmakers race to develop an effective shot to help control the COVID-19 pandemic. (Kelland, 10/2)

Luke Hutchison woke up in the middle of the night with chills and a fever after taking the Covid-19 booster shot in Moderna’s vaccine trial. Another coronavirus vaccine trial participant, testing Pfizer’s candidate, similarly woke up with chills, shaking so hard he cracked a tooth after taking the second dose.  High fever, body aches, bad headaches and exhaustion are just some of the symptoms five participants in two of the leading coronavirus vaccine trials say they felt after receiving the shots. (Farr and Lovelace Jr., 10/1)