JNJ) plans on enrolling up to 60,000 people in a coronavirus vaccine trial, likely as part of a global development and regulatory approval strategy, ex-FDA Commissioner Scott Gottlieb said Friday on CNBC’s “Squawk Box.”” data-reactid=”19″ type=”text”>Johnson & Johnson (NYSE: JNJ) plans on enrolling up to 60,000 people in a coronavirus vaccine trial, likely as part of a global development and regulatory approval strategy, ex-FDA Commissioner Scott Gottlieb said Friday on CNBC’s “Squawk Box.”
J&J will likely look to oversee large trials in many regions at the same time to make it easier to file for regulatory approval, he said.
In order to gain regulatory approval from foreign agencies, a vaccine maker needs to conduct studies in that specific region, Gottlieb said.
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PFE) are recruiting 30,000 people in the U.S., the ex-FDA commissioner said.” data-reactid=”28″ type=”text”>COVID-19 Timeline Update: Vaccine makers like Pfizer Inc. (NYSE: PFE) are recruiting 30,000 people in the U.S., the ex-FDA commissioner said.
Even at half the size of J&J
4:55 PM ET
Major League Baseball commissioner Rob Manfred told MLB Players Association executive director Tony Clark on Friday that if the sport doesn’t do a better job of managing the coronavirus, it could shut down for the season, sources familiar with the conversation told ESPN.
The league and players recognize the coming days are a critical juncture following an outbreak among the Miami Marlins in which 21 members of the organization have tested positive for COVID-19. Two positive tests by St. Louis Cardinals players on Friday exacerbated concerns inside the sport about the presence of the coronavirus and whether the jointly agreed-upon protocols are being followed properly to prevent outbreaks similar to Miami’s.
Should another outbreak materialize, Manfred, who has the power to shut down the season, could move in that direction. Multiple players briefed on the call fear the season could be shut down as soon as Monday if positive tests jump or if players continue not to strictly abide by the league’s protocols.
State and local governments have pressured baseball about players skirting the mandates outlined in the league’s 113-page operations manual, sources told ESPN. Broadcasts that have shown players high-fiving, spitting and not wearing masks have left government officials wondering how seriously players are taking the protocols, sources said.
Further, there is concern about off-the-field choices, with one high-ranking official saying: “There are some bad decisions being made.”
The Cardinals’ game against the Milwaukee Brewers was postponed Friday and rescheduled to a doubleheader Sunday. Already, the Marlins and Philadelphia Phillies, who last played Miami on Sunday, were missing scheduled games, leaving 20% of the league’s Friday slate empty.
Major League Baseball and the MLBPA on Friday jointly announced the results of COVID-19 testing through Thursday. Of the 11,895 samples taken over the past week, there were 29 positive tests — 20 by players and nine by staff members.
(CNN)The commissioner of the US Food and Drug Administration on Sunday declined to defend President Donald Trump’s unfounded claim that 99% of coronavirus cases are “totally harmless” and repeatedly refused to say whether Trump’s remark is true or false.
ENGLEWOOD, Colo. — NFL Commissioner Roger Goodell sent a memo to all 32 clubs on Wednesday outlining initial plans for the reopening of team facilities.
UCHealth Training Center and the remaining 31 training facilities have been closed since late March as part of the league’s response to COVID-19.
Goodell’s memo details protocols that will allow an initial reopening phase that includes a portion of the team’s employees returning to work. No more than 50 percent of the team’s employees (or up to 75 people) will be allowed in the building in a day.
These guidelines could be stricter depending on local and state guidelines.
No players would return to the facilities during this initial phase, unless they were visiting to continue rehab and treatment that was already taking place when facilities initially closed.
Those who return to the facilities must follow a number of protocols, including wearing a cloth mask and undergoing a daily temperature screening, according to a report by NFL Network’s Tom Pelissero.
Goodell’s memo suggests teams should prepare to install these protocols by May 15.
The league is also working on crafting guidelines for a second phase of reopening that includes a larger number of staff members and also includes players. The memo says that the NFL is working with the NFLPA to develop proper protocols as it relates to access to the facilities.
All protocols were developed in a process led by Dr. Allen Sills and reviewed by Duke University’s infectious disease physicians, the NFLPA’s medical director and the CDC. Sills will contact each team’s physician and newly established Infection Control Officer before the facilities reopen.
The memo also states that the league is working to plan for the 2020 season and that the NFL will be prepared for contingencies.
The 2020 NFL schedule is expected to be released on Thursday at 5:30 p.m. MT.