By Nectar Gan, Adam Renton, Amy Woodyatt, Ed Upright, Meg Wagner and Melissa Macaya, CNN
From CNN's Sarah Moon
California Gov. Gavin Newsom, speaking at a news conference today, told residents to “wake up” to the reality of “how deadly this disease continues to be.”
“What more evidence do you need?” Newsom said as he referred to the state’s seven-day average of deaths, which is 109.
“Please, let's wake up to that reality,” he added.
California has the highest number of coronavirus cases across the nation with 460,550 confirmed cases. The state reported a total of 8,445 deaths on Monday.
From CNN’s Maggie Fox
Drug giant Pfizer and its partner BioNTech said Monday they have approval to start an advanced trial of their experimental coronavirus vaccine in US volunteers.
The companies said the US Food and Drug Administration approved their plan for a phase 2/3 trial of the vaccine in the United States.
“Today, we are starting our late-stage global study, which will include up to 30,000 participants,” BioNTech founder Dr. Ugur Sahin said in a statement.
“Participants will be screened and dosed in the next few days,” a spokesperson for the company told CNN.
Earlier Monday, Moderna started a Phase 3 trial in the United States of its experimental vaccine. Pfizer’s vaccine is slightly different, but also uses an experimental approach that employs genetic material to stimulate an immune response against a key part of the coronavirus.
A Phase 2/3 study looks for a combination of safety, efficacy and optimal dosing of a vaccine or drug.
Last week the US Department of Health and Human Services and the Department of Defense announced an agreement with Pfizer for “large-scale production and nationwide delivery of 100 million doses of a Covid-19 vaccine in the United States following the vaccine’s successful manufacture and approval.” The $1.95 million deal also allowed the US government to acquire an additional 500 million doses.
Preliminary data released in a pre-print paper earlier this month from Pfizer and BioNTech said the vaccine appeared safe and elicited antibody and T-cell immune responses in a Phase 1/2 trial. The company had said it could start a Phase 3 trial of the vaccine in late July if it received regulatory approval.
“We selected BNT162b2 as our lead candidate for this Phase 2/3 trial upon diligent evaluation of the totality of the data generated so far. This decision reflects our primary goal to bring a well-tolerated, highly effective vaccine to the market as quickly as possible, while we will continue to evaluate our other vaccine candidates as part of a differentiated COVID-19 vaccine portfolio,” Sahin said. The companies have three other experimental vaccines in the works.
“By the end of the trial, the Phase 2/3 study is expected to be active at approximately 120 clinical investigational sites around the world, including 39 states across the United States and countries including Argentina, Brazil, and Germany. Investigator sites are selected based on factors including scientific expertise and capabilities, the epidemiology of the disease, and prior experience conducting clinical trials,” Pfizer said in the statement.
From CNN’s Abel Alvarado
Bolivia's interim president Jeanine Añez said she was discharged from a hospital after recovering from coronavirus.
“Thank you with all my heart for the love and support during my coronavirus disease,” Añez tweeted Monday. “Your displays of affection gave me strength to keep going. Bolivians, we are a great family. We will move forward.”
Añez announced on July 9 that she had tested positive for coronavirus.
At least 14 other government officials in Bolivia announced they also tested positive for coronavirus.
Bolivia reported a total of 69,429 Covid-19 cases on Sunday and 2,583 deaths, according to the country’s health ministry.
From Rodrigo Pedroso and Ben Tinker
São Paulo state Gov. João Doria said he expects Brazilians to receive vaccinations against novel coronavirus in January if the trials in progress are successful.
"At the end of the year, with no complications in the tests, we will be able to start production in December and have vaccinations in January, not only in São Paulo but in the country," Doria said during a news conference Monday.
Chinese firm Sinovac began trials last week in São Paulo, and US pharma giant Pfizer plans to do so soon, bringing a race among powers to prove their vaccine works first. Oxford is also entering phase three of trials for its vaccine in São Paulo City.
Meanwhile, US President Trump said in a briefing that vaccine trials are progressing "under Operation Warp Speed."
"Not only is operational warp speed accelerating the development of the vaccine, we are also directing a colossal industrial mobilization to ensure its rapid delivery," Trump said. "America will develop a vaccine very soon, and we will defeat the virus. We will have it delivered in record time."
There are currently 25 vaccines in human trials around the world: four in the US, seven in China, two in the UK, two in Germany, one in South Korea, one in Russia, two in India, one in Japan, one in Canada, three in Australia, one in Singapore and 140 are in preclinical trial around the world, according to the World Health Organization.
From CNN's Hollie Silverman and Elizabeth Stuart
George Washington University in Washington, DC, announced Monday that undergraduate courses will be given online for the fall 2020 semester, with limited exceptions.
In addition, most graduate programs will also be conducted online, except for a few in-person classes.
On-campus housing will be provided for a limited number of students with extenuating personal or academic circumstances, according to a letter sent by university president Thomas J. LeBlanc and other university leaders.
"We know just how much many of you were looking forward to being on campus this fall, and we understand that this news is disappointing," the letter said. "However, we must always make the decisions that best support the health, safety and care of our community while fulfilling our core academic mission."
GW will be giving a 10% tuition reduction to all undergraduate students who do not return to campus in the fall, recognizing both the financial difficulties that some students are under, and that students who remain at home "will not have access to certain in-person resources they would have had as residential students."
According to GW's website, it is the largest higher education institution in DC, with more than 26,000 students. GW is also one of DC's largest private employers.
From CNN's Ross Levitt
The CEOs of Hilton, Marriott International, and Hyatt Hotels are urging President Trump and Congress to take a stronger role in making Covid-19 testing faster and more effective.
According to a letter Monday addressed to Trump and Congressional leaders, 14 CEOs from some of the biggest US travel companies say more efficient testing is crucial to a sustained economic recovery. Testing around the country has slowed in recent weeks, with results taking two weeks or more.
"The travel industry has aggressively gathered data on the coronavirus outbreak and its fallout," the letter states, adding that its analysis shows that "broader testing—in concert with other key factors such as a robust federal policy framework of relief and stimulus, rigorous health and safety standards adopted by travel-related businesses, and the universal embrace of good health practices (such as the wearing of masks) by the public—is an essential component of reopening and recovery."
The group says that results should be available within 24-28 hours, and is asking that provisions to improve testing methods be incorporated in the next legislative package.
The travel industry has taken a big financial hit during the pandemic. Several travel brands, including Hyatt and Hilton, have announced layoffs. Hotel stays have fallen nearly 40% from this time last year.
CNN's Vanessa Yurkevich contributed to this report.
From CNN's Paul LeBlanc
The University of Notre Dame announced Monday it will withdraw from hosting the first presidential debate in September due to concerns about the coronavirus pandemic.
The debate, scheduled for Sept. 29, will now take place at Case Western Reserve University in Cleveland.
Notre Dame said in a statement that Father John Jenkins, the president of the university, "made what he called 'this difficult decision because the necessary health precautions would have greatly diminished the educational value of hosting the debate on our campus.'"
He added: "I am grateful to the many members of the University community who have devoted countless hours planning this event, and to the Commission on Presidential Debates leadership for their professionalism and understanding. But in the end, the constraints the coronavirus pandemic put on the event — as understandable and necessary as they are — have led us to withdraw.”
From CNN’s Wes Bruer
Researchers hope to have 15,000 participants enrolled in the Phase 3 trial of the Moderna Covid-19 vaccine by the end of the week, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said during a call with reporters on Monday.
“I'm not sure that we're going to get there, but hopefully we'll get as many as we possibly can in order to keep our timeline the way we want it to be,” he said.
The first dose of a vaccine candidate in the Phase 3 trial took place Monday morning in Savannah, Georgia. The trial is expected to enroll about 30,000 adult volunteers.
The start of Moderna’s Phase 3 vaccine candidate trial on Monday is “the best we in the United States have ever done,” Fauci said.
Fauci said it took 62 days from the time the virus sequence was made publicly available for Moderna to start a Phase 1 trial.
“And now six months later, we’re beginning a Phase 3 trial,” Fauci said.
From CNN’s Rebekah Riess
Kentucky Gov. Andy Beshear announced Monday additional steps to combat the coronavirus pandemic, including closing bars and limiting indoor restaurant capacity to 25%
Bars will be closed for two weeks, effective tomorrow, the governor said.
While the state will be reducing indoor restaurant capacity to 25%, outdoor seating can continue with social distancing.
“We are going to work with our cities and localities to do what we need to do administratively, to allow that outside seating to expand,” Beshear said.
Additionally, the governor has recommended that schools postpone in-person instruction until the third week in August.
“Now it’s time to do the things that we got to do, given the stage that we’re in, to control this virus. And I know there ended up being questions out there about ‘why didn’t you take this step four weeks ago, or six weeks ago?’ Listen, this virus doesn’t care about our schedules,” the governor added.
