Moderna's Covid-19 vaccine was designed in just two days
From CNN's John Bonifield
Nurse Kathe Olmstead prepares a shot that is part of a possible COVID-19 vaccine, developed by the National Institutes of Health and Moderna Inc., in Binghamton, New York, on July 27. Hans Pennink/AP
Covid-19 vaccine maker Moderna designed its vaccine against the novel coronavirus in just two days.
On Jan. 11, Chinese authorities shared the genetic sequence of the novel coronavirus, according to Moderna's website.
Two days later, on Jan. 13, the National Institutes of Health and Moderna’s infectious disease research team finalized the sequence for mRNA-1273, the formal name of the company's Covid-19 vaccine.
The company then went on to formulate a clinical batch, according to a company spokesperson.
Moderna announced it intends to apply today to the US Food and Drug Administration for authorization of its Covid-19 vaccine.
The company will ask the FDA to review an expanded data set showing the vaccine is 94.1% effective at preventing Covid-19 and 100% effective at preventing severe cases of the disease.
9:34 a.m. ET, November 30, 2020
NYC Mayor Bill de Blasio: "The schools are some of the safest places to be right now"
From CNN's Aditi Sangal
New York City Mayor Bill de Blasio speaks during an interview on November 30. CNN
New York City Mayor Bill de Blasio said schools are some of the safest places in the city while explaining his decision to reopen public elementary schools and resume in-person classes.
“When we laid down that 3% [infection rate threshold,] we did not have the information we have now,” he told CNN. “But now it's time for something different.”
“That 3% standard, after we had so much experience with the schools, proved to be different than we thought it would be,” he added, saying that the model needs to be more sustainable for until there is a coronavirus vaccine. “We decided we need a lot more testing and to make that [available] in every school.”
Students in 3K, Pre-K and grades K-5 can resume in-person classes on Dec. 7 and the city will address when middle and high schoolers can return to in-person classes in the future.
There will be weekly testing in every school, and students will need to be tested and get a consent form to come, de Blasio said about the reopening directives put in place.
The current testing capacity only allows the city to bring back elementary school students. Over time, the city will also bring back middle and high school students, de Blasio said.
In case a student tests positive for Covid-19, the entire classroom will quarantine, he added.
“[If] there's multiple cases in the school, there’s a careful investigation to determine whether the school only needs a temporary shutdown or full two-week quarantine," he said Monday. "That has worked and it's allowed us to keep the vast majority of our schools open the vast majority of the time. But it’s also given us the ability to pinpoint when there's a problem and address it quickly through our test and trace corps.”
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9:44 a.m. ET, November 30, 2020
Where things stand in the race to distribute a coronavirus vaccine
Pfizer Covid-19 vaccine vials. Pfizer
Pharmaceutical company Moderna this morning announced it intends to apply today to the US Food and Drug Administration for authorization of its Covid-19 vaccine.
That means there will be at least two vaccine candidates seeking FDA approval: Earlier this month, Pfizer and BioNTech submitted for emergency use authorization for their coronavirus candidate.
Here's where things stand on the race to develop and distribute a coronavirus vaccine:
When a vaccine could be approved: The FDA plans to make a decision about authorizing Pfizer’s coronavirus vaccine within a few weeks of a key meeting scheduled for Dec. 10, an agency official said last week.
Who might get a vaccine first: Advisers to the US Centers for Disease Control and Prevention have called an emergency meeting for tomorrow to vote on who they recommend should be the first to get a coronavirus vaccine once one is authorized. The CDC has already recommended that the first group — designated as 1a — should include frontline health providers and support personnel. The 1a group likely should also include residents of nursing homes and other long-term care facilities, who have been badly hit by the pandemic, the CDC has said.
How many doses there could be: The federal government has said 40 million coronavirus vaccine doses could be available by the end of December. Dr. Larry Corey of the University of Washington, who is heading up coronavirus vaccine clinical trials in the US, has said if both Pfizer and Moderna get vaccines authorized, they could supply 50 million more doses in January and 60 million more in February and March.
But remember: There are not going to be enough vaccines for everyone at first, so choices have to be made. The CDC estimates there are 21 million healthcare personnel, 87 million essential workers, 100 million adults with high-risk medical conditions and 53 million others 65 and older.
9:28 a.m. ET, November 30, 2020
European Commission agrees vaccine deal with CureVac
From CNN's Sharon Braithwaite
The Logo of Curevac is seen on a sign in front of the CUREVAC building on November 21 in Tuebingen, Germany. Harry Langer/DeFodi Images/Getty Images
The European Commission has signed a Covid-19 vaccine contract with German biopharmaceutical company CureVac, President Ursula von der Leyen announced Monday.
"Today we signed our 5th vaccine contract, with CureVac," von der Leyen tweeted from her official account.
She said the European Commission has now secured almost 2 billion doses of potential coronavirus vaccines and that Europeans would have access to them once they are approved as safe and effective, "hopefully before the end of the year!"
EU Health Commissioner Stella Kyriakides said on Twitter that the deal put European and global citizens and economies another "step closer to delivering a safe and sustainable exit strategy from the crisis."
8:08 a.m. ET, November 30, 2020
Novavax enrolls UK Phase 3 trial, expects US/Mexico trial to launch in “coming weeks"
From CNN's Jamie Gumbrecht
A researcher works on coronavirus vaccine development at Novavax labs in Gaithersburg, Maryland on March 20. Andrew Caballero-Reynolds/AFP/Getty Images
Vaccine maker Novavax has completed enrollment of the Phase 3 trial for its Covid-19 vaccine in the UK, and a large-scale clinical trial in the United States and Mexico will begin “in the coming weeks,” the company announced Monday.
The UK trial enrolled 15,000 participants, and will determine the efficacy and safety of Novavax’s experimental vaccine, called NVX-CoV2373. Interim results from that Phase 3 trial are expected “as soon as early first quarter 2021,” depending on how fast Covid-19 is spreading in the region, the company said.
Novavax also announced it has fully enrolled its Phase 2b vaccine trial in South Africa, with more than 4,400 participants. Among its trials, more than 20,000 participants have been dosed to date.
The Phase 3 clinical trial in the United States and Mexico will begin “in the coming weeks” -- later than it had previously suggested. The vaccine maker said earlier in November that this trial would likely begin by the end of the month.
It would be the fifth coronavirus vaccine to enter late-stage clinical trials in the United States. The Maryland-based company was awarded $1.6 billion from the federal government’s Operation Warp Speed to fund its Phase 3 trial in the US and Mexico and to scale-up manufacturing.
Novavax's vaccine is made by growing synthetic versions of the coronavirus spike protein in armyworm moth cells. The vaccine combines these particles with the company’s adjuvant – a plant-based compound that helps boost the immune response to the vaccine.
##Vaccines#
7:53 a.m. ET, November 30, 2020
Florida hospitalizations have gone up 30% in two weeks
From CNN's Rosa Flores and Denise Royal
The number of Covid-19 patients hospitalized in Florida increased by 30% in the past two weeks from 3,118 to 4,059, according to data from the Covid Tracking Project.
In Miami-Dade County, the count of coronavirus patients requiring ventilators increased by 33% over the past two weeks, the county reported. The number requiring intensive care treatment increased by 18%.
Hospitalizations across the United States reached a record high of 93,238 on Sunday, according to the Covid Tracking Project.
In California, the number of hospitalized patients doubled from 4,000 on November 12 to more than 8,000.
Hong Kong imposes stricter pandemic measures as city records 76 new cases
From CNN’s Sophie Jeong and Eric Cheung in Hong Kong
Hong Kong Chief Executive Carrie Lam during a press conference on Covid-19 measures in Hong Kong on Monday, November 30. Vernon Yuen/Shutterstock
Hong Kong's Chief Executive Carrie Lam announced stricter pandemic measures on Monday, as the city struggles to contain its latest coronavirus outbreak.
The new measures will be in effect for two weeks from Wednesday until December 15.
Hong Kong reported 76 confirmed cases Monday, including nine cases with unknown sources of infection.
The rules include:
Dining services will end at 10 p.m. instead of midnight
The number of people per table will be reduced from four to two
Playgrounds, entertainment venues, karaoke venues, mahjong parlors and swimming pools will close
Government performance venues will open only for rehearsals and online shows
Fitness centers can stay open but are limited to groups of two people
Beauty and massage parlors can stay open under stricter requirements
Amusement parks in Hong Kong, Disneyland and Ocean Park will close
Lam said in the news briefing that the restrictions on gatherings would go back to when it was most stringent, to a maximum of two people. All business premises must display the “Leave Home” app QR codes to help with contact tracing.
On Sunday, Hong Kong suspended face-to-face classes at all kindergartens and schools from Wednesday until after the Christmas holidays.
7:24 a.m. ET, November 30, 2020
America’s Black churches have enlisted the help of mental health professionals during the pandemic
From Aneri Pattani, Kaiser Health News
Keon Gerow, senior pastor at Catalyst Church in West Philadelphia, talks openly about mental health ― from the pulpit and one-on-one with his congregants. Courtesy Kass McIntosh/Kaiser Health News
Black churches in the US say the coronavirus pandemic has catapulted mental health efforts to the forefront of their mission.
Some are preaching about mental health from the pulpit for the first time. Others are inviting mental health professionals to speak to their congregations, undergoing mental health training themselves or adding therapists to the church staff.
"Covid undoubtedly has escalated this conversation in great ways," said Keon Gerow, senior pastor at Catalyst Church in West Philadelphia. "It has forced Black churches -- some of which have been older, traditional and did not want to have this conversation -- to actually now have this conversation in a very real way."
Across the US, mental health needs are soaring. And Black Americans are experiencing significant strain: A study from the Centers for Disease Control and Prevention this summer found 15% of non-Hispanic Black adults had seriously considered suicide in the past 30 days and 18% had started or increased their use of substances to cope with pandemic-related stress.
Yet national data shows Blacks are less likely to receive mental health treatment than the overall population.
Moderna to apply today for FDA authorization of its Covid-19 vaccine with "amazing" extra data
From CNN Health’s Elizabeth Cohen
Pharmaceutical company Moderna intends to apply Monday to the US Food and Drug Administration (FDA) for authorization of its Covid-19 vaccine.
The company will ask the FDA to review an expanded data set showing the vaccine is 94.1% effective at preventing Covid-19 and 100% effective at preventing severe cases of the disease.
This is striking,” said Dr. Paul Offit, a member of the FDA’s vaccine advisory committee. “These are amazing data.”
One other company, Pfizer, has already applied for FDA authorization for a coronavirus vaccine, with efficacy data very similar to Moderna’s results. The FDA is expected to review both companies’ applications in December, and Anthony Fauci, director of the National Institute for Allergy and Infectious Diseases, said he expects the first vaccinations in the US to occur “towards the latter part of December.”
By the end of 2020, Moderna expects to have approximately 20 million doses of its vaccine available in the United States, and it’s on track to manufacture 500 million to 1 billion doses globally next year, according to the company’s news release Monday.
