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5:31 a.m. Dec. 28, 2020 - By Ciara Linnane
Novavax starts Phase 3 COVID vaccine trial with plans to enroll 30,000 volunteers in U.S. and MexicoNovavax Inc. said Monday it is starting a late-stage trial of its COVID-19 vaccine candidate with plans to enroll up to 30,000 volunteers at about 115 sites in the U.S. and Mexico. The trial is being supported by partners of Operation Warp Speed, the federal government program that aims to quickly develop vaccines and therapies, including the Department of Defense and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response. Barda is providing up to $1.6 billion to fund the trial under a Department of Defense agreement. The trial will be randomized, placebo-controlled and will evaluate the efficacy of the treatment, called NVX-CoV2373, in patients aged 18 and older. Shares were slightly higher Monday, and have gained more than 3,000% in 2020 on hopes for the vaccine.
3:18 a.m. Dec. 10, 2020 - By Ciara Linnane
Moderna doses first patients in Phase 2/3 study of COVID-19 vaccine in adolescents Moderna Inc. said Thursday it has dosed the first participants in a Phase 2/3 study of its COVID-19 vaccine candidate in adolescents aged 12 to less than 18. The study is being conducted in collaboration with Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services. The biotech is aiming to generate data in the spring of 2021 that will support the use of the vaccine in that age group, Chief Executive Stéphane Bancel said in a statement. The trial will be randomized and include a control group and the company is aiming to enroll 3,000 participants in the U.S. who will be monitored for 12 months after the second dose. Shares rose 1.5% in premarket trade, but have gained 701% in the year to date, while the SPDR S&P Biotech ETF has gained 44% and the S&P 500 has gained 13.7%.
2:18 a.m. Dec. 7, 2020 - By Quentin Fottrell
Joe Biden’s pandemic plan: Restore Obamacare, mandatory masks, paid sick leave and free COVID-19 tests The President-elect said: ‘Dealing with the coronavirus pandemic is one of the most important battles our administration will face’The President-elect said: ‘Dealing with the coronavirus pandemic is one of the most important battles our administration will face.’
4:36 a.m. Dec. 4, 2020 - By Ciara Linnane
Moderna to provide Israel health ministry with additional 4 million doses of its COVID-19 vaccine candidateModerna Inc. said Friday it is amending its supply agreement with the Israeli health ministry and will provide an additional 4 million doses of its experimental COVID-19 vaccine mRNA-1273. The amendment brings the total number of doses secured by Israel to 6 million. The vaccine is currently awaiting review for an emergency use authorization in the U.S., and has been submitted for approval in Europe. The company has initiated the rolling regulatory review process with the Ministry of Health in Israel, it said in a statement. The vaccine has proven to have 94% efficacy in a preliminary analysis of a Phase 3 trial conducted on 196 cases. The trial involves more than 30,000 participants and is being conducted with the NIAID part of the NIH and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services. Moderna is also working to scale up manufacturing and aims to deliver about 500 million doses a year and up to 1 billion doses a year starting in 2021. Shares were slightly lower premarket, but have gained 704% in the year to date, while the JSPDR S&P 500 Biotech ETF has gained 41% and the S&P 500 [ has gained 13%.
9:47 a.m. Nov. 9, 2020 - By Quentin Fottrell
Joe Biden announces his COVID-19 task force The team of public-health experts will advise the Biden administration and the transition’s COVID-19 staffThe team of public-health experts will advise the Biden administration and the transition’s COVID-19 staff.
2:39 a.m. Aug. 13, 2020 - By Ciara Linnane
Moderna stock rally fades as analysts weigh in on what U.S. government supply deal means for COVID-19 vaccine pricing ‘We now await visibility on what agreements with other countries might look like but see the news as a positive signal re: Moderna’s potential entry into a commercial space often dominated by big-cap,’ says one analystThe rally in Moderna Inc. shares sparked by news late Tuesday that the U.S. government has ordered 100 million doses of its COVID-19 vaccine candidate dissipated on Wednesday, as analysts weighed in on what the order means for pricing.
11:09 a.m. July 17, 2020 - By Ciara Linnane
Coronavirus update: Global cases of COVID-19 edge closer to 14 million as U.S. sets record case tally, Brazil tops 2 million Netflix’s blowout quarter is overlooked as investors focus on a lackluster second half, and cruise operators sink as CDC extends ‘no-sail’ order The number of confirmed cases of the coronavirus illness COVID-19 edged closer to 14 million on Friday, as the U.S. counted a record number of cases in a single day and regions around the world resumed restrictions on movement in a battle to contain the spread.
11:07 a.m. July 7, 2020 - By Ciara Linnane
Coronavirus update: U.S. COVID-19 cases climb above 2.9 million; ‘We’re still knee-deep in the first wave,’ Dr. Fauci warns Novavax stock rockets on news of $1.6 billion in funding from U.S. government’s accelerated vaccine program ‘Operation Warp Speed’The number of U.S. cases of the coronavirus illness COVID-19 climbed above 2.9 million on Tuesday, as Dr. Anthony Fauci warned Americans the country is “still knee deep in the first wave,” and reiterated his message to young people that they are not invulnerable.
5:25 a.m. July 4, 2020 - By Jaimy Lee
After months of speculation, investors get excited about Pfizer, BioNTech’s coronavirus vaccine candidate FDA’s new guidelines for vaccine development ‘do not suggest that a widely usable vaccine will be available at ‘warp speed’ in 2020,’ says one analystThe path to a COVID-19 vaccine has started to come into view this week, following the stock-moving disclosures of preliminary clinical data for two candidates and a rigorous new regulatory road map from the Food and Drug Administration.
11:55 a.m. May 11, 2020 - By Ciara Linnane
Coronavirus update: Global case tally tops 4.1 million; South Korea reports cluster from Seoul nightclubs, and Wuhan, China, has 4 new cases Tesla sues California county stopping its Fremont plant from reopening and AMC stock soars on report of takeover talks with AmazonThe number of cases of COVID-19 rose above 4.1 million on Monday, as South Korea reported a new cluster stemming from Seoul’s nightclub district and China reported four new cases in Wuhan, the city believed to be the source of the outbreak late last year.
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