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It’s time to consider delaying the second dose of coronavirus vaccine
https://www.washingtonpost.com/opinions/2021/01/03/its-time-consider-delaying-second-dose-coronavirus-vaccine/
The Washington Post; Wachter RM and Jha AK.

Until recently, we supported the strict vaccine regimen, requiring two doses within a month. Both the Pfizer and Moderna clinical trials were carried out this way, and the much-touted 95 percent efficacy rates were drawn from those trials. But as Mike Tyson famously said, “Everybody has a plan until they’ve been punched in the mouth.”

How Safe Is It to Switch and Space COVID-19 Vaccine Doses?
https://www.medscape.com/viewarticle/943562

Jan 6th, 2021 - LONDON/CHICAGO (Reuters) - Britain and other nations are considering ways to stretch scarce supplies of COVID-19 vaccines, including by delaying second doses, reducing dose sizes and switching vaccine types between the first and second shots. The proposals have generated fierce debate among scientists. Here is the rationale behind, and criticism of, these alte...

Experts Debate Wisdom of Delaying Second COVID-19 Vaccine Dose
https://www.medscape.com/viewarticle/943533

Jan 4th, 2021 - Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center. A proposal to delay administration of the second dose of COVID-19 vaccines — suggested as a strategy to boost the number of people who get some degree of protection from a single immunization with the Pfizer/BioNTech or Moderna vaccines — is inciting a strong debate among clinicians and public health of...

CDC Panel Sounds Alarm on COVID Variants, Even as Vaccine Supply Rises
https://www.medscape.com/viewarticle/946741

Mar 2nd, 2021 - Editor's note: Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center. Expanding the number of Americans vaccinated against SARS-COV-2 will aid in the fight against emerging variants of the virus, but the challenges of having only a limited supply of COVID-19 shots will persist for some time, federal advisers and government scientists agreed in a panel discussion o...

South Africa BCG booster trials seek low-cost weapon against COVID-19
https://www.reuters.com/article/us-health-coronavirus-safrica-vaccine/south-africa-bcg-booster-trials-seek-low-cost-weapon-against-covid-19-idUSKBN22V15I

May 20th, 2020 - CAPE TOWN (Reuters) - The idea of testing the BCG vaccine in Africa against COVID-19 was bound to cause controversy, yet officials say efforts underway could, if successful, give the continent a cheap and easily deployable weapon against the virus. South African biotech group TASK this month started the continent’s first trial to see whether 250 high-risk workers given a booster dose of ...

Neoadjuvant Melanoma Therapy: Patient Selection
https://www.onclive.com/view/neoadjuvant-melanoma-therapy-patient-selection

Apr 2nd, 2021 - Brian Gastman, MD: When do we think about neoadjuvant treatment? Neoadjuvant treatment is important in the era of COVID-19 [coronavirus disease 2019] because we may not be able to get a patient in anyway, so the fact that there is a concept of neoadjuvant treatment is important. I was part of the NCCN [National Comprehensive Cancer Network] ad hoc guidelines for what to do with melanoma during ...

Pharma Innovation Is Saving the World
https://www.onclive.com/view/pharma-innovation-is-saving-the-world

Jan 19th, 2021 - In March 2020, the United States was in the early stages of the coronavirus disease 2019 (COVID-19) pandemic. We shut down the entire country and ground the economy to a halt to slow the spread of the virus. Think about how much uncertainty we were living under. Nine months later, the FDA approved 2 COVID-19 vaccines under emergency authorization. Before New Year’s Day, millions of Ameri...

Let Me Tell You About My Vaccine
https://www.medscape.com/viewarticle/949424

Apr 16th, 2021 - Editor's note: Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center. Welcome to our national obsession: Vaccines! You may have noticed – it’s all talk, all the time, with short breaks to discuss what we’re watching on Netflix. For months, every session with almost every patient includes a commentary on someone they know who has gotten "the sh...

UK COVID-19 Update: England's Unlocking Going Ahead, NHS Staffing Pressures Mounting
https://www.medscape.com/viewarticle/954598

Jul 12th, 2021 - Editor's note, 12 July 2021: This article was updated with new information from the Commons, a Downing Street briefing, and additional comments. These are the UK coronavirus stories you need to know about today. England's Unlocking Going Ahead England's Health Secretary Sajid Javid told the Commons plans to remove COVID-19 restrictions in England will go ahead next week. He said delay...

Variants or 'Scariants': Are the Threats Real or Just Media Hype?
https://www.medscape.com/viewarticle/946641

Mar 2nd, 2021 - Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center. "Scariants" are COVID-19 variants of concern but without proven or peer-reviewed data. "All variants are innocent until proven guilty." Of the highest concern are variants that are infectious, virulent, and have immune evasion. We don't have any variants with all three of those properties. However, the ...

UK COVID-19 Update: 'Unprecedented Pressure', Staff Jabs, Photocall Fail
https://www.medscape.com/viewarticle/943715

Jan 7th, 2021 - Editor's note, 7 January 2021: This article was updated with new information from a Downing Street briefing. Doctors' Association UK described the announcement as "brilliant news". Hancock's Photocall Fail GPs in England began the main roll out of the Oxford/AstraZeneca vaccine today with 180 GP-led services due to come online this week. Matt Hancock arrived to mark this with a photocall...

UK COVID-19 Update: BMA's Lockdown Exit Plan, 'Exciting' Vaccine News
https://www.medscape.com/viewarticle/941200

Nov 18th, 2020 - These are the UK coronavirus stories you need to know about today. BMA's Lockdown Exit Strategy The BMA has issued a strategy document for England's exit from the current lockdown on 3 December. It says measures are needed to bridge the gap until widespread vaccination. Recommendations include: Reforming Test and Trace with more local involvement Replacing the 'rule of six' with a two household...

COVID-19 Jumpstarts RNA Cancer Vaccine Field
https://www.onclive.com/view/covid-19-jumpstarts-rna-cancer-vaccine-field

Apr 8th, 2021 - The success of the COVID-19 vaccines based on messenger RNA has led to a surge of interest from investigators, pharmaceutical companies, and investors in similar technology for other diseases, including a number of oncology indications. Experts say approved mRNA therapies for cancer are still years away, but several vaccines for melanoma and other malignancies are being evaluated ...

Hormonal Agents Improve Survival in mCSPC, but Novel Targets Are Needed For Further Drug Development
https://www.onclive.com/view/hormonal-agents-improve-survival-in-mcspc-but-novel-targets-needed-for-further-drug-development

Feb 25th, 2021 - Although intensified therapy with hormonal agents like apalutamide (Erleada), enzalutamide (Xtandi), and abiraterone acetate (Zytiga) has improved survival in patients with metastatic castration- sensitive prostate cancer (mCSPC), new targets and novel approaches are necessary for those who progress on these agents, according to Neeraj Agarwal, MD. By moving novel hormonal therapies to the up-...

An Autopsy of Breast Cancer Management Amidst the COVID-19 Pandemic
https://www.onclive.com/view/an-autopsy-of-breast-cancer-management-amidst-the-covid-19-pandemic

Mar 7th, 2021 - One year into the COVID-19 pandemic has allowed for some reflection on the different evolutions that the oncology community went through in response to the many challenges posed by the virus. Cancer screenings plummeted. Treatment plans were rapidly adapted to reduce the risk of unnecessary infection. The utility of telemedicine took the world by storm. Investigators from all over the globe jo...

A Desire to Be a Healer Drives Breast Cancer Expert Forward
https://www.onclive.com/view/a-desire-to-be-a-healer-drives-breast-cancer-expert-forward

Apr 23rd, 2021 - Sara A. Hurvitz, MD, can remember the exact moment she decided to become an oncologist. It was her first day at the University of Southern California (USC) School of Medicine, which she had entered in 1995 without a firm idea of what discipline she wanted to pursue. Alexandra Levine, MD, a pioneering investigator into lymphomas and AIDS-related malignancies who was then chief of hematology at ...

More Innovation Is on Tap for 2021: Five Experts Describe Key Trends
https://www.onclive.com/view/more-innovation-is-on-tap-for-2021-five-experts-describe-key-trends

Jan 8th, 2021 - The development of additional molecularly targeted therapies and the search for enhanced immunotherapy regimens are expected to permeate the oncology landscape across a broad range of malignancies as 2021 unfolds, according to experts. Those were among the key trends for the New Year that experts in breast, lung, genitourinary, and hematologic malignancies described in interviews with Oncology...

North Coast Biologics - 607532 - 05/21/2020
http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/north-coast-biologics-607532-05212020

Product: Biologics Drugs Recipient: Recipient Name Johnny T. Stine North Coast Biologics 4025 Stone Way N Seattle, WA 98103 United States Johnny@northcoastbio.com Issuing Office: Center for Biologics Evaluation and Research (CBER) United States Federal Trade Commission WARNING LETTER Date:   May 21, 2020 RE:     Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) T...

Smarter Nutrition, Inc. - 610024 - 12/28/2020
http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/smarter-nutrition-inc-610024-12282020

Delivery Method: United Parcel Service Product: Drugs Food & Beverages Recipient: Recipient Name Daqing Goa Recipient Title President Smarter Nutrition, Inc. 17870 Newhope St. Suite 104-480 Fountain Valley, CA 92708 United States Issuing Office: Division of Human and Animal Food Operations West V United States WARNING LETTER December 28, 2020 WL 610024 Dear Mr. Goa: This letter is to advise you...