>>13280234

Coincidence?

March 21, 2021

José Baselga, renowned cancer researcher and AstraZeneca oncology R&D head, dies at 61

José Baselga, a storied oncology researcher and pharmaceutical executive whose discoveries helped pave the way for new breast cancer therapies, died Sunday at the age of 61.

His death was confirmed by AstraZeneca, where Baselga had been serving as executive vice president for research and development in oncology. The company did not provide a cause of death; the Spanish newspaper La Vanguardia reported it was Creutzfeldt-Jakob disease, a rare brain infection that causes degeneration and death.

Baselga had joined AstraZeneca two years ago, after his academic career ended amid a conflict-of-interest scandal at Memorial Sloan Kettering Cancer Center.

“An outstanding scientific leader, José leaves a lasting legacy in the scientific community and here at AstraZeneca,” company CEO Pascal Soriot said in a statement. Soriot added of Baselga, “His visionary leadership, deep scientific expertise and strategic insight have delivered so many achievements that we can all be proud of and that will benefit patients’ lives in the years to come.”

Anas Younes, who worked with Baselga in academia and at AstraZeneca and had known him since 1986, told STAT that Baselga was “ambitious, resilient, caring, brilliant — and joyful.”

“People don’t understand that — he was a really funny person to be around,” Younes said.

Baselga had both an M.D. and Ph.D., and his academic career included stops at Vall d’Hebron University Hospital in his native Spain, Massachusetts General Hospital, and Memorial Sloan Kettering, where he was ultimately chief medical officer and physician-in-chief.

During his career, Baselga was involved in the clinical development of multiple cancer therapies, including trastuzumab (also known as Herceptin), according to a biography from the American Association for Cancer Research. His scientific pursuits focused on finding therapeutic agents based on genetic mutations and molecular targets on tumors, and on investigating how cancers became resistant to treatment.

Baselga was best known as a breast cancer researcher, but in his leadership at MSKCC, he shaped scientific strategies across disease types, Younes said.

During his academic career, Baselga collaborated with and served as an adviser to startups as well as major pharmaceutical companies, which is common for investigators working on taking potential treatments from research labs into patients.

But in 2018, ProPublica and the New York Times reported that Baselga had failed to disclose receiving millions of dollars from drug and other health care companies in research articles he published in academic journals. Baselga told the news organizations the omissions had been unintentional.

Baselga resigned from MSKCC soon after, and in January 2019, joined AstraZeneca as the drug maker shifted more of its focus to cancer.

He is survived by his wife, Silvia, and four children.

“José was more than a colleague to me,” Soriot’s statement said. “He was a friend, and someone I immensely respected and cherished. I will enormously miss having him alongside me, and I will continue to be inspired by his work and vision.”

https://www.statnews.com/2021/03/21/jose-baselga-astrazeneca-renowned-cancer-researcher-dies-at-61/

>>13280234

>>13280336

>>13280343

Federal agency raises 'concern' about AstraZeneca vaccine trial data

Results from AstraZeneca's recent Covid-19 vaccine trial "may have included outdated information" that "provided an incomplete view of the efficacy data," a federal health institute said early Tuesday.

The National Institute of Allergy and Infectious Diseases issued the unusual statement after AstraZeneca announced Monday that the trial showed no serious side-effects, and that it was 100 percent effective in stopping severe and fatal cases.

The NIAID said that it had been notified late Monday about the "concern" by the the data and safety monitoring board, a panel of independent experts that reviews safety and efficacy data for vaccines in the United States.

"We urge the company to work with the DSMB to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible," it said, using the acronym for the data and safety monitoring board.

The agency, which is part of the National Institutes of Health, did not suggest that the vaccine made by AstraZeneca and Oxford University is unsafe or ineffective against the coronavirus. It has been taken by tens of millions of people around the world and approved by dozens of other countries' regulators.

NBC News has reached out to AstraZeneca for comment.

This is a breaking news story, please check back for more updates.

https://www.msn.com/en-us/news/world/federal-agency-raises-concern-about-astrazeneca-vaccine-trial-data/ar-BB1eREkb

>>13280234, >>13280336, >>13280343, >>13280357

niaid.nih.gov

Statement—Investigational AstraZeneca Vaccine Prevents COVID-19

March 22, 2021

Results from a large clinical trial in the United States and South America indicate that AstraZeneca’s COVID-19 vaccine, AZD1222, is well-tolerated and protects against symptomatic COVID-19 disease, including severe disease or hospitalization. The independent Data and Safety Monitoring Board (DSMB) overseeing the trial identified no safety concerns related to the vaccine. The United Kingdom-based global biopharmaceutical company AstraZeneca developed the vaccine and led the trial as regulatory sponsor.

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response, provided funding support for the trial through the federal COVID-19 response.

The placebo-controlled trial began in August 2020. The analysis is based on results from 32,449 adult volunteer participants enrolled across 88 sites in the United States, Chile and Peru. One participant received a placebo for every two participants who received AZD1222, resulting in approximately 20,000 people receiving the investigational vaccine. The vaccine was administered as two doses of 5 x1010 viral particles four weeks apart.

AZD1222 demonstrated statistically significant vaccine efficacy of 78.9% in preventing symptomatic COVID-19 and 100% efficacy in preventing severe or critical disease and hospitalization.In participants 65 years and older, who comprised 20% of the trial population, vaccine efficacy against symptomatic COVID-19 was 79.9%.

The DSMB conducted a review of thrombotic events (blood clots) and cerebral venous sinus thrombosis (CVST) among participants and found no increased risk of these conditions in vaccinated participants.

Approximately 79% of participants were white, 22% were Hispanic, 8% were Black or African American, 4% were Native American, including American Indian/Alaska Native participants residing in the U.S., and 4% were Asian. Vaccine efficacy was consistent across ethnicity. Approximately 60% of participants of any age had underlying health conditions associated with an increased risk of developing severe COVID-19, such as diabetes, severe obesity or cardiac disease.

Authorization and guidelines for use of the vaccine in the United States will be determined by the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) after thorough review of the data by independent advisory committees. Today’s results build on data from multiple clinical trials of AZD1222 conducted worldwide. The World Health Organization has recommended use of the vaccine for prevention of COVID-19 in adults and it is currently available for use in more than 70 countries. The European Commission has granted a conditional marketing authorization for the vaccine in the European Union.

The current trial defined symptomatic COVID-19 as having SARS-CoV-2 infection and at least one respiratory symptom (pneumonia, shortness of breath or low oxygen requiring supplemental oxygen) or at least two of the following symptoms: fever, new or worsening cough, muscle pain, fatigue, vomiting and/or diarrhea, and loss of smell and/or loss of taste. Severe or critical COVID-19 was defined as having SARS-CoV-2 infection and any of the following: clinical signs of severe systemic illness, respiratory failure (defined as needing high-flow oxygen, noninvasive ventilation, mechanical ventilation or extracorporeal membrane oxygenation, known as ECMO), evidence of shock, significant acute renal, hepatic or neurologic dysfunction, or admission to an intensive care unit or death.

cont…

https://www.niaid.nih.gov/news-events/statement-investigational-astrazeneca-vaccine-prevents-covid-19

>>13280393

Statement—Investigational AstraZeneca Vaccine Prevents COVID-19

AZD1222 was developed by Oxford University’s Jenner Institute and Oxford Vaccine Group and then licensed to AstraZeneca for further development. It is a viral vector-based vaccine that uses a safe, non-replicating chimpanzee adenovirus to deliver the genetic code of a protein found on the surface of SARS-CoV-2 (called the spike protein) to human cells so that the cells can make the protein. Adenoviruses can cause the common cold in humans, but the virus has been modified so that it cannot replicate and cause disease. The technology is based on a vaccine that Oxford previously was developing for Middle East respiratory syndrome coronavirus (MERS-CoV). AZD1222 can be stored, transported and handled at 36 to 46 degrees Fahrenheit (normal refrigeration temperatures) for at least six months.

A DSMB formed by NIH monitored the trial to ensure participant safety and the validity and integrity of the data. The same DSMB is overseeing other ongoing Phase 3 vaccine clinical trials as part of the federal COVID-19 response effort. Representatives from AstraZeneca, NIAID and BARDA receive recommendations from the DSMB.

Sites that are part of the COVID-19 Prevention Network (CoVPN) enrolled volunteers in the clinical trial. The CoVPN is composed of existing NIAID-supported clinical research networks with infectious disease expertise and was designed for efficient and thorough evaluation of vaccine candidates and monoclonal antibodies for the prevention of COVID-19. CoVPN investigators Ann R. Falsey, M.D., professor of medicine, University of Rochester School of Medicine in New York, and Magdalena E. Sobieszczyk, M.D., associate professor of medicine at Columbia University Medical Center in New York, are coordinating investigators for the trial.

Participants will continue to be followed as part of the trial for approximately two years following their second injection. More details about the trial are available at PreventCovid.org and at clinicaltrials.gov under identifier NCT04516746.

Content last reviewed on March 22, 2021

https://www.niaid.nih.gov/news-events/statement-investigational-astrazeneca-vaccine-prevents-covid-19