Archive for the ‘moderna’ Category

COVID vaccine makers vow science—not Trump—will dictate release timing

September 8th, 2020
Woman receives an experimental COVID-19 vaccine at the University of Massachusetts Medical School in Worcester, MA on September 04, 2020, as part of a clinical trial.

Enlarge / Woman receives an experimental COVID-19 vaccine at the University of Massachusetts Medical School in Worcester, MA on September 04, 2020, as part of a clinical trial. (credit: Getty | Boston Globe)

In an extraordinary move Tuesday, nine top pharmaceutical executives made a public pledge that they will not prematurely release a COVID-19 vaccine and that they will only seek federal approval to distribute a vaccine after rigorous ethical and scientific standards are met.

The pledge was signed by the CEOs of AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax, Pfizer, and Sanofi. All of the represented companies are working on a vaccine against COVID-19 and four—AstraZeneca, Moderna, and a joint venture between BioNTech and Pfizer—have vaccines in phase 3 clinical trials.

The vow appears to be a coordinated resistance to pressure from the Trump administration, which is pushing for a rollout of a vaccine by November 1, just before the presidential election. Last week, the Centers for Disease Control and Prevention told states to be ready to start distributing vaccines by November 1.

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Posted in Astrazeneca, CDC, COVID-19, fda, gsk, infectious diseases, moderna, Pfizer, public health, SARS-CoV-2, science, Trump, vaccine | Comments (0)

Moderna begins first late-stage US trial of COVID-19 vaccine

July 27th, 2020
Image of a woman in a lab coat holding scientific instruments.

Enlarge / A research associate works at the Moderna Therapeutics Inc. lab in Cambridge, Massachusetts. (credit: Bloomberg/Getty Images)

Moderna has given the first doses of its experimental COVID-19 vaccine to participants in what will be a 30,000-person trial, as the United States moved into a new phase of the race to develop a vaccine by the start of next year.

The Boston-based biotech said on Monday that it had begun the first Phase III study of a vaccine in the US, a large-scale trial that is usually the last before a new product is submitted for regulatory approval.

The company’s shares were up as much as 10.6 percent before paring some of their gains.

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Meet the 4 frontrunners in the COVID-19 vaccine race

July 23rd, 2020
A volunteer receives an injection from a medical worker during the country's first human clinical trial for a potential vaccine against COVID-19 at the Baragwanath Hospital on June 28, 2020 in Soweto, South Africa. It is reported that Africa's first COVID-19 vaccine trial began on June 24 in South Africa. The vaccine, developed by Oxford University's (UK) Jenner Institute, will inoculate 2,000 South Africans.

Enlarge / A volunteer receives an injection from a medical worker during the country's first human clinical trial for a potential vaccine against COVID-19 at the Baragwanath Hospital on June 28, 2020 in Soweto, South Africa. It is reported that Africa's first COVID-19 vaccine trial began on June 24 in South Africa. The vaccine, developed by Oxford University's (UK) Jenner Institute, will inoculate 2,000 South Africans. (credit: Getty | Felix Dlangamandla)

Researchers have now reported data from early (and small) clinical trials of four candidate COVID-19 vaccines.

So far, the data is positive. The vaccines appear to be generally safe, and they spur immune responses against the novel coronavirus, SARS-CoV-2. But whether these immune responses are enough to protect people from infection and disease remains an important unknown.

The four candidates are now headed to larger trials—phase III trials—that will put them to the ultimate test: can they protect people from COVID-19 and end this pandemic?

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Posted in antibodieis, Astrazeneca, cansino, china, COVID-19, Features, immune system, immune system response, immunity, immunology, moderna, mRNA, Pfizer, public health, SARS-CoV-2, science, vaccines | Comments (0)

COVID vaccine execs hyped vague data to cash in $90M in stock, watchdog says

June 4th, 2020
Moderna Inc. headquarters in Cambridge, Massachusetts.

Enlarge / Moderna Inc. headquarters in Cambridge, Massachusetts. (credit: Getty | Bloomberg)

An anti-corruption watchdog is pressing the US Securities and Exchange Commission to investigate executives of the biotech company Moderna after they cashed in about $90 million in company shares days after promoting “positive" but vague data from its early COVID-19 vaccine clinical trial.

The watchdog group, Accountable.US, called the timing of the trades suspicious and questioned whether executives coordinated their stock sales prior to the data release.

In a letter to the SEC that was released to CBS Moneywatch, Accountable.US President Kyle Herrig wrote, "This misconduct was particularly egregious because it involved not only financial fraud and manipulation of the financial markets, but also because it exploited widespread fears surrounding the ongoing COVID-19 pandemic.” In all, the executives' exploitation served to "boost the company's value, as well as their own bank accounts.

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Posted in antibodies, COVID-19, insider trading, moderna, NIH, Pharmaceutical industry, public health, SARS-CoV-2, science, SEC, vaccine | Comments (0)