Biologics

Moderna Covid Vaccine SEC Filing

In a filing with the Securities and Exchange Commission, Moderna says the Phase 1 clinical trial of its mRNA-1273 potential vaccine against the novel coronavirus SARS-CoV-2 (Covid-19) is proceeding according to protocol. The study is being led by the National Institutes of Health, the filing says, with the first of 45 healthy adult participants in Washington state dosed 3/16.

The study is evaluating the safety and immunogenicity of three dose levels of mRNA-1273 administered on a two-dose vaccination schedule given 28 days apart. Study participants will be followed through 12 months after the second vaccination, the company says.

The Moderna filing also discusses the impact of the Covid-19 pandemic on the company, noting that if it continues to spread, company business operations could be delayed or interrupted, including clinical trials.

The filing says that while a company official told Goldman Sachs that it is scaling up manufacturing capacity toward the production of millions of doses of mRNA-1273 per month, its ability to make this many “is contingent on investments in the scale-up and further buildout of the company’s existing manufacturing infrastructure.”

In an online post, TechCrunch says Moderna’s is the first potential vaccine to enter human trials in the U.S. While company officials said that mass production of a successful vaccine could be 12-18 months away, they also said they would seek an FDA emergency use authorization to offer it to healthcare workers in early fall. The newsletter says the proposed vaccine makes use of messenger RNA, rather than relying on either a small or inactive sample of the COVID-19 virus itself, the source of most existing effective vaccines. “The mRNA method means there is no actual virus introduced to subjects who receive it, which in turn means that they are not at risk of actually contracting the virus from the vaccine itself, which can be an issue in the testing and development phase of any traditional virus-based immune therapy,” it says.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome