Biologics

FDA Stresses ‘High Standards’ for Coronavirus Vaccine

FDA has issued an immediately-in-effect guidance, Development and Licensure of Vaccines to Prevent Covid-19, to assist sponsors in developing coronavirus vaccines and to reassure the public that the agency will use high standards in considering any vaccine for approval. The document will remain in effect for the duration of the HHS coronavirus public health emergency.

“This guidance describes FDA’s current recommendations regarding the data needed to facilitate clinical development and licensure of vaccines to prevent Covid-19,” it says. “There are currently no accepted surrogate endpoints that are reasonably likely to predict clinical benefit of a Covid-19 vaccine. Thus, at this time, the goal of development programs should be to pursue traditional approval via direct evidence of vaccine safety and efficacy in protecting humans from SARS-CoV-2 infection and/or clinical disease.”

An agency statement says the guidance reflects advice the agency has been providing over the past several months to companies, researchers, and others. “FDA has the scientific expertise to evaluate any potential Covid-19 vaccine candidate regardless of the technology used to produce or to administer the vaccine,” it says. “This includes the different technologies such as DNA, RNA, protein, and viral vectored vaccines being developed by commercial vaccine manufacturers and other entities.”

FDA says that given the current understanding of SARS-CoV-2 immunology, the goal of development programs at this time should be to support the traditional FDA approval by conducting studies to directly evaluate the ability of the vaccine to protect humans from SARS-CoV-2 infection and/or disease.

The agency says it strongly encourages the use of diverse populations in all phases of clinical development, including populations most affected by Covid-19, specifically racial and ethnic minorities, as well as adequate representation in late phase trials of elderly individuals and those with medical comorbidities. “Sponsors are also encouraged to include studies in their development plans that would provide data to support use during pregnancy, as well as plan for pediatric assessments of safety and effectiveness,” the statement says.

FDA says it would expect that a Covid-19 vaccine would prevent disease or decrease severity in at least 50% of people who are vaccinated. After approval of any vaccine, the agency says, the vaccine must continue to be closely monitored using various existing surveillance systems. “FDA may also require post-marketing studies to further assess known or potential serious risks,” 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

Read more

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