FDA commissioner Stephen Hahn: ‘Decisions about approving vaccines will be based solely on good science’

| | August 12, 2020
FDA Commissioner Stephen Hahn. Credit: Alex Brandon/AP
This article or excerpt is included in the GLP’s daily curated selection of ideologically diverse news, opinion and analysis of biotechnology innovation.

The framework in the United States to support a covid-19 vaccine is now in place. Testing is underway and manufacturing capacity is rapidly expanding. But let’s be clear: The development effort must adhere to standards that will ensure any covid-19 vaccine’s safety and effectiveness.

To prepare for the completion of tests and data submission, our agency has announced that any authorized or approved covid-19 vaccine would need to show that it prevents the disease or decreases its severity in at least 50 percent of people who are vaccinated. This is a reasonable standard given the nature and impact of the pandemic.

One key element in the FDA’s testing requirements is assuring diversity among the test subjects. All phases of vaccine clinical development should include the people most affected thus far by covid-19, specifically racial and ethnic minorities, elderly individuals, and people with other medical conditions. Only by gathering data on these populations can we gain a full understanding of a vaccine candidate’s safety and effectiveness.

Related article:  Esketamine nasal spray, touted as biggest advance in years for treating depression, gets FDA approval
Follow the latest news and policy debates on agricultural biotech and biomedicine? Subscribe to our newsletter.

I have been asked repeatedly whether there has been any inappropriate pressure on the FDA to make decisions that are not based on good data and good science. I have repeatedly said that all FDA decisions have been, and will continue to be, based solely on good science and data. The public can count on that commitment.

Read the original post

Outbreak
Outbreak Daily Digest

podcasts GLP Podcasts More...
Biotech Facts & Fallacies
Talking Biotech
Genetics Unzipped

video Videos More...
stat hospitalai ink st x mod x

Meet STACI: STAT’s fascinating interactive guide to AI in healthcare

The Covid-19 pandemic underscores the importance of the technology in medicine: In the last few months, hospitals have used AI ...

bees and pollinators Bees & Pollinators More...
mag insects image superjumbo v

Disaster interrupted: Which farming system better preserves insect populations: Organic or conventional?

A three-year run of fragmentary Armageddon-like studies had primed the journalism pumps and settled the media framing about the future ...
dead bee desolate city

Are we facing an ‘Insect Apocalypse’ caused by ‘intensive, industrial’ farming and agricultural chemicals? The media say yes; Science says ‘no’

The media call it the “Insect Apocalypse”. In the past three years, the phrase has become an accepted truth of ...

infographics Infographics More...
breastfeeding bed x facebook x

Infographic: We know breastfeeding helps children. Now we know it helps mothers too

When a woman becomes pregnant, her risk of type 2 diabetes increases for the rest of her life, perhaps because ...

GMO FAQs GMO FAQs More...
biotechnology worker x

Can GMOs rescue threatened plants and crops?

Some scientists and ecologists argue that humans are in the midst of an "extinction crisis" — the sixth wave of ...
food globe x

Are GMOs necessary to feed the world?

Experts estimate that agricultural production needs to roughly double in the coming decades. How can that be achieved? ...
eating gmo corn on the cob x

Are GMOs safe?

In 2015, 15 scientists and activists issued a statement, "No Scientific consensus on GMO safety," in the journal Environmental Sciences ...
glp profiles GLP Profiles More...
Screen Shot at PM

Charles Benbrook: Agricultural economist and consultant for the organic industry and anti-biotechnology advocacy groups

Independent scientists rip Benbrook's co-authored commentary in New England Journal calling for reassessment of dangers of all GMO crops and herbicides ...
Screen Shot at PM

ETC Group: ‘Extreme’ biotechnology critic campaigns against synthetic biology and other forms of ‘extreme genetic engineering’

The ETC Group is an international environmental non-governmental organization (NGO) based in Canada whose stated purpose is to monitor "the impact of emerging technologies and ...
report this ad report this ad report this ad

Trending

News on human & agricultural genetics and biotechnology delivered to your inbox.
Optional. Mail on special occasions.
Send this to a friend