Tag: Robert Califf

FDA Settles Lawsuit over Ivermectin Social Media Posts

Ms. Cat

FDA Settles Lawsuit over Ivermectin Social Media Posts

The FDA has agreed to delete and never republish several social-media posts suggesting that ivermectin, a drug that some doctors used to treat COVID-19, is for animals and not humans.

While the FDA still does not approve of using ivermectin to treat COVID, it settled Thursday a lawsuit brought by three doctors who sued it, as well as the Department of Health and Human Services and its secretary, Xavier Becerra, and FDA secretary Robert Califf. All parties have settled.

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At its website as of Friday, the FDA still is not recommending it for COVID and says large doses are dangerous and that prescriptions should be filled by a pharmacy and taken exactly as prescribed.

The FDA declined to respond to Kennedy’s assertion, though it reiterated that it “has not changed its position that currently available clinical trial data do not demonstrate that ivermectin is effective against COVID-19. The agency has not authorized or approved ivermectin for use in preventing or treating COVID-19.”

I honestly don’t know what difference this’ll make. 🤷🏼‍♀️

New COVID Booster Approved From Final Study of Mice, Not Humans, But Using Only Animal Data Is a Needless Gamble

Ms. Cat

VERIFY: New COVID booster approved from final study of mice, not humans

According to documents on the CDC website, human tests of Moderna’s version of the new booster are still “ongoing.” Right now, there is only final evidence from “8-10 mice” per group.”

The FDA’s website shows for Pfizer the agency also relayed on the final study evidence from “8 mice.” But human trials are also ongoing. So far, the new boosters “showed a similar local reaction and systemic event profile.” That means side effects appear to be about the same including “mild to moderate injection site pain, fatigue, and muscle pain.”

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“To advance the Omicron BA.4/BA.5 bivalent vaccine as rapidly as possible, regulators, including the FDA, WHO and EMA, have advised that our submissions be based on safety and immunogenicity data generated in adults with an Omicron BA.1 bivalent vaccine and supported by BA.4/BA.5 bivalent pre-clinical data and BA.4/BA.5 bivalent quality and manufacturing data. These packages follow a similar model to that provided to public health officials who evaluate seasonal flu vaccines each year. Moving forward, this approach may help address the pressing need for vaccines that provide a high level of protection against current and emerging variants of concern so that we can remain vigilant against this evolving virus. The FDA has authorized our Omicron BA.4/BA.5 bivalent vaccine based on clinical data generated in adults with an Omicron BA.1 bivalent vaccine, pre-clinical data with a BA.4/BA.5 bivalent vaccine and BA.4/BA.5 bivalent quality and manufacturing data. Pre-clinical data showed a booster dose of Pfizer and BioNTech’s Omicron BA.4/BA.5- bivalent vaccine generated a strong neutralizing antibody response against Omicron BA.1, BA.2 and BA.4/BA.5 variants, as well as the original wild-type strain. A clinical study investigating the safety, tolerability and immunogenicity of the Omicron BA.4/BA.5 bivalent vaccine in individuals 12 years of age and older is ongoing. Data will be shared with regulators when available. We are facing a virus with an exceptionally high mutation rate, which the nimble mRNA platform is well situated to address. Only the mRNA sequence requires updating to match emerging strains, and utilizing a bivalent vaccine aims to provide broader coverage against known and future COVID-19 variants of concern.”

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Biden Nominates (Pharma) Industry Insider Robert Califf to Head the FDA

Ms. Cat

Nature.com

After nearly ten months without a permanent commissioner, US President Joe Biden has nominated Robert Califf, former head of the Food and Drug Administration (FDA), to lead the agency once again. Although some in the research community are opposed to the nomination because of Califf’s ties to industry, others welcome a permanent director after such a long delay, particularly amidst the COVID-19 pandemic, in which the agency plays a crucial part.

Biden Nominates (Pharma) Industry Insider Robert Califf to Head the FDA