Tag: Ashish Jha

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

Tina Marie (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.”

…

“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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“Immense Frustration”: Monkeypox Spreads Amid Slow U.S. Response, Few Vaccines; WHO Declares Emergency

Tina Marie (Ms. Cat)2 Comments

“Immense Frustration”: Monkeypox Spreads Amid Slow U.S. Response, Few Vaccines; WHO Declares Emergency

But we also know — look, COVID is — you know, a lot of us, by now, have done COVID isolation, 10 days, even five days. It is incredibly difficult. It is costly. Sometimes you miss out on work. Sometimes you have to get a hotel to isolate in. It is really difficult to do. Here we have an isolation with monkeypox that is two to six weeks. That is incredibly disruptive for people’s lives. We’ve been having to crowdfund to get people the money that they need to take time off work. We need emergency funds and hotel rooms so people can properly isolate to prevent the spread. And none of that, none of those funds and resources have been coming from any level of government.

Two to six weeks! 😳

Biden tests positive for COVID-19, has ‘very mild symptoms’

Tina Marie (Ms. Cat)

By ZEKE MILLER and CHRIS MEGERIAN, Associated Press

WASHINGTON (AP) — President Joe Biden tested positive for COVID-19 on Thursday and is experiencing “very mild symptoms,” the White House said, as new variants of the highly contagious virus are challenging the nation’s efforts to get back to normal after two and a half years of pandemic disruptions.

Biden tests positive for COVID-19, has ‘very mild symptoms’