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I think what governors are agitating for are some clear guideposts that define what the on and off ramp is for this. When do we start to roll back this mitigation ? We don't have an agreed upon set of nomenclature and metrics for measuring that, what governors are sensing is that we need to agree upon a set of metrics -- when we're going to start to roll back these mitigation steps, and give people a light at the end of the tunnel.
We may need to decide that once we get to 20 cases per 100,000 per day that may be the point at which we start to withdraw these things, i'm not so sure we're going to get to 10 anytime soon. Right now, Washington DC is at 15. New York's at 75. With this new Omicron strain that's circling we may stall out around 20 -- and that may be the point where we have to consider withdrawing a lot of these measures.
Right now, you look at a lot of federal health guidance and it says that these measures should be lifted when there's low prevalence, that was the old measure. In the age of Omicron, with a much more contagious variant and with the fact that the population has a lot of immunity, so we're less susceptible overall, we may need to rethink that.
I think states are going to have a hard time doing it, so long as the booster is under an emergency use authorization and it's unclear when FDA is going to give full approval to the booster -- probably some time soon.
Found on CNN 11 months ago
And that could push it into 2022. Previously we had talked about trying to have that data available before the end of this year, which could have prompted an authorization perhaps by the end of the year, at least in kids ages 2-4. I think that it's more likely that it slips into the first quarter of next year at the very least, but not too far into next year.
There's a lot of parents like me that, as soon as the vaccines available for their children, are going to go out and get their kids vaccinated, that see the benefits of vaccination, there's a lot of parents who still have a lot of questions around vaccination. I think for them, they should have a conversation with their pediatrician to try to get comfortable with the idea of vaccinating kids.
I worry that, going forward, we're going to see vaccination rates decline as this becomes more of a political football, and we see people -- literally, governors running against vaccines and vaccine mandates -- in the next presidential cycle. That's going to the be deleterious to the public health, generally, if that's what comes out of this episode we're in.
The data came a little earlier than some were expecting, and depending on how long The FDA takes to review the application, whether it's a four-week review or a six-week review, you could have a vaccine available to children as early as probably by the end of October, perhaps The FDA slips a little bit into November.
Because by the time you actually make that decision ... and you start operationalizing a booster campaign, you're talking about maybe late October if the decision comes in September, that you can start getting a sizeable number of people boosted, it takes time to get that stood up and get people into the doctors' offices to get injections. And it will take a couple of weeks for the immunity to mature.
These kinds of lab leaks happen all the time, actually, even here in the United States, we’ve had mishaps, and in China, the last six known outbreaks of SARS-1 have been out of labs, including the last known outbreak, which was a pretty extensive outbreak that China initially wouldn’t disclose that it came out of a lab.
The entire Pacific Rim has less than 1,000 infections a day, people want to say China is lying about the two dozen cases that they’re reporting a day, which I don’t believe they are [lying]. Certainly, the entire Pacific Rim isn’t in on the conspiracy. It isn’t inevitable that we have a raging epidemic.
We’re going to have to update our vaccines and our antibody drugs and other therapeutics regularly to keep up with these new variants as they emerge.
Found on Reuters 1 year ago
Access to affordable insulin can be a matter of life and death for Americans with diabetes. Insulin is a critical hormone that regulates sugar metabolism, but access to this critical drug can be increasingly difficult for these Americans. Insulin list prices regularly increase by double digits annually.
We won't ignore data regarding the popularity of mint - and menthol-flavored [ vapes ] among kids, should the concern rise, we'll continue to use all available resources to monitor the rates and use patterns among youth and adults for these products, and we'll reconsider our policies with respect to these products, if appropriate.
When a consumer goes online to buy medicines purportedly from Canada, they may get a medicine sourced from elsewhere that could be counterfeit, expired or misbranded. While operations or illegal online pharmacies may state on their websites that its medicines are coming from Canada, the United Kingdom, Australia, etc., this is not necessarily always the case, such operations and illegal online pharmacies take advantage of unsuspecting Americans by purporting to distribute safe and effective imported drugs, at least some of which are instead expired, mislabeled, subject to recalls or potentially counterfeit and that are provided outside of the closed American distribution system meant to protect patient safety.
Such operations and illegal online pharmacies take advantage of unsuspecting Americans by purporting to distribute safe and effective imported drugs, at least some of which are instead expired, mislabeled, subject to recalls or potentially counterfeit and that are provided outside of the closed American distribution system meant to protect patient safety.
Our ongoing effort has determined that the impurities may be generated by specific chemical reactions in the manufacturing process of the drug's active pharmaceutical ingredients. FDA scientists have developed novel and sophisticated testing methods specifically designed to detect and measure N-Nitrosodimethylamine( NDMA) and N-Nitrosodiethylamine( NDEA) impurities in ARB medicines. Because of the potential for discovering other nitrosamine impurities, we are conducting an extensive organic chemistry analysis to develop novel testing methods to detect additional nitrosamine impurities, including NMBA.
It's important to underscore that, based on the FDA's initial evaluation, the increased risk of cancer to patients with NMBA exposure appears to be the same for NDMA exposure but less than the risk from NDEA exposure. That said, any presence of such impurities in drug products is not acceptable. Over the past few months, the FDA has conducted a major investigation and has worked with drug companies to address the presence of impurities in these products, our ongoing effort has determined that the impurities may be generated by specific chemical reactions in the manufacturing process of the drug's active pharmaceutical ingredients. FDA scientists have developed novel and sophisticated testing methods specifically designed to detect and measure N-Nitrosodimethylamine( NDMA) and N-Nitrosodiethylamine( NDEA) impurities in ARB medicines. Because of the potential for discovering other nitrosamine impurities, we are conducting an extensive organic chemistry analysis to develop novel testing methods to detect additional nitrosamine impurities, including NMBA.
As part of our Youth Tobacco Prevention Plan, we'll continue to employ all the tools at our disposal to monitor, penalize and prevent sales of all tobacco products, including e-cigarettes, to minors at brick-and-mortar stores and Internet storefronts as we work to ensure these products are sold in ways that make them less accessible and appealing to kids.
The most challenging part of this is the human capital side of this, we are asking a lot of people to do work that will miss a paycheck, and not everyone is at the high end of the pay scale. I used to live paycheck to paycheck. We know people will be in difficult circumstances, and we are asking them to do hard things.
Widespread reports of youth use of JUUL products are of great public health concern, youth may not understand the nicotine or other characteristics of Juul Labs.
Found on CNN 4 years ago
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