u/ageitgey
ageitgey
ageitgey
Oxford is doing weekly testing of all trial participants in the UK, so they should catch most asymptomatic carriers. It will be interesting to see what they report and how they frame it versus the endpoints that these two vaccines are reporting.
ageitgey
English translation via Google Translate:
Anvisa pauses clinical studies of the CoronaVac vaccine
This type of interruption is provided for by Anvisa standards and is part of the Good Clinical Practice procedures expected for clinical studies conducted in Brazil
Posted on 11/09/2020 9:25 PM Updated on 11/09/2020 10:03 PM
After the occurrence of a serious adverse event *, Anvisa determined the interruption of the clinical study of the CoronaVac vaccine. The event that occurred on 10/29 was communicated to the Agency, which decided to interrupt the study to evaluate the data observed so far and judge the risk / benefit of continuing the study.
This type of interruption is provided for by Anvisa's standards and is part of the Good Clinical Practice procedures expected for clinical studies conducted in Brazil.
With the study interrupted, no new volunteers can be vaccinated. Anvisa reiterates that, according to national and international regulations on Good Clinical Practices, data on clinical research volunteers must be kept confidential, in accordance with principles of confidentiality, human dignity and protection of participants.
Anvisa maintains its commitment to the Brazilian State to act in the interests of public health.
* According to RDC 9/2015 , serious adverse events are considered:
a) death;
b) potentially fatal adverse event (one that, in the opinion of the notifier, puts the individual at immediate risk of death due to the adverse event that occurred);
c) persistent or significant incapacity / disability;
d) requires hospitalization of the patient or prolongs hospitalization;
e) congenital anomaly or birth defect;
f) any suspicion of transmission of an infectious agent by means of a medical device;
g) clinically significant event.
tl;dr - The Chinese-developed vaccine CoronaVac was being trialed in Brazil. The trial has been paused after a serious adverse event was reported. The pause is to determine if the adverse event is related to the vaccine or not. No other news has been released yet.
ageitgey
I think this paper is interesting because of how representative it is of the kind of papers that are coming out during the epidemic and how out of left field they can be in both good and bad ways.
This is a paper by two software people, one of whom describes himself on Twitter simply and primarily as "Libertarian" and anti-progressive. They have no apparent qualifications in epidemiology and self-proclaim a political slant. So in that sense, one would tend to be very skeptical of their methodology and claims.
But on the other hand, they released their full model as an interactive app at https://www.sars2seir.com/ and you can view the javascript code to see how it works and you can play with all the numbers in real time. That's way better than what we usually get from papers from epidemiologists. Of course that doesn't mean the model is accurate, but at least they are showing their work.
They also make huge, controversial claims in the paper. They are saying that if it takes more than a couple of months to get a vaccine in a place like Madrid, the best course of action is to have everyone under 60 go have a giant COVID party in a stadium to super-spread the disease as quickly as possible while everyone over 60 stays home (that's literally what they claim on Twitter). The idea is that the death rate is so much lower for younger people, that no restrictions on younger people to reach immunity faster is ultimately a net win in fewer deaths over social distancing for everyone.
I'm not saying you should take the paper seriously. But it is interesting to live in a world where literally anyone with a laptop can put out a paper, for good and bad.
ageitgey
I don't have the time to watch the whole video, but was he suggesting wide use of the Oral Polio Vaccine as a preventative? OPV hasn't been legal in the USA since 2000 and has been fully replaced with an inactivated vaccine. The issue is that orally vaccinated children shed the virus in sewage and poor sanitation can lead to vaccine-derived poliovirus outbreaks (in rare cases).
I can't imagine anyone wants to accidentally cause a polio outbreak in the hope that the vaccine somehow reduces the severity of COVID infections. It just seems like something that would be incredibly hard to convince the public to try in the US even if the risk is relatively low.
ageitgey
I got sick for 1 day after injection with mild symptoms (just feeling bad) but was better the next day. They said that was normal. Of course I don't know if I got the real vaccine or the stand-in vaccine because it's a blind trial.
ageitgey
I was injected a week ago. I have to do a weekly covid swab test (at home) and a behavior survey every week and then go in monthly or so for blood work. Different groups of the trial have slightly different schedules. One group gets booster doses but most just get one shot.
My understanding is that everyone takes the weekly covid test so they can flag those 20 infected people ASAP to get study results as soon as possible.
ageitgey
They have indeed started Phase 2/3 trails and injected thousands in the UK already. Injections happened over the last 2-3 weeks.
Source: I am in the Phase 3 trial. You can also find all the trial docs online if you look here: http://www.isrctn.com/ISRCTN90906759
According to an interview the project lead did last week (Search 'COVID Conversations: Sarah Gilbert on Vaccines' on YT), they expect to report Phase 1 safety information within a month. For efficacy results, they are waiting until more people get the virus in the Phase 2/3 group of 10,000. They estimate they need about 20 people out of 10,000 to get infected to know if it works. But with the virus fading in the UK rapidly (currently between 1 in 1,700 to 1 in 10,000 people are infected, depending on survey), the worry is that they won't hit that mark of 20 people infected any time soon. So they have thus started the trial wing in Brazil to get more data.
ageitgey
I had the exact same situation (mid-Jan, but London) but later tested negative for covid antibodies. Remember that even if covid was circulating earlier than thought, it must have been pretty rare and most anecdotal stories won't pan out.
ageitgey
Yeah, a little under $1200 US if you buy everything new from Amazon (free shipping at least):
- Rancilio Silvia espresso machine - $685
- Rancilio Rocky coffee grinder - $355
- A metal tamper - $43
- A couple of metal milk frothing pitchers - $15
- Bottomless Portafilter like this video - $65
- Some coffee from your favorite local coffee place - $20
Then of course you'll want to buy little add-ons like the matching Silvia + Rocky base that will cost you another $120.
That's the set up that I have. It's great, but it takes lots of practice to use well and a good bit of cleaning to keep it running well.
It's a fun hobby, but it's not super practical. Making drinks takes a time and can be messy. You have to drink a lot of coffee for it actually to be a money savings in the long run.
In that sense, it's like taking photographs with film or collecting records. It's not the most sane or practical solution, but it's a fun solution.
It's widely assumed that Henry Cole (founding director of the Victoria and Albert Museum in London) started the trend in 1843. I'll refrain from explaining the history as I'm not an expert, but there are lots of good details online about the 1843 date.