An interim analysis released on Monday, and based on 95 patients with confirmed Covid infections, found the candidate vaccine has an efficacy of 94.5%. The company said it now plans to apply to the US regulator, the Food and Drug Administration, for emergency-use authorisation in the coming weeks. In the analysis, 90 of the patients received the placebo with the remaining five the vaccine.
An interim analysis released on Monday, and based on 95 patients with confirmed Covid infections, found the candidate vaccine has an efficacy of 94.5%. The company said it now plans to apply to the US regulator, the Food and Drug Administration, for emergency-use authorisation in the coming weeks. In the analysis, 90 of the patients received the placebo with the remaining five the vaccine.
I'm sceptical as to how you could determine efficacy to 1 part in 200 with such a small sample size.
Re: Developing the Covid-19 vaccine
Posted: Mon Nov 16, 2020 12:57 pm
by lpm
The nice thing about having a huge surge of cases in the US is that it speeds up the trial. Whereas ordinary countries would need an age to get 95 cases, in the US you can reach that in five minutes by running the trial in a small town in South Dakota.
Re: Developing the Covid-19 vaccine
Posted: Mon Nov 16, 2020 1:38 pm
by Herainestold
The Moderna vaccine doesn't have the same cold storage requirements as Pfizer. It should be easier to distribute.
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Nov. 16, 2020-- Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced new data showing that mRNA-1273, its COVID-19 vaccine candidate, remains stable at 2° to 8°C (36° to 46°F), the temperature of a standard home or medical refrigerator, for 30 days. Stability testing supports this extension from an earlier estimate of 7 days. mRNA-1273 remains stable at -20° C (-4°F) for up to six months, at refrigerated conditions for up to 30 days and at room temperature for up to 12 hours.
“We believe that our investments in mRNA delivery technology and manufacturing process development will allow us to store and ship our COVID-19 vaccine candidate at temperatures commonly found in readily available pharmaceutical freezers and refrigerators,” said Juan Andres, Chief Technical Operations and Quality Officer at Moderna. “We are pleased to submit these extended stability conditions for mRNA-1273 to regulators for approval. The ability to store our vaccine for up to 6 months at -20° C including up to 30 days at normal refrigerator conditions after thawing is an important development and would enable simpler distribution and more flexibility to facilitate wider-scale vaccination in the United States and other parts of the world.”
An interim analysis released on Monday, and based on 95 patients with confirmed Covid infections, found the candidate vaccine has an efficacy of 94.5%. The company said it now plans to apply to the US regulator, the Food and Drug Administration, for emergency-use authorisation in the coming weeks. In the analysis, 90 of the patients received the placebo with the remaining five the vaccine.
Out of 30,000 participants in the clinical trials, 95 had been identified with confirmed cases of Covid-19, the company said. Among those infected, only five people had received the two-dose vaccine, known as mRNA-1273, while 90 had received a placebo.
Out of 30,000 participants in the clinical trials, 95 had been identified with confirmed cases of Covid-19, the company said. Among those infected, only five people had received the two-dose vaccine, known as mRNA-1273, while 90 had received a placebo.
Doing the analysis at ~100 cases gives you about 1% precision (assuming the vaccine generally works).
You need a lot of participants if you need to wait for them to "naturally" catch covid rather than challenging them - the more participants you have the sooner you will have a statistically useful number of infections.
Doing the analysis at ~100 cases gives you about 1% precision (assuming the vaccine generally works).
You need a lot of participants if you need to wait for them to "naturally" catch covid rather than challenging them - the more participants you have the sooner you will have a statistically useful number of infections.
Yes, I see - about 0.3% of the participants became infected in the study, and the 90:5 ratio, represents ~5.5% the overall infection rate amongst the vaccinated group. One more or less in the non-placebo group would have moved the ratio about 1% either way.
Re: Developing the Covid-19 vaccine
Posted: Mon Nov 16, 2020 2:21 pm
by shpalman
A challenge trial is obviously faster and potentially more accurate but ethically a whole other problem.
Covid doesn't have a massively high R_0 or IFR so I think it's more important to vaccinate lots of people in the trial to check there aren't lots of serious adverse reactions, and then to make sure it basically works better than nothing. 90% or 91% or 94% or 95% or whatever doesn't change things that much, since R_t will be way less than one as once the susceptible population is down to 5-10% of the actual population.
Well it's not that simple of course if the people who get the vaccine first will be those most at risk and not necessarily those who might be spreading it the most. In that case you might want to assume that the subject will definitely be exposed to covid at some point so that factor gives you their risk of getting infected. In that case it's more like a factor of 2 difference between 90% and 95%, even if that's still the ratio between two small numbers.
Re: Developing the Covid-19 vaccine
Posted: Mon Nov 16, 2020 3:12 pm
by Bird on a Fire
I'm cautiously optimistic about this, which by 2020 standards probably means I'm about to have my heart broken.
I literally cannot wait to go back to huffing strangers' fomites all day, and will do the second we've been jabbed. f.ck this sh.t.
I'm cautiously optimistic about this, which by 2020 standards probably means I'm about to have my heart broken.
I literally cannot wait to go back to huffing strangers' fomites all day, and will do the second we've been jabbed. f.ck this sh.t.
I go through phases when I'm watching stuff on TV where I barely bat an eyelid and other times when I'm like HOW ARE YOU STANDING SO CLOSE TO EACH OTHER?? Remind me what it's like to suffer someone's bad breath, or be worried about your own?
And god, I even got jealous watching the episode of Peep Show where Jeremy ends up eating someone's dead dog out of a bin bag because at least they got to randomly meet some people in a pub and see where the night took them. To disaster, in their case, but that's not the point.
Anyway to go a bit more back on topic, if we end up with a number of viable vaccines (say 2 or 3, I don't really know), that are effective in different ways e.g. reducing symptoms, stopping spread etc - how could that work in practice? If we could technically distribute both, would that need further safety tests? How does intellectual property work in this situation in terms of the vaccine companies sharing information and collaborating?
Re: Developing the Covid-19 vaccine
Posted: Mon Nov 16, 2020 3:32 pm
by shpalman
I wonder how long it will take before we have that kind of detail, and how long it will take before there's freedom to pick and choose which vaccine, rather than getting whatever is available to the at-risk population as soon as possible.
I'm cautiously optimistic about this, which by 2020 standards probably means I'm about to have my heart broken.
I literally cannot wait to go back to huffing strangers' fomites all day, and will do the second we've been jabbed. f.ck this sh.t.
Even with a vaccine it's not going to be over any time soon. You might not be able to go back to normal after you've been jabbed, because the vaccine won't work for all so you'll have to wait till enough people have had it before you can start licking doorknobs again.
But if you're young, you'll probably be in the back of the queue, so maybe!
And god, I even got jealous watching the episode of Peep Show where Jeremy ends up eating someone's dead dog out of a bin bag because at least they got to randomly meet some people in a pub and see where the night took them. To disaster, in their case, but that's not the point.
hahahaha omg, sorry disco but that has made me crack right up. The quintessential 2020 sentiment.
I definitely remember a time when I could actually relax while out of the house. I think it was February. And yes, watching TV characters stand close to each other in bars already seems as anachronistic as watching them light up a fag in a restaurant.
I'm cautiously optimistic about this, which by 2020 standards probably means I'm about to have my heart broken.
I literally cannot wait to go back to huffing strangers' fomites all day, and will do the second we've been jabbed. f.ck this sh.t.
Even with a vaccine it's not going to be over any time soon. You might not be able to go back to normal after you've been jabbed, because the vaccine won't work for all so you'll have to wait till enough people have had it before you can start licking doorknobs again.
But if you're young, you'll probably be in the back of the queue, so maybe!
Yeah for sure, that's why I put 'we' - I'm not that worried about the risks to my own health (I've taken far bigger ones in the name of having a good time), but I really don't want to endanger other people. I'd like to be able to hug my mum without worrying I've just killed her, for instance.
And god, I even got jealous watching the episode of Peep Show where Jeremy ends up eating someone's dead dog out of a bin bag because at least they got to randomly meet some people in a pub and see where the night took them. To disaster, in their case, but that's not the point.
hahahaha omg, sorry disco but that has made me crack right up. The quintessential 2020 sentiment.
I definitely remember a time when I could actually relax while out of the house. I think it was February. And yes, watching TV characters stand close to each other in bars already seems as anachronistic as watching them light up a fag in a restaurant.
There is an XKCD for that. (Spoilered for off-topicness.) Spoiler:
Mouse-over text: She referenced Billie Eilish, so this must be getting pretty close to the pandemic. But we've seen the last two years in-universe, so if it's set in the future, they must be in at least 2023 by now. [*adds thumbtacks and string to wall*]
And god, I even got jealous watching the episode of Peep Show where Jeremy ends up eating someone's dead dog out of a bin bag because at least they got to randomly meet some people in a pub and see where the night took them. To disaster, in their case, but that's not the point.
hahahaha omg, sorry disco but that has made me crack right up. The quintessential 2020 sentiment.
I definitely remember a time when I could actually relax while out of the house. I think it was February. And yes, watching TV characters stand close to each other in bars already seems as anachronistic as watching them light up a fag in a restaurant.
Hahaha no need to apologise, it was meant to be a bit funny
But yeah I get vicarious anxiety watching people randomly walk into bars and pubs and stuff on telly. Can't beat a bit of mild trauma.
Yeah for sure, that's why I put 'we' - I'm not that worried about the risks to my own health (I've taken far bigger ones in the name of having a good time), but I really don't want to endanger other people. I'd like to be able to hug my mum without worrying I've just killed her, for instance.
Sorry, read that as "I". Stupid incorrect head words.
Carry on.
Re: Developing the Covid-19 vaccine
Posted: Mon Nov 16, 2020 4:27 pm
by sTeamTraen
Naturally, the pushback against this new vaccine has already started. Apparently if you look at it under a microscope, you can see the face of the dead baby who is dissolved in every dose.
Re: Developing the Covid-19 vaccine
Posted: Mon Nov 16, 2020 4:35 pm
by shpalman
Meh, a person refusing it just means my place in the queue skips one place forward.
Anyway to go a bit more back on topic, if we end up with a number of viable vaccines (say 2 or 3, I don't really know), that are effective in different ways e.g. reducing symptoms, stopping spread etc - how could that work in practice? If we could technically distribute both, would that need further safety tests?
There's a global aspect and a local aspect. In a rational world, it might be that the Pfizer vaccine goes to rich countries who can handle the cold chain, while Moderna's is prioritised for poorer countries. On a local scale, we might give Vaccine A, which reduces symptoms but not infection, to older people, and prioritise Vaccine B, which is good at controlling infection, for younger people.
That's in the medium term. In the short term (next 6 months say), jabs will go to the countries with the deepest pockets and the most vulnerable people. In the longer term (>2 years say) when the fires are largely out and it's just mopping up, we should have enough time and data to manage things more efficiently.
It's not unprecedented to have a choice of vaccines: see HPV (Gardasil and the other one) for instance.
Anyway to go a bit more back on topic, if we end up with a number of viable vaccines (say 2 or 3, I don't really know), that are effective in different ways e.g. reducing symptoms, stopping spread etc - how could that work in practice? If we could technically distribute both, would that need further safety tests?
There's a global aspect and a local aspect. In a rational world, it might be that the Pfizer vaccine goes to rich countries who can handle the cold chain, while Moderna's is prioritised for poorer countries. On a local scale, we might give Vaccine A, which reduces symptoms but not infection, to older people, and prioritise Vaccine B, which is good at controlling infection, for younger people.
That's in the medium term. In the short term (next 6 months say), jabs will go to the countries with the deepest pockets and the most vulnerable people. In the longer term (>2 years say) when the fires are largely out and it's just mopping up, we should have enough time and data to manage things more efficiently.
It's not unprecedented to have a choice of vaccines: see HPV (Gardasil and the other one) for instance.
Hm that makes sense, thanks. Almost a bit too logical really.
I hadn't realised there were only about 418,000 elderly people living in UK care homes. The vast majority live in their own homes, there's also the retirement homes. It's going to be pretty easy to vaccinate all care homes.
