Developing the Covid-19 vaccine

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Herainestold
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Re: Developing the Covid-19 vaccine

Post by Herainestold » Thu Apr 01, 2021 1:33 pm

raven wrote:
Thu Apr 01, 2021 10:57 am
I think it's looking more likely that these unusual clotting events are a rare but real side effect of AZ. Which will presumably have an impact on our vaccine roll out here in the UK as we get to younger people. Oh dear.

But at least it's treatable if it's caught in time and we've got Moderna coming...
Time to swallow our pride and approve Sputnik and the Chinese vaccines. We are going to need them.

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Re: Developing the Covid-19 vaccine

Post by Herainestold » Thu Apr 01, 2021 3:11 pm

Pfizer announces new vaccine safe for adolescents in press release.
CHICAGO (Reuters) - Pfizer and BioNTech's COVID-19 vaccine is safe, effective and produces robust antibody responses in 12- to 15-year olds, the companies said on Wednesday, paving the way for them to seek U.S. and European approval to use the shot in this age group within weeks.

The data from a clinical trial, which puts the shot ahead of other Western vaccine developers in the quest to protect children, will likely allow for its use in that group before the next school year, Pfizer Chief Executive Albert Bourla said in a statement.
The vaccine was well tolerated, with side effects in line with those seen among those aged 16 to 25 in the adult trial. It did not list the side effects for the younger group, but the adult trial’s side effects generally were mild to moderate and included injection-site pain, headaches, fever and fatigue.

The companies also studied a subset of teens to measure the level of virus-neutralizing antibodies a month after the second dose and found it was comparable to study participants aged 16 to 25 in the pivotal trial in adults.
Scientists welcomed the news, which has not been published in a medical journal or peer reviewed, but said more data was needed.
https://news.yahoo.com/pfizer-covid-19- ... 01604.html

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Re: Developing the Covid-19 vaccine

Post by raven » Thu Apr 01, 2021 4:44 pm

Herainestold wrote:
Thu Apr 01, 2021 1:33 pm
raven wrote:
Thu Apr 01, 2021 10:57 am
I think it's looking more likely that these unusual clotting events are a rare but real side effect of AZ. Which will presumably have an impact on our vaccine roll out here in the UK as we get to younger people. Oh dear.

But at least it's treatable if it's caught in time and we've got Moderna coming...
Time to swallow our pride and approve Sputnik and the Chinese vaccines. We are going to need them.
Why? We've got J&J, Moderna and Novavax in the pipeline. Surely that's more than enough.

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Re: Developing the Covid-19 vaccine

Post by Herainestold » Thu Apr 01, 2021 5:04 pm

raven wrote:
Thu Apr 01, 2021 4:44 pm
Herainestold wrote:
Thu Apr 01, 2021 1:33 pm
raven wrote:
Thu Apr 01, 2021 10:57 am
I think it's looking more likely that these unusual clotting events are a rare but real side effect of AZ. Which will presumably have an impact on our vaccine roll out here in the UK as we get to younger people. Oh dear.

But at least it's treatable if it's caught in time and we've got Moderna coming...
Time to swallow our pride and approve Sputnik and the Chinese vaccines. We are going to need them.
Why? We've got J&J, Moderna and Novavax in the pipeline. Surely that's more than enough.
They may not show up. If you are counting on them coming from America or Europe you may be in for a long wait.

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Re: Developing the Covid-19 vaccine

Post by shpalman » Thu Apr 01, 2021 5:49 pm

Given that the idea seems to be to produce the Sputnik V vaccine under license locally I don't see why those production facilities aren't being used to produce the AstraZeneca one already.
molto tricky

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Re: Developing the Covid-19 vaccine

Post by Herainestold » Thu Apr 01, 2021 7:35 pm

shpalman wrote:
Thu Apr 01, 2021 5:49 pm
Given that the idea seems to be to produce the Sputnik V vaccine under license locally I don't see why those production facilities aren't being used to produce the AstraZeneca one already.
If you make AZ doses there, you will just have to export them to the UK (where they are safe and don't cause blood clots).
Sputnik is better because it doesnt kill people, and because it uses two different adenoviruses in its two doses.
Go with Sputnik.

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Re: Developing the Covid-19 vaccine

Post by shpalman » Thu Apr 01, 2021 9:31 pm

That's a bit unfair, we know that the AstraZeneca vaccine is 60% 90% 63% 79% 72% effective if you give two doses three weeks apart half a dose and then a full dose two full doses with the second one whenever some f.cking vaccines get delivered and the EMA has already ruled it safe with the respect to the blood clotting issues it causes but is not linked to in the conclusions of a report they haven't started working on yet.
molto tricky

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Re: Developing the Covid-19 vaccine

Post by jdc » Thu Apr 01, 2021 11:55 pm

Herainestold wrote:
Thu Apr 01, 2021 5:04 pm
raven wrote:
Thu Apr 01, 2021 4:44 pm
Herainestold wrote:
Thu Apr 01, 2021 1:33 pm


Time to swallow our pride and approve Sputnik and the Chinese vaccines. We are going to need them.
Why? We've got J&J, Moderna and Novavax in the pipeline. Surely that's more than enough.
They may not show up. If you are counting on them coming from America or Europe you may be in for a long wait.
Novavax doses are coming all the way from... Barnard Castle. Apparently they're producing the antigen in Stockton at Fujifilm and GSK are doing the fill and finish at Barnard Castle. I'm hoping there isn't any kind of intermediate stage that takes place in the EU and this Conversation article suggests there isn't ("Novavax production for the UK market is entirely UK-based"). We haven't actually approved Novavax yet, mind.

Moderna, I thought we'd be getting our supply from the EU but Sky seem to reckon USA. https://news.sky.com/story/what-are-the ... d-12261784

J&J. Dunno. Janssen is in Belgium apparently so... EU?

Have the Chinese and Russian vaccine manufacturers applied to the MHRA or EMA for authorisation in the UK or the EU? Have there been any talks at all on deals between the UK or EU and the mfrs? If not, then presumably approval of any of those vaccines is going to be either way down the line or not at all. By the time we get the deals done and go through the approvals process we'll probably have had all the vaccines we needed anyway. We might be onto next generation vaccines by then.

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Re: Developing the Covid-19 vaccine

Post by Herainestold » Fri Apr 02, 2021 12:06 am

jdc wrote:
Thu Apr 01, 2021 11:55 pm
Herainestold wrote:
Thu Apr 01, 2021 5:04 pm
raven wrote:
Thu Apr 01, 2021 4:44 pm


Why? We've got J&J, Moderna and Novavax in the pipeline. Surely that's more than enough.
They may not show up. If you are counting on them coming from America or Europe you may be in for a long wait.
Novavax doses are coming all the way from... Barnard Castle. Apparently they're producing the antigen in Stockton at Fujifilm and GSK are doing the fill and finish at Barnard Castle. I'm hoping there isn't any kind of intermediate stage that takes place in the EU and this Conversation article suggests there isn't ("Novavax production for the UK market is entirely UK-based"). We haven't actually approved Novavax yet, mind.

Moderna, I thought we'd be getting our supply from the EU but Sky seem to reckon USA. https://news.sky.com/story/what-are-the ... d-12261784

J&J. Dunno. Janssen is in Belgium apparently so... EU?

Have the Chinese and Russian vaccine manufacturers applied to the MHRA or EMA for authorisation in the UK or the EU? Have there been any talks at all on deals between the UK or EU and the mfrs? If not, then presumably approval of any of those vaccines is going to be either way down the line or not at all. By the time we get the deals done and go through the approvals process we'll probably have had all the vaccines we needed anyway. We might be onto next generation vaccines by then.
Thats the world we live in, where you have to pay attention to where your vaccine is manufactured.
Novavax, have they started making it yet? And as you say, totally in the UK so probably okay there, but when?
J&J, Moderna if it is coming from the EU or America, don t count on it. 2022 maybe
Sputnik has applied to EMA, Chinese vaxes, don't know, I suspect not.

Russia and China are using vaccination s as a geopolitical tool, willingly exporting them, not the case for EU and America.

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Re: Developing the Covid-19 vaccine

Post by jdc » Fri Apr 02, 2021 1:07 am

I did read that they've been producing Novavax in the north-east, but as we've just announced the fill-and-finish contract I'm assuming they're not on with that stage yet.

I've not seen anything that suggests we have expressed any interest in the Chinese or Russian vaccines (or that they've expressed any interest in supplying us). If we haven't even started to talk to them, then (trials aside) we're about as far away from approving their vaccines as we can be. Approval of the other vaccines was done relatively quickly, partly because regulators were seeing data as trials were running. We'd be starting from scratch with approval of these vaccines.

We've already first-dosed half the country and second-dosed 4m people just using Pfizer and AZ. If we're adding Novavax and possibly getting a few Moderna and J&J on top of our AZ and Pfizer supplies, I don't think we're the country most in need of Chinese or Russian vaccines. I'm not sure there's much point us joining the back of either of those queues now.

Also, they're manufacturing Valneva in Scotland now. If that gets approval (trials still running I think), that's another 60m by the end of the year (maybe) plus another 40m next year (ish).

GSK/Sanofi well behind so I'm not expecting those this year.

Also, also... as of three months ago we'd ordered 200m doses from AZ/PFizer/Novavax, another 30m J&J, plus 17m Moderna, 60m Valneva, so even without GSK/Sanofi that's over 300 million doses. And I'm fairly sure we've increased some of those orders since January. That's rather more than the number of doses we need to fully vaccinate the population and it's cost rather a lot of money. If we've already ordered a huge surplus of vaccines I'm not sure people will be all that keen to spend millions more in order to have an even bigger surplus. Especially if we're not sure they'll have even been approved by the time we finish vaccinating the population.

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Re: Developing the Covid-19 vaccine

Post by Herainestold » Fri Apr 02, 2021 4:34 am

UK is relying on AZ for a major part of the vaccination program. If it gets thrown out then we are going to need a stopgap.
Nova vax would likely work if they are as far along as it seems. Just needs to be approved.
I just wouldn't count on anything more from the EU or America in the current climate.
I am perfectly happy to take my 2nd AZ dose, but from the point of view of vaccine hesitancy/acceptance, it might be in the public interest to replace it with an alternative.
So if Novavax and valneva come in we won't need the Russian or Chinese ones. It would just be nice to have another option.

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Re: Developing the Covid-19 vaccine

Post by Woodchopper » Fri Apr 02, 2021 7:46 am

Pfizer “Vaccine was 100% effective in preventing COVID-19 cases in South Africa, where the B.1.351 lineage is prevalent”

https://www.pfizer.com/news/press-relea ... no-serious

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Re: Developing the Covid-19 vaccine

Post by jdc » Fri Apr 02, 2021 3:12 pm

Herainestold wrote:
Fri Apr 02, 2021 4:34 am
UK is relying on AZ for a major part of the vaccination program. If it gets thrown out then we are going to need a stopgap.
Nova vax would likely work if they are as far along as it seems. Just needs to be approved.
I just wouldn't count on anything more from the EU or America in the current climate.
I am perfectly happy to take my 2nd AZ dose, but from the point of view of vaccine hesitancy/acceptance, it might be in the public interest to replace it with an alternative.
So if Novavax and valneva come in we won't need the Russian or Chinese ones. It would just be nice to have another option.
If we were going to suspend AZ due to the blood clot scare I think we'd have done it by now. Adding an 'adverse event' warning to the leaflet seems more likely.

In the short-term, I can't see the EU blocking the export of vaccines to the UK where the manufacture of those vaccines relies on the import of vaccine ingredients from the UK. There's a shortage of lipid nanoparticles and Pfizer at least have been getting theirs from a British company (Croda). Longer-term, it won't matter as we'll all have been 2-dosed and the UK will have AZ, Novavax, and possibly Valneva (trial results and approval pending).

BTW, don't you think people in the UK would be suspicious of the Chinese and Russian vaccines? We're about as xenophobic as they come, and there were people talking about waiting for the British vaccine when Pfizer was being rolled out never mind Sputnik. I noted that the Chinese were suspicious of the Chinese vaccine: https://www.japantimes.co.jp/news/2021/ ... cine-slow/
seven weeks into China’s campaign, the picture is surprisingly underwhelming. The more than 31.2 million doses administered since its official start date of Dec. 15 put it second only to the U.S., with its nearly 35 million shots. Yet for a population of 1.4 billion, China has delivered a little more than two doses for every 100 people, compared to three in the European Union, 10 in the U.S. and nearly 60 in Israel, according to Bloomberg’s vaccine tracker.

The effort is also appearing to fall short of an internal target of vaccinating 50 million people by the Chinese New Year holiday that starts Feb. 11
China’s lack of momentum isn’t being caused by the distribution hiccups or production shortfalls seen in places like Europe, with vaccines being rolled out at more than 25,000 sites, including re-purposed stadiums, museums and community centers. It’s also been giving out some shots under emergency authorization since mid-2020 ...

Instead, the slowness appears to be due to widespread hesitation across the Chinese population, for reasons ranging from concern over the safety and level of protection promised by the local vaccines, to a lack of urgency, with COVID-19 largely confined to winter flareups in parts of the north ...

China’s vaccine developers have been criticized for their lack of transparency on the safety and effectiveness of their shots, releasing less data than their western counterparts. That’s fueled skepticism in countries like Pakistan and Indonesia that have vaccine deals with China. As in other countries, medical workers in China are also concerned about being guinea pigs for the first vaccines.

Sophia Qu, a doctor at a hospital in Guangdong province, southern China, didn’t take up the vaccine offer because she’s worried about negative side effects. Fewer than half her colleagues got vaccinated, she said.

Some in China would also rather wait for a foreign-made vaccine, given past scandals over shoddy Chinese-made shots.

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Re: Developing the Covid-19 vaccine

Post by Brightonian » Fri Apr 02, 2021 3:16 pm

Woodchopper wrote:
Fri Apr 02, 2021 7:46 am
Pfizer “Vaccine was 100% effective in preventing COVID-19 cases in South Africa, where the B.1.351 lineage is prevalent”

https://www.pfizer.com/news/press-relea ... no-serious
Hoping it's not another misleading press release à-la-Astra Zeneca. By chance, my father, who's had his second Pfizer jab, asked me last night whether the Pfizer is effective against variants, especially the South African, and what I thought. I said I''d research this. Edit to add: I'm guessing he saw a news snippet about this last night which is why he's asked.

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Re: Developing the Covid-19 vaccine

Post by shpalman » Fri Apr 02, 2021 4:45 pm

molto tricky

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Re: Developing the Covid-19 vaccine

Post by bob sterman » Fri Apr 02, 2021 5:23 pm

jdc wrote:
Fri Apr 02, 2021 1:07 am
Also, also... as of three months ago we'd ordered 200m doses from AZ/PFizer/Novavax, another 30m J&J, plus 17m Moderna, 60m Valneva, so even without GSK/Sanofi that's over 300 million doses. And I'm fairly sure we've increased some of those orders since January. That's rather more than the number of doses we need to fully vaccinate the population ...
You're not factoring in the post-lockdown population explosion! ;)

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Re: Developing the Covid-19 vaccine

Post by jdc » Fri Apr 02, 2021 5:43 pm

bob sterman wrote:
Fri Apr 02, 2021 5:23 pm
jdc wrote:
Fri Apr 02, 2021 1:07 am
Also, also... as of three months ago we'd ordered 200m doses from AZ/PFizer/Novavax, another 30m J&J, plus 17m Moderna, 60m Valneva, so even without GSK/Sanofi that's over 300 million doses. And I'm fairly sure we've increased some of those orders since January. That's rather more than the number of doses we need to fully vaccinate the population ...
You're not factoring in the post-lockdown population explosion! ;)
None of the vaccines are approved for use in children yet so whatever population figure you have in mind needs to be lower. A lot lower. Not only do you need to exclude lockdown babies, you also have to exclude older children. I don't think we've approved for any age group below 16 yet. Was there a trial in 12-15 year olds that finished recently?

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Re: Developing the Covid-19 vaccine

Post by bob sterman » Fri Apr 02, 2021 6:09 pm

jdc wrote:
Fri Apr 02, 2021 5:43 pm
None of the vaccines are approved for use in children yet so whatever population figure you have in mind needs to be lower. A lot lower. Not only do you need to exclude lockdown babies, you also have to exclude older children. I don't think we've approved for any age group below 16 yet. Was there a trial in 12-15 year olds that finished recently?
Maybe the population estimate is just based on Boris being over-cautious - he seems to have trouble keeping count of babies!

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Re: Developing the Covid-19 vaccine

Post by Herainestold » Fri Apr 02, 2021 7:13 pm

jdc wrote:
Fri Apr 02, 2021 3:12 pm
Herainestold wrote:
Fri Apr 02, 2021 4:34 am
UK is relying on AZ for a major part of the vaccination program. If it gets thrown out then we are going to need a stopgap.
Nova vax would likely work if they are as far along as it seems. Just needs to be approved.
I just wouldn't count on anything more from the EU or America in the current climate.
I am perfectly happy to take my 2nd AZ dose, but from the point of view of vaccine hesitancy/acceptance, it might be in the public interest to replace it with an alternative.
So if Novavax and valneva come in we won't need the Russian or Chinese ones. It would just be nice to have another option.
If we were going to suspend AZ due to the blood clot scare I think we'd have done it by now. Adding an 'adverse event' warning to the leaflet seems more likely.

In the short-term, I can't see the EU blocking the export of vaccines to the UK where the manufacture of those vaccines relies on the import of vaccine ingredients from the UK. There's a shortage of lipid nanoparticles and Pfizer at least have been getting theirs from a British company (Croda). Longer-term, it won't matter as we'll all have been 2-dosed and the UK will have AZ, Novavax, and possibly Valneva (trial results and approval pending).

BTW, don't you think people in the UK would be suspicious of the Chinese and Russian vaccines? We're about as xenophobic as they come, and there were people talking about waiting for the British vaccine when Pfizer was being rolled out never mind Sputnik. I noted that the Chinese were suspicious of the Chinese vaccine: https://www.japantimes.co.jp/news/2021/ ... cine-slow/
seven weeks into China’s campaign, the picture is surprisingly underwhelming. The more than 31.2 million doses administered since its official start date of Dec. 15 put it second only to the U.S., with its nearly 35 million shots. Yet for a population of 1.4 billion, China has delivered a little more than two doses for every 100 people, compared to three in the European Union, 10 in the U.S. and nearly 60 in Israel, according to Bloomberg’s vaccine tracker.

The effort is also appearing to fall short of an internal target of vaccinating 50 million people by the Chinese New Year holiday that starts Feb. 11
China’s lack of momentum isn’t being caused by the distribution hiccups or production shortfalls seen in places like Europe, with vaccines being rolled out at more than 25,000 sites, including re-purposed stadiums, museums and community centers. It’s also been giving out some shots under emergency authorization since mid-2020 ...

Instead, the slowness appears to be due to widespread hesitation across the Chinese population, for reasons ranging from concern over the safety and level of protection promised by the local vaccines, to a lack of urgency, with COVID-19 largely confined to winter flareups in parts of the north ...

China’s vaccine developers have been criticized for their lack of transparency on the safety and effectiveness of their shots, releasing less data than their western counterparts. That’s fueled skepticism in countries like Pakistan and Indonesia that have vaccine deals with China. As in other countries, medical workers in China are also concerned about being guinea pigs for the first vaccines.

Sophia Qu, a doctor at a hospital in Guangdong province, southern China, didn’t take up the vaccine offer because she’s worried about negative side effects. Fewer than half her colleagues got vaccinated, she said.

Some in China would also rather wait for a foreign-made vaccine, given past scandals over shoddy Chinese-made shots.
Maybe we don't stop administering the AZ vax, but younger people may not want to take it, as more and more blood clot cases are discovered in the health records. We have good alternatives in Pfizer/Moderna, but do we have enough to cover a possible shortfall, caused by vaccine hesitance? Will Europe allow more Pfizer to be exported, given that they are souring on AZ eren more than we are?

Should we not approve Chinese vaccines because of the xenophobia and racism of the British people? I am just arguing for keeping all of our options open.

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Re: Developing the Covid-19 vaccine

Post by jdc » Fri Apr 02, 2021 7:31 pm

Your argument against AZ is based on what you see as the potential for vaccine hesitancy. I'm just wondering whether that's going to be any less of a problem for Russian or Chinese vaccines.

Are more and more blood clot cases being discovered in the health records? What's the current tally?

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Re: Developing the Covid-19 vaccine

Post by Herainestold » Fri Apr 02, 2021 7:41 pm

jdc wrote:
Fri Apr 02, 2021 7:31 pm
Your argument against AZ is based on what you see as the potential for vaccine hesitancy. I'm just wondering whether that's going to be any less of a problem for Russian or Chinese vaccines.

Are more and more blood clot cases being discovered in the health records? What's the current tally?
30 in the UK. A couple of weeks ago it was zero.
I personally dont have a problem with it. Pfizer is a good alternate, but I dont think we will be able to get enough of it.

https://www.reuters.com/article/us-heal ... SKBN2BO6Y0

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Re: Developing the Covid-19 vaccine

Post by jdc » Fri Apr 02, 2021 8:35 pm

The 30 cases figure is an update after a review and apparently the figures cover 9 December 2020 to 21 March. If we've done the review and updated the numbers then what makes you think there'll be "more and more"? We've gone from 0 to 5 to 30 but that doesn't mean the numbers will keep going up.

The actual and potential risks of AZ don't seem to be changing the view of regulators (or the UK govt) that the benefits are worth it.

And vaccine hesitancy never changed our govt policy on MMR vaccines (they refused to provide single vaccines on the NHS) so I'd be a bit surprised if it did with AZ.

But let's assume that I'm completely wrong on all the above points. 30 today is 60 next week, surveys show a significant chunk of under-50s won't take AZ, and Johnson panics.

So we should approve the Chinese and Russian vaccines in order to deal with a potential short-term shortage.

It normally takes 9-18 months for approval according to experts*, and our regulators haven't been conducting rolling reviews of the vaccines that we haven't sought to purchase so the shortening of the approval process that was possible for AZ and Pfizer won't be possible for Chinese or Russian vaccines. So, if we conclude a deal with the manufacturers in record time (quick phone call, job done) and start the approval process tomorrow we can expect to have approval in place sometime next year after we've all been double-dosed and had our autumn variant booster.

Or later, if the MHRA are busy dealing with the approval of J&J, Novavax, Valneva, GSK, and Curevac. And even later if we don't conclude negotiations at breakneck speed.

And that's assuming there are no issues with "inspections and certification all along the chain: GLP, GCP, GMP &c."

* Spoiler:

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Re: Developing the Covid-19 vaccine

Post by Herainestold » Fri Apr 02, 2021 8:42 pm

You're right should have got on it sooner.

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Re: Developing the Covid-19 vaccine

Post by jdc » Fri Apr 02, 2021 9:22 pm

Herainestold wrote:
Fri Apr 02, 2021 8:42 pm
You're right should have got on it sooner.
Probably for the best that we didn't, overall. Think of all the countries benefiting from Russian and Chinese vaccines that don't have to contend with us grabbing millions of doses.

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Re: Developing the Covid-19 vaccine

Post by Millennie Al » Sat Apr 03, 2021 1:59 am

jdc wrote:
Fri Apr 02, 2021 8:35 pm
The 30 cases figure is an update after a review and apparently the figures cover 9 December 2020 to 21 March. If we've done the review and updated the numbers then what makes you think there'll be "more and more"? We've gone from 0 to 5 to 30 but that doesn't mean the numbers will keep going up.
From media reports it seems that the supposed problem is cerebral venous sinus thrombosis (CVST), which wikipedia says has occurs at a rate of "3-4 cases per million annual incidence in adults". By 21st March, 27,997,976 people had received their first vaccination (from https://coronavirus.data.gov.uk/details/vaccinations). So over a year, we would expect 84-112 cases of CVST in that many people, or 21-24 per quarter. If we then halve it to allow for a linear rate of vaccination, we get around 11 expected cases. While this is below the 30 found so far, it is still a very small number and it's not at all clear that it's anything other than a statistical fluctuation, or maybe even a result of finding more of something that you're looking for. Obviously, it is worth careful monitoring, but it is far too small an effect to justify drastic action such as refusing to use the vaccine, which is likely to kill far more people.
Covid-19 - Don't catch it: don't spread it.

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