Developing the Covid-19 vaccine

[raven]

Thanks for that, jdc

[sTeamTraen]

FDA has the data up [PDF, short link via Twitter]. The numbers look very good indeed, especially since, within the limits imposed by the relatively small sample size(*), they seem to be quite uniform across participant categories (age, ethnicity, comorbidities).

(*) For these kinds of analyses, the effective sample size is the number of cases of the disease, not the number of participants. The only use of more participants is to get more cases. For example, there were only 5 cases of COVID-19 in people with cancer (Table 10, "Any malignancy"). That's sufficiently small that the 95% confidence interval includes -145.8, a value that would mean that the vaccine was actively harming cancer patients at quite a rate, even though the actual cases were distributed in a favourable way for the vaccine (1 in the vaccine group, 4 in the placebo group).

[shpalman]

Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK

I'm assuming the DOI will be 10.1016/s0140-6736(20)32661-1 but it's not live yet.

full pdf

ChadOx_tab1.png (161.29 KiB) Viewed 2110 times

ChadOx_tab2.png (191.42 KiB) Viewed 2110 times

[shpalman]

Looks like a 1:1 split between treatment and control after all?

[shpalman]

There are two results from the trial of more than 20,000 volunteers in the UK and Brazil.

Overall, there were 30 cases of Covid in people who had two doses of the vaccine and 101 cases in people who received a dummy injection. The researchers said it worked out at 70% protection, which is better than the seasonal flu jab.

...

However, protection was 90% in an analysis of around 3,000 people given a half-sized first dose and a full-sized second dose.

Is there any statistical legitimacy behind the 90% result?

To get 90% in the 3000 people and 62% in the remaining 17,000 you could have 30 vs. 3 cases in control vs. vax in the 3000, and 71 vs 27 in the remaining 17,000 for example.

And it turns out that these were the correct numbers of cases, if not the correct numbers of trial participants.

[Herainestold]

Chinese Sinovac Covid-19 vaccine is 97% effective

Good to see some numbers for some other vaccines, looking forward to their final results. Also heartening to see developing countries being able to access vaccine stocks.

The coronavirus vaccine developed by Chinese company Sinovac is up to 97% effective, according to interim data from tests by Indonesia’s state-owned pharmaceutical company Bio Farma.

“Our clinical trial team found, within one month, that the interim data shows up to 97% for its efficacy,” Bio Farma spokesperson Iwan Setiawan said at a news conference, reports Reuters. Some 1,600 people participated in the clinical trials.

https://www.brusselstimes.com/belgium/1 ... -biontech/

[sTeamTraen]

The Oxford numbers are less impressive than Pfizer's, but it's cheap, easy to handle, and nobody in the vaccine group was hospitalised. The last point would be stronger if there had been more than 10 cases hospitalized in the control group, but the p value is .002 which suggests the vaccine makes a difference to symptom intensity.

If my local health centre offers me a choice of the two then I'd take the Pfizer vaccine, but if that turns out to be logistically difficult then the Oxford one could be a valid choice for public health systems. Apparently as well as the -80C storage you also need a pharmacist to mix up the active ingredients at the last minute and it comes in lots of 1000 that you have to use in "one go", whatever that means.

There is also the question of how long immunity lasts. Again, if we are going to need an annual booster, the Oxford vaccine looks like a good candidate for being dropped off at pharmacies in October and administered either there and then, or at the nearest blood-draw lab or GP surgery.

[shpalman]

this offers this graphic for Italy's vaccination campaign, which is as good as anything else I've found I suppose.

It says they'll actually see the first doses on the 26th of January.

italy-campaign.jpg (139.96 KiB) Viewed 2058 times

I could explain what it says but there's probably not much point since it will probably all change by then.

The TV news just said there would be 28 million doses of vaccine between January and March for 6.5 million people, don't know why they want to give everyone four doses.

[sTeamTraen]

Even the Failing New York Times is asking the same question as me.

Here’s Why Vaccinated People Still Need to Wear a Mask

[shpalman]

seems like a couple of NHS staff with enough of a history of anaphylaxis to need to carry EpiPens* with them had bad reactions

* - other brands of adrenaline autoinjectors are available

Does it mean they already finished all the old and vulnerable people yesterday, that they've already moved on to staff?

[bob sterman]

seems like a couple of NHS staff with enough of a history of anaphylaxis to need to carry EpiPens* with them had bad reactions

* - other brands of adrenaline autoinjectors are available

Does it mean they already finished all the old and vulnerable people yesterday, that they've already moved on to staff?

Reactions can be managed but what will make mass rollout more difficult is this line from the MHRA advice...

“Resuscitation facilities should be available at all times for all vaccinations. Vaccination should only be carried out in facilities where resuscitation measures are available.”

Probably not a problem for conventional vaccination clinic locations (e.g. GP practices) but could present difficulties for proposed unconventional locations (e.g. car parks, shopping centres etc) although for outdoor locations I guess you could park an ambulance with paramedics there.

[headshot]

seems like a couple of NHS staff with enough of a history of anaphylaxis to need to carry EpiPens* with them had bad reactions

* - other brands of adrenaline autoinjectors are available

Does it mean they already finished all the old and vulnerable people yesterday, that they've already moved on to staff?

Reactions can be managed but what will make mass rollout more difficult is this line from the MHRA advice...

“Resuscitation facilities should be available at all times for all vaccinations. Vaccination should only be carried out in facilities where resuscitation measures are available.”

Probably not a problem for conventional vaccination clinic locations (e.g. GP practices) but could present difficulties for proposed unconventional locations (e.g. car parks, shopping centres etc) although for outdoor locations I guess you could park an ambulance with paramedics there.

Finally, the St John's Ambulance people will have their day in the spotlight!

[lpm]

A football stadium has plenty of indoor space. Set up a resuscitation facility in the corporate meeting rooms.

[shpalman]

It will probably be less demanding than the medical facilities which are on site for an actual football match.

[OneOffDave]

Reactions can be managed but what will make mass rollout more difficult is this line from the MHRA advice...

“Resuscitation facilities should be available at all times for all vaccinations. Vaccination should only be carried out in facilities where resuscitation measures are available.”

Probably not a problem for conventional vaccination clinic locations (e.g. GP practices) but could present difficulties for proposed unconventional locations (e.g. car parks, shopping centres etc) although for outdoor locations I guess you could park an ambulance with paramedics there.

This has always been part of the planning for mass vaccination and other mass distribution of medications that are taken on site. It's one of the limiting factors on through put as you need to keep an eye on people for a minute or two post vaccination. The ideal process is a flow from one end to the other, covering documentation, actual vaccination, short term holding then away. Outdoor sites in the UK winter aren't really viable as your vaccinators would get too cold and you can't really get people to remove outer layers. You need somewhere warm-ish, dry, well lit, ideally phone and internet connectivity, space for staff parking, deliveries, queueing space and ideally good public transport links and parking. The numbers of vaccinators and support staff you need will depend on your planned through put

[TimW]

A football stadium has plenty of indoor space. Set up a resuscitation facility in the corporate meeting rooms.

We could do with a resuscitation facility in midfield.

[shpalman]

Backlash after Russian official warns against drinking alcohol after having Sputnik vaccine

Anna Popova, head of the consumer health watchdog, told the Komsomolskaya Pravda radio station on Tuesday that people should stop drinking alcohol at least two weeks before getting the first of two injections. They should continue to abstain for a further 42 days, she advised.

“This really bothers me,” said Elena Kriven, a Moscow resident. “I’m unlikely to not be able to drink for 80 days and I reckon the stress on the body of giving up alcohol, especially during what is a festive period, would be worse than the [side effects of the] vaccine and its alleged benefits,” she said.

[Trinucleus]

seems like a couple of NHS staff with enough of a history of anaphylaxis to need to carry EpiPens* with them had bad reactions

* - other brands of adrenaline autoinjectors are available

Does it mean they already finished all the old and vulnerable people yesterday, that they've already moved on to staff?

I heard that if a planned patient doesn't show, they'll do a staff member instead

[Gfamily]

seems like a couple of NHS staff with enough of a history of anaphylaxis to need to carry EpiPens* with them had bad reactions

* - other brands of adrenaline autoinjectors are available

Does it mean they already finished all the old and vulnerable people yesterday, that they've already moved on to staff?

Priorities list starts
1. residents in a care home for older adults and their carers
2. all those 80 years of age and over and frontline health and social care workers

As the Pfizer vaccine is not immediately suitable/licensed for use in locations where only small batches are required, it is restricted to the 'carers' aspect in #1 and those in #2 that can get to suitable locations (mostly hospitals I would guess this week).

[shpalman]

Backlash after Russian official warns against drinking alcohol after having Sputnik vaccine

Anna Popova, head of the consumer health watchdog, told the Komsomolskaya Pravda radio station on Tuesday that people should stop drinking alcohol at least two weeks before getting the first of two injections. They should continue to abstain for a further 42 days, she advised.

“This really bothers me,” said Elena Kriven, a Moscow resident. “I’m unlikely to not be able to drink for 80 days and I reckon the stress on the body of giving up alcohol, especially during what is a festive period, would be worse than the [side effects of the] vaccine and its alleged benefits,” she said.

This seems to have been downgraded to "try not to get f.cking wasted for six days" which is still a lot to ask.

[Herainestold]

Sinopharm covid vaccine, efficacy of 86%, says UAE.

SEOUL — One of China's coronavirus vaccines has been approved for general use by a government for the first time, with the United Arab Emirates on Wednesday endorsing a vaccine made by ­Sinopharm after reviewing the drugmaker's assessment that the shot was 86 percent effective.

The announcement comes as a relief for China, which has already approved widespread emergency use of the vaccine. A number of other countries, including Morocco, have pinned their hopes on Sinopharm.

Sinopharm’s efficacy rate puts the company’s vaccine behind Moderna’s 94.5 percent and ­Pfizer-BioNTech’s 95 percent but ahead of AstraZeneca’s 70 percent. However, data from the Phase 3 trial has not yet been released, with UAE officials giving only a few headline numbers. Sinopharm did not immediately respond to requests for comment Wednesday.

Good to see more positive results from the Chinese vaccines. These are the vaccines that the developing world will need.

https://www.washingtonpost.com/world/as ... story.html

[Martin_B]

Backlash after Russian official warns against drinking alcohol after having Sputnik vaccine

Anna Popova, head of the consumer health watchdog, told the Komsomolskaya Pravda radio station on Tuesday that people should stop drinking alcohol at least two weeks before getting the first of two injections. They should continue to abstain for a further 42 days, she advised.

“This really bothers me,” said Elena Kriven, a Moscow resident. “I’m unlikely to not be able to drink for 80 days and I reckon the stress on the body of giving up alcohol, especially during what is a festive period, would be worse than the [side effects of the] vaccine and its alleged benefits,” she said.

Is Elena the Russian for Karen?

[Herainestold]

Johnson&Johnson has reduced the size of its US trial from 60000 to 40000 peoples, because the prevalence of coronavirus in America means that they will reach the target number of infections with a smaller number of participants.

“We have already recruited more than 38,000 subjects in the study,” Slaoui said. “With J&J, we decided to cap the recruitment to around 40,000 subjects, which will happen by the end of this week, so in the next two [or] three days.”

In a statement, J&J said: “We continue to anticipate that interim data from the ENSEMBLE trial will be available by the end of January. If the vaccine is safe and effective, an emergency use authorization application could be submitted to the FDA in February.”

I thought they were a bit further along, so we will have to wait some more.

Because Covid-19 cases are skyrocketing in the U.S., J&J will reach this milestone while enrolling fewer patients. That leaves the J&J study as about the same size as that run by Pfizer and BioNTech, which included 44,000 volunteers in their study of the first vaccine to deliver positive results, and somewhat bigger than the 30,000-patient study run by Moderna, which developed the second vaccine to show positive results.

Johnson & Johnson is also conducting a second study using two doses of the same vaccine in Europe and the U.S. That study plans to enroll 30,000 volunteers.

https://www.statnews.com/2020/12/09/joh ... se-in-u-s/

[Millennie Al]

seems like a couple of NHS staff with enough of a history of anaphylaxis to need to carry EpiPens* with them had bad reactions

* - other brands of adrenaline autoinjectors are available

Does it mean they already finished all the old and vulnerable people yesterday, that they've already moved on to staff?

According to https://www.scientificamerican.com/arti ... et-to-you/ the last step in preparation leaves you with vaccine which must be used within six hours, so I expect that there are old and vulnerable people scheduled to appear, and any left over is then used on whoever is available. You wouldn't want an old/vulnerable person to make the visit and not get the vaccine, so there are probably not quite enough scheduled to use the amount planned to be prepared (to allow for some loss during the day, e.g. if someone drops a vial) with a list of backup candidates to use up any left over. We'll probably get a better idea once there are stories appearing saying how many have been vaccinated so far.

[Millennie Al]

Johnson&Johnson has reduced the size of its US trial from 60000 to 40000 peoples, because the prevalence of coronavirus in America means that they will reach the target number of infections with a smaller number of participants.

“We have already recruited more than 38,000 subjects in the study,” Slaoui said. “With J&J, we decided to cap the recruitment to around 40,000 subjects, which will happen by the end of this week, so in the next two [or] three days.”

In a statement, J&J said: “We continue to anticipate that interim data from the ENSEMBLE trial will be available by the end of January. If the vaccine is safe and effective, an emergency use authorization application could be submitted to the FDA in February.”

I thought they were a bit further along, so we will have to wait some more.

That must be this trial: https://clinicaltrials.gov/ct2/show/NCT04505722 which started in September. Comparing with the Biontech one which is https://clinicaltrials.gov/ct2/show/NCT04368728 and which started in April, to have results in January seems pretty quick.