The Vaccine Thread

[mommyoffive]

Report: First baby born with COVID-19 antibodies (kttc.com)

[mommyoffive]

COVID vaccine to be available for all Mississippi residents (apnews.com)

[ScoutTN]

I read my city’s vaccination stats today and I have a question. 
 

When it says 19%, does that mean 19% of the entire population? But the entire population isn’t eligible to be vaccinated bc there isn’t a shot approved for kids under 16 and the Pfizer seems rare around here. They do list actual numbers of people and that is helpful.
 

Many people, including me, have gotten their vax in a county where they do not live, so it seems that statewide numbers are more helpful than local ones. 

Also, do vaccination numbers have reporting lags like other covid stats? 

[ScoutTN]

4 minutes ago, kand said:

It should be 19% of the population, not just the percentage eligible. 

Right, but without knowing the percentage of the population that actually could get the vax as a reference, it seem rather a meaningless number. 
 

[mommyoffive]

Ohio expands COVID-19 vaccine eligibility to 40+, cancer, obesity; all over age 16 eligible March 29

 

Coronavirus vaccine: Ohio expands eligibility to 40+, others in Phase 1E, Phase 2C (usatoday.com)

[frogger]

3 hours ago, ScoutTN said:

I read my city’s vaccination stats today and I have a question. 
 

When it says 19%, does that mean 19% of the entire population? But the entire population isn’t eligible to be vaccinated bc there isn’t a shot approved for kids under 16 and the Pfizer seems rare around here. They do list actual numbers of people and that is helpful.
 

Many people, including me, have gotten their vax in a county where they do not live, so it seems that statewide numbers are more helpful than local ones. 

Also, do vaccination numbers have reporting lags like other covid stats? 

A good website would tell you. Our state site has tabs for total percentage, percentage of 16+ , and percentage of 65+.  So without knowing the actual city and looking at it I doubt anyone could tell you. There really isn't a standard way to report.

 

[Laura Corin]

This  show is good at answering a lot of questions,  including about the non-relationship between strength of vaccine reactions and subsequent level of immunity.

https://www.bbc.co.uk/programmes/m000t48v

[1234]

nm

Edited March 17, 2021 by Joker2

[Roadrunner]

https://www.yahoo.com/finance/news/astrazenecas-covid-19-vaccine-no-103036443.html
 

AstraZeneca's COVID-19 Vaccine Has No Efficacy Against South African Virus Strain, Study Shows

not good news 😞 

 

Edited March 17, 2021 by Roadrunner

[JennyD]

18 hours ago, ScoutTN said:

I read my city’s vaccination stats today and I have a question. 
 

When it says 19%, does that mean 19% of the entire population? But the entire population isn’t eligible to be vaccinated bc there isn’t a shot approved for kids under 16 and the Pfizer seems rare around here. They do list actual numbers of people and that is helpful.
 

Many people, including me, have gotten their vax in a county where they do not live, so it seems that statewide numbers are more helpful than local ones. 

Also, do vaccination numbers have reporting lags like other covid stats? 

I think the topline numbers are probably only useful for measuring progress, but if you really want to get into the weeds it all seems to be here. (scroll down for the downloadable datasets).  

Vanderbilt is only using Pfizer, and they vaccinated all the public school teachers.   I think the main vaccination center downtown is also Pfizer.  No idea about the other big hospitals, but when I looked at the Walmart and Kroger lists it was mostly Moderna and JnJ, especially outside the city.

The TN state health commissioner held a press conference yesterday.  She said that in Middle Tennessee -- excluding Nashville/Davidson county--80% of available appointments are taken.  (No idea why they'd exclude the city from the stats, but whatever.)  In East TN, 50% are taken, but in rural West Tennessee, less than 20%. of available appointments have been filled.   She said that the demand in rural areas has been less than expected.  

[ScoutTN]

@JennyD thanks!

I wonder if they also figure in the numbers of people who have had covid in the last 90 days and so been told by their docs not to get the vax yet? 
 

I know about 50 people who have had the vax and all except the VUMC folks got the Moderna.

[ScoutTN]

If there are vaccines ready for teens or younger kids by the fall, will vaccination be required for school?

What thinks the Hive?

[JennyD]

2 hours ago, ScoutTN said:

If there are vaccines ready for teens or younger kids by the fall, will vaccination be required for school?

What thinks the Hive?

I can't imagine public schools requiring Covid vaccines for the coming year -- even if they are available for kids, presumably it will be as an EUA rather than full licensure, which presents legal problems.  Furthermore, from what I understand public health folks are already anticipating that a lot of parents will be reluctant to get their kids vaccinated, and I have to think that simply from a public health perspective, government entities mandating vaccination at this early stage would be counterproductive in getting more people to accept the vaccine.

Private schools, OTOH, are a different story.  I would bet that a subset of them -- especially selective private schools in high-vaccination areas --  will push very hard on urging, if not actually requiring, kids be vaccinated as soon as vaccines are available.

Edited March 18, 2021 by JennyD

[Pam in CT]

re schools and vaccinations

3 hours ago, ScoutTN said:

If there are vaccines ready for teens or younger kids by the fall, will vaccination be required for school?

What thinks the Hive?

Concur with Jenny that no government authority will mandate vaccination under EUA.  I doubt private schools will either.  Strongly encourage, put various incentive carrots in place, but not require. 

Where I do see mandates potentially going into place sooner rather than later is some sort of vaccine passport as a requirement for entry into other countries and... from that... from airlines as a condition for boarding an international flight.

[Dmmetler]

4 hours ago, JennyD said:

I think the topline numbers are probably only useful for measuring progress, but if you really want to get into the weeds it all seems to be here. (scroll down for the downloadable datasets).  

Vanderbilt is only using Pfizer, and they vaccinated all the public school teachers.   I think the main vaccination center downtown is also Pfizer.  No idea about the other big hospitals, but when I looked at the Walmart and Kroger lists it was mostly Moderna and JnJ, especially outside the city.

The TN state health commissioner held a press conference yesterday.  She said that in Middle Tennessee -- excluding Nashville/Davidson county--80% of available appointments are taken.  (No idea why they'd exclude the city from the stats, but whatever.)  In East TN, 50% are taken, but in rural West Tennessee, less than 20%. of available appointments have been filled.   She said that the demand in rural areas has been less than expected.  

The big cities have their own health departments and are managing their own vaccinations. There is a health network that is contracted for rural sites. They're probably using those numbers. 

 

I'm in Memphis, and until about 3 weeks ago, a lot of people were driving to the rural counties to get vaccinated because they were doing 1b and 1c, but Memphis was stuck on 1a. But they did teachers at a bunch of pop ups all at once, many sites had extras, so people got family members and friends vaccinated and then opened up for health conditions, and suddenly, appointments are much more available. I suspect a lot of the folks in 1c had found a way to get vaccinated somewhere else by then.

DH and L aren't eligible yet. I am hoping that they will be soon. S was able to be vaccinated under 1c given her risk factors. 

[Dmmetler]

I can see colleges requiring it to live on campus, especially schools that are testing everyone regularly currently. I am hoping that L will have the opportunity before fall since only 1/3 of the approved vaccines are approved for 16 yr olds, and I can easily imagine colleges providing the one dose vaccine on campus. I know that when there were measles outbreaks when I was in grad school, all students were required to get vaccinated again or get a waiver. Like thousands of kids lining up in the gym to get the shot and a lollipop (yes, they provided lollipops. And, if memory serves correctly, a variety of cartoon Band-Aids). 

[Laura Corin]

More real life vaccine data. There's somewhat less data about AstraZeneca than Pfizer because it hasn't been used for so long.

https://www.thetimes.co.uk/article/just-one-shot-of-the-pfizer-or-oxford-vaccine-offers-80-protection-9b8h7zd82

[Roadrunner]

57 minutes ago, Laura Corin said:

More real life vaccine data. There's somewhat less data about AstraZeneca than Pfizer because it hasn't been used for so long.

https://www.thetimes.co.uk/article/just-one-shot-of-the-pfizer-or-oxford-vaccine-offers-80-protection-9b8h7zd82

Strange way to present data. It seems they are averaging the rates to get 80%. Or are they saying it’s 80% for either one? Because that would be different yet again from data released before. I couldn’t open to read the entire article. Maybe answers are there. 

[Laura Corin]

3 minutes ago, Roadrunner said:

Strange way to present data. It seems they are averaging the rates to get 80%. Or are they saying it’s 80% for either one? Because that would be different yet again from data released before. I couldn’t open to read the entire article. Maybe answers are there. 

Here's more data.

https://www.gov.uk/government/news/phe-study-shows-three-quarters-of-over-70s-have-covid-19-antibodies

[Roadrunner]

3 minutes ago, Laura Corin said:

Here's more data.

https://www.gov.uk/government/news/phe-study-shows-three-quarters-of-over-70s-have-covid-19-antibodies

That shows data for the elderly. Looks very positive. 

doesn’t explain the 80% number in the previous article though. 

[ScoutTN]

The vaccines are approved for emergency use now. What is the path to full approval and how long will it take in the US? 

[Corraleno]

6 hours ago, ScoutTN said:

The vaccines are approved for emergency use now. What is the path to full approval and how long will it take in the US? 

I don't know the details of the full approval process (called a Biologics License Application), but there has been a lot of discussion on how trialing a vaccine in the middle of a pandemic complicates that process. Normally vaccine developers would be continuing the Phase 3 trial for a couple of years, to collect long-term data, and I believe that all of the EUAs granted so far included plans for 2 years of follow-up in the applications. But there is an obvious ethical issue in leaving thousands of people in the placebo groups unvaccinated in the middle of a deadly pandemic — especially when they don't even know they're unvaccinated. I think both Pfizer and Moderna have stated that they will go ahead and vaccinate the placebo group, which means they will no longer have a control group for comparison. There seem to be enough vaccine refusers in the US that they could do some sort of matched cohort study, but I don't know if there are specific plans for that.

[JennyD]

 

3 minutes ago, Corraleno said:

but there has been a lot of discussion on how trialing a vaccine in the middle of a pandemic complicates that process.

Yes.  This article cites the director of the relevant FDA panel saying that they'd like to see six months of followup efficacy and safety data in a BLA application, but the efficacy data may be very difficult to collect, especially for Moderna and JnJ.  (Pfizer has collected a lot of data through the Israeli health system and may be ahead of the game on this.)

It's not even clear to me that all of these companies will seek full licensure for their Covid vaccines.  On the one hand, the first company to get a BLA would have a competitive advantage over the others.  On the other, if the pandemic fades in the US and/or another company develops a clearly better vaccine for global distribution (e.g., a highly effective single-dose vaccine that is cheap to produce and can be stored at room temperature) I could imagine Pfizer and Moderna deciding to just pack up their Covid vaccine projects and move on to other mRNA vaccines.  But then again, I'm no kind of biotech expert and don't actually know how these companies make decisions.  

 

[ktgrok]

Orange County, Florida, where Orlando is, just announced anyone 40 and up can get vaccinated at the big convention center as of Monday. 

[Ditto]

5 hours ago, Corraleno said:

I don't know the details of the full approval process (called a Biologics License Application), but there has been a lot of discussion on how trialing a vaccine in the middle of a pandemic complicates that process. Normally vaccine developers would be continuing the Phase 3 trial for a couple of years, to collect long-term data, and I believe that all of the EUAs granted so far included plans for 2 years of follow-up in the applications. But there is an obvious ethical issue in leaving thousands of people in the placebo groups unvaccinated in the middle of a deadly pandemic — especially when they don't even know they're unvaccinated. I think both Pfizer and Moderna have stated that they will go ahead and vaccinate the placebo group, which means they will no longer have a control group for comparison. There seem to be enough vaccine refusers in the US that they could do some sort of matched cohort study, but I don't know if there are specific plans for that.

The husband of a friend of mine was part of the Moderna trial.  He was informed that he was in the placebo group and at that point Moderna arranged to have him vaccinated.  I am not sure of the timeline but he is fully vaccinated and has been for awhile now.

[mommyoffive]

Gibraltar Vaccinates Entire Adult Population in 9 Weeks Thanks to Supplies From the U.K. (msn.com)

[mommyoffive]

UK announces half of all adults have received at least first coronavirus shot (msn.com)

[Laura Corin]

https://www.astrazeneca.com/media-centre/press-releases/2021/astrazeneca-us-vaccine-trial-met-primary-endpoint.html

This was with a 4-week gap, but the text suggests better results (in other trials and based on immune response) with a longer gap.

Edited March 22, 2021 by Laura Corin

[Kanin]

I just read that finally, Brazil is getting some AstraZeneca vaccine doses through the WHO. Seems like they need millions upon millions of doses to start making a dent in their cases, though. 

And I can't help but wonder, won't the Brazil variant be widespread here, too? It's a race between vaccines and virus. 😕 

 

[Ausmumof3]

5 hours ago, Laura Corin said:

https://www.astrazeneca.com/media-centre/press-releases/2021/astrazeneca-us-vaccine-trial-met-primary-endpoint.html

This was with a 4-week gap, but the text suggests better results (in other trials and based on immune response) with a longer gap.

Seems like it’s overall slightly less effective than Pfizer/Moderna but equally good for severe Covid and hospitalisation.  I guess the next thing will be to see how long immunity lasts from the different vaccines.

[Ausmumof3]

1 hour ago, kand said:

Ugh. I don’t see details yet, but this looks concerning that AZ may have bungled the data again. I really hope not: https://www.nih.gov/news-events/news-releases/niaid-statement-astrazeneca-vaccine?utm_source=dlvr.it&utm_medium=twitter

Oh dear!

[Ausmumof3]

19 hours ago, Kanin said:

I just read that finally, Brazil is getting some AstraZeneca vaccine doses through the WHO. Seems like they need millions upon millions of doses to start making a dent in their cases, though. 

And I can't help but wonder, won't the Brazil variant be widespread here, too? It's a race between vaccines and virus. 😕 

 

Plus the P1 variant had the thing that gets around antibodies so will the vaccines work as well?

[Corraleno]

50 minutes ago, kand said:

Still not many details, but definitely doesn’t look good. The monitoring board overseeing the AZ trials feels AZ has misrepresented their data in some way. What’s extra frustrating is that this doesn’t appear to have anything to do with safety of the vaccine, and I’ll be surprised if better data doesn’t still show that the vaccine works (though I expect not as well as they said), but this kind of thing casts doubt for people, which is so unhelpful. I do hope as a silver lining that people worried that the process is being rushed or isn’t being followed will see that oversight is happening and if there’s an issue, it’s being called out. 

Apparently the stats AZ released on Monday excluded the most recent data, suggesting that the efficacy rate would be lower if they included all data. The second issue is that the monitoring board does not feel they were rigorous enough in determining whether trial participants had covid. From NYT:

"The independent monitoring board twice pushed AstraZeneca to take a more rigorous approach, telling the company it had sufficient information to determine how many trial participants had the disease. That had the potential to reduce the vaccine’s apparent effectiveness. But AstraZeneca unveiled its interim results on Monday without conducting the full analysis the board requested, possibly casting its vaccine in an overly favorable light."

There seems to be a lot of suspicion that they released positive interim results to counter growing resistance in European countries, even though they know those results are not accurate.

The fact that they've been so cagey and inconsistent with their data from the very beginning really doesn't engender a sense of trust and transparency. First there was the whole mis-dosing thing, with AZ and Oxford contradicting each other about how and why a half-dose of the first shot was given to some participants. AZ said it was totally accidental, but Oxford said it was intentional, and then admitted that the half-doses were from a totally different vaccine batch from a different manufacturer, without elaborating why they would have purposely chosen to use a half-dose of that batch in violation of their own trial protocol. And then when the half-dose trial in a small group of 2700 participants showed 90% efficacy — much higher than the 62% in the regular trial — they combined the results to report 70% efficacy, even though they were not using the half-dose protocol. They also failed to inform US authorities that they had halted trials due to neurological issues; the FDA only found out about it through media reports.

Edited March 23, 2021 by Corraleno

[Not_a_Number]

2 minutes ago, Corraleno said:

Apparently the stats AZ released on Monday excluded the most recent data, suggesting that the efficacy rate would be lower if they included all data. The second issue is that the monitoring board does not feel they were rigorous enough in determining whether trial participants had covid. From NYT:

"The independent monitoring board twice pushed AstraZeneca to take a more rigorous approach, telling the company it had sufficient information to determine how many trial participants had the disease. That had the potential to reduce the vaccine’s apparent effectiveness. But AstraZeneca unveiled its interim results on Monday without conducting the full analysis the board requested, possibly casting its vaccine in an overly favorable light."

There seems to be a lot of suspicion that they released positive interim results to counter growing resistance in European countries, even though they know those results are not accurate.

The fact that they've been so cagey and inconsistent with their data from the very beginning really doesn't engender a sense of trust and transparency. First there was the whole mis-dosing thing, with AZ and Oxford contradicting each other about how and why a half-dose of the first shot was given to some participants. AZ said it was totally accidental, but Oxford said it was intentional, and then admitted that the half-doses were from a totally different vaccine batch from a different manufacturer, without elaborating why they would have purposely chosen to use a half-dose of that batch in violation of their own trial protocol. And then when the half-dose trial in a small group of 2700 participants showed 90% efficacy — much higher than the 62% in the regular trial — they combined the results to report 70% efficacy, even though they were not using the half-dose protocol. They also failed to inform US authorities that they had halted trials due to neurological issues; the FDA only found out about it through media reports.

Yeesh. Ok, I hate to say this, but I hope I don’t get this vaccine (if it ever gets approved here.) This is all really shady.

[Corraleno]

15 minutes ago, Not_a_Number said:

Yeesh. Ok, I hate to say this, but I hope I don’t get this vaccine (if it ever gets approved here.) This is all really shady.

I'll be surprised if ends up being available here. We've already ordered more doses of Pfizer, Moderna, and J&J than needed to vaccinate the entire population, so unless one of those manufacturers runs into major issues and can't fill those orders, we really don't need another vaccine. AZ "owes" the US 400 million doses in return for more than a billion dollars in funding, but I'd bet we end up donating those doses to the COVAX program for distribution in other countries. 

Edited March 23, 2021 by Corraleno

[Not_a_Number]

Just now, Corraleno said:

I'll be surprised if its approved here. We've already ordered more doses of Pfizer, Moderna, and J&J than needed to vaccinate the entire population, so unless one of those manufacturers runs into major issues and can't fill those orders, we really don't need another vaccine. AZ "owes" the US 400 million doses in return for more than a billion dollars in funding, but I'd bet we end up donating those doses to the COVAX program for distribution in other countries. 

Yeah, I don’t disagree there. I just feel kind of bad because all of their lack of transparency is really reducing my faith in them!!

[Laura Corin]

14 minutes ago, Not_a_Number said:

Yeah, I don’t disagree there. I just feel kind of bad because all of their lack of transparency is really reducing my faith in them!!

My suspicion (based on not very much) is that the tech may actually be fine but they are basically not a vaccine company, and they had to build their knowledge about the vaccine approval process on the fly.

[Corraleno]

45 minutes ago, Not_a_Number said:

Yeah, I don’t disagree there. I just feel kind of bad because all of their lack of transparency is really reducing my faith in them!!

Fauci called the latest screw-up an "unforced error," and said it's really unfortunate because it's a good vaccine but their lack of transparency erodes trust not only in the AZ vaccine but in vaccines in general.

Even if the true efficacy is only 69%, that's a decent vaccine, comparable to J&J, and it exceeds the threshold for approval. They don't need to lie about their efficacy rate, they're just shooting themselves in the foot for no reason.

Edited March 23, 2021 by Corraleno

[Corraleno]

9 minutes ago, Laura Corin said:

My suspicion (based on not very much) is that the tech may actually be fine but they are basically not a vaccine company, and they had to build their knowledge about the vaccine approval process on the fly.

Well, Moderna had never developed a vaccine before or been through the approval process for any product, and they managed to not screw up their trials or purposely fudge their stats. The Oxford Vaccine Group was founded in 1994 and has been involved in clinical trials for other vaccines. AZ has been involved in drug trials for decades, which work basically the same way, and has dozens of products approved for use in the US. There does seem to be some friction between the Oxford group that is supervising the research and the corporate folks at AZ who are more concerned with keeping their stock price up than releasing accurate data.

[JennyD]

1 hour ago, Corraleno said:

Well, Moderna had never developed a vaccine before or been through the approval process for any product, and they managed to not screw up their trials or purposely fudge their stats. The Oxford Vaccine Group was founded in 1994 and has been involved in clinical trials for other vaccines. AZ has been involved in drug trials for decades, which work basically the same way, and has dozens of products approved for use in the US. There does seem to be some friction between the Oxford group that is supervising the research and the corporate folks at AZ who are more concerned with keeping their stock price up than releasing accurate data.

Yeah, a year ago if you had asked me to bet on random startup Moderna (with its total lack of financial transparency and seemingly iffy stock trades by execs) or a partnership between Oxford University and AstraZeneca, that would have been an easy -- and totally wrong -- choice.  

This article, from a few days ago, was illuminating.  In particular, this quote:

"Hill [member of Oxford team] said if he could do things over, he wouldn’t change much — with the exception of potentially looking at the data even earlier, so that a vaccine could have been shown effective in August. He questioned why the AstraZeneca vaccine had to be subjected to further trials before being authorized in the United States.

Really?  You wouldn't do anything differently? It's all gone great?

Edited March 23, 2021 by JennyD

[TCB]

Just heard an interview with one of the AZ/Oxford vaccine developers and she mentioned that the criteria for severe Covid was different in the US trial and meant it was more difficult to meet the severe definition there and that might account for some of the differences in results. She also said that they had given over 10 million doses in the UK with good efficacy and good safety. 

[Laura Corin]

3 hours ago, Corraleno said:

 There does seem to be some friction between the Oxford group that is supervising the research and the corporate folks at AZ who are more concerned with keeping their stock price up than releasing accurate data.

That makes a lot of sense.

[SKL]

I have another dumb question.

What does 95% effective mean?  Kindergarten language, as my kid would say.

ETA also, when they test these vaxes on kids, are they focused on efficacy, or only on safety?

Edited March 23, 2021 by SKL

[Lanny]

Hello from Colombia: I am in "Group 2" which includes elderly people between 60 and 80 years old. They have begun vaccinating people in Group 2 and I received a phone call last Saturday about Noon. My wife spoke with the person and she asked which of the approximately 5 COVID-19 vaccines I would get and the person said something like whatever they have that day. Not all of them have arrived in Colombia so far. I think some Pfizer/BioNTech and some Sinovac from China and now some AstraZeneca.  I don't think any Moderna or Janssen (J&J has arrived yet.

For a long time, I have been interested in, if I have a choice, the Pfizer/BioNTech or the Moderna. And recently I became more interested in the Janssen (J&J)  one shot vaccine.

AstraZeneca went to the bottom of my list when I read that South Korea had suspended it, approximately 6 weeks ago. Since then, a number of things have happened to AstraZeneca which have lowered my confidence in that vaccine and it is off of my list now.

I read that all of the trials of Moderna were done in the USA.  If so that's not good IMO. 

I would like to see a recent, easy to understand short article about which vaccines offer the most protection to elderly people. 

I had read that the U.S. Government funded AstraZeneca last year when the COVID-19 crisis began, with a 3.2 billion dollar loan or grant.  At the moment that doesn't seem to be a good "investment" but it was for a good cause.  I suspect AstraZeneca will apply for and receive the EUA in the USA in the near future.

If I had to receive the vaccine today, and I had to choose between AstraZeneca and Sinovac I would choose Sinovac. I read that 70 million people have received Sinovac so far. Certainly Sinovac is not near  the top of my list, but AstraZeneca is no longer on my list.

[Corraleno]

1 hour ago, SKL said:

I have another dumb question.

What does 95% effective mean?  Kindergarten language, as my kid would say.

ETA also, when they test these vaxes on kids, are they focused on efficacy, or only on safety?

Efficacy rates compare the rate of [X outcome] in the treatment and placebo groups. So 95% efficacy against symptomatic covid means that for every 100 people in the placebo group who had symptomatic covid, there were only 5 in the vaccine group, suggesting that the vaccine prevented 95% of the cases that would be expected without the vaccine. Or to use J&J's stats, 66% efficacy against moderate disease and 85% efficacy against severe disease means that for every 100 people in the placebo group who had moderate or severe cases there were 34 and 15, respectively, in the vaccine group.

Looks like Moderna's pediatric trial is testing both safety and efficacy: "Part 2 will evaluate the safety, tolerability, reactogenicity and effectiveness of two doses of mRNA-1273 given 28 days apart. The Company intends to enroll approximately 6,750 pediatric participants in the U.S. and Canada ages 6 months to less than 12 years."

 

[JennyD]

1 hour ago, Corraleno said:

 

Looks like Moderna's pediatric trial is testing both safety and efficacy: "Part 2 will evaluate the safety, tolerability, reactogenicity and effectiveness of two doses of mRNA-1273 given 28 days apart. The Company intends to enroll approximately 6,750 pediatric participants in the U.S. and Canada ages 6 months to less than 12 years."

 

I think that the pediatric trials will be measuring efficacy differently than did the adult trials; instead of waiting to see how many kids get sick in each group, they will see whether (and at what dosages) the antibody levels in children match those of vaccinated adults.  Probably not as good a metric, particularly since we don't actually know for sure what antibodies and/or immune markers correlate to being protected against this virus, but since kids are frequently asymptomatic it's presumably the most workable option. 

Edited March 24, 2021 by JennyD

[Corraleno]

20 minutes ago, JennyD said:

I think that the pediatric trials will be measuring efficacy differently than did the adult trials; instead of waiting to see how many kids get sick in each group, they will see whether (and at what dosages) the antibody levels in children match those of vaccinated adults.  Probably not as good a metric, particularly since we don't actually know for sure what antibodies and/or immune markers correlate to being protected against this virus, but since kids are frequently asymptomatic it's presumably the most workable option. 

It looks like they will also be measuring the numbers of symptomatic and asymptomatic infections, but those are listed as secondary outcomes (with antibody levels as a primary outcome), so perhaps those are listed as secondary in case they do not have high enough numbers for statistical significance within a fairly short time frame? Perhaps they're planning to apply for an EUA fairly quickly based on serum antibody levels, while continuing to look at numbers of infections throughout the follow-up period.

https://clinicaltrials.gov/ct2/show/NCT04796896?term=Moderna&draw=4&rank=17 

[Penelope]

With so few symptomatic infections in children and almost no moderate to severe disease, they would need a lot more than 6,000 to determine significant efficacy. They needed 30-40,000 for adults, in the time frame they wanted.
And with Covid infections going down overall and vaccination increasing, there will be even fewer infections occurring in children. 

I wonder if we will have any answers at all about efficacy with any of the vaccines in children. It will be interesting to see what side effects are like, and maybe one dose will be deemed “good enough” for them. If second dose symptoms are similar to those in adults, it’s a pretty hard sell for younger kids without full study and approval, especially once overall symptomatic cases and hospitalizations fall to near zero.

Edited March 24, 2021 by Penelope

[Not_a_Number]

6 minutes ago, Penelope said:

If second dose symptoms are similar to those in adults, it’s a pretty hard sell for younger kids without full study and approval, especially once overall symptomatic cases and hospitalizations fall to near zero.

The question is whether cases will fall to near zero with kids as vectors. 

[Laura Corin]

Interesting on vaccine hesitancy 

https://www.theguardian.com/society/2021/mar/24/covid-vaccine-hesitancy-england-wales-being-overcome-study-finds?CMP=Share_AndroidApp_Other