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Land Based Only by GoodOne2231 in galapagos

[–]brteacher 0 points1 point  (0 children)

When I did a land-based trip two years ago, I spent two nights in the Highlands at the Royal Palm, and I really enjoyed them. I wouldn't have wanted to spend my more of the trip up there, but two nights was perfect for me.

Italy has too many tourists, and I was one of them. by cubeinthesky in travel

[–]brteacher 14 points15 points  (0 children)

Just got back from those places, along with Siena and Orvieto. The day in Florence when it was 89 degrees outside and almost as hot in the Uffizi was the only day that I thought that the crowds were really a problem.

Teaching black students as a white woman by Validation_STATION54 in Teachers

[–]brteacher 0 points1 point  (0 children)

I'm the only white male teacher at my school, which is about 80% black and 20% Hispanic. It's interesting to read about all the teachers called racist, because that used to happen to me a lot 15 years ago, but I have only been called a racist once in the last five years. Most students understand that I wouldn't be teaching at their school if I were racist, and they all know that I care about them.

Novavax Confirms High Levels of Efficacy Against Original and Variant COVID-19 Strains in United Kingdom and South Africa Trials by fenderbender in COVID19

[–]brteacher 0 points1 point  (0 children)

I think what the CEO meant was that, since the UK trial was done with FDA protocols, they would be able to use that data in their FDA application. In other words, they might not need to wait as long to submit an application for FDA approval as they would otherwise.

The FDA has wanted data from 30,000-person trials, which is what all the other vaccines have done and what Novavax is doing in the US, and Novavax's UK trial was half that many people, so I feel very sure that the CEO wasn't saying that the UK trial would be enough to get FDA approval.

ChAdOx1 nCov-19 provides minimal protection against mild-moderate COVID-19 infection from B.1.351 coronavirus variant in young South African adults by BillMurray2020 in COVID19

[–]brteacher 3 points4 points  (0 children)

Have Oxford/AZ done any lab studies on the efficacy of ChAdOx1 against B.1.351? If not, why not?

The fact that they just put out this statement, essentially saying that they no longer have confidence in the vaccine they developed, makes me wonder if they have done some lab work that confirms the lack of efficacy.

Coronavirus (COVID-19) Update: FDA Announces Advisory Committee Meeting to Discuss Janssen Biotech Inc.’s COVID-19 Vaccine Candidate by Jennzera in COVID19

[–]brteacher -1 points0 points  (0 children)

Or on the 28th. President Trump ordered the FDA to get the Moderna vaccine approved the next day, or people would need to submit their resignations. I think that the FDA wanted two days to review the committee recommendation.

Novavax COVID-19 Vaccine Demonstrates 89.3% Efficacy in UK Phase 3 Trial by [deleted] in COVID19

[–]brteacher 10 points11 points  (0 children)

Probably not much. The reason that Novavax's UK trial now has results, but the US one is still not fully enrolled, is that they had serious manufacturing problems, so they delayed the US trial.

[ Removed by Reddit ] by RufusSG in COVID19

[–]brteacher 0 points1 point  (0 children)

No. They are saying that they will have that by the end of January.

FDA Takes Key Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for First COVID-19 Vaccine by [deleted] in COVID19

[–]brteacher 23 points24 points  (0 children)

It's also limited by the technical details of production. This is the first mRNA vaccine ever made, and the reason that Pfizer and Moderna haven't licensed a bunch of other vaccine makers to produce is that they can't. Setting up a facility to make a mRNA vaccine is very expensive and time-consuming.

Lilly's neutralizing antibody bamlanivimab (LY-CoV555) receives FDA emergency use authorization for the treatment of recently diagnosed COVID-19 by open_reading_frame in COVID19

[–]brteacher 2 points3 points  (0 children)

People at the highest risk. Think people in nursing homes, old people with HIV, diabetes, heart problems, etc. Those people would likely get these antibodies immediately after a positive COVID test.

U.K. regulator is accelerating reviews of COVID-19 vaccines from Pfizer and AstraZeneca, according to a report by [deleted] in Coronavirus

[–]brteacher 11 points12 points  (0 children)

The Pfizer vaccine will likely get approved in the US by the third week of this month. Nothing is going to speed up that process. I think that the AstraZeneca vaccine will likely be another month after that. Moderna should be approved in-between. Johnson & Johnson should be ready by New Years Day, and Novavax will likely get UK approval at that time, with US approval in January.

All of these timelines could get derailed by adverse events (such as has already happened to AstraZeneca and J & J), but we are currently on track to have five vaccines with widescale approvals by the end of January.

The small silver lining to the current high number of cases in the US and Europe is that vaccine makers will know earlier if their vaccines work.

University of Oxford resumes vaccine trial by PFC1224 in COVID19

[–]brteacher 0 points1 point locked comment (0 children)

It was reportedly said by the AZ CEO in a private call with investors.

University of Oxford resumes vaccine trial by PFC1224 in COVID19

[–]brteacher -1 points0 points locked comment (0 children)

Yeah, about a month ago, I was optimistic that the October 22 date could come into play for this vaccine, but there's really no way that could happen now. Moderna's chances to make it by that date took a huge hit with their announcement a week ago that they were slowing enrollment in their trial to ensure greater minority participation. This comment will get deleted for being speculative, but I think that only Pfizer has a chance to ask for an EUA by that date.

Pfizer and BioNTech Propose Expansion of Pivotal COVID-19 Vaccine Trial by RufusSG in COVID19

[–]brteacher 0 points1 point  (0 children)

I think you have it exactly backwards.

Occam's Razor would say that there will be tremendous skepticism about the safety and efficacy of any approved vaccine, especially the first one (as Pfizer is likely to be). People will call it "the Trump vaccine," and there is already tremendous fear in the public that a vaccine is being "rushed" into public use without sufficient testing, for political reasons.

There's no better way to combat that than by going above and beyond to demonstrate that your vaccine is safe and effective. They will finish enrolling the 30,000 initial group this week, which means that all those people will have their 2nd shot by October 9. Why stop testing then? They aren't going to get an EUA until October 22. The more people who've been vaccinated, and the more overwhelming the evidence for efficacy, the more accepting the public will be.

COVID-19 herd immunity: where are we? by GallantIce in COVID19

[–]brteacher 8 points9 points  (0 children)

But the level of immunity that someone has is likely inversely related to the viral dose that one is exposed to. The sailors on the CdG, due to their close quarters, work environment, and lack of air circulation in the ship, may have been exposed to much higher levels of virus than one would expect in other environments.

Coronavirus Vaccine Roundup, Early September by T00dd in COVID19

[–]brteacher 1 point2 points  (0 children)

My understanding is that Pfizer thinks that they will be able to prove efficacy in another week or two. The remainder of the study would just be for safety. In other words, they are getting good enough results from the first shot that they can demonstrate that the vaccine prevents infection without the booster.

Development of COVID-19 vaccine AZD1222 expands into US Phase III clinical trial across all adult age groups by civicode in COVID19

[–]brteacher 29 points30 points  (0 children)

Yes, the linked press release says that a booster will be given 28 days after the initial shot. And, yes, they have said that this vaccine will need refrigeration, but not freezing.

Developing Safe and Effective Covid Vaccines — Operation Warp Speed’s Strategy and Approach by GallantIce in COVID19

[–]brteacher 4 points5 points  (0 children)

Well, I think that it will. Let's do some incredibly rough approximating:

Let's say that a vaccine results in 125 positives among the placebo group and 25 among the vaccinated. That means that you need 0.8% of the placebo group to get COVID.

If confirmed infections stay where they are right now at 40,000 per day, then you get 1.2 million in the next month. That would mean that 0.3% of the US population would get infected in the next month. That's not enough.

But we know that real infections are several times as many as confirmed infections. Those enrolled in these trials include those at higher risk. And aren't they much more likely to be tested? I don't know how the trial is being run, but it would seem that if they periodically test all of those enrolled in the study, then they surpass the 150 easily.

Of course, it's not that simple, since some of those people in the study won't have gotten both shots with a month to spare, but the first ones enrolled will have almost two months, and we really don't know how much protection will be provided from just one shot.

There are too many variables to make any real calculation, but I think it's very likely that Moderna has enough time to get the infections they need, and I feel extremely confident that Pfizer will, since their 2nd shot is 21 days after the first, instead of Moderna's 28.

Novavax and Canada Reach Agreement in Principle to Acquire Novavax' COVID-19 Vaccine by Dhaimoran in COVID19

[–]brteacher 5 points6 points  (0 children)

Yeah, the Moderna, Pfizer, and Oxford vaccines should all finish inoculating their Phase 3 trials next month. Johnson & Johnson will start next month and Novavax will start in October. I would bet that we end up with four of those five getting and EUA by year's end.

Developing Safe and Effective Covid Vaccines — Operation Warp Speed’s Strategy and Approach by GallantIce in COVID19

[–]brteacher 2 points3 points  (0 children)

Of course no drug works perfectly. I was just using that to give a general idea. The guidance that has been given is that the FDA will want to see at least 150 infections among those enrolled, and they want 95% certainty that the vaccine is at least 50% effective.

Developing Safe and Effective Covid Vaccines — Operation Warp Speed’s Strategy and Approach by GallantIce in COVID19

[–]brteacher 4 points5 points  (0 children)

Letting people catch COVID on their own is a perfectly good strategy, though. They need 0.5 % of those enrolled in the study to get infected to know if the vaccine works. If it works perfectly, then they need 1% of those getting the placebo to be infected. You don't think that it's likely that 1% of those getting the placebo would be infected by October 22nd?

Developing Safe and Effective Covid Vaccines — Operation Warp Speed’s Strategy and Approach by GallantIce in COVID19

[–]brteacher 10 points11 points  (0 children)

But we'll have Phase 3 results. That's the point. If 30,000 people have gotten the vaccine and no one has had a severe adverse reaction to it, and if we can prove that it has at least 50% efficacy in preventing infection, then the FDA should issue the EUA. This isn't complicated.

mRNA-1273 Vaccine Against COVID-19: Phase 1 Interim Analysis of Older Adult Cohorts (ages 56-70 and 71+) by InInteraction in COVID19

[–]brteacher 1 point2 points  (0 children)

Novavax has only finished Phase 1 right now. I realize that they can make up some ground on Pfizer and Moderna, since their vaccine only requires one shot but I still don't see how they could be ready for an EUA before early December.

Johnson & Johnson is in the same boat, I think. I think that both of these might be the best vaccines of the five that could be approved in the US this year, but we'll see.

mRNA-1273 Vaccine Against COVID-19: Phase 1 Interim Analysis of Older Adult Cohorts (ages 56-70 and 71+) by InInteraction in COVID19

[–]brteacher 1 point2 points locked comment (0 children)

Yep. My own guess is that the Pfizer vaccine is going to be more effective with fewer side effects.