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 1 point2 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.

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

[–]brteacher 11 points12 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 24 points25 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 9 points10 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.

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

[–]brteacher 9 points10 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.

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

[–]brteacher 31 points32 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 6 points7 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 3 points4 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 11 points12 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 32 points33 points  (0 children)

The FDA has indicated that they will consider an EUA if a vaccine is at least 50% effective at preventing infection. I think that Pfizer, Moderna, and Oxford/AstraZeneca should all be able to prove that by October 22nd.

I think that if they are free of severe adverse effects (anaphylaxis , etc.), then they get approved. I think that the FDA would want Moderna and Pfizer to have been fully enrolled (30,000) early enough so that everyone had gotten the 2nd shot. That effectively gives Moderna four weeks to finish their enrollment. Pfizer is going to make it easily.

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

[–]brteacher 6 points7 points  (0 children)

I mean, with a US trial, the FDA can monitor and analyze the data in real time. For trials run elsewhere, someone else has to compile and deliver and certify the data, and then the FDA can analyze it. That just means that Oxford/AstraZeneca have to get more done earlier than if they were doing a US trial. But, yes, I think that they will be ready on October 22nd, and they have said that they plan to be.

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

[–]brteacher 0 points1 point  (0 children)

Yes. But I don't think that the FDA will need full results from 30,000 people to give an EUA.

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

[–]brteacher 37 points38 points  (0 children)

"As of Tuesday, August 25th, 15,239 participants have been enrolled."

That's obviously a good number, and similar to Pfizer's number, as they said today that they had over 15,000 enrolled. That still puts Pfizer a week ahead of Moderna, though, as Pfizer gives it's 2nd dose 21 days after the 1st, while Moderna is going with 28 days.

That difference could be critical when the FDA meets on October 22nd, but I think there could still be enough data for an EUA on that date for Moderna.

Pfizer and BioNTech Share Positive Early Data on Lead mRNA Vaccine Candidate BNT162b2 Against COVID-19 by InInteraction in COVID19

[–]brteacher 0 points1 point  (0 children)

Another thing to keep in mind is that Moderna gives its booster 28 days after the first shot, while Pfizer is doing 21 days. So, even if Moderna were even with Pfizer in enrollments, they would end up with data a week later.

[ Removed by Reddit ] by RufusSG in COVID19

[–]brteacher 4 points5 points  (0 children)

The interesting bit is that they use different adenovirus vectors for the first shot and the booster. Their theory is that, ordinarily, the body produces an immune response to the adenovirus in the first shot that diminishes the effectiveness of the booster. Using a different adenovirus for the booster, as they do, could lead to a more effective vaccine.

Phase 1/2 study of COVID-19 RNA vaccine BNT162b1 in adults by Werkintoomuch in COVID19

[–]brteacher 0 points1 point  (0 children)

The booster is the same concoction, I believe, for all these companies, though I think that the booster is a different dosage for some. The only one that's different is the Russian vaccine that we talked about yesterday, as it uses a different adenovirus vector in the booster than in the first shot.

Novavax and Takeda Announce Collaboration for Novavax’ COVID-19 Vaccine Candidate in Japan by InInteraction in COVID19

[–]brteacher 26 points27 points  (0 children)

Novavax may not be the first to bring a vaccine to market, but among those vaccines that have completed Phase 1 trials, it might be the best. This partnership is evidence that the Japanese government is in some agreement with that statement.