SARS-CoV-2 vaccines

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Anaxagoras
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Re: SARS-CoV-2 vaccines

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Meanwhile, Israel now has vaccinated over 9% of its population. They are far ahead of any other country. Not in absolute numbers but per capita. Their population is around 9 million.

https://ourworldindata.org/covid-vaccinations

Israel nears one million coronavirus vaccinations (Jerusalem Post)
Israel is expected to have over a million citizens vaccinated by the end of Friday, after over 153,000 Israelis received the coronavirus vaccine in Israel on Thursday, bringing the total number of vaccinations administered to 950,000, the Health Ministry announced on Friday morning.

"So how are Israel's 950,000 vaccinated citizens? Just yesterday we broke another record and vaccinated 153,430 people at 325 vaccination stations across the country. Today we will pass the [milestone of a] million vaccinated," said Health Minister Yuli Edelstein. "On behalf of all of you, I thank the medical staff for the amazing work."
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Re: SARS-CoV-2 vaccines

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Warp Speed chief: U.S. won’t get AstraZeneca vaccine until April
Americans likely won’t receive AstraZeneca's coronavirus vaccine before April because of lingering questions about its effectiveness in certain groups, a top Trump administration health official said hours after U.K. regulators authorized the company’s shot Wednesday.

The prediction by Moncef Slaoui, head of Operation Warp Speed, moves back the U.S. government’s timeline for greenlighting the AstraZeneca shot by at least two months. Slaoui earlier this month estimated the British drugmaker would file for emergency use authorization with the Food and Drug Administration as early as February.
“We project, if everything goes well, that the readout and emergency use authorization may be granted somewhere early in the month of April,” Slaoui said on a press call Wednesday.
Slaoui said that while the AstraZeneca vaccine appears very effective against severe disease, its efficacy among elderly people is “effectively unknown” because few older people were enrolled early in the trial. He said that remains his biggest question about the company’s shot, given the virus’ impact on elderly people.
The UK thinks it's OK to use it already, but apparently the US government (or at least this guy) is taking a different view.

Is there any reason to think it might not work as well in older people given that trials mostly involved younger people?

Could it be nationalism? The AstraZeneca vaccine is the so-called Oxford vaccine, isn't it? Why has only the UK approved it, and conversely, is Operation Warp Speed trying stave off the competition to benefit Pfizer and Moderna?

ETA: or even more troubling, this guy is probably going to leave his position in January when Biden takes over. Is he going to parachute into a lucrative position at Pfizer or Moderna?
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Pyrrho
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Re: SARS-CoV-2 vaccines

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I have read that there are important questions about how the AstraZeneca clinical trials were conducted and how the data were gathered.

Let's see what the FDA says about it. No doubt there will be an advisory committee meeting devoted to it.

eta: Oh yeah, here it is:

viewtopic.php?f=5&t=49841&p=1045070&hil ... a#p1045070

Some other discussion in that thread.
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Re: SARS-CoV-2 vaccines

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Peer reviews of Pfizer/BioNTech vaccine results and the Moderna vaccine results.

https://www.nejm.org/doi/full/10.1056/NEJMoa2034577

https://www.nejm.org/doi/full/10.1056/NEJMoa2035389
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Re: SARS-CoV-2 vaccines

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240 Israelis found with COVID after vaccination, underscoring need for vigilance

Pfizer’s shot only begins having an effect 8-10 days after first injection, and only reaches full potential after the second dose

Among the nearly one million Israelis vaccinated against coronavirus so far, some 240 Israelis have been diagnosed with the virus days after getting the shot, Channel 13 News reported Thursday.

The figure underscores the need for individuals to continue to protect themselves for weeks after being inoculated, as the body takes time to develop effective antibodies against the SARS-CoV-2 virus, which causes COVID-19.

The Pfizer vaccine is not made with the coronavirus itself, meaning that there is no chance anyone could catch it from the shots. Instead, the vaccine contains a piece of genetic code that trains the immune system to recognize the spiked protein on the surface of the virus and create antibodies to attack if it encounters the real thing.

But this process takes time, and studies of the vaccine so far have shown immunity to the virus rises only some 8-10 days after the first injection — and then only to around 50 percent effectiveness.

This is why the second dose of the vaccine, given 21 days after the first, is critical: It strengthens the immune system’s response to the virus, bringing it to 95% effectiveness and ensuring that immunity lasts. This level of immunity is only reached about a week after the second dose — or 28 days after the first.

Anyone who is infected a few days before getting the vaccine’s first dose or in the weeks before full effectiveness is reached is still in danger of developing symptoms. (Even when the vaccine reaches its top potential, there remains a 5% chance of this.)
https://www.timesofisrael.com/240-israe ... vigilance/

You've been warned. :|
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Re: SARS-CoV-2 vaccines

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I think it's well known that you don't get immunity immediately. Or at least it should be. Even in the clinical trials, there were people who got sick within a 10-day period after getting the first shot. After that, compared to the placebo group, it went down considerably.

Israel is vaccinating so fast it’s running out of vaccine (Washington Post)
Jan. 4, 2021 at 10:20 p.m. GMT+9
JERUSALEM — Israel, which has inoculated a higher proportion of its population against the coronavirus than any other country, is delivering shots so quickly that it is outstripping its supply of vaccine.
Health officials are scrambling to buy more doses and said they may pause giving the first round of shots to younger citizens to deliver the second, final injections to the elderly.
The situation is essentially the opposite of that in many parts of the United States, where vaccines are sitting unused as mass inoculation programs struggle to build momentum.
That's frustrating. For some reason, the US has vaccines available and unused, but shots are not getting into arms like they are in Israel.
Israel seems to have no trouble getting what shots they do have into arms.

And Japan hasn't even approved it yet. Incidentally, it looks like Japan will have another emergency declaration (at least in Tokyo and the 3 adjacent prefectures), which is what they did to slow the spread last spring, and it seemed to work at the time. At a high cost to be sure, but it slowed the spread and it stayed at a fairly low level for the rest of the summer, and then started to grow again as the weather turned colder. The situation objectively is not as dire here as it is in the United States and some other countries I suppose, in terms of the number of infections and deaths, but numbers are rising rapidly.
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Re: SARS-CoV-2 vaccines

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There are significant logistics problems in the US, coupled with an administration that does not appear give a damn.
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Re: SARS-CoV-2 vaccines

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I think a bureaucracy sitting on its thumbs during a transition is more on point.:dunno:
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Re: SARS-CoV-2 vaccines

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They've had their thumbs up their asses the entire year. Now they're about to start cutting vaccine doses in half because they failed to ramp up logistics, leaving it to the states to figure out for the most part.
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Re: SARS-CoV-2 vaccines

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Federalism, love it or hate it.
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Re: SARS-CoV-2 vaccines

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A comparison of the Pfizer/BioNTech vaccine and the Moderna vaccine:

https://www.statnews.com/2020/12/19/a-s ... -vaccines/
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Re: SARS-CoV-2 vaccines

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https://www.fda.gov/news-events/press-a ... 9-vaccines
We have been following the discussions and news reports about reducing the number of doses, extending the length of time between doses, changing the dose (half-dose), or mixing and matching vaccines in order to immunize more people against COVID-19. These are all reasonable questions to consider and evaluate in clinical trials. However, at this time, suggesting changes to the FDA-authorized dosing or schedules of these vaccines is premature and not rooted solidly in the available evidence. Without appropriate data supporting such changes in vaccine administration, we run a significant risk of placing public health at risk, undermining the historic vaccination efforts to protect the population from COVID-19.

The available data continue to support the use of two specified doses of each authorized vaccine at specified intervals. For the Pfizer-BioNTech COVID-19 vaccine, the interval is 21 days between the first and second dose. And for the Moderna COVID-19 vaccine, the interval is 28 days between the first and second dose.
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Re: SARS-CoV-2 vaccines

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Image

:pound_head:
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Re: SARS-CoV-2 vaccines

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It is reasonable to be concerned about the rapid development resulting in atypically shorter times to evaluate effects. Post-study surveillance is not turning up anything of major concern at this point. By the time most people get the vaccine it will have been several months since the conclusion of phase 3 clinical trials and more will be known.
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Re: SARS-CoV-2 vaccines

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Pyrrho wrote: Mon Jan 04, 2021 10:05 pm A comparison of the Pfizer/BioNTech vaccine and the Moderna vaccine:

https://www.statnews.com/2020/12/19/a-s ... -vaccines/
Each dose of Pfizer’s contains 30 micrograms of vaccine. Moderna went with a much larger dose of vaccine, 100 micrograms. It means it is using a little more than three times as much vaccine per person as Pfizer is. And yet, they aren’t getting better results.
Smaller doses seem to be just as effective
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Re: SARS-CoV-2 vaccines

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The mechanism of action is likely to be different for each vaccine.
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Re: SARS-CoV-2 vaccines

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Re: SARS-CoV-2 vaccines

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Wealthy donors received vaccines through Florida nursing home

The invitations alarmed local officials and may have violated state and national guidelines.
https://www.washingtonpost.com/health/2 ... d-vaccine/

Ah, Florida, South America in the USA. :mrgreen:
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Re: SARS-CoV-2 vaccines

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Moderna CEO says vaccine likely to protect for 'couple of years'

PARIS (Reuters) - Moderna’s COVID-19 mRNA vaccine is likely to offer protection of up to a couple of years, its chief executive said on Thursday, even though more data is still needed to make a definitive assessment.

The U.S. biotech company, which stunned the world last year by coming up with a vaccine against the disease caused by the new coronavirus in just a few weeks, received approval for its shot from the European Commission on Wednesday.

Given vaccines development and pharmacovigilance usually requires years, the protection duration of COVID-19 shots is a lingering question for scientists and regulators.

“The nightmare scenario that was described in the media in the spring with a vaccine only working a month or two is, I think, out of the window,” Moderna CEO Stephane Bancel said at an event organised by financial services group Oddo BHF.

“The antibody decay generated by the vaccine in humans goes down very slowly (...) We believe there will be protection potentially for a couple of years.”

Bancel added his company was about to prove that its vaccine would also be effective against variants of the coronavirus seen in Britain and South Africa.
https://www.reuters.com/article/us-heal ... SKBN29C0YK
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Re: SARS-CoV-2 vaccines

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Re: SARS-CoV-2 vaccines

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Norwegian Medicines Agency links 13 deaths to vaccine side effects. Those who died were frail and old

The Norwegian Medicines Agency linked 13 deaths to the corona vaccine’s side effects. Those who died had two things in common – they were old and frail.

A total of 23 deaths have been reported in connection with the corona vaccination.

So far, 13 of these have been assessed.

“The reports might indicate that common side effects from mRNA vaccines, such as fever and nausea, may have led to deaths in some frail patients,” chief physician Sigurd Hortemo in the Norwegian Medicines Agency noted.

Side effects

The Norwegian Medicines Agency and the National Institute of Public Health (FHI) jointly assess all side effects reports.

As a result, the FHI has updated the corona vaccination guide with new advice on the vaccination of frail elderly people.

“If you are very frail, you should probably not be vaccinated,” Steinar Madsen at the Norwegian Medicines Agency said at a webinar on corona vaccine for journalists on Thursday.
https://norwaytoday.info/news/norwegian ... d-old/amp/

Better to be young, rich and healthy than old, poor and sick…
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Re: SARS-CoV-2 vaccines

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Witness wrote: Fri Jan 15, 2021 11:33 pm
Norwegian Medicines Agency links 13 deaths to vaccine side effects. Those who died were frail and old

The Norwegian Medicines Agency linked 13 deaths to the corona vaccine’s side effects. Those who died had two things in common – they were old and frail.

A total of 23 deaths have been reported in connection with the corona vaccination.

So far, 13 of these have been assessed.

“The reports might indicate that common side effects from mRNA vaccines, such as fever and nausea, may have led to deaths in some frail patients,” chief physician Sigurd Hortemo in the Norwegian Medicines Agency noted.

Side effects

The Norwegian Medicines Agency and the National Institute of Public Health (FHI) jointly assess all side effects reports.

As a result, the FHI has updated the corona vaccination guide with new advice on the vaccination of frail elderly people.

“If you are very frail, you should probably not be vaccinated,” Steinar Madsen at the Norwegian Medicines Agency said at a webinar on corona vaccine for journalists on Thursday.
https://norwaytoday.info/news/norwegian ... d-old/amp/

Better to be young, rich and healthy than old, poor and sick…
This is the first time I've heard of actual deaths caused by the vaccines.

So those who are very frail are also very likely to die if they do get the Covid. Which risk is higher?
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Re: SARS-CoV-2 vaccines

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What kind of metric is "very frail"?
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Re: SARS-CoV-2 vaccines

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The Trump Administration Was Just Kidding When It Said It Had Tons More Vaccine Doses to Ship Out (It Has Zero)

Surprise: Team Trump has royally f---ed up the COVID-19 vaccine rollout.

Earlier this week, Health and Human Services Secretary Alex Azar announced that the federal government would start releasing COVID-19 doses that had been held in reserve for second shots, as part of an effort to ramp up a distribution process that has been plagued by chaos and delay. “This new system gives states a strong incentive to ensure that...doses are going to work protecting people rather than sitting on shelves or in freezers,” Azar said at the time. The move was applauded by many, including Ohio governor Mike DeWine, who called it a “welcome change,” with other supporters saying that despite the fact that it might result in a small delay for people’s second shots, it was more important to get as many doses out as quickly as possible as deaths from the virus hit record numbers and a new, even more contagious variant spreads through the U.S. There was just one teeny, tiny problem with the new plan, so small that the federal government apparently didn’t think to mention it at the time. It didn‘t have any more doses to ship out. Whoops! Their bad.

On Friday, The Washington Post reported the news of the colossal fuckup:
Because both of the vaccines authorized for emergency use in the United States are two-dose regimens, the Trump administration’s initial policy was to hold back second doses to protect against the possibility of manufacturing disruptions. But that approach shifted in recent weeks, according to the officials, who spoke on the condition of anonymity because they were not authorized to discuss the matter. These officials were told that Operation Warp Speed, which is overseeing the distribution of vaccines, stopped stockpiling second doses of the Pfizer-BioNTech vaccine at the end of last year. The last shots held in reserve of Moderna’s supply, meanwhile, began shipping out over the weekend.

[It] meant there was no stockpile of second doses waiting to be shipped, as Trump administration officials suggested this week. Azar, at a Tuesday briefing, said, “Because we now have a consistent pace of production, we can now ship all of the doses that had been held in physical reserve.” He explained the decision as part of the “next phase” of the nation’s vaccination campaign.
Now, local health and government officials throughout the country who had expected their exceedingly limited supply of vaccines to be doubling starting next week, and had planned to dramatically expand availability to millions of high-risk and elderly people, are learning that, no, that’s not happening. And, not surprisingly, they’re pretty pissed. On Friday, Oregon governor Kate Brown took to Twitter to express her palpable—and reasonable!—outrage, writing: “Last night, I received disturbing news, confirmed to me directly by General Perna of Operation Warp Speed: States will not be receiving increased shipments of vaccines from the national stockpile next week, because there is no federal reserve of doses. I am demanding answers from the Trump Administration. I am shocked and appalled that they have set an expectation on which they could not deliver, with such grave consequences. This is a deception on a national scale. Oregon’s seniors, teachers, all of us, were depending on the promise of Oregon’s share of the federal reserve of vaccines being released to us.”

Colorado governor Jared Polis was similarly enraged, tweeting: “I’m shocked we were lied to and there is no national reserve. Federal announcements that 2nd dose being held in reserve was going to be released led us to expect 210,000 doses next week, other Govs made similar plans now we find out we’ll only get 79,000 next week.

Of course, ask the Trump administration, and it did nothing wrong. States just misunderstood them when they claimed many more doses were on the way. Per CNN:
Oregon Health Director Patrick Allen, in a letter to Azar in which he recounted a call with Brown and Operation Warp Speed CEO General Gustave Perna on Thursday, demanded that the HHS chief reconcile his statement about “releasing the entire supply” with this revelation.

In an interview with CNN, Allen described the call as an “awkward discussion” in which Perna had confirmed there was no physical stockpile of vaccine but made it seem as if states had simply misunderstood the administration’s plans. “I do not believe I misunderstood,” Allen said. Allen confirmed that Oregon will have to delay its plan to start vaccinating seniors January 23, since no surge in vaccine is coming. “It’s just so disappointing,” he added. “People are desperate for the vaccine, and we have worked so hard to be able to expand who’s eligible, and to not be able to do it is just crushing right now.”
https://www.vanityfair.com/news/2021/01 ... s-screw-up for the rest.

Warped speed… :|