SARS-CoV-2 vaccines

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Re: SARS-CoV-2 vaccines

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https://www.statnews.com/2020/12/29/pub ... e-rollout/
He pledged to “move heaven and earth to get us going in the right direction,” and foreshadowed a number of policy efforts he’s likely to take in his first 100 days in office, including using the Defense Production Act to speed vaccine manufacturing, setting up a public health awareness campaign, and sending mobile vaccination units to hard-to-reach communities. Biden also reiterated his previous pledge to make sure 100 million doses of the Covid-19 vaccines are administered in his first 100 days in office.
So Biden is promising 100 million doses in 100 days. That's still just 1 million per day and remember that it takes 2 doses per person. At that rate it would take almost 2 years to vaccinate everyone in the United States.
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Re: SARS-CoV-2 vaccines

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It is a daunting logistics problem that cannot be overcome by means of promises.
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Re: SARS-CoV-2 vaccines

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Anaxagoras wrote: Tue Dec 29, 2020 7:54 am This vaccine tracker from Bloomberg shows how many people have been vaccinated in real time. Supposedly gets updated multiple times per day:

https://www.bloomberg.com/graphics/covi ... tribution/
Currently stands at 2.67 million for the US and 5.6 million worldwide. That's up about 0.54 million and 1 million respectively from the last time I checked, which was about 42 hours ago.

Hopefully the pace will pick up next month. I imagine it does take time to ramp up to full production. And the distribution is tricky too.
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Re: SARS-CoV-2 vaccines

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Re: SARS-CoV-2 vaccines

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Shots are slow to reach arms as Trump administration leaves final steps of mass vaccination to beleaguered states
In suburban Milwaukee, clinicians recently discarded 500 doses of coronavirus vaccine after vials were left unrefrigerated. In southeastern Arizona, a rural clinic has enough shots but too few employees lining up to take them. And on the coast of Maine, physicians have been left in the dark about when they will get vaccinated.
Great. So there are people who are prioritized to receive shots who don't want them. Let those of us who do want to get vaccinated have the vaccines if people don't want them.
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Re: SARS-CoV-2 vaccines

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Re: SARS-CoV-2 vaccines

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In Ohio, 60% of nursing home staff have so far refused vaccination.
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Re: SARS-CoV-2 vaccines

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If you work at a nursing home it really should be mandatory. Unless you have a history of anaphylactic reactions or some special legitimate medical reason.
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Re: SARS-CoV-2 vaccines

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U.S. Department of Defense Awards Moderna $1.97 Billion COVID-19 Vaccine Contract

The U.S. United States Department of Defense (DOD) awarded Moderna a contract worth $1,966,598,000 for an additional 100 million doses of its COVID-19 vaccine. The manufacturing will be handled in Cambridge, Massachusetts and is expected to be fulfilled by June 30, 2021.

Moderna’s vaccine has been granted emergency use authorization (EUA) in the U.S. and in Canada. The EUA was granted by the FDA on December 18 for individuals 18 years of age and older. Health Canada granted authorization on December 23. The Canadian authorization came under Health Canada’s Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 and was based on a rolling review of data that started on October 12. It included data from the Phase III COVE trial of 30,000 volunteers.

Earlier in December, the Canadian government exercised its option to increase its confirmed order of the vaccine by 20 million doses, bringing the total commitment to 40 million doses.
https://www.biospace.com/article/u-s-de ... -contract/
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Re: SARS-CoV-2 vaccines

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Well, it appears we have our first case of deliberate sabotage. Those 500 spoiled doses mentioned in the article above? Not an accident.

Employee intentionally removed COVID-19 vaccine from fridge, ruining more than 500 doses, hospital says; FBI investigating
MILWAUKEE — Advocate Aurora Health says a now-fired employee intentionally removed 57 vials of the Moderna coronavirus vaccine from a refrigerator last weekend, causing them to become ineffective and be discarded.

Each vial contains enough vaccine for 10 vaccinations.

Initially, Aurora was "led to believe" the removal was an error. But Wednesday, the employee "acknowledged that they intentionally removed the vaccine from refrigeration," according to a statement from the health care provider.

Grafton Police Department said in a statement late Wednesday that it was notified by Aurora shortly after 6 p.m. "regarding an employee tampering with vials of the COVID-19 vaccine" at its hospital.

The statement goes on to say the incident is being investigated by the FBI and the Food and Drug Administration as well as Grafton police.

Aurora said the action by the employee is "a violation of our core values."

The employee was fired, and Aurora said it notified "appropriate authorities for further investigation."

Aurora said no other employees were involved and that it plans to release more information on Thursday.
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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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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/

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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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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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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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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… :|
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Fauci: Single dose vaccine likely only two weeks away from FDA application

Dr. Anthony Fauci explains that neither of the two currently available vaccines, Pfizer and Moderna, are better than the other, and estimates that a single dose vaccine is only two weeks away from asking the FDA for emergency use authorization.
https://www.msnbc.com/rachel-maddow/wat ... 9904070001 (video at the link)
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Witness
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Re: SARS-CoV-2 vaccines

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CDC director says federal government does not know how much Covid vaccine the U.S. has
  • The director of the Centers for Disease Control and Prevention warned Sunday that the federal government doesn't know how much coronavirus vaccine the nation has.
  • "I can't tell you how much vaccine we have, and if I can't tell it to you then I can't tell it to the governors and I can't tell it to the state health officials," CDC director Dr. Rochelle Walensky told "Fox News Sunday."
...

In a dig at the Trump administration, Walensky said the lack of knowledge of vaccine supply is indicative of "the challenges we've been left with."
https://www.cnbc.com/2021/01/24/cdc-dir ... s-has.html
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Re: SARS-CoV-2 vaccines

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Israel sees 60% drop in hospitalizations for age 60-plus 3 weeks after 1st shot

Full effects of Pfizer’s shots only kick in around a month after inoculation, but data from Israel shows there is a stark drop in infections even before that point

Vaccines are quickly averting serious cases of COVID-19 among the most vulnerable members of society, an Israeli healthcare provider has indicated.

The full effects of Pfizer’s vaccine are only slated to kick in around a month after the first shot, but data from Israel, home to the world’s fastest vaccination drive, has already shown that there is a stark drop in infections even before this point.

Attracting widespread international interest by sharing early data, Maccabi Healthcare Services reported earlier this month that it has seen a 60 percent reduction in coronavirus infections three weeks after the first shot is administered.

But it wasn’t clear if the benefits were being felt equally by those who have a propensity to mild infection and those who would be likely to take COVID-19 badly.

Now, Maccabi is starting to answer the question that hospitals and health ministers around the world are anxiously asking, amid fears of health service meltdowns: How quickly will COVID-19 wards start to see the benefits of vaccination?

The decrease in hospital admissions is swift after vaccination, Maccabi suggests in its latest data, finding that hospitalizations start to fall sharply from Day 18 after people receive the first shot. Galia Rahav, head of infectious diseases at Israel’s largest hospital, Sheba Medical Center, described the data as “very important.”

By Day 23, which is 2 days after the second shot, there is a 60% drop in hospitalizations among vaccinated people aged 60-plus, Maccabi revealed after monitoring 50,777 patients. It compared their hospitalization rate at that point with their hospitalization rate soon after receiving the vaccine, using 7-day moving averages.
https://www.timesofisrael.com/israel-se ... ccination/
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Re: SARS-CoV-2 vaccines

Post by Anaxagoras »

That sounds like good news.

Saw this New York Times article in the Japan Times:

As virus grows stealthier, vaccine makers reconsider battle plans
As the coronavirus assumes contagious new forms around the world, two drugmakers reported on Monday that their vaccines, while still effective, offer less protection against one variant and began revising plans to turn back an evolving pathogen that has killed more than 2 million people.

The news from Moderna and Pfizer-BioNTech underscored a realization by scientists that the virus is changing more quickly than once thought, and may well continue to develop in ways that help it elude the vaccines being deployed worldwide.

The announcements arrived even as U.S. President Joe Biden banned travel to the United States from South Africa beginning Saturday, in hopes of stanching the spread of one variant. And Merck, a leading drug company, on Monday abandoned two experimental coronavirus vaccines altogether, saying they did not produce a strong enough immune response against the original version of the virus.

Moderna and Pfizer-BioNTech both said their vaccines were effective against new variants of the coronavirus discovered in Britain and South Africa. But they are slightly less protective against the variant in South Africa, which may be more adept at dodging antibodies in the bloodstream.

The vaccines are the only ones authorized for emergency use in the United States.

As a precaution, Moderna has begun developing a new form of its vaccine that could be used as a booster shot against the variant in South Africa. “We’re doing it today to be ahead of the curve, should we need to,” Dr. Tal Zaks, Moderna’s chief medical officer, said in an interview. “I think of it as an insurance policy.”

“I don’t know if we need it, and I hope we don’t,” he added.

Moderna said it also planned to begin testing whether giving patients a third shot of its original vaccine as a booster could help fend off newly emerging forms of the virus.

Dr. Ugur Sahin, the chief executive of BioNTech, said in an interview Monday that his company was talking to regulators around the world about what types of clinical trials and safety reviews would be required to authorize a new version of the Pfizer-BioNTech vaccine that would be better able to head off the variant in South Africa.

Studies showing decreased levels of antibodies against a new variant do not mean a vaccine is proportionately less effective, Sahin said.

BioNTech could develop a newly adjusted vaccine against the variants in about six weeks, he said. The Food and Drug Administration has not commented on what its policy will be for authorizing vaccines that have been updated to work better against new variants.

But some scientists said that the adjusted vaccines should not have to go through the same level of scrutiny, including extensive clinical trials, that the original versions did. The influenza vaccine is updated each year to account for new strains without an extensive approval process.

“The whole point of this is a rapid response to an emerging situation,” said John Moore, a virus expert at Weill Cornell Medicine in New York.

Sahin said a similar booster shot eventually may be necessary to stop COVID-19. The vaccine’s reduced efficacy may also mean that more people will need to get the shots before the population achieves herd immunity.
(continues)

Another story about the Chinese vaccine:

China wanted to show off its vaccines. It’s backfiring.
China’s coronavirus vaccines were supposed to deliver a geopolitical win that showcased the country’s scientific prowess and generosity. Instead, in some places, they have set off a backlash.

Officials in Brazil and Turkey have complained that Chinese companies have been slow to ship the doses and ingredients. Disclosures about the Chinese vaccines have been slow and spotty. The few announcements that have trickled out suggest that China’s vaccines, while considered effective, cannot stop the virus as well as those developed by Pfizer and Moderna, the American drugmakers.

In the Philippines, some lawmakers have criticized the government’s decision to buy a vaccine made by a Chinese company, Sinovac. Officials in Malaysia and Singapore, which both ordered doses from Sinovac, have had to reassure their citizens that they would approve a vaccine only if it had been proved safe and effective.

“Right now, I would not take any Chinese vaccine because there’s insufficient data,” said Bilahari Kausikan, an influential former official at Singapore’s Ministry of Foreign Affairs. He added that he would consider it only with “a proper report.”

At least 24 countries, most of them low and middle income, signed deals with the Chinese vaccine companies because they offered access when richer nations had claimed most of the doses made by Pfizer and Moderna. But the delays in getting the Chinese vaccines and the fact that the vaccines are less effective mean that those countries may take longer to vanquish the virus.

Beijing officials who had hoped the vaccines would burnish China’s global reputation are now on the defensive. State media has started a misinformation campaign against the American vaccines, questioning the safety of the Pfizer and Moderna shots and promoting the Chinese vaccines as a better alternative. It has also distributed online videos that have been shared by the anti-vaccine movement in the United States.

Liu Xin, an anchor with CGTN, the state broadcaster, asked on Twitter why the foreign media has failed to “follow up” on the deaths of people in Germany who had taken one vaccine — though scientists have said the people were already seriously ill. Liu’s tweet was shared by Zhao Lijian, a top spokesman at China’s Foreign Ministry.

George Gao, head of the Chinese Center for Disease Control and Prevention, has questioned the safety of the American vaccines because their developers used new techniques rather than the traditional method embraced by Chinese makers.

China had hoped its vaccines would prove it had become a scientific and diplomatic powerhouse. It remains on par with the United States in the number of vaccines approved for emergency use or in late-stage trials. Sinopharm, a state-owned vaccine-maker, and Sinovac have said they can produce up to a combined 2 billion doses this year, making them essential to the global fight against the coronavirus.

Unlike the Pfizer and Moderna vaccines, their doses can be kept at refrigerated temperatures and are more easily transported, making them appealing to the developing world. They have been doled out as aid to countries like Pakistan and the Philippines.
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Re: SARS-CoV-2 vaccines

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U.S. goal to squeeze more COVID shots from Pfizer vials hampered by syringe production

Jan 25 (Reuters) - The world’s largest syringe maker does not have the capacity to substantially increase U.S. supplies of specialty syringes needed to squeeze more doses from Pfizer Inc COVID-19 vaccine vials in the coming weeks, an executive said in an interview.

The vaccine made by Pfizer and its German partner BioNTech, one of two authorized for U.S. emergency use, is shipped in vials initially indicated to hold five doses. Six doses can be drawn with special syringes, call low dead space, which minimize the amount of vaccine left in the syringe after use.

If healthcare providers can reliably extract the sixth dose it would allow supplies to be stretched 20% further and could be a financial boost for Pfizer, which is paid per dose.

The U.S. government has begun giving healthcare providers new syringe kits to extract six shots from each vial. It said that three of the low dead space syringes in each six-needle kit would allow extraction, according to an email reviewed by Reuters. A CDC spokeswoman said the new kits would contain a “majority” of low dead space syringes.

Syringe maker Becton Dickinson has contracted with the U.S. government to provide 286 million syringes for use with COVID-19 vaccines, including around 40 million low dead space syringes, and is fully prepared to deliver on that agreement, said Troy Kirkpatrick, the company’s senior director of public relations.

Low dead space syringes are a niche product and Becton Dickinson had not discussed plans with the U.S. government to substantially boost their output when they began preparing for the vaccine rollout last year, he said.

“We are ready to support the U.S. government but we are trying to make sure everyone understands that those devices are not something we have infinite capacity to produce and bringing up new lines does take time,” Kirkpatrick said.

The Franklin Lakes, New Jersey-based company is the largest syringe and needle maker in the world, according to 360iResearch, and Kirkpatrick said it has boosted overall production capacity by about 1 billion syringes for 2021, with most of the capacity allocated.
https://www.reuters.com/article/health- ... SL1N2JX1YG

Unexpected bottleneck. :|
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Re: SARS-CoV-2 vaccines

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Novavax:

https://www.sciencenews.org/article/cov ... ca-variant
A COVID-19 vaccine made by Novavax is about 89 percent effective against illness, but doesn’t protect as well against a virus variant that arose in South Africa. The data also suggest that people who previously had coronavirus infections may not be immune to the South Africa variant, known as 501Y.V2 or B.1.351, which is now circulating in at least 30 countries.
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