lurker wrote: Fri Jan 08, 2021 12:01 pm

featureless wrote: Fri Jan 08, 2021 10:39 am From the "duh" files...

wow, what a bunch of geniuses! who would have imagined that putting large numbers of people in close proximity in enclosed buildings would do that?

Dr. Anthony S. Fauci, the top infectious disease expert in the United States, predicted on Thursday that the daily death toll from the coronavirus would continue to rise for weeks to come, and counseled patience with the vaccination program gearing up across the nation.

Hours later, officials across the United States reported yet another daily record for deaths, over 4,000. The total for the pandemic in the U.S. has surpassed 365,400. In an interview with NPR, Dr. Fauci said the high toll was likely to continue, and was probably a reflection of increased travel and gatherings over the holidays. “We believe things will get worse as we get into January,” he said.

Dr. Fauci advised Americans to be patient with the snags and delays that have slowed the vaccination effort and provoked widespread frustration.

So far, at least 5.9 million people in the United States have received a dose of one of the two Covid-19 vaccines that have been authorized for use, according to the Centers for Disease Control and Prevention. That figure is far short of the goal federal officials had set to give at least 20 million people their first shots by the end of December.

Dr. Francis S. Collins, the head of the National Institutes of Health, said Wednesday he was “not totally surprised” that vaccine distribution had gotten off to a “rocky” start. We had this remarkable plan that Warp Speed had put in place to have doses ready to go the very next day after the F.D.A. approval, but that’s a lot of logistics,” he told The Washington Post, referring to Operation Warp Speed, the administration’s vaccine development program. “So maybe we shouldn’t be too shocked that it didn’t go like clockwork.”

He also echoed Dr. Fauci’s warning, and said “the next couple of weeks are going to be really critical.”

Back in October, when it seemed like California had the coronavirus under control, a group of researchers at the Institute for Health Metrics and Evaluation made a devastating prediction. According to their computer models, even if 95% of U.S. residents donned masks each time they left the house, at least another 100,000 Americans would die of COVID-19 by the end of February. In nine states, the death rate would still climb high enough to necessitate another lockdown by December. California was one of those nine states.

That seemed surprising. Unlike many other states, California was taking the virus seriously. Indoor dining was off limits in much of the state, most schools remained shuttered, and mask mandates were firmly in place with no sign of going anywhere. With all these precautions, surely we wouldn’t experience the worst of the suffering. But as we now know all too well, the modelers were right. For a variety of reasons — including overcrowded living spaces, a high number of workers deemed essential and high poverty rates — the state has been overwhelmed by the winter surge, and the epicenter of the devastation is Southern California.

In fact, the only thing the researchers got wrong in their forecast was the size of the surge in California — it has turned out to be significantly larger than they expected, said Ali Mokdad, a public health professor at the institute, which is based at the University of Washington. Today, with the numbers of new infections, hospitalizations and deaths in the state continuing to break records, Mokdad talked about when his group is predicting this nightmare will end. He also discussed the factors that will play the largest role in the virus’ retreat and what numbers we should be tracking to know when we’ve finally turned the corner.

Please keep in mind that as with any model, this one should be taken with a grain of salt: It’s a computer simulation, not a crystal ball. “It could all change tomorrow if everyone in California stays home and doesn’t go out,” Mokdad said. In addition, the further in the future a model looks, the less likely it is to be accurate. “We know that people’s behavior is dynamic,” Mokdad said. “When cases go up, people put on masks, they become more vigilant. When cases go down, people go back to normal business.”

When will new cases peak in California?
My projection is that California will see a peak in infections on Jan. 27, with 135,800 new infections. Peak mortality will be after that — around Feb. 9, with 652 deaths from the virus in one day. Our current projection is 70,837 cumulative deaths in California as of April 1, but it may go higher. There was not a lot of reporting of new cases over the holidays in many states, so these numbers are based on data from two weeks ago.

What about across the United States as a whole?
Because of seasonality, we expect numbers will keep increasing this winter, but we also expect that states will reimpose mandates because the cases are increasing too much and too fast. The peak will happen sometime toward the end of January and start coming down after that. Across the United States, we expect the cumulative number of deaths to be 567,200 by April 1. The vaccine and warm weather seasonality will help us. So sometime in April or May it will be much better, and all our projections for the summer look like not much COVID-19. The concern is what will happen after summer. That will depend on how many people receive the vaccine. It will need to be 70% to 80% to prevent another surge.

What factors does your model consider to get that result?
We have data on mask wearing, mobility — how much people are moving around — the amount of testing happening in a region, density and seasonality. We know from tracking the virus over the summer in the Southern Hemisphere that it acts similar to pneumonia with numbers going up when the weather is cold. We expect that states will reimpose mandates if cases are increasing too much and too fast, and we factor that in as well. We also look at vaccines.

Why haven’t California’s many mandates moved the needle this winter?
When a member of the public sees a mandate being imposed and sees only a small reduction in cases, they may say it’s not having much impact. But someone who does epidemiology sees it totally differently. We are not comparing it to what came before. We compare it to what would have happened if we didn’t do it. The main message is that mandates work, but people have to adhere to them. We have to change our behavior. Usually when case numbers go up, we also see compliance with mandates goes up too. And we are seeing that now in California.

When will the COVID-19 vaccines make a difference?
Vaccinations won’t help us this month or the next. We don’t have enough vaccine, and we won’t have enough until June or July. However, we might see deaths across the U.S. decline earlier if we vaccinate the elderly first.

What numbers should we watch to see if California is turning things around? Checking the number of hospitalizations is the best. Not everyone who is infected gets tested, but people who need to be hospitalized will end up at a hospital. The number of hospitalizations is also an indicator that will inform policy-making because they don’t want ICUs to fill all the way up. You need the ICU for other diseases besides COVID as well, so it is very important to be very careful and monitor hospitalizations.

The UK has launched its biggest mass-vaccination programme, aimed at protecting tens of millions of people from Covid-19 within months. In a race against a faster-spreading variant of coronavirus, ministers have pinned their hopes of ending a third national lockdown on protecting the most vulnerable groups by spring. But there are huge challenges, not least the unprecedented scale but also the need for rigorous safety checks and deep-freeze storage as well as establishing enough vaccination centres and recruiting enough vaccinators.

But to meet this target, ministers need to deliver more than two million jabs a week by the end of January, in one of the largest civilian logistical operations launched in Britain. Since the beginning of last month, about 2.4 million people across the UK have been vaccinated, Prime Minister Boris Johnson said on Monday. But more than 13 million people will need to receive jabs in the next five weeks. And the UK's chief medical adviser, Prof Chris Whitty, has described such a timetable as "realistic but not easy".

The NHS began administering a vaccine made by Pfizer-BioNTech. But the operation is being significantly ramped up following the approval of a second vaccine, from Oxford University and AstraZeneca. A third vaccine, from Moderna, was approved on Friday.

On top of this, Mr Johnson has referred to the "rate-limiting factor" of batch testing - the process of ensuring vaccines released by manufacturers are safe and up to standard.

The UK's Medicines and Healthcare Products Regulatory Authority (MHRA) requires vaccines to be checked by the National Institute of Biological Standards and Control (NIBSC) to ensure they are:

effective
structurally intact
free of contaminants
And this process can take a long time as it has to be done twice - before the vaccine enters vials and after.

Testing a batch is sterile takes two weeks.

Mass polio vaccination in Columbus, Georgia circa 1961 for the National Polio Immunization Program

sig230 wrote: Mon Jan 11, 2021 12:16 pm Technology was already making them smaller and more efficient:

President-elect Joe Biden will aim to release nearly every available dose of the coronavirus vaccine when he takes office, a break with the Trump administration's strategy of holding back half of US vaccine production to ensure second doses are available.

Releasing nearly all vaccine doses on hand could quickly ratchet up the availability of coronavirus vaccines by allowing more people access to a first dose. It could also be a risky strategy as both Pfizer/BioNTech and Moderna's vaccines require two doses, administered at specific intervals, and vaccine manufacturing has not ramped up as rapidly as many experts had hoped.

"The President-elect believes we must accelerate distribution of the vaccine while continuing to ensure the Americans who need it most get it as soon as possible. He supports releasing available doses immediately, and believes the government should stop holding back vaccine supply so we can get more shots in Americans' arms now," said TJ Ducklo, a spokesman for Biden's transition. "He will share additional details next week on how his Administration will begin releasing available doses when he assumes office on January 20th."

A transition official said the Biden team believes that vaccine manufacturers will be able to produce enough second doses in a timely fashion while administering first doses to more Americans. Biden's team plans to use the Defense Production Act to produce vaccine materials and other supplies in order to ensure there's enough vaccine for both doses.

The transition official added that the Biden team may hold back a small amount of doses in case of unforeseen circumstances. The Trump administration also does this -- in addition to holding back the second doses -- in the event of incidents such as shipment errors or vaccine spoilage.

The Trump administration will recommend providing a wider distribution of a coronavirus vaccine, just days after aides to President-elect Joseph R. Biden Jr. said his administration would make a similar adjustment by using more of the already procured vaccines for initial doses.

Mr. Biden’s team has said it would aim to distribute the doses more quickly at federally run vaccination sites at high school gyms, sports stadiums and mobile units to reach high-risk populations.

The Trump administration plans to release the shots that had been held back and aims to make the vaccine available to everyone over 65 in an attempt to accelerate lagging distribution.

The doses had been held back to ensure that those who receive a first dose had the second and final inoculation available when it was needed. The change means all existing doses will be sent to states to provide initial inoculations. Second doses are to be provided by new waves of manufacturing.

The idea of using existing vaccine supplies for first doses has raised objections from some doctors and researchers, who say studies of the vaccines’ effectiveness proved only that they worked to prevent illness when using two doses.

The agency is expected to announce the new guidelines at a briefing at noon Eastern on Tuesday, according to an official briefed on the plans who was not authorized to speak publicly about the change. Axios earlier reported the new guidelines.

More than 375,000 people have died from Covid-19 in the United States since the start of the pandemic. In recent days, the number of daily deaths in the country has topped 4,000.

Researchers in Ohio said Wednesday that they've discovered two new variants of the coronavirus that likely originated in the U.S. — one of which quickly became the dominant strain in Columbus, Ohio, over a three-week period in late December and early January.

featureless wrote: Wed Jan 13, 2021 12:36 pm

Researchers in Ohio said Wednesday that they've discovered two new variants of the coronavirus that likely originated in the U.S. — one of which quickly became the dominant strain in Columbus, Ohio, over a three-week period in late December and early January.

https://www.cnbc.com/amp/2021/01/13/ohi ... he-us.html

California’s Vaccine Advisory Committee held an urgent community meeting to discuss late-breaking coronavirus vaccination recommendations from the Federal government Tuesday.

The state was already moving in the direction, though health officials have not seen specific guidelines, said Dr. Tomas Aragon, Director and State Health Officer for the California Department of Public Health.

California’s coronavirus vaccine advisory committee is comprised of representatives from health, labor, and other community groups across the state.

Representatives from those organizations continued to lobby for their constituents which is comprised of healthcare workers, the elderly, the homeless, essential workers, and many other Californian’s. They urged that the state not lose sight of its commitment to an equitable vaccine rollout.

highdesert wrote: Wed Jan 13, 2021 1:03 pm Ugh and WHO is saying the end won't be in 2021. Hope CDC is doing a lot of sequencing like the UK to keep on top of all these variants.

To investigate the evolution of SARS-CoV-2 in the immune population, we co-incubated authentic virus with a highly neutralizing plasma from a COVID-19 convalescent patient. The plasma fully neutralized the virus for 7 passages, but after 45 days, the deletion of F140 in the spike N-terminal domain (NTD) N3 loop led to partial breakthrough. At day 73, an E484K substitution in the receptor-binding domain (RBD) occurred, followed at day 80 by an insertion in the NTD N5 loop containing a new glycan sequon, which generated a variant completely resistant to plasma neutralization. Computational modeling predicts that the deletion and insertion in loops N3 and N5 prevent binding of neutralizing antibodies. The recent emergence in the United Kingdom and South Africa of natural variants with similar changes suggests that SARS-CoV-2 has the potential to escape an effective immune response and that vaccines and antibodies able to control emerging variants should be developed.

featureless wrote: Wed Jan 13, 2021 1:25 pm

highdesert wrote: Wed Jan 13, 2021 1:03 pm Ugh and WHO is saying the end won't be in 2021. Hope CDC is doing a lot of sequencing like the UK to keep on top of all these variants.

It is looking more and more like this is going to be an extended game of whack-a-mole. I don't see resolution this year at the rate we're going. Mutations, at a minimum, will reduce vaccine efficacy. It is only a matter of time until a (or several) mutation arises that escape immunity from previous cases and the vaccine. At which point, we will start again.

And the below is not good news at all. Not definitive, but worrisome (most of the article is beyond my paygrade, but the summary is accessible enough).

To investigate the evolution of SARS-CoV-2 in the immune population, we co-incubated authentic virus with a highly neutralizing plasma from a COVID-19 convalescent patient. The plasma fully neutralized the virus for 7 passages, but after 45 days, the deletion of F140 in the spike N-terminal domain (NTD) N3 loop led to partial breakthrough. At day 73, an E484K substitution in the receptor-binding domain (RBD) occurred, followed at day 80 by an insertion in the NTD N5 loop containing a new glycan sequon, which generated a variant completely resistant to plasma neutralization. Computational modeling predicts that the deletion and insertion in loops N3 and N5 prevent binding of neutralizing antibodies. The recent emergence in the United Kingdom and South Africa of natural variants with similar changes suggests that SARS-CoV-2 has the potential to escape an effective immune response and that vaccines and antibodies able to control emerging variants should be developed.

https://www.biorxiv.org/content/10.1101 ... 451v1.full

Oh, and China has 20 million in lockdown.

A large-scale trial of a new treatment it is hoped will help stop Covid-19 patients from developing severe illness has begun in the UK. The first patient received the treatment at Hull Royal Infirmary on Tuesday afternoon.

It involves inhaling a protein called interferon beta which the body produces when it gets a viral infection. The hope is it will stimulate the immune system, priming cells to be ready to fight off viruses. Early findings suggested the treatment cut the odds of a Covid-19 patient in hospital developing severe disease - such as requiring ventilation - by almost 80%.

It was developed at Southampton University Hospital and is being produced by the Southampton-based biotech company, Synairgen. A course of treatment with the new drug could cost around £2,000, which is not that expensive for a hospital treatment. "To be viable it will have to represent good value for money," Synairgen's chief executive Richard Marsden said.

President-elect Joe Biden has picked Dr. David Kessler, a former head of the US Food and Drug Administration, to lead federal Covid-19 vaccine efforts for the incoming administration, Biden's presidential transition team announced Friday.

Kessler, who is currently the co-chair of the Biden transition's coronavirus task force, will help lead Operation Warp Speed in the new role, helming the group that began under President Donald Trump to speed up vaccine development and distribution. Kessler previously led the FDA under Presidents George H.W. Bush and Bill Clinton.

Kessler will take over for Moncef Slaoui, who led the effort during the Trump administration. Slaoui, the most visible official leading the Trump administration's vaccine effort who was a notable voice of cooperation at a time when Trump refused efforts to begin a transition, announced earlier this week he was resigning at the Biden transition team's request. Slaoui will stay on for another month to "ensure a smooth transition," a Biden transition official told CNN earlier this week.

Early stage trials of Johnson & Johnson’s experimental coronavirus vaccine show it generated an immune response in nearly all volunteers, with minimal side-effects, after a single dose. The company expects to report details of more advanced trials later this month and is hoping to apply for authorization from the US Food and Drug Administration soon after.

Researchers who tested the vaccine in a combined Phase 1-2 trial — mostly meant to show safety — found either one or two doses of the vaccine generated both antibody and T-cell responses against the coronavirus. The trials were not designed to show whether the vaccine protected people against either infection or symptoms of coronavirus — that’s what the ongoing Phase 3 trials are designed to do. Writing in the New England Journal of Medicine, an international team of researchers who tested the vaccine in around 800 volunteers said the early stage trials showed it was safe and probably should work.

The researchers — in the Netherlands, the United States and Belgium — tested the vaccine in a group of people 65 and older and a group ages 18 to 55. Vaccination elicited neutralizing antibodies — expected to stop the virus from infecting cells — in 90% of all participants by the 29th day after the first dose of vaccine and in all of them by two months after the first dose. The levels of these antibodies stayed stable for at least 71 days, they reported.

Johnson & Johnson’s vaccine arm, Janssen, uses a different approach for its vaccine, called for now by its experimental name, Ad26.COV2.S. It uses a weakened version of a common cold virus called adenovirus 26 to carry genetic material from the virus into the body, prompting human cells to produce pieces of the virus which are then recognized by the immune system.

“A single dose of Ad26.COV2.S elicited a strong humoral response in a majority of vaccine recipients, with the presence of S-binding and neutralizing antibodies in more than 90% of participants, regardless of either age group or vaccine dose,” the researchers wrote.

“An efficacious single-dose Covid-19 vaccine have obvious logistic advantages over a two-dose vaccine, especially during a pandemic.” The company is studying whether a second dose increases efficacy or durability of the immune response. Side effects included headache, body ache and, more rarely, fever.

“The Company anticipates announcing topline Phase 3 data for its single-dose Janssen COVID-19 vaccine candidate in late January 2021; however, as this trial is dependent on disease events, the timing is approximate,” Johnson & Johnson said in a statement. But with the pandemic raging in the US and Europe, vaccine experts say, answers are coming quickly for vaccine trials.

“If the single-dose vaccine is shown to be safe and effective, the Company expects to submit an application for Emergency Use Authorization with the U.S. Food and Drug Administration shortly afterwards, with other regulatory applications around the world to be made subsequently,” Johnson & Johnson added.

All of the companies making coronavirus vaccine have been manufacturing doses even as they test them, so they can roll them straight out to people should they get FDA authorization. Johnson & Johnson is contracted to deliver 100 million doses to the US government if it wins EUA from the FDA.

Bisbee wrote: Fri Jan 15, 2021 1:22 pm Another advantage is it’s half the cost of the other two vaccine at $10 ea. (Sorry. I’m Chinese. I have to point out a bargain when I see one.) At half the cost per dose and only one dose necessary for the same protection ($10 vs $40) the 75% savings is actually very, very significant.

When Health and Human Services Secretary Alex Azar announced this week that the federal government would begin releasing coronavirus vaccine doses held in reserve for second shots, no such reserve existed, according to state and federal officials briefed on distribution plans. The Trump administration had already begun shipping out what was available beginning at the end of December, taking second doses directly off the manufacturing line.

Now, health officials across the country who had anticipated their extremely limited vaccine supply as much as doubling beginning next week are confronting the reality that their allocations will remain largely flat, dashing hopes of dramatically expanding access for millions of elderly people and those with high-risk medical conditions. Health officials in some cities and states were informed in recent days about the reality of the situation, while others are still in the dark.

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.

When Azar embraced the change four days later — after initially saying it was shortsighted and potentially unethical to put people at risk of missing their booster shots — he did not say the original policy had already been phased out, or that the stockpile had been exhausted. Signaling to states that they would soon see expanded supply, he also urged them to begin vaccinating adults 65 and older and those under 64 with a high-risk medical condition. Officials in some states embraced that directive, while others said suddenly putting hundreds of thousands of additional people at the front of the line would overwhelm their capacity.

A highly contagious coronavirus variant first detected in the UK could become the dominant strain in the US by March, health officials have said. The Centers for Disease Control and Prevention (CDC) warned of "rapid growth" of the variant in coming weeks. It said such a spike could further threaten health systems already strained by a winter Covid surge.

The warning came on Friday as President-elect Joe Biden unveiled an ambitious plan to ramp up vaccinations. To meet his target of inoculating 100 million Americans within his first 100 days in office, Mr Biden said his administration would take a more active role in stepping up the distribution of vaccines.

He outlined a plan to set up new mass vaccination centres, hire extra health workers, and ensure the shot is available to everyone, including minority communities that have been hit hardest by the epidemic.

The US has recorded the highest number of confirmed coronavirus infections - 23.5 million - of any country in the world. At about 391,000, the country's coronavirus deaths account for a fifth of the global total, which passed the two-million mark on Friday.

The crisis is particularly acute in the state of California, where deaths have surged by more than 1,000% since November.

sig230 wrote: Sat Jan 16, 2021 6:56 am There are currently four or five variants of Covid-19 circulating across the world.