My position is that Joe Biden has a couple weeks to sort this mess out and get the front end of a federal plan in motion with some obvious positive results in terms of getting jabs in arms..... otherwise he owns the mess. Within the past few days we are now seeing a supply problem in some states as well as a distribution problem. Why Has America’s Vaccination Drive Suddenly Stalled? https://nymag.com/intelligencer/2021/01/why-has-americas-vaccination-drive-suddenly-stalled.html JAN. 21, 2021 Operation Warp Speed stood as the Trump administration’s one gold-plated achievement, but now it’s looking more like a chintzy bronze façade. Having been denied access to federal vaccine-distribution plans during the transition, President Joe Biden’s incoming staffers said they were chagrined to find upon taking office that there were none. “We are going to have to build everything from scratch,” one source told CNN. Simultaneously, vaccine supplies unexpectedly dried up across the country, forcing New York City and other localities to suspend inoculations. “We’ve had to tell 23,000 New Yorkers who had an appointment this week that they will not be able to get that appointment for lack of supply,” said Mayor Bill de Blasio at a press conference Wednesday. The first intimations of trouble came last week. “We usually hear what we’re going to get for the following week no later than Wednesday night,” says Andrew Rubin, vice-president for clinical affairs and ambulatory care at NYU Langone Health. “This particular Wednesday, we didn’t hear anything. That, of course, made us anxious. So we started talking to the state more emotionally aggressively on Thursday: Where’s the vaccine? Where’s the vaccine? And, quite frankly, nobody really knew where it was.” By last Friday, NYU Langone Health had decided not to schedule any appointments for the week ahead. The Mount Sinai Health System began canceling appointments that had already been made. Only on Sunday did it receive confirmation that its allotment would fall short. “They didn’t have the supply to give us,” says Sue Mashni, Mount Sinai’s chief pharmacy officer. While New York had received a steady supply of doses in the first month after Pfizer and Moderna received approval for their vaccines in December, the number of doses delivered subsequently slipped, from about 300,000 per week to the state overall to 250,000. The city’s allocation dropped from 100,000 doses per week to 53,000. Mashni still doesn’t know the reason for the hang-up. “We’re doing everything we can to reach out to partners just to get more information, but there just doesn’t seem to be any,” she told Intelligencer. “There’s just a lack of visibility.” The failure of vaccine supply comes as the pandemic is raging at peak intensity across the country, with the death total crossing 400,000 on Tuesday and the half-million mark expected next month. Demand for the vaccine is so high that a false rumor spread on social media last Thursday that extra doses were available at the end of the day at the Brooklyn Army Terminal for anyone who showed up to ask. Long lines formed in the winter darkness and persisted even after staff told the crowd the rumor was false. So far, there has been no explanation from the Department of Health and Human Services for the hold-up. For its part, Pfizer reports no hiccups in its production process and anticipates no interruptions in shipments from its plant in Kalamazoo, Michigan. “We have provided [Operation Warp Speed] with a specific schedule, and we foresee no issues in delivering on the commitments we have made,” spokesperson Keanna Ghazvini told Intelligencer. The shortfall undermines both Governor Andrew Cuomo’s goal of vaccinating 1 million New Yorkers by the end of January and President Biden’s promise to vaccinate 100 million Americans in his first 100 days. Both goals are reachable only under the assumption that both vaccine production and the capacity to administer it to patients increase dramatically, and soon. While the state and the city have successfully ramped up the number and capacity of their distribution centers, shipments of vaccines haven’t kept pace. “When you look at what we’ve been getting, it hasn’t gone up,” Cuomo said at a press conference on Monday. As of Wednesday, about 11 million Americans had received the first dose of a vaccine, a significant underperformance of the expectations set by then–HHS Secretary Alex Azar, who said last month that 50 million might receive a first jab by the end of January. If deliveries remain slow, the pandemic’s grip will last commensurately longer. Just to vaccinate the 7 million New York residents who currently meet vaccination criteria, “you’re talking about seven months,” Cuomo said. To reach herd immunity nationally, estimated at 75 percent of the population, would take until 2022 at this rate. If a significant portion of the population remains unprotected come fall, that opens up the possibility of another major wave of infection and death then. And this doesn’t even count new variants of the virus that are more transmissible. At a press conference during his first full day in office, Biden declared, “The rollout has been a dismal failure thus far. I understand why Americans are frustrated,” adding, “Let me be very clear, things will get worse before they get better.” He announced that his administration would establish a network of vaccination centers, improve communication and coordination with state and local authorities, and use the Defense Production Act to boost vaccine production, all with an eye to meeting his 100-day pledge.
EU vaccine rollout thrown into further disarray as AstraZeneca announces delay Member states warn ‘delays cost lives’ amid threats of legal action and calls to cut bureaucracy, while Hungary turns to Russia https://www.independent.co.uk/news/...t-astrazeneca-delay-coronavirus-b1791672.html Hopes for a boost to the EU’s ailing vaccine rollout have been dealt a heavy blow after AstraZeneca warned initial supplies of its jab would be lower than promised, as the bloc’s leaders – largely at the mercy of pharmaceutical giants – grapple with mounting delays and frustration. With neighbouring Israel and the UK among those pushing ahead with vaccination programmes, concerns over the lack of available doses in the EU were already acute on Friday when it emerged that deliveries of the British-Swedish pharmaceutical giant’s jab would fall well below the figure expected. EU leaders had been banking on arrivals of the AstraZeneca jab – due to be approved by the bloc’s regulator next week – to energise its stilted vaccination drive, having been forced just days earlier to halt supply of Pfizer’s vaccine to some member states after the firm said it was delaying shipments for several weeks in order to increase capacity at its Belgian factory. But now just 31 million doses of the AstraZeneca vaccine are expected to arrive by the end of March, a senior official involved in the talks told Reuters – amounting to a 60 per cent drop on the 80 million doses reportedly promised previously. Meanwhile, the continent is grappling with ways to counter the emergence of several more contagious variants and a surge of new infections. Following EU leaders’ first video summit of the year on Thursday evening, European Commission president Ursula von der Leyen announced the creation of new “dark red” zones to designate hotspots – which could face tougher travel restrictions, such as quarantines and mandatory negative test results. With the meeting dominated by worries over vaccine supply shortages, European Council president Charles Michel said he still believed the EU should still hit its target of inoculating 70 per cent of its adult population by summer. While the 27 member states appear largely prey to the whim and fortune of vaccine manufacturers, Italy and Poland have both raised the threat of legal challenges if Pfizer fails to deliver the number of agreed doses. Within the bloc, there have been calls to reduce bureaucracy in order to speed up the process, despite the leaders of multiple member states issuing messages of unity and continued support for the EU’s broad vaccination strategy following Thursday’s meeting. On Friday, Estonia, Latvia and Lithuania amplified existing calls for the European Medicines Agency to expedite regulatory approval of AstraZeneca’s jab, with the leaders of all three Baltic nations writing on Twitter: “Precision of procedures matters. But so does speed. The delays cost lives.” And Politico reported that during the videoconference, Denmark’s prime minister Mette Frederiksen had urged EU officials to consider distributing doses of AstraZeneca’s jab to member states ahead of regulatory approval, prompting warnings from fellow leaders of possible legal ramifications. Mr Michel was later quoted as saying: “All possible means will be examined to ensure rapid supply, including early distribution to avoid delays.” It came as Hungary threatened to undermine EU solidarity by inking a deal with Russia for two million doses of its Sputnik V vaccine, becoming the first European nation to buy Moscow’s jab. Viktor Orban’s government is also in talks with China over its Sinopharm jab, which is already being used in neighbouring Serbia, despite Beijing’s lack of transparency over late-stage trials. Meanwhile, the European Ombudsman announced on Friday that it is investigating the secrecy with which the EU executive is handling vaccine supply contracts. It follows a refusal by the Commission to share details of its contract with AstraZeneca with the Corporate Europe Observatory campaign group. Despite the bloc facing its own widespread shortages, Ms Von Der Leyen also proposed on Friday that the EU should set up its own system to help ailing international efforts – such as the UN-backed COVAX scheme – to ensure vaccinations reach the world’s poorest countries. “As there is a global rush to vaccines, there is thus a shortage,” Ms Von Der Leyen said. “I have suggested an EU mechanism to share access to some of our vaccines until COVAX is able to deliver poor countries with large quantities of vaccines.” “In a couple of months in Europe we will have more doses than we can use,” she added.
Pfizer says its Covid vaccine trial for kids ages 12 to 15 is fully enrolled https://www.cnbc.com/2021/01/22/pfi...for-kids-ages-12-to-15-is-fully-enrolled.html Pfizer has fully enrolled its Covid-19 vaccine trial in kids ages 12 to 15. It’s a key step before the vaccine could be used in younger age groups. Enrollment in Moderna’s adolescent trial got off to a slower start than hoped. Pfizer said it had fully enrolled its Covid-19 vaccine trial in kids ages 12 to 15, a key step before the vaccine could be used in that age group. The study, an extension of the one used to support the company’s Emergency Use Authorization of the vaccine in people 16 and older, has enrolled 2,259 kids between 12 and 15, Pfizer told CNBC Friday. Its entry on a government website for clinical trials was updated to note it’s no longer recruiting subjects. The vaccine, developed with German partner BioNTech, was authorized for people ages 16 and older in December. Trials in younger age groups are necessary to ensure the correct dose, as well as safety and efficacy in those different groups, said Dr. Evan Anderson, a pediatrician at Emory University School of Medicine. “I am very uncomfortable sending my children back to school, where — despite the best efforts of the school — there is a real risk for contracting Covid-19,” Anderson told CNBC in October. While children are less affected by Covid-19 than adults, they do still catch the virus and get sick. Some have even died. More than 2.5 million cases of Covid-19 had been reported in children as of Jan. 14, about 13% of all cases, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association. “Children can still get sick and die from Covid-19,” said Dr. Paul Offit, director of the Vaccine Education Center and an infectious diseases physician at the Children’s Hospital of Philadelphia. “As many children this past year died from Covid-19 as died from influenza. And we recommend an influenza vaccine for children.” Offit also pointed out that children can suffer from a disease called multisystem inflammatory syndrome associated with Covid-19, “which can be debilitating.” There have been 1,659 cases of the syndrome in children, referred to as MIS-C, and 26 deaths associated with it as of Jan. 8, according to data from the Centers for Disease Control and Prevention. There have been 78 total deaths from Covid-19 among kids 4 and under, and 178 in kids 5 to 17, CDC data show, although those numbers don’t account for all deaths reported from the U.S. Pfizer declined to say when it expected results from the trial, which are dependent on the rate of infections observed to be able to compare the rates in the placebo group to those receiving the vaccine. With higher infection rates across the U.S. since the fall — the seven-day average of daily cases is now about 187,500, according to a CNBC analysis of Johns Hopkins University data — vaccine efficacy trials have seen their readouts sped up. But recruitment for trials in adolescents had been slower than hoped, at least for Moderna’s study in kids age 12 to 17, said Moncef Slaoui, chief adviser to Operation Warp Speed, the Trump Administration’s vaccines effort, at its last briefing Jan. 12. As of then, about 800 kids had been enrolled in the trial over a month, he said, out of about 3,000 needed. Moderna’s vaccine was authorized for people 18 and over in December, weeks after it began its trial in adolescents. Pfizer lowered the age of its trial to 12 in October. “While enrollment was lower over the holiday season, we expect to see an increase in the new year as planned,” Moderna spokeswoman Colleen Hussey said Friday. “We are on track to provide updated data around mid-year 2021.” AstraZeneca, whose Oxford University-developed vaccine is in late-stage trials in the U.S. and authorized in the U.K., told CNBC Friday it plans to continue U.K. trials in a new protocol for kids between ages 5 and 18 “beginning in the coming months.” Johnson & Johnson, whose phase three results in adults are expected imminently, said it’s in discussions with regulators about including pediatric populations in its development plan. It noted the same technology it’s using for the Covid-19 vaccine has been used in vaccines given to more than 200,000 people, including people over 65, infants, children, HIV-positive adults and pregnant women. Typically vaccine trials proceed into younger age groups after they’re proven safe and effective in older groups, and the manufacturers of Covid-19 vaccines have indicated they’ll follow that plan here as well. Moderna’s chief executive, Stephane Bancel, said this month it’s unlikely the company would have data in kids age 11 and younger, which would involve a lower dose, before next year. He said he expects data for kids 12 and up may be available before September. Public health officials in the U.S., like White House chief medical adviser Dr. Anthony Fauci, have said they hope as much as 75% to 80% of the U.S. population could be vaccinated by the fall to enable life to return to some form of normalcy. About 78% of the U.S. population, or 255 million people, are over the age of 18, according to a CNBC analysis of Census data. Another 25 million people are aged 12 to 17. Fauci didn’t immediately respond to an inquiry about whether including kids in vaccinations is necessary to reach his goal of 75% to 80% coverage. “It’s important for all kids to get vaccinated and the manufacturers can’t do those trials quickly enough,” Angela Rasmussen, a virologist and affiliate at the Georgetown Center for Global Health Science and Security, told CNBC Friday. “The more people of any age vaccinated, the better.”
Joe's lefty buddies: ie. The Washington Post and CNN/Chris Cuomo and even Fauci sort of cut Joe off at the knees last week when they vehemently objected to Joe saying that "nothing was done in regard to distribution planning." Truthfully, I am not sure why the Post and CNN did that. I found it somewhat unexpected. Maybe they were reeling from all the accusations about love-fest reporting on Joe and wanted to pretend to be fair and balanced. Or maybe they are scared shiiteless like lots of other people and want to see Joe get going rather than setting the bar even lower for himself. Fauci came out and defended the previous work it with the assertion that a lot had been done but more needs to be done type of thing, not only to be diplomatic but - as contentious as it was- Fauci was upfront, involved in what was done under Trump, and Joe sort of neuters him a bit by saying "we start from scratch." If the whole thing was a clown show, then Joe is saying Fauci was one of the clowns. Don't know. Did not expect those people and entities to rise up and speak against Joe on that. Chris Cuomo could just be acting in the tank for his brother and trying to motivate Joe to start delivering to the states. You need a scorecard to tell the players with some of this.
In a major setback, Merck to stop developing its two Covid-19 vaccines and focus on therapies https://www.statnews.com/2021/01/25...two-covid-19-vaccines-and-focus-on-therapies/ Merck said Monday it will stop developing both of the current formulations of the Covid-19 vaccines the company was working on, citing inadequate immune responses to the shots. Work will continue on at least one of the vaccines, which is being developed in partnership with the International AIDS Vaccine Initiative (IAVI), to see if using a different route of administration would improve how effective it is. The announcement marks a shocking setback for one of the most storied vaccine makers, and will raise tensions around readouts expected soon from other companies, including Johnson & Johnson and the upstart NovaVax. Merck said it remains committed to research on Covid-19 and will focus on two treatments it is developing. One is an antiviral medicine against SARS-CoV-2, the virus that causes the disease. The other is a medicine aimed at helping hospitalized patients by reducing the immune system’s over-response to the virus; it has already shown promise in clinical studies. “We’re disappointed by this result,” Nick Kartsonis, a senior vice president for infectious disease and vaccines at Merck Research Laboratories, said in an interview with STAT. “But it also allows us to continue to focus on our therapeutic candidates and move those forward. And, you know, we are open to continue the work to see if we can address the pandemic in any way we can add value.” The results from a Phase 1 trial, described briefly in Merck’s press release, were resoundingly disappointing. The hope was that Merck’s vaccines, which were unique because they used viruses that could replicate once they were in the body, would be long-lasting, one-dose vaccines. The virus used for the vaccine being developed with IAVI is the one used in Merck’s successful vaccine against Ebola. The other vaccine used measles virus, a type of vaccine Merck has manufactured for decades. Both vaccines, however, produced lower levels of antibodies against SARS-CoV, including binding antibodies and neutralizing antibodies, than is seen in the blood of individuals who have recovered from Covid-19. Kartsonis said it was difficult to compare results from different studies because researchers have used different assays to measure antibody levels. But it appears neither vaccine performed as well as the Pfizer/BioNTech and Moderna vaccines, which resulted in antibody levels several times above those seen in people who have recovered from Covid-19, and the AstraZeneca/Oxford vaccine, which led to antibody levels roughly equivalent to those seen in people who have recovered from Covid-19. There are biologically plausible explanations for why the vaccine Merck was developing in partnership with IAVI underperformed in the Phase 1 trial, IAVI President Mark Feinberg told STAT. The vaccine was administered by intramuscular injection; an oral or intranasal administration route might work better, he said. “While these data are disappointing, this is not the end of the program for us,” Feinberg said.
Presumably they had some sort of capacity or plan in place to produce their vaccine had it been more efficacious. So, if The Joe Biden wants to be ballsy, he should use the Defense Production Act to order them to use that capacity to produce one of the other vaccines.
The other bad news for the day; Moderna Vaccine Not Effective Against "Mutant" South African COVID Strain, But Works With UK Variant Moderna's latest trial data includes some good news...and some bad news. The good news is that the biotech company's original COVID jab is effective against two mutations of SARS-CoV-2 which were first isolated in the UK and South Africa, respectively. The bad news is that, at least when it comes to the South African variant, Moderna's jab is much less effective than scientists had expected. That's a bad sign, because it suggests the vaccines might not perform as well, particularly in elderly patients, or that the immunity they provide might not last as long, as various strains of the virus continue to mutate. https://www.zerohedge.com/covid-19/...ive-against-mutant-south-african-covid-strain
It's Science Lesson time... The "Common Cold" includes over 300 coronavirus types (229E, NL63, OC43, HKU1, etc.). Each of these types would require a separate vaccine. COVID-19 includes only one type and multiple variants. COVID-19 only requires one vaccine (in two doses generally) which covers all the variants. COVID-19 coronavirus is much more deadly than the common cold.