Przegląd wiadomości od 30.10 do 12.11 z rynku szczepień na świecie w związku z koronawirusem, zebrane przez Children’s Health Defense.
November 12, 2020
Boris Johnson to Meet Bill Gates to Plan National Vaccine Rollout With Pharma Giants. The Sun reported:
“A spokesperson for Downing Street said Mr. Gates, Mr. Johnson and bosses from pharmaceutical giants would discuss the [Prime Minister’s] ‘five point plan to stop future pandemics.’
“The plan was developed with the help of the Bill and Melinda Gates Foundation and the Trust, and aims to build a massive network of ‘zoonotic hubs’ to identify potentially dangerous viruses before they leap from animals to humans.”
Biden Coronavirus Task Force Doctor Says 4 to 6 Week Lockdown Could Control the Pandemic. Yahoo Finance reported:
“As the U.S. continues to set new daily record highs of coronavirus cases, at least one doctor on President-elect Joe Biden’s coronavirus task force is floating the idea of shutting down businesses in a lockdown that could last four to six weeks to control the spread of the pandemic.”
China Is Inoculating Thousands With Unapproved COVID-19 Vaccines. Why? NPR reported:
“One early November morning, a Peking duck cook, several construction workers and a software engineer patiently lined up outside a Beijing vaccine facility, awaiting their turn to be injected with a coronavirus vaccine still awaiting regulatory approval.”
Why COVID-19 Vaccine Policies Could Be Deadly for Older People, and the Age Discrimination Has Already Started. Marketwatch reported:
“‘When I read about the proposed ‘Fair Priority Model’ for allocating COVID-19 vaccines in Science magazine recently — from University of Pennsylvania medical ethicist Ezekiel Emanuel and 18 others — I realized that ageist policies might just kill older people like me.’”
Live Music Stocks Soar on COVID-19 Vaccine Breakthrough. Billboard reported:
“Companies related to live entertainment, travel and tourism have been especially battered in 2020. News of the vaccine has helped push these companies’ share prices multiples above their pandemic low marks: Live Nation now trades 212.4% above its 2020 low of $21.70; American Airlines share price is 55.4% above its 2020; and Hilton Worldwide is 132.4% above its pandemic low after a 11.1% bump on Monday morning.”
Fauci: Coronavirus Won’t Be a Pandemic For ‘a Lot Longer’ Thanks to Vaccines. The Hill reported:
“Anthony Fauci said Thursday the global coronavirus outbreak will not be a pandemic for ‘a lot longer’ because of the development of vaccines, striking a hopeful note even as the situation worsens in the short term.
“’Certainly it’s not going to be pandemic for a lot longer because I believe the vaccines are going to turn that around,’ Fauci said at an event hosted by the think tank Chatham House.”
Brazil Health Regulator Allows Resumption of China COVID Vaccine Trials. The Guardian reported:
“Brazil’s health regulator has allowed resumption of late-stage clinical trials for China’s Sinovac COVID-19 vaccine, which had been suspended due to a study subject’s death that was registered in Sao Paulo as a suicide.”
Moderna Hits COVID-19 Case Goal for Vaccine Candidate, Results Imminent. Boston Herald reported:
“The surge in coronavirus cases across Moderna vaccine trial sites in the U.S. will now allow the Cambridge-based company to complete the analysis of its mRNA vaccine candidate.
Coronavirus Vaccine: Eu Seals Deal With Biontech, Pfizer to Secure Doses. EIN News reported:
“The European Commission approved a contract with German pharmaceutical firm BioNTech and their U.S. partner Pfizer on Wednesday, guaranteeing that the bloc will receive millions of doses of their experimental coronavirus vaccine.
“After locking down the details of the deal on Tuesday, Commission President Ursula von der Leyen said the bloc hopes to ‘deploy it quickly, everywhere in Europe.’”
Who Will Make Coronavirus Vaccines for the Developing World? India Holds the Key. Washington Post reported:
“Wealthy countries have already grabbed a major chunk of the available supply. The U.S., the U.K., Japan and Canada have struck deals large enough to vaccinate their entire populations. By contrast, a pooled global effort to distribute vaccines equitably to more than 150 countries — including dozens of low-income nations — has secured only 700 million doses.”
CDC Thanksgiving Recommendations: Eat Outdoors, Limit Guests, Don’t Sing. CBS Boston reported:
The Centers for Disease Control and Prevention (CDC) points out celebrating virtually or keeping the meal to just members of your own household poses the lowest risk for spreading COVID-19.
November 11, 2020
Pfizer’s CEO Sold $5.6 Million in Stock on Same Day of Vaccine News. Axios reported:
“Pfizer CEO Albert Bourla sold $5.6 million worth of stock on Monday — the same day it said its and BioNTech’s coronavirus vaccine showed 90% effectiveness in preliminary results, which saw the company’s stock soaring almost 8%.
“The stock sale is perfectly legal through a predetermined plan called Rule 10b5-1, but the optics aren’t great. A Pfizer spokesperson did not add any new information in a statement [to Axios], saying the sale was part of a predetermined plan created in August.”
How COVID-19 Vaccine Can Destroy Your Immune System. Mercola.com reported:
“According to a study that examined how informed consent is given to COVID-19 vaccine trial participants, disclosure forms fail to inform volunteers that the vaccine might make them susceptible to more severe disease if they’re exposed to the virus.”
Eli Lilly Wins FDA’s Emergency Nod for COVID-19 Antibody — But, Thanks to Mixed Data, It’s Limited. Fierce Pharma reported:
“The FDA authorized Eli Lilly’s bamlanivimab for emergency use on Monday, making it the first antibody therapy to win that distinction. Dubbed LY-CoV555, it’s an anti-SARS-CoV-2 antibody therapy the Indianapolis pharma is co-developing with AbCellera.
“The OK comes with some caveats: It’s limited to patients 12 years and older who aren’t hospitalized but who are at high risk of developing severe illness, including elderly people and those with certain underlying conditions. And Lilly is advising infusion within 10 days of symptom onset.”
FDA requires Lilly to hire consultants to monitor quality control problems at plant making Covid-19 drug. Stat reported:
“The Food and Drug Administration is requiring Eli Lilly (LLY) to hire consultants to test batches and vet quality-testing data at a manufacturing plant where its COVID-19 antibody treatment is being made, a mandate that comes after the agency found quality control problems during two separate inspections over the past year.”
Pfizer, BioNTech Set for Billions in Yearly Sales as Fast COVID-19 Vaccine Launch Looms: Analysts. Fierce Pharma reported:
“Pfizer’s early COVID-19 vaccine data have spurred intense hope about quashing the pandemic and lifted expectations for other vaccine programs in the works. And for the drug giant specifically, some analysts are predicting billions in sales for the shot for years to come.
“In a note to clients Tuesday, SVB Leerink analyst Geoffrey Porges said the results should ‘boost confidence of the general public in COVID vaccines, which should drive up the early adoption rate.’ The analysts see Pfizer’s vaccine snagging all of the early share of the market and generating $258 million in the fourth quarter of 2020.”
What Medical Experts Think About Pfizer’s New COVID-19 Vaccine. Huffington Post reported:
“Health experts agree these preliminary results are promising and exciting, but we still don’t have the full picture. We need much more data to understand which participants got sick and how severe their illness was. Researchers will also need to track the study participants in the months ahead to determine how the vaccine holds up over time.”
November 10, 2020
China Vaccine Trial Halted in Brazil After Serious Adverse Event. Bloomberg reported:
“The final-stage trial of a Chinese frontrunner vaccine candidate has been halted in Brazil due to a serious adverse event, the first time that any of the Asian nation’s rapidly developed COVID-19 shots have met with such a setback.
“Testing of Sinovac Biotech Ltd.’s vaccine, called Coronavac, has been halted in Brazil after an event that occurred on Oct. 29, said the Brazil Health Agency on Tuesday, without giving any further detail on what happened. The study is interrupted in accordance with regulations while the agency analyzes if the study should continue, it said.”
Pfizer Says Trials Show COVID Vaccine Is 90% Effective, But Questions Remain on Safety of Novel Technology. Children’s Health Defense reported:
“But the New York Times cautioned that Pfizer’s data — delivered in a news release, not a peer-reviewed medical journal — ‘is not conclusive evidence that the vaccine is safe and effective, and the initial finding of more than 90 percent efficacy could change as the trial goes on.’”
HHS Secretary: Coronavirus ‘General Vaccination’ Programs by Spring. NBC News reported:
“Secretary of Health and Human Services Alex Azar predicted Tuesday that there would be enough COVID-19 vaccine for general public vaccination campaigns by spring 2021.”
U.S. Banks in Line for Windfall After COVID-19 Vaccine Progress. Financial Times reported:
“Stephen Scherr, Goldman Sachs’ chief financial officer, told a conference on Monday that the vaccine news ‘will be good for banks’ by giving rise to ‘reflationary outcomes’ and ‘more slope to the yield curve.’”
Oxford-Astrazeneca COVID-19 Vaccine Production Begins in Australia. Times Now News reported:
“Thirty million doses of the vaccine will enter manufacturing in Victoria on Monday, according to Sydney’s 2GB radio.
“’[The vaccine] is going to be voluntary but we will encourage as many people as possible,’ Health Minister Greg Hunt told 2GB on Monday. ‘We are confident that we will have a very high take-up amongst the Australian population,’” he added.”
Pfizer CEO Says He Would Take Coronavirus Vaccine First to Ease Public Concern. CNBC reported:
“Pfizer CEO Albert Bourla said Monday that he would like to be among the first to take a coronavirus vaccine to ease public concerns about vaccine safety.
“But there are ethical considerations for that, Bourla said during an interview on CNBC’s ‘Squawk Box.’ ‘If we have a limited number of doses, I’m not sure if people would recommend people of my age … or work capacity to be among the first to get a vaccine. So, I want to respect that.’”
Could a COVID Vaccine Bring Back Normality? The Guardian reported:
“England is back in lockdown. It happened not a moment too soon. As of 2 November almost three-quarters of a million new cases have been officially counted since 21 September, when the government’s scientific advisory committee Sage advised lockdown. On that day, Britain had only had about 360,000 cases since COVID-19 arrived. Now the figure is three times that. So many more cases mean it will take longer, and possibly require tougher social restrictions, to get numbers down by imposing lockdown than it would have in September, says James Naismith, head of the Rosalind Franklin Institute in Oxford.”
Pfizer Vaccine’s Funding Came From Berlin, Not Washington. Bloomberg reported:
“BioNTech is credited for contributing the messenger RNA technology, which prompts the body to make a key protein from the virus, creating an immune response. The biotechnology company already had a history of working with Pfizer on influenza vaccines, and in March they clinched a deal to co-develop a shot to prevent against COVID-19 at research sites both in the U.S. and Germany. The two companies began human testing of the vaccine in April, before the existence of Operation Warp Speed was revealed publicly.”
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November 6, 2020
CDC Report: Officials Knew Coronavirus Test Was Flawed But Released It Anyway. NPR reported:
“One HHS official told NPR this shouldn’t have been a tough call. ‘The QC records showed that the test had a problem,’ the official said. ‘Lindstrom signed off on a quality control that was clearly flawed. He should not have released that kit.’”
CDC Seeks to Create a Centralized Reporting System for COVID-19 Test Results. Becker’s Hospital Review reported:
“CDC would like to partner with one or more organizations that have the infrastructure, capability, scalability, and safeguards to enable centralized public health laboratory data reporting from testing entities to state and large local health departments, with a focus on multi-state, large regional, and state-wide reporting entities.”
First COVID-19 Vaccine Doses to Go to Health Workers, Say CDC Advisers. NPR reported:
“Healthcare workers will almost certainly get the first doses of COVID-19 vaccine in the U.S. when one is approved, according to Dr. José Romero, head of the committee that develops evidence-based immunization guidelines for the Centers for Disease Control and Prevention.”
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November 5, 2020
Cincinnati Children’s Seeks Volunteers for COVID-19 Vaccine Trial. Local 12 reported:
“Cincinnati Children’s is seeking volunteers for its AstraZeneca COVID-19 vaccine trial.
“The center is specifically reaching out to people who are black and Hispanic as well as seniors and first responders.”
Gilead Won Valuable FDA Voucher With Its Veklury Approval, but Patient Advocates Are Urging Company to Give It Up. Fierce Pharma reported:
“Public Citizen’s [Peter] Maybarduk called on Gilead to ‘relinquish’ the voucher, arguing that taxpayers have contributed more than $70 million toward Veklury’s development. Plus, Gilead is already benefiting from Veklury sales, he argued. In the third quarter, the drug raked in $873 million, and analysts figure the medicine is on track to post another $650 million to $950 million during the fourth quarter.”
COVID-19 Vaccine Rollout to Feature App Tracking, Monitoring of Vulnerable Groups. The Wall Street Journal reported:
“Government health officials and drugmakers plan to roll out extra tools to detect whether COVID-19 vaccines cause any serious side effects once the shots are cleared for widespread use, aiming to fill gaps in existing safeguards given the expected speed and scope of the rollout.”
Pfizer Sidelines U.S. Government in COVID-19 Vaccine Distribution Strategy. Fierce Pharma reported:
“Pfizer is under pressure from all sides to make its COVID vaccine rollout a success. With interim data from a phase 3 trial yet to come, the company already has a $1.95 billion deal with the U.S. government to supply up to 100 million doses of its candidate vaccine, BNT162b2. Pfizer has vowed to distribute 40 million of those doses before the end of the year.”
Brazil Allows Johnson & Johnson to Resume Trial of COVID-19 Vaccine. Reuters reported:
“Brazilian health regulator Anvisa has authorized resumption of a clinical trial of Johnson & Johnson’s experimental COVID-19 vaccine, according to a statement from the government agency on Tuesday.
“The J&J vaccine is one of four being tested in Brazil, which has the world’s third worst outbreak behind the United States and India, and the second-highest COVID-19 death toll.”
The FDA’s Cutoff for COVID-19 Vaccine Effectiveness is 50 percent. What does that mean? NBC News reported:
“Over the summer, the Food and Drug Administration announced that in order for an experimental COVID-19 vaccine to get the green light, it would need to be safe and ‘prevent disease or decrease its severity in at least 50 percent of people who are vaccinated.’”
Challenges in Creating Herd Immunity to Sars-cov-2 Infection by Mass Vaccination. The Lancet reported:
“Vaccines to protect against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) have risen up the agenda of most policy makers and individuals as the second wave of COVID-19 in northern hemisphere countries grows and there is increasing pressure on health-care systems.”
AstraZeneca Expects COVID-19 Vaccine Trial Results This Year. The Wall Street Journal reported:
“AstraZeneca PLC said late-stage trials for the COVID-19 vaccine it is developing with the University of Oxford are on track to produce results “later this year,” with a potential rollout soon after, subject to regulatory approval.”
England Puts Doctors on Alert for Covid Vaccine Before Christmas. Bloomberg reported:
“Simon Stevens, chief executive of the National Health Service in England, told the BBC on Wednesday that with more than 200 COVID-19 vaccines in development, one will “hopefully” be available in the first part of next year, but doctors will be “gearing up” in case it is ready sooner.
“The U.K.’s drug regulator has started accelerated reviews of vaccines under development by Pfizer Inc. and AstraZeneca Plc, as Britain gets ready to approve the first successful shot as quickly as possible.”
November 3, 2020
3 Maine Students Given Flu Shots at School Without Parental Consent. USA Today reported:
“Three students received flu shots at school, even though their parents had not consented to the vaccinations, a spokesperson for the healthcare organization that administered the shots confirmed.”
FDA Whitewashes Warnings About Coronavirus Vaccine Trials. Project on Government Oversight reported:
“During the meeting, members of the committee explained several reasons to worry about the clinical trials now underway to test potential coronavirus vaccines and how the FDA review process could unfold.
“Some of the concerns related to the potential for the FDA to issue emergency use authorizations for experimental vaccines. Such orders would allow distribution of vaccines before they qualify for formal approval.”
Cuomo Questions CDC Plan to Require ID for COVID-19 Vaccination. The Buffalo News Reported:
“The governor said the agency would require states to provide to the CDC personal information about each person who gets vaccinated — including an ID number.”
The FDA’s Cutoff for COVID-19 Vaccine Effectiveness is 50 percent. What Does That Mean? NBC News reported:
“Based on the effectiveness threshold the FDA has set for a COVID-19 vaccine to be approved or granted emergency use authorization, it’s possible a vaccine becomes available that helps only half of people receiving it, while offering no benefit to the other half. It’s also possible that a vaccine could have different effects in different people — helping to prevent disease in some people while reducing the severity of COVID-19 in others.”
COVID-19 Vaccine Mandates at Work Promise Employer Headaches. Bloomberg reported:
“Employers that want their workers to take a COVID-19 vaccine once it’s available would be better off encouraging and facilitating its use, rather than requiring it as a condition of employment, according to legal and public health observers.”
Drug Company Insiders Are Profiting Handsomely from the World’s Desperate Hope for a COVID-19 vaccine. The Boston Globe reported:
“‘These drug companies have a great scheme going,’ said Eli Zupnick, a spokesman for Accountable.US, a progressive group in Washington, D.C., that says it is committed to exposing corruption. ‘Taxpayers cover the upfront investment costs and shoulder any downside, while their executives and shareholders can capture the upside if their drugs pan out and are shoveling obscene amounts of money into their pockets throughout the process.’”
In Boost to CVS and Walgreens, U.S. Expands COVID-19 Vaccination Powers to Pharmacy Techs. Forbes reported:
“Pharmacy technicians will join their pharmacist colleagues in the effort to quickly immunize Americans against the Coronavirus once a vaccine against COVID-19 is approved by the U.S. government, perhaps by the end of the year.”
Protests in Brazil Support President in Anti-Vaccine Stance. The Star-Tribune reported:
“PoderData poll said this week the percentage of Brazilians who say they would take a coronavirus vaccine dropped to 63% in October from 85% four months earlier. The percentage rejecting the idea of taking a vaccine rose to 22% from 8% in July.”
Scientists Warn Americans Are Expecting Too Much From a Vaccine. Connecticut Mirror reported:
“The White House and many Americans have pinned their hopes for defeating the COVID-19 pandemic on a vaccine being developed at “warp speed.” But some scientific experts warn they’re all expecting too much, too soon.”
Britain Starts Accelerated Review for AstraZeneca’s Potential COVID-19 Vaccine. Reuters reported:
“AstraZeneca and Pfizer are among the frontrunners in the race to develop a vaccine for the coronavirus, with the race also including Johnson & Johnson and Moderna Inc. Their vaccine candidates are in late-stage trials, interim data from which are expected in the coming weeks.”
Government Minister Admits Vaccine That Crushes COVID ‘May Never Materialize.’ DevonLive reported:
“Business Secretary Alok Sharma promised a ‘steady but significant’ deployment of rapid coronavirus tests as he acknowledged a vaccine which can eradicate COVID-19 ‘may never materialize.’”
October 30, 2020
Professors Demand Transparency in COVID-19 Vaccine Trials. Yale Daily News reported:
“Five Yale law, medicine and public health professors, along with a national team of scientists, signed an open letter last week addressed to U.S. Secretary of Health and Human Services Alex Azar LAW ’91 calling for greater transparency in COVID-19 vaccine clinical trials.”
Black Americans Are the Most Hesitant to Get a COVID Vaccine. USA Today reported:
“Black Americans distrust the government so much they’re not participating in large numbers in COVID-19 clinical trials, and many say they won’t get a COVID-19 vaccine — at least not until many others get it.
States Say They Lack Federal Funds to Distribute Coronavirus Vaccine as CDC Tells Them to Be Ready by Nov. 15. The Washington Post reported:
“State health officials are expressing frustration about a lack of federal financial support as they face orders to prepare to receive and distribute the first doses of a coronavirus vaccine by Nov. 15, even though one is not likely to be approved until later this year. The officials say they don’t have enough money to pay for the enormous and complicated undertaking.”
Already, Pharmaceutical Companies’ Predictions About COVID-19 Vaccines Haven’t Come True. CNN reported:
“Dr. Paul Offit, a member of the U.S. Food and Drug Administration vaccine advisory committee, said pharmaceutical companies would be wise to stop making forecasts about their timelines.
“‘Companies should stop making predictions, because nature is very humbling,’ Offit said.”
No-fault Compensation for Vaccine Injury — the Other Side of Equitable Access to COVID-19 Vaccines. The New England Journal of Medicine reported:
“Wealthy governments that have invested in vaccine candidates have made bilateral agreements with developers that could result in vaccine doses being reserved for the highest-income countries — a phenomenon known as ‘vaccine nationalism’ — potentially leaving people in poor countries vulnerable to COVID-19.
COVID-19 Vaccine Won’t Be Available Until January, Fauci Says. Bloomberg reported:
“President Donald Trump, pharmaceutical industry leaders and some public-health officials had said previously that an immunization to prevent COVID-19 could be available before the Nov. 3 election. That date has been consistently pushed back, however, as clinical studies — which are running at unprecedented speed — started to hit a few hurdles.
Federal Government Says it Will Pay for Any Future Coronavirus Vaccine for All Americans. CNN reported:
“The Centers for Medicare and Medicaid Services said it will pay for any COVID-19 vaccine that is authorized or approved by the U.S. Food and Drug Administration to allow for “broad vaccine access and coverage for all Americans.
“The agency also announced it will help cover a larger portion of the cost of new COVID-19 treatments that may be coming down the pipeline for Medicare recipients.”
Meet the Youngest Participants in COVID-19 Vaccine Trials: Teens and Tweens. NBC reported:
“Earlier this month, Pfizer became the first pharmaceutical company in the United States to receive approval from the Food and Drug Administration to test its vaccine on children as young as 12.”