WASHINGTON (WJLA) — The U.S. Food and Drug Administration has issued a warning about two COVID-19 tests manufactured by Empowered Diagnostics because the tests are not authorized or approved by the FDA, despite labeling that indicates they are.
CovClear COVID-19 Rapid Antigen and ImmunoPass COVID-19 Neutralizing Antibody Rapid tests have been recalled by Empowered Diagnostics, the FDA said.
The FDA is concerned about the potential for false test results.
The recall is listed as a Class 1 recall, which the FDA says is the most serious type.
“The U.S. Food and Drug Administration (FDA) is warning people to stop using the Empowered Diagnostics CovClear COVID-19 Rapid Antigen Test and ImmunoPass COVID-19 Neutralizing Antibody Rapid Test. These tests were distributed with labeling indicating they are authorized by the FDA, but neither test has been authorized, cleared, or approved by the FDA for distribution or use in the United States,” the statement said.
The French parliament just voted for requiring vaccine passports – no longer allowing testing, as in the case of the health pass. The government of Austria plans to do forced vaccination from February. However, the UK Prime Minister is canceling the NHS Covid pass, and the mask mandates. It’s a bit late for the 90% over 60 who got a booster. Nonetheless, it’s better than endless boosters. It will be interesting to see if Boris gets thrown out and the mandates reinstated, or if the mandates are really over in the UK. Based on the speech, this may not apply for Scotland but for England and apparently Northern Ireland. For Wales, we don’t know.
According to an Associated Press (AP) report on Monday, President Joe Biden’s administration will require United States insurers to cover at-home tests for COVID-19 beginning on January 15.
The AP report also said that the new requirement will require up to eight tests per month for each individual, meaning a family of four would qualify to receive 32 tests each month, covered by their carrier.
The new Biden policy will allow Americans to either acquire free testing kits through their insurers, or present receipts for tests to their insurers for reimbursement.
In a statement on Monday, Health and Human Services (HHS) Secretary Xavier Becerra said, “This is all part of our overall strategy to ramp up access to easy-to-use, at-home tests at no cost. By requiring private health plans to cover people’s at-home tests, we are further expanding Americans’ ability to get tests for free when they need them.”
The Biden Administration has been criticized for the nationwide shortage of testing kits for the Omicron COVID-19 variant. The variant has caused a surge in cases where people want and need the testing kits across the country.
White House press secretary Jen Psaki was asked by numerous reporters’ why the administration has taken so long to ramp up testing during a Monday briefing.
Psaki answered, “There has been a massive surge in cases, there has been an unprecedented demand for test. So, what we have done over the course of the last few weeks, even before that, is the president quadrupled our testing capacity since this summer, we opened 20,000 sites across the country, and we have also opened additional federal sites, including one in D.C. only recently.”
Psaki continued, “If you look to a year ago, there were no tests, or maybe one depending on the timeline, that was available on the market. Now we have nine. If you look to about a year ago, there was about 900,000 or maybe slightly higher tests that were being issued every day. Now we’re at about 10 or 11 million. 300 million tests are done in this country every month. So, there’s enormous progress being made.”
President Biden admitted on December 28 that there is “clearly not enough” COVID-19 testing available in the United States. Residents in states across the country have resorted to waiting in hours-long line to acquire tests. Biden said, “We went from no over-the counter tests in January to 36 million in October, 100 million in November and almost 200 million in December. But it’s not enough. It’s clearly not enough.” “If I had — we had known, we would have gone harder, quicker if we could have,” he added.
FILE – Passengers wearing face masks to help protect against the coronavirus take a rest at Pudong International Airport in Shanghai, China, on July 25, 2021. (AP Photo/Andy Wong, File)
U.S. airlines say China has blocked more than a dozen recent and future flights from entering the country, which has been tightening already-strict COVID-19 travel restrictions.
China ordered the cancellations after some passengers tested positive for COVID-19 on flights that arrived in China in late December, according to industry officials.
American Airlines said Tuesday that six of its flights from Dallas-Fort Worth to Shanghai in late January and early February have been canceled. United Airlines said it was forced to cancel six flights from San Francisco to Shanghai later this month. Delta Air Lines said it canceled one flight last week and another this Friday to Shanghai.
Airlines for America, which represents the largest U.S. passenger and cargo carriers, said it was discussing the matter with U.S. and Chinese government officials to find ways to minimize the impact on travelers.
The Biden administration had no immediate comment.
The blocking of flights is the latest development in a dispute between the two countries over international flights and rules designed to prevent the spread of the coronavirus.
China has been ratcheting up travel restrictions after recent outbreaks of COVID-19 as it prepares to host the Winter Olympics in early February. China limits capacity on inbound flights — currently to 75% — and requires passengers to be tested before departure and after arriving in the country.
If passengers test positive, the airline that carried them can be forced to cancel two to four flights, depending on the number of positive cases.
Last month, Delta said new requirements for cleaning planes between flights caused a plane bound for Shanghai to return to Seattle. The airline said the new rules extended the time planes would need to sit on the ground in Shanghai, and weren’t workable. The Chinese consulate in San Francisco lodged a protest over Delta’s decision.
In 2020, the Trump administration backed down from a threat to block four Chinese airlines after China agreed to let United and Delta resume limited operations that were shuttered earlier in the pandemic.
Last August, the U.S. Transportation Department limited the number of passengers on four Chinese airlines’ flights to the U.S. after China imposed similar limits on United Airlines. The U.S. said China was putting an unreasonable burden on U.S. airlines for travelers who test positive after arriving in China.
Asked on ABC’s “Good Morning America” about a study showing that vaccines targeting COVID-19 and its variants have successfully prevented serious illness, Dr. Rochelle Walensky, the head of the Centers for Disease Control (CDC), said the “overwhelming” number of deaths in vaccinated people occurred in those who had at least four comorbidities.
Walensky started by answering a question about the new CDC guidelines that suggest that people who have contracted the virus should isolate for only five days, reduced from the previous numbers, and then reintegrate into society wearing a mask. She replied:
Isolation, we talk about isolation in the context of people who’ve had a positive test, who know that they are infected. And we now have dozens of studies referenced on the CDC website that have demonstrated that you are most infectious in the one to two days before your symptoms and the two to three days after your symptoms. So by five days after your symptoms, the vast majority of your contagiousness is really behind you.
“And what we say at day five, then, is: Are your symptoms gone? Are you feeling better? Is your cough gone? Sore throat gone?” she continued. “And if so, then it is safe to go out if you are wearing a mask all the time. And that means not going out to restaurants; not going out to gyms, not going out in visiting grandma, but really conscientiously wearing your mask for those last five days.”
“Now, some have said they are interested in using an antigen or a home test at the end of those five days, and if people are interested and have access then they may choose to take that extra step and do that antigen test,” she stated, adding, “And that means that if that test is positive, you should stay home for five days but if that test is negative, you should go out and continue to wear your mask.”
Asked about a new study showing how successful vaccines have been in preventing serious illness and whether that should provoke rethinking about how to live with the virus in perpetuity, Walensky appealed to a study that shows that 78% of vaccinated persons who died had more than four comorbidities.
“The overwhelming number of deaths, over 75%, occurred in people who had at least four comorbidities. So, really, these are people who were unwell to begin with. And yes, really encouraging news in the context of Omicron; this means not only just to get your primary series but to get your booster series. And yes, we’re really encouraged by these results.”
The study, from the CDC, says: “Among 1,228,664 persons who completed primary vaccination during December 2020–October 2021, severe COVID-19–associated outcomes (0.015%) or death (0.0033%) were rare. Risk factors for severe outcomes included age ≥65 years, immunosuppressed, and six other underlying conditions. All persons with severe outcomes had at least one risk factor; 78% of persons who died had at least four.”
On Sunday, Walensky was asked by Fox News anchor Bret Baier how many of the 800k+ covid deaths in America were “with covid” as opposed to “from covid.” He inquired, “Do you know how many of the 836,000 deaths in the U.S. linked to COVID are from COVID or how many are withCOVID but they had other comorbidities? Do you have that breakdown?”
“Yes, of course with Omicron we’re following that very carefully,” Walensky dodged. “Our death registry, of course, takes a few weeks to — and is a — takes a few weeks to collect, and of course, Omicron has just been with us for a few weeks, but those data will be forthcoming.”
This article has been updated to include the context of Walensky’s remarks, which was about deaths in the vaccinated, not the unvaccinated. The study has been added as well.
World|A U.S. Navy combat ship is stranded in Guantánamo Bay with a virus outbreak.
Carol Rosenberg, Aishvarya Kavi 3 – 4 minutes
Dec. 25, 2021Updated 3:23 p.m. ET
A Navy combat ship deployed to intercept drug trafficking in the Caribbean and East Pacific is stuck in the port at Guantánamo Bay, Cuba, with a coronavirus outbreak among its fully vaccinated crew.
Only some of those infected onboard the ship, the U.S.S. Milwaukee, were experiencing mild symptoms, said Commander Kate Meadows, a Navy spokeswoman. It was not clear how many infections involved the Omicron variant, which continues to gain dominance rapidly around the world.
The crew held an open-air Christmas service on the pier on Saturday, which allowed the sailors to remain socially distanced and to follow public health guidelines, according to Commander Meadows.
“They are using the open space and fresh air for as many safe activities as they can,” she said. “The chefs onboard are making a special Christmas meal today for everyone.”
The Milwaukee had more than 100 sailors plus a helicopter combat crew and Coast Guard law enforcement unit on board when it left its home port in Jacksonville, Fla., on Dec. 14 as part of the U.S. Southern Command’s efforts to fight drug trafficking. The ship made a refueling and resupply stop at Guantánamo Bay on Monday and extended its stay there because of the outbreak.
Commander Meadows added that the sailors had been confined to the pier and had not entered the base since arriving, sparing the small community at Guantánamo Bay the possibility of being exposed.
In a statement on Friday, the Navy said that “the ship is following an aggressive mitigation strategy” and that “the vaccine continues to demonstrate effectiveness against serious illness” among the crew.
Before the Milwaukee left Florida, Brian A. Forster, the ship’s commanding officer, said in a Navy news release that many of the crew members were on their first deployment and “eager to see the world and accomplish missions.”
In March 2020, one of the military’s first encounters with the virus occurred aboard the aircraft carrier Theodore Roosevelt. The ship docked in Guam, in the South Pacific, and ended up stranded there for months after dozens of sailors were infected and one died. The ship’s commander at the time sent a letter to Navy officials pleading for help tackling the outbreak and criticizing the Navy’s failure to provide the proper resources. He was removed from command of the ship after the episode.
Active-duty troops in the Army and Navy were fired this month over their refusal to get vaccinated after President Biden mandated vaccination for the armed services in August. But there were only a small group of holdouts last week, with the Navy reporting that more than 98 percent of its members had been vaccinated.
December 16, 20215:33 AM ESTLast Updated an hour ago 11 – 14 minutes
BRUSSELS/BANGKOK, Dec 16 (Reuters) – Tens of millions of migrants may be denied COVID-19 vaccines from a global programme because some major manufacturers are worried about legal risks from harmful side effects, according to officials and internal documents from Gavi, the charity operating the programme, reviewed by Reuters.
Nearly two years into a pandemic that has already killed more than 5 million people, only about 7% of people in low-income countries have received a dose. Vaccine deliveries worldwide have been delayed by production problems, hoarding by rich countries, export restrictions and red tape. Many programmes have also been hampered by hesitancy among the public read more .
The legal concerns are an additional hurdle for public health officials tackling the coronavirus – even as officials say unvaccinated people offer an ideal environment for it to mutate into new variants that threaten hard-won immunity around the world. Many COVID-19 vaccine manufacturers have required that countries indemnify them for any adverse events suffered by individuals as a result of the vaccines, the United Nations says.
Register now for FREE unlimited access to Reuters.com
Where governments are not in control, that is not possible.
The concerns affect people, such as those displaced by the Myanmar, Afghanistan and Ethiopian crises, who are beyond the reach of national governments’ vaccination schemes.
For refugees, migrants and asylum-seekers, as well as people afflicted by natural disasters or other events that put them out of reach of government help, the global programme known as COVAX created a Humanitarian Buffer – a last-resort reserve of shots to be administered by humanitarian groups. Gavi, the vaccine alliance, is a public-private partnership set up in 2000 to promote vaccination around the world.
But that buffer does not have any mechanism to offer compensation. Gavi, which operates COVAX with the World Health Organization (WHO), says that where those applying for doses, mainly NGOs, can’t bear legal risks, deliveries from that stockpile can only be made if vaccine-makers accept liability.
The companies that are willing to do so under these circumstances provide only a minority of the programme’s vaccines, according to people familiar with the matter and the documents, written by Gavi staff for a board meeting starting at the end of November.
More than two-thirds of COVAX doses have come from Pfizer Inc. (PFE.N) and its partner BioNTech SE (22UAy.DE), AstraZeneca PLC (AZN.L) and Moderna Inc. (MRNA.O), Gavi says. Moderna declined to comment. AstraZeneca and Pfizer said they were in talks with Gavi but declined to comment further. All three said they are committed to making doses available to poorer nations at relatively low prices. Pfizer said it was collaborating directly with governments in Jordan and Lebanon to donate doses for refugees.
Mainly because of the legal concerns, less than 2 million doses have so far been sent from the buffer, Gavi says. About 167 million people risk being excluded from national programmes, according to United Nations data cited in the documents.
Unless all the firms accept legal liability, “access to vaccines for some populations will remain a challenge,” the Gavi documents say, adding that new crises will generate additional demand to cover displaced populations.
The vaccine makers’ reluctance to take on the legal risks is “a major hurdle” in attempts to provide vaccines for the buffer, a spokesperson for Gavi told Reuters. Gavi did not comment on the details in the documents, but said applications for vaccines are confidential until the doses are delivered. In September, Gavi’s CEO, Seth Berkley, tweeted an appeal to drugmakers to waive their requirements for legal indemnity.
Three Chinese drugmakers have agreed to shoulder legal risks when their shots are delivered through the buffer: SinoVac Biotech Ltd (SVA.O), Sinopharm Group Co. Ltd (1099.HK), and Clover Biopharmaceuticals Co. Ltd, according to the Gavi document. The drugmakers did not respond to requests for comment.
Johnson & Johnson (JNJ.N) of the United States confirmed it would waive a requirement for indemnity for deliveries from the buffer: “We are proud to be part of this effort to protect the world’s most vulnerable people,” said Paul Stoffels, Vice Chairman of the Executive Committee and Chief Scientific Officer. He did not elaborate.
However, less than one-third of COVAX supplies have come from these four firms, COVAX data shows: Clover’s shot has not yet been approved so is not in use.
The global industry association, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), said “no company has refused to consider” taking on the legal risk. However, in the case of shots delivered from the buffer, it said some firms felt they could not do so without full knowledge of where and how vaccines would be used.
It would be hard to continuously monitor vaccines for safety in refugee camps, and delivery is logistically very challenging and not suitable for all types, said the European Federation of Pharmaceutical Industries and Associations (EFPIA), which represents large pharmaceutical companies in Europe.
People may blame vaccines for problems that emerge afterwards even if they are unrelated, it said.
“This could then lead to an increased number of litigation cases … during which the safety and efficacy of the vaccine would be publicly questioned,” it said in a statement to Reuters. That might lead to increased vaccine hesitancy and a slower recovery from the pandemic, it said.
So far there is scant information on COVID vaccine litigation, but claims made to out-of-court compensation programmes are one measure of the risk. A programme in the United States has so far not paid out anything, public data show; neither has one set up by the WHO for lower income countries, the WHO said. In Europe, a handful of compensation awards have been granted for undisclosed amounts of money, official data from Denmark, Germany, Norway and Switzerland show read more .
Globally there have been few reported COVID infections among refugees, migrants and asylum-seekers – testing is not always systematic and infections can generate only mild symptoms especially in younger people.
But cramped conditions and weak healthcare expose them to high infection risk. This, combined with low levels of vaccination in a mobile population could favour the emergence of new variants and be a vector for infection, said Mireille Lembwadio, Global Vaccination Coordinator at the International Organization of Migration (IOM), a U.N.-related body that advises governments and migrants.
“Leaving them unvaccinated could help spread the virus and its variants across the world,” she said.
WAITING FOR DOSES
Francois Nosten, a French professor who helps coordinate healthcare for people from Myanmar living on the border with Thailand, is one of those waiting for vaccines. In June, he put in a request from the Humanitarian Buffer for 70,000 doses – some for some of the 90,000 or so who are sheltering in camps along the border, but most for unregistered migrants in the border town of Mae Sot and nearby villages.
Nosten, whose main work is researching malaria, is expecting the doses – a fraction of the more than 8 billion administered worldwide – this month. He has been told they will come from Sinopharm, and he hopes they can help inoculate key at-risk groups in Thailand’s Tak province. Gavi said delivery arrangements are still being finalised.
About 20,000 doses will be given to people in the camps by the International Rescue Committee (IRC), a humanitarian group working with Nosten.
“At this point whatever vaccine we can secure we are grateful for,” said its Thailand Director, Darren Hertz. He added that the IRC believed the likelihood that a member of the refugee population would attempt to take legal action in case of side-effects was “extremely low.”
Hertz said the IRC has received a handful of ad hoc vaccine donations from the Thai government and is currently tackling significant outbreaks in five of nine camps on the border, where about 3,000 cases have been confirmed, including at least 26 deaths. A Thai foreign ministry spokesperson confirmed the government was working with the IRC on providing vaccinations in shelters along the border.
Nosten’s charity, Border Health Foundation (BHF), is one of eight organisations worldwide that have applied to distribute the shots from the Humanitarian Buffer and one of three to be approved, Gavi said.
Ann Burton, Chief of Public Health at the U.N. refugee agency UNHCR, said the liability issue was one reason agencies have been slow to apply. The programme has also been delayed by the general shortage of vaccines and administrative hurdles read more .
Organisations applying for supplies from the buffer may not choose which vaccines they receive. Working with displaced people, Nosten said it would be more convenient to give them Johnson & Johnson’s vaccine, which offers protection after a single dose instead of the two doses needed for Sinopharm’s.
But the Sinopharm version will be “better than nothing,” he said.
More than 100 national governments have promised to offer vaccines where possible to all the displaced people on their soil, according to the IOM. However, the U.N. group says migrants and refugees are often effectively excluded from such schemes because of administrative or cultural hurdles.
In cases where governments aren’t in charge or have not agreed to vaccinate migrants, COVAX’s Humanitarian Buffer is the only option. At least 40 countries have yet to include unauthorised migrants in their vaccination programmes, according to the IOM – it and the UNHCR declined to name the countries.
Gavi set up the buffer in March 2021, planning to reserve up to 5% of vaccine doses as they become available to COVAX, which would amount to roughly 70 million doses so far.
The only shots delivered from the buffer so far – just over 1.6 million Sinopharm doses – landed in Iran in November, where high numbers of displaced Afghans have arrived, UNICEF Iran said. That’s enough to inoculate about 800,000 people; more will likely be needed, UNICEF said.
NEED FOR SPEED
The vaccine makers’ legal concern is rooted in the unprecedented speed of the effort to develop the COVID shots, the EFPIA said.
In normal circumstances, drugmakers buy insurance to cover liability for vaccines’ potential adverse effects. But COVID forced them to develop drugs so quickly that some side effects – for instance, a rare blood-clotting condition in some of those who took the AstraZeneca vaccine – are emerging as shots go into people’s arms.
Many governments and international agencies have set up compensation schemes to reimburse victims and avoid lengthy litigation. An emergency law invoked by the U.S. government provides legal immunity for drug companies for side effects from their COVID-19 vaccines used in the country. The only exception is for instances of “wilful misconduct.”
For drug companies, accepting potential liability runs counter to standard practice.
“Vaccine manufacturers try to minimize legal risks in almost every setting,” said John T. Monahan, Professor at Georgetown University. “The gold standard is full immunity from lawsuits. If they accept carve-outs, it may become more difficult to reach that goal.”
Register now for FREE unlimited access to Reuters.com
Louisiana Western District U.S. Judge Terry Doughty’s decision follows an identical ruling Monday from Missouri U.S. District Judge Matthew Schelp, but Schelp’s decision only covered 10 states.
Doughty ruled on the lawsuit led by Republican Louisiana Attorney General Jeff Landry and joined by 13 other states, but Doughty added a nationwide injunction in his ruling.
“If the executive branch is allowed to usurp the power of the legislative branch to make laws, two of the three powers conferred by our Constitution would be in the same hands,” Doughty wrote. “If human nature and history teach anything, it is that civil liberties face grave risks when governments proclaim indefinite states of emergency.”
Louisiana Attorney General Jeff Landry praised the ruling and slammed Biden for “villainiz[ing] our healthcare heroes with his ‘jab or job’ edicts.”
“While our fight is far from over, I am pleased the Court granted preliminary relief against the President’s unconstitutional and immoral attack on not only our healthcare workers but also the access to healthcare services for our poor and elderly,” Landry said. “I will see this case through to the end – fighting every step of the way to prevent the federal government from imposing medical tyranny on our citizens and turning last year’s healthcare heroes into this year’s unemployed.”
The Food and Drug Administration is asking a federal court to allow it to take nearly 55 years to release data on Pfizer’s COVID-19 vaccine to the public.
The agency said in a court filing Monday that in order to complete a Freedom of Information Act request for data and information on the Pfizer-BioNTech vaccine, it will need to process 329,000 pages of documents and can only do so at a rate of 500 pages per month. At that rate, the information requested will not be fully released until the year 2076.
The FOIA request was submitted to the FDA in August by Public Health and Medical Professionals for Transparency, a group of more than 30 international public health professionals, medical professionals, scientists, and journalists that “exist solely to obtain and disseminate the data relied upon by the FDA to license COVID-19 vaccines.” The group includes academics and medical experts from Yale, Harvard Medical School, and UCLA; alumni from the Trump administration; and prominent health experts from around the world.
The medical transparency group had requested “all data and information for the Pfizer vaccine” including safety and effectiveness data; a protocol for a test or study; adverse reaction reports, product experience reports, consumer complaints, and other similar data and information; a list of all active ingredients and any inactive ingredients; an assay method or other analytical method; all correspondence and written summaries of oral discussions relating to the vaccine; all records showing Pfizer and BioNTech’s testing of a particular lot; and all records showing the testing of and action on a particular lot by the FDA.
PHMPT also made a request for expedited processing of its FOIA submission, arguing there is a “compelling need” for the FDA to speedily release Pfizer vaccine data “because a lack of transparency erodes the confidence the medical and scientific community and the public have in the conclusions reached by the FDA.”
“During a time when COVID-19 vaccine mandates are being implemented over the objection of those that have questions about the data and information supporting the safety and efficacy of the Pfizer Vaccine, and individuals with these questions are being expelled from employment, school, transportation, and the military, the public has an urgent and immediate need to have access to this data,” PHMPT said in its FOIA request.
The group filed a lawsuit in September after the FDA denied their request to expedite the release of its records. In Monday’s court filing, the plaintiff and the defendant are seeking a decision from a judge to resolve a dispute over the disclosure schedule for the requested documents.
“The FDA’s promise of transparency is, to put it mildly, a pile of illusions,” attorney Aaron Siri wrote Wednesday in a blog post about the case.
“It took the FDA precisely 108 days from when Pfizer started producing the records for licensure (on May 7, 2021) to when the FDA licensed the Pfizer vaccine (on August 23, 2021). Taking the FDA at its word, it conducted an intense, robust, thorough, and complete review and analysis of those documents in order to assure that the Pfizer vaccine was safe and effective for licensure,” he wrote.
“While it can conduct that intense review of Pfizer’s documents in 108 days, it now asks for over 20,000 days to make these documents available to the public.”
The FDA argued in the court filing that to comply with federal law it must redact certain information that is exempt from the records request filed by the plaintiff. Information about Pfizer-BioNTech’s confidential business and trade secrets and personal privacy data on patients who participated in clinical trials are examples of documents the FDA is prohibited by law from releasing.
“Reviewing and redacting records for exempt information is a time-consuming process that often requires government information specialists to review each page line-by-line,” the FDA told the court. “When a party requests a large amount of records, like Plaintiff did here, courts typically set a schedule whereby the processing and production of the non-exempt portions of records is made on a rolling basis.”
The FDA said that court precedent has determined a rate of 500 pages per month to be an efficient response to a large request like the one filed by PHMPT. The agency also said it’s FOIA response office does not have enough funding or staff to answer the request at a quicker pace and that if the plaintiff wishes to hurry the process along, the group can do so by narrowing the scope of their document request.
The plaintiff argues the FDA should complete the FOIA request no later than March 3, 2022. “This 108-day period is the same amount of time it took the FDA to review the responsive documents for the far more intricate task of licensing Pfizer’s COVID-19 vaccine,” the plaintiff told the court.
“The ability of a majority of Americans to participate in civil society, and even exercise basic liberty rights, are now contingent on receiving this product,” PHMPT’s lawyers wrote, noting that President Joe Biden’s vaccine mandates have made vaccination a condition of employment for millions of Americans.
“There are few whose livelihood, education, service, and participation in civil society are not contingent on a government requirement to receive this product. On this basis alone, basic liberty and government transparency demand that the documents and data submitted by Pfizer to license this product be made available to Plaintiff and the public forthwith, precisely as contemplated by federal regulations,” the plaintiff said.
“The entire purpose of the FOIA is to assure government transparency,” the plaintiff told the judge. “It is difficult to imagine a greater need for transparency than immediate disclosure of the documents relied upon by the FDA to license a product that is now being mandated to over 100 million Americans under penalty of losing their careers, their income, their military service status, and far worse.”
The FDA granted full approval for Pfizer-BioNTech’s COVID-19 vaccine on August 23, 2021, under the label Comirnaty.
Earlier this month, a now-former employee of Ventavia Research Group, one of the companies contracted with Pfizer to run its Phase III vaccine clinical trials, made allegations that raised questions about the data submitted before Comirnaty received FDA approval.
Brook Jackson, a former regional director for Ventavia, told the British Medical Journal that her company “falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events reported in Pfizer’s pivotal phase III trial.”
After Jackson notified Ventavia of these issues, she emailed a complaint to the FDA and was fired within hours.
According to investigative reporter Paul Thacker, the FDA did not inspect Ventavia’s trial sites even though it was alerted to the issues.
In a statement to the Epoch Times, the FDA declined to comment on the Ventavia matter but said it “has full confidence in the data that were used to support the Pfizer-BioNTech COVID-19 vaccine authorization and the Comirnaty approval.”
As of Nov. 17, more than 258,642,454 doses of Pfizer’s COVID-19 vaccine have been administered in the United States.
By Omar MoslehEdmonton BureauSat., Nov. 13, 2021timer3 min. readupdateArticle was updated 1 hr ago 5 – 6 minutes
The emergence of two sublineages of the COVID-19 Delta variant in Western Canada holds important lessons for the rest of the country on the consequences of allowing a virus to spread unchecked, infectious disease experts say.
But it’s yet to be known if the sublineages, called AY.25 and AY.27, are more effective at replicating or a greater threat to Canadians.
Dr. Jessica Minion, a medical microbiologist with the Saskatchewan Health authority, highlighted her concerns with the Delta variant sublineages in a town hall last Thursday.
The Delta variant is the dominant variant in Saskatchewan, making up nearly 100 per cent of cases. Minion said the AY lineage cases are “exploding” in number, from only 12 on Oct. 9 to nearly 125 as of Nov. 5.
“It is very difficult from an epidemiologic perspective to sort out whether those expansions of the AY lineages are due to advantageous mutations that are making them more transmissible … (or) maybe this particular lineage got into a population that was largely unvaccinated, got into a super-spreader event and is expanding exponentially due to pure chance,” she said.
Alberta and Saskatchewan have grappled with the highest rates of infection and the lowest rates of vaccination among the provinces in the fourth wave. Dr. Ilan Schwartz, an infectious diseases expert and assistant professor at the University of Alberta, said the more opportunities a virus has to replicate the more likely genetic mutations will occur.
“It’s unsurprising in a climate where the virus has basically been given free reign over the summer and fall months specifically in Alberta and Saskatchewan,” Schwartz said.
“The question is to what extent these random mutations are going to confer a fitness or survival advantage that is going to allow the one particular mutant or variant to be able to out-compete other random mutants or variants?”
YOU MIGHT BE INTERESTED IN…
That still remains to be seen. The earliest detection of the AY.25 and AY.27 sublineages were in Western Canada, specifically Alberta and B.C., but that doesn’t mean they originated here, said Dr. Jeffrey Joy, an assistant professor at the University of British Columbia’s faculty of medicine and an expert in genomic epidemiology.
“I was able to see that there’s actually an identical sequence detected in India at around the same time. So I think the jury is still out a little bit on whether it actually evolved here or whether it came here,” Joy said, noting there is a lot of interchange between Canada and India.
“We were doing a lot more surveillance here than they were doing in India at that time,” he added.
What it does show is that the virus will continue to mutate and evolve, something that is expected, but especially in areas where there are large populations of people unvaccinated.
“It highlights for everybody that evolution is happening right here in Canada, potentially, and every new infection is an opportunity for the virus to evolve,” Joy said.
Caroline Colijn, an epidemiologist, mathematician and professor at Simon Fraser University, said AY.25 was circulating in other parts of the world whereas AY.27 is an almost exclusively a Western Canadian phenomenon.
“That doesn’t mean it’s only here, because of course people in the world are not sequencing all of the cases,” she said.
What does it mean for Canadians? The sublineages are already on the move and could become the dominant strain in Canada. Thus far, there is some indication the new sublineages are slightly more effective at spreading.
But they don’t seem to pose a much greater threat than the baseline Delta variant.
“It looks like they are expanding and have a slight transmission advantage. (But) it’s not to Delta the way Delta was to Alpha or the way Alpha was to the original COVID,” Colijn said.
While experts are cautious to ring alarm bells over the discovery, Schwartz said they offer a cautionary tale to the rest of the country.
“It doesn’t really change what we do clinically, but it does sort of reinforce what scientists have been saying for many months, which is it’s bad idea to allow unhindered replication of this,” he said.
“This is something we’re paying for now in terms of increased cases, but then we may ultimately see consequences down the road in terms of giving this virus the opportunity to generate new variants that may potentially create some difficulty for us.”
A new report from Italy’s Higher Institute of Health provides an objective analysis of the nation’s misleading covid-19 death tally. Italy’s official covid death tally rose to 132,161 in October of 2021. This tally is unrealistic because covid-19 was diagnosed in haste and under conditions of financial bribery using non-specific diagnostic criteria.
Covid-19 was often listed as the cause of death when it was merely “suspected” and when “it could not be ruled out.”
After careful review of the medical reports, it turns out that respiratory infections may have been a contributing factor but did not cause most of these covid-19 deaths outright.
Various forms of medical malpractice, withheld treatment, inhumane isolation, undernourishment, and unethical standards of care are at the root of this worldwide medical crisis. The deaths are real, but the causes are skewed.
The Biden administration announced on Monday that children under 18 and people from dozens of countries with a shortage of vaccines, will be exempt from new rules that will require most travelers coming to the United States to be vaccinated from COVID-19.
The new updated policy comes as the Biden administration moves away from restrictions that ban non-essential travel from several dozen countries, most of Europe, China, Brazil, South Africa, India and Iran, instead of focusing on classifying individuals by risk they pose to others.
It also reflects the White House’s embrace of vaccination requirements as a tool to push more Americans to get the shots by making it inconvenient to remain unvaccinated.
Beginning on November 8, foreign, non-immigrant adults traveling to the U.S. will need to be fully vaccinated, with only limited circumstances or exceptions, and all travelers will need to be tested for the virus before boarding a plane to the U.S. It will require unvaccinated U.S. citizens and long-term residents to have to present a negative Covid test taken a day before re-entering the country, while unvaccinated foreign nationals will be able to enter only in limited circumstances, an administration official said Monday. Fully vaccinated Americans will have to be tested three days before traveled with tightened restrictions for American and foreign citizens who are not fully vaccinated.
For foreign nationals, the administration announced in September it will require all visitors to be fully vaccinated before entering the country, but on Monday outlined exemptions to that requirement.
People coming from countries with vaccination rates under 10 percent, for example, will also have to provide a compelling reason for why they are traveling to the U.S., a senior administration official said. The government will require airlines to collect contact information on passengers regardless of whether they have been vaccinated to help with contact tracing, if that becomes necessary.
The officials also said the U.S. will accept any of the vaccines approved by the World Health Organization (WHO) even if they are not cleared in the U.S., including Russian and Chinese vaccines, which have limited data on their effectiveness against the Delta variant.
Chuck Norris asks if the Chinese military is playing biological warfare games
October 18, 2021
In nine seasons as“Walker, Texas Ranger,”I investigated hundreds and hundreds of crimes. If I were still filming the show, this crime would take the cake.
Despite being 18 months into the coronavirus pandemic, we the people still don’t know the origins of it. But I don’t believe for a minute someone in the U.S. government doesn’t know. It’s high time for Mr. Biden and other U.S. officials to come clean and settle this matter with the American public.
The Food and Drugs Administration (FDA) on Wednesday gave its approval for Americans to get booster shots that are different from the COVID vaccine they initially received.
Why it matters: The recommendation from the FDA, which also authorized booster shots for people who received Moderna and Johnson & Johnson vaccines on Wednesday, paves the way for an expansion of booster shots.
Details: Moderna boosters may be given six months after completing the two-dose series while J&J boosters may be given two months after the initial jab, the FDA said in a statement.
The Moderna booster is half of the dose that is administered for a primary series dose.
The FDA recommends that people 65 and older as well as those over 18 with a higher risk of severe COVID or exposure to the virus receive a booster.
Some individuals will undoubtedly benefit from getting a booster shot, but experts say that the most important goal for the U.S. right now should be convincing vaccine holdouts to get their initial round of shots, Axios’ Caitlin Owens writes.
About 77% of the eligible U.S. population have received at least one dose of the vaccine, per the CDC.
What they’re saying: Acting FDA commissioner Janet Woodcock said that the new recommendation is important for “continued protection” against COVID-19, citing data that suggest immunity in fully vaccinated people wanes over time.
“[S]cience has shown that vaccination continues to be the safest and most effective way to prevent COVID-19, including the most serious consequences of the disease, such as hospitalization and death,” Woodcock said.
As winter approaches and travelers start dreaming of warm weather, the Caribbean beckons. But 19 months into the pandemic, much of the region is struggling with the delta variant surge and insufficient access to coronavirus vaccines.
Late last month, the Pan American Health Organization warned that health systems in some Eastern Caribbean islands were becoming overwhelmed with the increase of cases and shortages of workers and supplies.
The majority of destinations in the Caribbean — as well as Bermuda and the Bahamas —are characterized by the Centers for Disease Control and Prevention as “Level 4” because of very high rates of covid-19, which means the public health agency recommends avoiding travel.
Those countries and territories include such popular spots as Jamaica, Puerto Rico, Aruba, the U.S. Virgin Islands and, as of Monday, Barbados. In all, more than 20 destinations are listed as Level 4.
Another handful — including Anguilla, Bonaire, Turks and Caicos, and Trinidad and Tobago — are Level 3, which means rates of the coronavirus are high and only vaccinated people should visit. Just a few are at the two lowest levels, including the Dominican Republic and Cayman Islands.
“The road to recovery in the region is not smooth,” Neil Walters, acting secretary general of the Caribbean Tourism Organization, said in an emailed statement. “The changes in the health situation and the ever-shifting travel arena could create much turmoil.”
The tourism group said that in the first half of the year, international tourist arrivals to the Caribbean reached 6.6 million — down 12 percent from the first half of 2020, and more than 62 percent from 2019. But some destinations have seen growth.
In the Bahamas, for example, visitation through August increased nearly 50 percent from last year to more than 612,000 as airlines increased service.
I. Chester Cooper, the Bahamas’ deputy prime minister and the minister of tourism, investments and aviation, said in an emailed statement that the country is optimistic that a “robust holiday season” is possible.
“Throughout this pandemic we have had to pivot and evolve to strike the delicate balance between protecting the health and safety of our citizens and visitors and creating opportunities that enable our vital tourism economy to begin recovering,” he said.
That is the balance the entire region has been trying to find as destinations have reopened with a variety of entry procedures.
“In the Caribbean, tourism is our bread and butter, so we really needed to ensure that we are able to keep our borders open,” said Vanessa Ledesma, acting CEO and director general of the Caribbean Hotel and Tourism Association. “Everything we can do to mitigate the impact, we will continue to do so.”
In some countries, that means vaccine requirements, quarantines, mandatory testing, travel insurance coverage — or some combination of those rules. The hotel and tourism association maintains a grid online with various protocols to try to help potential visitors keep track.
“We know it’s been challenging and we have lobbied for harmonization across the region as much as possible,” Ledesma said. “Every destination has different limitations or requirements.”
That can be confusing for travelers who are trying to choose from a region with more than two dozen destinations — and just as many different mandates for entry. That lack of consistency has “added complexity and concern” for clients, said travel adviser Mike Salvadore, of 58 Stars Travel.
“And many clients are concerned that policies will change quickly, and they may be stuck or lose their investment,” he said in an email.
One thing that isn’t really discouraging visitors, Salvadore said: travel advisories. While there was a dip of interest in the summer after Europe’s reopening and during hurricane season, he said interest in the region moving into the fall and holiday period is “robust.”
“Caribbean travel was the first to see a resurgence in early 2021, and while most destinations continue to maintain a level 4 status with the CDC, it hasn’t kept travelers away,” Salvadore wrote.
Within the Caribbean, the foreign travel advisories are viewed with some frustration. Ledesma wrote in September that the industry has gone to great lengths to protect visitors and those who work in the tourism industry.
Clive Landis, who chairs the covid-19 task force at the University of the West Indies in Barbados, said the recent change from Level 3 to 4 in Barbados doesn’t change anything about entry or exit protocols.
“We wonder what the value of it is,” he said.
Landis said the region has been skeptical of the travel warnings, especially when they are applied to countries that have overall low case rates such as Anguilla. More important, he said, is helping those destinations get all the vaccine doses they need.
“I think here in the Caribbean, our record — even now with the surge of the delta variant — is still, in terms of cases per capita … well below the U.S.,” Landis said. “It’s not as if they’re stepping into some kind of a hot spot that they’re not used to in their own country.”
Twitter has censored a post showing an obituary for a mother who died after suffering from “COVID Vaccine-Induced Thrombotic Thrombocytopenia.” Jessica Berg Wilson reportedly did not want to get vaccinated but did so in order to be participate as a “Room Mom” at her young daughters’ school.
Twitter tagged the post about Wilson’s death, and her cause of death, as “Misleading,” and provided links to “Learn why health officials consider COVID-19 vaccines safe for most people.” The tweet “can’t be replied to, shared, or liked.”
Clicking the links provided by Twitter brings users to Twitter’s information showing that Reuters has reported that “Scientists and public health experts say that vaccines are safe for most people.”
The obituary for the 37-year-old mom, published in Oregon Live, said that Wilson “passed away unexpectedly Sept. 7, 2021 from COVID-19 Vaccine-Induced Thrombotic Thrombocytopenia (VITT) surrounded by her loving family.”
Wilson was “an exceptionally healthy and vibrant 37-year-old young mother with no underlying health conditions,” Oregon Live reports. Her daughters are ages 5 and 3.
“She had been vehemently opposed to taking the vaccine,” Wilson’s obituary reads, “knowing she was in good health and of a young age and thus not at risk for serious illness. In her mind, the known and unknown risks of the unproven vaccine were more of a threat. But, slowly, day by day, her freedom to choose was stripped away.”
Wilson eventually got vaccinated in order to be a “Room Mom” at her children’s school, but she was unable to take on this role unless she also took the vaccine, which she did. She passed on Sept. 7, 2021, and was from Seattle, Wash.
Washington State Governor Jay Inslee announced in August that state employees would be required to be vaccinated against COVID-19.
This included workers in private health and long-term care settings, as well as contractors. Inslee mandated vaccinations for those all those working in K-12, childcare, and higher education on Aug. 18. All employees who would need to be vaccinated had to get the first shot of a double-dose vaccine by Sept. 6 to meet the Oct. 18 deadline for full vaccination.
Pfizer made $19 Billion in Q2 this year, or $211 million per day. Some known risks of their jab are blood clots and cardiomyopathy. Luckily for them they make Eliquis for treating blood clots – sales up 13%. They also make Vyndaqel to treat cardiomyopathy – sales are up 77%!
Following in the spirit of Britain's Queen Boudica, Queen of the Iceni. A boudica.us site. I am an opinionator, do your own research, verification. Reposts, reblogs do not neccessarily reflect our views.