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You really DO NOT want to take a monkey vaccine

THE VIRUS AND THE VACCINE
On any list of medical triumphs of the 20th century, polio vaccination is sure to rate a mention. In the 1950s and early 1960s, the shot and sugar-cube vaccines of Jonas Salk, and later Albert Sabin, offered people the first opportunities to protect themselves from a scourge as feared in its day as AIDS is in our own. Few back then grasped that these vaccines might also be a huge, inadvertent, uncontrolled experiment in interspecies viral transmission. But from 1955 to 1963, according to a 1976 US National Institutes of Health (NIH)-funded study, 98 million Americans alone probably were exposed to polio vaccines contaminated with SV40—a monkey virus that can cause cancers in animals. Now, a July 7 2004 report in New Scientist has raised fears that hundreds of millions of eastern Europeans, Asians, and Africans also may have been exposed to SV40 in Soviet-made polio vaccines. Michele Carbone of Loyola University Medical Center, Chicago, USA, announced at the 2004 Vaccine Cell Substrates meeting (Rockville, MD) that the Soviet vaccine could have been contaminated until the 1980s. This is worrying since, despite 44 years of medical debate, epidemiological studies have yet to establish conclusively whether SV40 has or hasn’t caused cancers in people.
When Salk developed his vaccine, instead of using human tissues, as did the scientists who won a Nobel Prize for first growing poliovirus in tissue culture, he used minced-up rhesus macaque monkey kidneys, which were remarkably efficient poliovirus factories. Those who sought to supplant Salk’s formaldehyde-inactivated vaccine with live, attenuated oral vaccine also used monkey kidney cultures. Despite a manufacturing problem that, at best, left six children who received the vaccine paralysed in the arm, and despite concerns about wild simian viruses, Salk’s shots were declared safe and effective after 1954 field trials. The next year, after grudging approval by sceptical government regulators, free Salk shots were made available throughout the USA.
By 1960, scientists and vaccine manufacturers knew that monkey kidneys were sewers of simian viruses. Such contamination often spoiled cultures, including those of an NIH researcher named Bernice Eddy, who worked on vaccine safety. In 1959, fresh from co-reporting that the mouse polyoma virus could cause cancer in other animals, Eddy tested the rhesus monkey kidney substrate used to make polio vaccine. She injected 154 newborn hamsters with extracts of the cell cultures: 109 developed tumours. Next, she ground up three of the tumours and injected the residue into other hamsters. The animals receiving injections from two of the three tumours developed cancers. But when Eddy put the substance back into the monkey cell culture, nothing happened, and she couldn’t isolate the suspected virus.
In The Virus and the Vaccine: The True Story of a Cancer-Causing Monkey Virus, Contaminated Polio Vaccine, and the Millions of Americans Exposed, Debbie Bookchin and Jim Schumacher report that in 1960, when Eddy presented her results to her boss, a polio vaccine champion named Joe Smadel, he was livid and disbelieving: “Its implications—that something in the polio vaccine could cause cancer—was an affront to his career.” Her discovery also threatened one of the USA’s most important public-health programmes. “By 1960, tens of millions of Americans had been vaccinated against polio, and it was federal health policy that everyone should be vaccinated and continue to receive Salk booster shots.”

Continue reading “You really DO NOT want to take a monkey vaccine”

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J & J Covid-19 vaccine study paused due to unexplained illness in participant

The study of Johnson & Johnson’s Covid-19 vaccine has been paused due to an unexplained illness in a study participant. A document sent to outside researchers running the 60,000-patient clinical trial states that a “pausing rule” has been met, that the online system used to enroll patients in the study has been closed, and that the data and safety monitoring board — an independent committee that watches over the safety of patients in the clinical trial — would be convened. The document was obtained by STAT. Contacted by STAT, J&J confirmed the study pause, saying it was due to “an unexplained illness in a study participant.” The company declined to provide further details. “We must respect this participant’s privacy. We’re also learning more about this participant’s illness, and it’s important to have all the facts before we share additional information,” the company said in a statement. J&J emphasized that so-called adverse events — illnesses, accidents, and other bad medical outcomes — are an expected part of a clinical study, and also emphasized the difference between a study pause and a clinical hold, which is a formal regulatory action that can last much longer. The vaccine study is not currently under a clinical hold. J&J said that while it normally communicates clinical holds to the public, it does not usually inform the public of study pauses. The data and safety monitoring board, or DSMB, convened late Monday to review the case. J&J said that in cases like this “it is not always immediately apparent” whether the participant who experienced an adverse event received a study treatment or a placebo. Though clinical trial pauses are not uncommon — and in some cases last only a few days — they are generating outsized attention in the race to test vaccines against SARS-CoV-2, the virus that causes Covid-19. Given the size of Johnson & Johnson’s trial, it’s not surprising that study pauses could occur, and another could happen if this one resolves, a source familiar with the study said. “If we do a study of 60,000 people, that is a small village,” the source said. “In a small village there are a lot of medical events that happen.” On Sept. 8, a large study of another Covid-19 vaccine being developed by AstraZeneca and Oxford University was put on hold because of a suspected adverse reaction in a patient in the United Kingdom. It’s believed that the patient had transverse myelitis, a spinal cord problem. Studies of the vaccine resumed roughly a week after it was paused in the United Kingdom, and have since been restarted in other countries as well. It remains on hold, however, in the United States. Johnson and Johnson began enrolling volunteers in its Phase 3 study on Sept. 23. Researchers planned to enroll 60,000 participants in the United States and other countries.

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Dr. Fauci says this simple drug that’s already available might reduce coronavirus risks

  • A new coronavirus study shows that vitamin D deficiency increases the risk of COVID-19 complications and deaths, echoing similar findings from earlier this year.
  • Dr. Anthony Fauci has endorsed vitamin D in a recent interview, emphasizing that it might help people who are vitamin D deficient fight a potential covid infection.
  • There’s no randomized clinical trial to prove the effectiveness of vitamin D therapy in COVID-19, however.

The novel coronavirus will remain a significant danger to all of us until effective vaccines and drug therapies are widely available. COVID-19 has killed more than 1 million people worldwide as of this past weekend, out of more than 33.4 million confirmed cases. While it’s true that it’s usually people who suffer from other medical issues and the elderly who are most at risk of death, there have been plenty of exceptions to that rule. Young people, including children who had no other medical problems, have died of COVID-19 complications. On top of that, many of us have preexisting conditions that we’re not even aware of. That’s why it’s so important to protect yourself as well as possible until treatments are widely available. Dr. Anthony Fauci already endorses. The best part about it is that you might not even need to take it in order to benefit from it. A study claimed a few months ago that vitamin D deficiency had been correlated with COVID-19 complications and death, and another study argued there’s no proof vitamin D can prevent or treat COVID-19. We’ve always told you that nothing is set in stone with coronavirus studies, and more research will be required to confirm early findings. When it comes to vitamin D, we already have more research that indicates sufficient levels can indeed reduce complications and death. The newest vitamin D data comes from the Boston University School of Medicine, via SciTechDaily. Doctors found that patients who were vitamin D sufficient (a blood level of 25-hydroxyvitamin D of at least 30 ng/ml) had a significantly decreased risk for complications, including unconsciousness, hypoxia, and death. People who had enough vitamin D in their systems had lower blood levels of C-reactive protein, which is a marker of inflammation that goes up when an infection is present. Lymphocyte counts were also higher. Those are the immune system cells that can fight illnesses, and which are diminished in COVID-19 cases. The doctors tested vitamin D levels in 235 COVID-19 patients and compared the outcomes of patients who were deficient to those who had sufficient vitamin D.

The researchers wrote that patients older than 40 who were vitamin D sufficient were 51.5% less likely to die from the infection.

Michael Holick, professor of medicine, physiology, biophysics and molecular medicine at Boston University School of Medicine, is one of the authors of the study. Previously, he published a paper concluding that a sufficient amount of vitamin D could reduce the risk of catching coronavirus by 54%. The risk of infection is still there, and vitamin D is not going to be a magical cure for COVID-19. However, the good news here is that vitamin D is something we already get from food. The skin even synthesizes it from sun exposure. Of course, vitamin D is also available as an over-the-counter supplement that anyone can take. Dr. Fauci also recommends vitamin D to possibly reduce the risk of infection. “If you are deficient in vitamin D, that does have an impact on your susceptibility to infection,” the health expert said during an Instagram Live chat with Jennifer Garner a few days ago. “So, I would not mind recommending, and I do it myself taking vitamin D supplements.” Testing for vitamin D deficiency might be advised before taking supplements. As CNBC points out, not all experts agree that routine testing for vitamin D is advised. It’s not just that the test results take longer to process, but they’re also costly and could lead to more people seeking vitamin D supplements. The report notes that there’s not enough scientific evidence to prove that taking vitamin D does anything helpful for people who do not have a vitamin D difficiency. Milana Frenkel-Morgenstern of Bar Ilan University told The Times of Israel on Sunday that vitamin D is “like a steroid,” after publishing what she says is the world’s largest population-based study of its kind. Her team studied a 7,807-strong sample of Israelis who were tested for the coronavirus. It found that the average vitamin D level for people who screened negative was in the internationally-accepted “adequate” range, while the average for those who tested positive fell in the “inadequate” category. Vitamin D levels of less than 20 nanograms per milliliter of blood are considered inadequate.

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Hospital staff infected with coronavirus in air released from ventilator

A doctor and two nurses at Sourasky Medical Center may have been infected with the coronavirus by the aerosol coming from a ventilator being used on a patient, according to an initial investigation of the incident, Israel Hayom reported. Eight ventilators were being used in tandem at the time. After the investigation, the hospital decided to place a limit of six patients on Vapotherm ventilators in each ward. Vapotherm ventilators are devices that use a nasal cannula with high pressure air flow instead of a mask or invasive tube. The ventilators will also be placed under air vents in order to reduce the amount of aerosol in the air. The infection in coronavirus wards of medical staff, who are equipped with maximal personal protective equipment (PPE), is considered a rare occurrence. In the first wave, only a few isolated cases of medical staff who were infected with the virus were those working in coronavirus wards, according to Israel Hayom, while most who were infected were infected in other wards, by family members or at social events.
“We have almost no infections within the coronavirus wards; this is an uncommon occurrence,” Dr. Yael Paran, an expert on infectious diseases and head of Sourasky’s Traveler’s Clinic, told the newspaper. “These are departments with an air intake system and negative pressure, departments that are entered into with ‘space suits’ in a very controlled manner and with observation on protection. Therefore, we investigated in order to understand what happened this time.” She added that, “When we investigated, we found that these were employees who were very strict about the procedures even outside of work and that none of their family members became infected. This is a sequence of incidents that happened during the last week and it lit a red light for us. Infection in the coronavirus ward is something we are very afraid of.” The hospital checked the integrity of the ventilators and the staff’s attention to regulations without finding anything wrong. After checking the schedule, they arrived at the conclusion that a week before the infections, the coronavirus ward was at peak capacity, with eight patients on ventilators at once.
Paran hypothesized that “when a certain threshold of aerosol formation is exceeded, it exceeds the flow threshold of the ventilation and protection systems,” according to Israel Hayom. There is some literature that supports this hypothesis as well, she said. A hospital in northern Israel also reported a similar incident. The US Centers for Disease Control and Prevention (CDC) in an updated guidance last week said COVID-19 can spread through airborne transmission, saying some people could get infected by exposure to the novel coronavirus in small droplets and particles or aerosols that can linger in the air for minutes to hours. Aerosols lingering in the air could be a major source of COVID-19 transmission, a group of US scientists warned in an unrelated open letter published in the medical journal Science last week.
Researchers around the world have reported findings showing evidence that the virus may be airborne since as early as April, although it remains unclear how infectious airborne droplets are.
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Trump’s stimulus proposal draws opposition from congressional Democrats and Republicans

WASHINGTON (Reuters) – A new $1.8 trillion economic stimulus proposal from the Trump administration drew criticism from congressional Democrats and Republicans on Saturday, diminishing hopes for a coronavirus relief deal before the Nov. 3 election. In a weekly letter to Democratic colleagues, Pelosi said the Trump administration’s proposal lacked a “strategic plan to crush the virus” and gave President Donald Trump too much discretion to decide how funds were allocated. “At this point, we still have disagreement on many priorities, and Democrats are awaiting language from the Administration on several provisions as the negotiations on the overall funding amount continue,” Pelosi’s letter said.

On a conference call on Saturday morning with Treasury Secretary Steven Mnuchin and White House chief of staff Mark Meadows, multiple Republican senators criticized the price tag of the Trump administration’s proposal, a source familiar with the matter said.

Mnuchin floated the $1.8 trillion proposal in a 30-minute Friday afternoon phone conversation with Pelosi, according to the White House. The new White House package was higher than an earlier $1.6 trillion Mnuchin offer and closer to the $2.2 trillion the Democratic-controlled House of Representatives passed last week. White House spokeswoman Alyssa Farah said the administration wanted to keep spending below $2 trillion but was eager to enact a fresh round of direct payments to individuals as well as aid for small businesses and airlines. Friday marked the third straight day of talks between Pelosi and Mnuchin. Senate Majority Leader Mitch McConnell, the top Republican in Congress, said on Friday he doubted lawmakers would pass a package before Nov. 3, although he has not directly participated in the talks. “The proximity to the election and the differences of opinion over what is needed at this particular juncture are pretty vast,” McConnell told a news conference. There was no immediate comment on Saturday from the Treasury, White House, or McConnell’s office.

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Pelosi rejects Trump’s $1.8T stimulus proposal

Pelosi accuses Trump of MONEY GRAB as she slams proposed $1.8 trillion stimulus package with more $1,200 checks

HOUSE Speaker Nancy Pelosi has accused Donald Trump of a money grab as she slammed the $1.8trillion stimulus package he had proposed.

Nancy Pelosi has rejected the latest stimulus offer from Donald Trump

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In a letter to her caucus, she called the plan “insufficient” and said it amounted to “one step forward, two steps back.”

“When the President talks about wanting a bigger relief package, his proposal appears to mean that he wants more money at his discretion to grant or withhold,” Pelosi said. She added the Democrats should push for more funding and details on the plan. The Democrats had previously rejected a $1.6trillion package, claiming it wasn’t generous enough. While hosting a “virtual rally” Friday on Rush Limbaugh’s radio show, Trump said: “I would like to see a bigger stimulus package frankly than either the Democrats or Republicans are offering.” He also wrote on Twitter that the aid package should “Go Big”. Americans have been waiting for months on a second round of $1,200 coronavirus stimulus checks, but talks between the White House and Pelosi have failed to reach a consensus and the GOP-controlled Senate has voiced opposition even to plans Trump supports.

  • $1,200 direct payments to adults plus $1,000 for each dependent child
  • $400 weekly federal unemployment benefits (end date unclear)
  • $300 billion in aid to state and local governments
  • $75 billion for coronavirus testing and tracing

Even if a deal was reached within the next few days, it’s unlikely most Americans would see the funds in their pockets until after the November 3 presidential election. Senate Majority Leader Mitch McConnell told attendees at an event in Kentucky that any deal would be unlikely in “the next three weeks,” according to Axios.

McConnell and Senate Republicans are more focused on uniting behind and confirming the nomination of Judge Amy Coney Barrett to the Supreme Court in the weeks ahead, a GOP source told Axios.

The source said: “You’re never going to get a deal out of Pelosi that Republicans can support. So do you really want to divide your party within days of an election?” The Axios source described Pelosi as “trying to jam up” Congress as they fight to get Barrett confirmed. “Pelosi’s out there doing 25th Amendment s**t today,” the source said. “Does this sound like a lady who wants a deal? There’s no way McConnell takes his eye off the ball. Republicans are intently focused on the Supreme Court.” The decision by Pelosi comes after she unveiled her 25th amendment plan to oust the president from office after she accused Donald Trump of being “in an altered state.” Pelosi mentioned that due to the drugs that Trump has been on since he was diagnosed with Covid last week, “medical professionals say this could have an impact on judgment.” “The president is, shall we say, in an altered state right now,” Pelosi said on Bloomberg TV. “I don’t know how to answer for that behavior.”

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WHO reports record one-day rise in global coronavirus cases amid European outbreak

Oct 8 (Reuters) – The World Health Organization reported a record one-day increase in global coronavirus cases on Thursday, with the total rising by 338,779 in 24 hours led by a surge of infections in Europe. Europe reported 96,996 new cases, the highest total for the region ever recorded by the WHO. Global deaths rose by 5,514 to a total of 1.05 million. The previous WHO record for new cases was 330,340 on Oct. 2. The agency reported a record 12,393 deaths on April 17. As a region, Europe is now reporting more cases than India, Brazil or the United States. India reported 78,524 new cases, followed by Brazil at 41,906 and the United States with 38,904 new infections, according to the WHO, whose data lags the daily reports by each country. According to a Reuters analysis of more recent country data, COVID-19 infections are rising in 54 countries, including surges in Argentina, Canada and much of Europe. Infections in the United Kingdom have reached record levels with over 17,000 new cases reported on Thursday. “We are seeing a definite and sustained increase in cases and admissions to hospital. The trend is clear, and it is very concerning,” said Dr Yvonne Doyle, medical director for Public Health England. France’s new daily COVID-19 infections remained above the record 18,000 threshold for the second day on Thursday with new measures to curb the outbreak expected. The average number of new infections reported in Belgium has been increasing for seven days straight and Germany reported its biggest daily increase in new cases since April on Thursday. While India still leads in the globe in most new cases reported per day, new infections are down 20% from its peak.

In the United States, which has the largest total number of cases and deaths in the world, new infections are edging higher along with the most hospitalized COVID-19 patients since early September.

 

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Coronavirus could spread ‘uncontrollably’ over the next few weeks, German official warns

  • Germany has issued a stark warning over the spread of the coronavirus.
  • Top health officials are sounding the alarm over potential further outbreaks in the country.
  • “The current situation worries me a lot. We don’t know how things will develop over the next few weeks,” Lothar Wieler, head of the Robert Koch Institute (RKI) for infectious diseases, said on

    Germany has been seen as a poster-child for its response to the initial coronavirus outbreak, having implemented a robust testing regime earlier on, as well as tracking and tracing cases effectively. It’s modern health care infrastructure helped to keep deaths relatively low. While Germany has reported 311,503 cases, according to a tally from Johns Hopkins University, and a similar number to Italy where the virus first emerged in Europe in February, it has reported far fewer deaths, with the tally still under 10,000. In recent weeks it has seen an increase in the number of new daily infections. On Thursday, it reported 4,058 new cases, with urban centers Berlin, Munich and Hamburg particular hotspots. Germany has moved to increase restrictions in such areas, with a curfew put on hospitality venues like bars and restaurants to curb the spread. Wieler warned against complacency, however, saying that while Germany “got through the summer comparatively well” that did not mean the epidemiological situation wasn’t dangerous. “Some claim that this shows that the virus is not that dangerous after all — that is a fallacy. Not that many people died because we took measures and kept to them,” the RKI tweeted, quoting Wieler. The RKI updated its risk assessment of the situation in Germany and worldwide Wednesday, saying it was “a very dynamic and serious situation.” “The number of cases continues to increase worldwide. The number of newly submitted cases in Germany declined from around mid-March to early July. Since the end of July, significantly more cases have been transmitted again, many of them initially related to travel. Since the end of August (week 35), more transmissions have been observed in Germany,” the RKI noted. “A continuous increase in transmissions in the population in Germany can currently be observed. The dynamic is increasing in almost all regions,” it said, adding that outbreaks were particularly connected to celebrations with family and friends, group events, and old people’s and nursing homes.The RKI continues to rate the risk to the health of the German population as “high,” and “very high” for particular at-risk groups.