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Tuesday, October 12, 2021

India OKs Covaxin for emergency use in kids as young as 2

 The subject expert committee of the national drug regulator on Tuesday cleared Covaxin Covid shot for emergency use in children aged two to 18 years giving India the first approved vaccine for use in kids as small as two.

Previously, the Drug Controller General of India had approved Zydus Cadila’s ZyCoV-D for emergency use in people aged 12 and above.

The clearance to Covaxin for children between two to 18 comes at a time when schools are reopening with challenges in respect of protection of children from disease mounting. Although there is no clear evidence of children being more vulnerable to a potential third wave of the virus, countries have been expanding vaccination drives to cover children.

India’s apex national body that lays down guidance for inoculations – the National Technical Advisory Group on Immunisation – is currently working to give guidance for Covid vaccination in children.

The NTAGI is already engaged on which segments among children should be prioritised for vaccination. The guidance for ZyCoV-D use among 12 to 18 year olds is also being deliberated upon.

The NTAGI will now take a combined call on vaccination for children, with Covaxin also approved today for emergency use in children.

The World Health Organisation, however, has given no guidance on Covid vaccine use among children, with larger evidence suggesting a natural immunity among children to viruses.

Countries are taking individual calls on the matter with the US and UK having taken the lead in inoculating children against Covid.

The approval of child vaccines by the DCGI means these can be used provided the expert vaccination panel that guides Indian policy on Covid inoculation lays down the conditions for use.

For instance, when the adult Covid vaccine drive was launched in January this year, it was prioritised for elderly and co-morbid populations before being further expanded.

A similar policy could be followed for children to start with considering the production would be limited.

It also remains to be seen how Covid shots for children will be rolled out. The adult vaccine drive is being managed by the government, with the Centre procuring 75 per cent produce from manufacturers for free distribution further to states.

Covaxin is a collaboration between ICMR and Bharat Biotech.

https://www.tribuneindia.com/news/schools/dcgi-panel-clears-covaxin-use-for-emergency-use-in-kids-as-young-as-2-323580

Monday, October 11, 2021

Wall Street Is Done With Covid: Pandemic No Longer Among Top 3 Risks

 The covid scare is officially over.

According to the latest monthly survey of 600 global market participants conducted by Deutsche Bank, for the first time since June, the biggest perceived risk to markets is no longer covid. Instead the top three risks are i) higher inflation and bond yields, ii) central bank policy error and iii) strong growth failing to materialize or being very short lived (i.e. stagflation and/or recession). New covid variants that bypass vaccines has slumped from 1st place, which it occupied for the previous three months, to 4th place in October.

FDA Responds To Nordic Countries Suspending Moderna COVID Vaccine Usage

 By Jack Phillips of The Epoch Times

The Food and Drug Administration (FDA) responded to Nordic countries limiting the use of Moderna’s COVID-19 vaccine last week, saying the shot’s benefits outweigh the risks.

Health officials in Finland, Norway, Sweden, and Iceland suspended the use of the Moderna vaccine for younger people due to a risk of side effects including myocarditis. Sweden said it would pause the vaccine for people under the age of 30, and Denmark did the same for those under 18. Finland said that males under the age 30 shouldn’t receive the jab, while Icelandic officials added over the weekend that they would suspend use of the shot.

“The FDA is aware of these data. At this time, FDA continues to find that the known and potential benefits of vaccination outweigh the known and potential risks for the Moderna COVID-19 Vaccine,” an FDA official said in a statement to news outlets over the weekend in response to the Nordic nations’ decision to suspend the vaccine for certain age groups.

Moderna, meanwhile, said in a statement after the countries’ decision that it was “aware of the very rare occurrence of myocarditis and/or pericarditis following administration of mRNA vaccines against COVID-19.”

“These are typically mild cases and individuals tend to recover within a short time following standard treatment and rest. The risk of myocarditis is substantially increased for those who contract COVID-19, and vaccination is the best way to protect against this,” the company’s statement continued.

Moderna’s vaccine is still being administered under the Food and Drug Administration’s emergency use authorization. The company’s application for full approval is still pending.

On Oct. 10, Iceland’s Health Directorate said the Moderna vaccine would be entirely suspended due to the risk of cardiac inflammation.

“As the supply of Pfizer vaccine is sufficient in the territory … the chief epidemiologist has decided not to use the Moderna vaccine in Iceland,” according to a statement published on the Health Directorate website.

The move was handed down due to “the increased incidence of myocarditis and pericarditis after vaccination with the Moderna vaccine, as well as with vaccination using Pfizer/BioNTech,” its statement continued.

And in Sweden, officials have “decided to pause the use of Moderna’s vaccine, Spikevax, for everyone born in 1991 and later, for precautionary reasons,” reads a statement from the Swedish health agency, according to a translation.

The agency further added there is “an increased risk of side effects such as inflammation of the heart muscle or heart sac,” noting that the risk is “very small.”

Mika Salminen, director of the Finnish health institute, said Finland would instead give Pfizer’s vaccine to men born in 1991 and later. Finland offers shots to people aged 12 and over.

“A Nordic study involving Finland, Sweden, Norway, and Denmark found that men under the age of 30 who received Moderna Spikevax had a slightly higher risk than others of developing myocarditis,” he said.

https://www.zerohedge.com/markets/fda-responds-nordic-countries-suspending-moderna-covid-vaccine-usage

COVID Immunity Through Infection or Vaccination: Are They Equal?

 Dr. Aaron Kheriaty, a University of California-Irvine psychiatry professor, felt he didn’t need to be vaccinated against covid because he’d fallen ill with the disease in July 2020.

So, in August, he sued to stop the university system’s vaccination mandate, saying “natural” immunity had given him and millions of others better protection than any vaccine could.

A judge on Sept. 28 dismissed Kheriaty’s request for an injunction against the university over its mandate, which took effect Sept. 3. While Kheriaty intends to pursue the case further, legal experts doubt that his and similar lawsuits filed around the country will ultimately succeed.

That said, evidence is growing that contracting SARS-CoV-2, the virus that causes covid-19, is generally as effective as vaccination at stimulating your immune system to prevent the disease. Yet federal officials have been reluctant to recognize any equivalency, citing the wide variation in covid patients’ immune response to infection.

Like many disputes during the covid pandemic, the uncertain value of a prior infection has prompted legal challenges, marketing offers and political grandstanding, even as scientists quietly work in the background to sort out the facts.

For decades, doctors have used blood tests to determine whether people are protected against infectious diseases. Pregnant mothers are tested for antibodies to rubella to help ensure their fetuses won’t be infected with the rubella virus, which causes devastating birth defects. Hospital workers are screened for measles and chickenpox antibodies to prevent the spread of those diseases. But immunity to covid seems trickier to discern than those diseases.

The Food and Drug Administration has authorized the use of covid antibody tests, which can cost about $70, to detect a past infection. Some tests can distinguish whether the antibodies came from an infection or a vaccine. But neither the FDA nor the Centers for Disease Control and Prevention recommend using the tests to assess whether you’re, in fact, immune to covid. For that, the tests are essentially useless because there’s no agreement on the amount or types of antibodies that would signal protection from the disease.

“We don’t yet have full understanding of what the presence of antibodies tells us about immunity,” said Kelly Wroblewski, director of infectious diseases at the Association of Public Health Laboratories.

By the same token, experts disagree on how much protection an infection delivers.

In the absence of certainty and as vaccination mandates are levied across the country, lawsuits seek to press the issue. Individuals who claim that vaccination mandates violate their civil liberties argue that infection-acquired immunity protects them. In Los Angeles, six police officers have sued the city, claiming they have natural immunity. In August, law professor Todd Zywicki alleged that George Mason University’s vaccine mandate violated his constitutional rights given he has natural immunity. He cited a number of antibody tests and an immunologist’s medical opinion that it was “medically unnecessary” for him to be vaccinated. Zywicki dropped the lawsuit after the university granted him a medical exemption, which it claims was unrelated to the suit.

Republican legislators have joined the crusade. The GOP Doctors Caucus, which consists of Republican physicians in Congress, has urged people leery of vaccination to instead seek an antibody test, contradicting CDC and FDA recommendations. In Kentucky, the state Senate passed a resolution granting equal immunity status to those who show proof of vaccination or a positive antibody test.

Hospitals were among the first institutions to impose vaccine mandates on their front-line workers because of the danger of them spreading the disease to vulnerable patients. Few have offered exemptions from vaccination to those previously infected. But there are exceptions.

Two Pennsylvania hospital systems allow clinical staff members to defer vaccination for a year after testing positive for covid. Another, in Michigan, allows employees to opt out of vaccination if they present evidence of previous infection and a positive antibody test in the previous three months. In these cases, the systems indicated they were keen to avoid staffing shortages that could result from the departure of vaccine-shunning nurses.

For Kheriaty, the question is simple. “The research on natural immunity is quite definitive now,” he told KHN. “It’s better than immunity conferred by vaccines.” But such categorical statements are clearly not shared by most in the scientific community.

Dr. Arthur Reingold, an epidemiologist at UC-Berkeley, and Shane Crotty, a virologist at the respected La Jolla Institute for Immunology in San Diego, gave expert witness testimony in Kheriaty’s lawsuit, saying the extent of immunity from reinfection, especially against newer variants of covid, is unknown. They noted that vaccination gives a huge immunity boost to people who’ve been ill previously.

Yet not all of those pushing for recognition of past infection are vaccine critics or torchbearers of the anti-vaccine movement.

Dr. Jeffrey Klausner, clinical professor of population and public health sciences at the University of Southern California, co-authored an analysis published last week that showed infection generally protects for 10 months or more. “From the public health perspective, denying jobs and access and travel to people who have recovered from infection doesn’t make sense,” he said.

In his testimony against Kheriaty’s case for “natural” immunity to covid, Crotty cited studies of the massive covid outbreak that swept through Manaus, Brazil, early this year that involved the gamma variant of the virus. One of the studies estimated, based on tests of blood donations, that three-quarters of the city’s population had already been infected before gamma’s arrival. That suggested that previous infection might not protect against new variants. But Klausner and others suspect the rate of prior infection presented in the study was a gross overestimate.

A large August study from Israel, which showed better protection from infection than from vaccination, may help turn the tide toward acceptance of prior infection, Klausner said. “Everyone is just waiting for Fauci to say, ‘Prior infection provides protection,’” he said.

When Dr. Anthony Fauci, the top federal expert on infectious diseases, was asked during a CNN interview last month whether infected people were as well protected as those who’ve been vaccinated, he hedged. “There could be an argument” that they are, he said. Fauci did not immediately respond to a KHN request for further comment.

CDC spokesperson Kristen Nordlund said in an email that “current evidence” shows wide variation in antibody responses after covid infection. “We hope to have some additional information on the protectiveness of vaccine immunity compared to natural immunity in the coming weeks.”

A “monumental effort” is underway to determine what level of antibodies is protective, said Dr. Robert Seder, chief of the cellular immunology section at the National Institute of Allergy and Infectious Diseases. Recent studies have taken a stab at a number.

Antibody tests will never provide a yes-or-no answer on covid protection, said Dr. George Siber, a vaccine industry consultant and co-author of one of the papers. “But there are people who are not going to be immunized. Trying to predict who is at low risk is a worthy undertaking.”

https://www.medscape.com/viewarticle/960533

Moderna has no plans to share its Covid vaccine tech

 

  • Moiderna Chairman Noubar Afeyan also reiterated a pledge Moderna made a year ago not to enforce patent infringement on anyone else making a coronavirus vaccine during the pandemic.
  • “We didn’t have to do that,” Afeyan said. “We think that was the responsible thing to do.” He added: “We want that to be helping the world. 
  • Moderna has no plans to share the recipe for its Covid-19 vaccine because executives have concluded that scaling up the company’s own production is the best way to increase the global supply, the company’s chairman said Monday.

    In an interview with The Associated Press, Noubar Afeyan also reiterated a pledge Moderna made a year ago not to enforce patent infringement on anyone else making a coronavirus vaccine during the pandemic.

    “We didn’t have to do that,” Afeyan said. “We think that was the responsible thing to do.” He added: “We want that to be helping the world. 

    The United Nations health agency has pressed Moderna to share its vaccine formula. Afeyan said the company analyzed whether it would be better to share the messenger RNA technology and determined that it could expand production and deliver billions of additional doses in 2022.

    Moderna “went from zero production to having 1 billion doses in less than a year,” Afeyan said, referring to the Massachusetts-based company’s sprint to develop the vaccine and produce it in large quantities. “And we think we will be able to go from 1 to 3 billion” in 2022.

    The Covid-19 vaccine is Moderna’s only commercial product. The company announced plans last week to open a vaccine plant somewhere in Africa. Afeyan said he hopes a decision will be made soon on an exact location. Still, it could take years to get the plant up and running.

    Afeyan spoke on the last full day of a visit to Italy in which he met Pope Francis, who has appealed for universal vaccine access. He also appeared in Venice to promote a humanitarian prize initiative.

  • “Within the next six to nine months, the most reliable way to make high-quality vaccines and in an efficient way is going to be if we make them,” Afeyan said. Asked about appeals from the World Health Organization and others, he contended that such pleas assumed “that we couldn’t get enough capacity, but in fact we know we can.”

  • https://www.cnbc.com/2021/10/11/moderna-has-no-plans-to-share-its-covid-vaccine-recipe.html

Northwell Health's new COVID PCR tests will be faster, cheaper

 New York state's largest hospital system is rolling out a new COVID test that could be a game changer.


The new process will allow 10 times more testing at one tenth of the cost and it's just as accurate, if not more so, than the current PCR testing we have for COVID.
So why is that? It's automated. These machines load 96 PCR tests at once, and then another machine tests 384 all at once.

The technology, called LabGold, is part of a grant at Northwell Health from the Bill and Melinda Gates Foundation. The idea was borrowed from the agriculture industry.

Northwell lab scientists in New Hyde Park demonstrated how they've now perfected it.

"Anyone who needs testing can get testing simply and inexpensively and immediately when you need it," Northwell Labs Executive Director Dr. Dwayne Breining.

It means no more testing sites, and the PCR turnaround is quicker -- about a day.

The 6-year-old son of a Northwell doctor, showed how simple it really is, and you don't need to swab so far up your nose.

Eyewitness News reporter Stacey Sager also demonstrated the swab, saying "I'm not going too deep up, and it doesn't feel like it's puncturing my brain."

Northwell hopes to roll out these kits to the general public in the coming weeks, but the FDA will require people to be monitored as they do them.

Ultimately, they're hoping people can just do the tests themselves.

A multi-dotted rolling plastic has other amazing implications. For example, it can answer if it's not COVID -- what is it.

Each dot can do a PCR for things like the common cold, RSV, and other bugs in the future.

"And so, we envision being able to run all of those off a single swab -- all at once," Northwell Labs Vice Chair Dr. Tylis Chang said.

Technology that's been around - but now, is being accelerated by the pandemic.

NanoViricides COVID Treatment Candidate Effective Against Variants In Lab Study

Shares of NanoViricides Inc 

 (Get Free Alerts for NNVC), a developer of antiviral therapies based on a novel nanomedicines technology, are higher Monday.

NanoViricides said its pan-Coronavirus COVID-19 drug candidate, NV-CoV-2, was found to be effective against SARS-CoV-2 in a standard cell culture pseudovirion assay.

"We have now demonstrated that NV-CoV-2 is highly effective in cell cultures against SARS-CoV-2, human coronavirus NL-63, and human coronavirus 229E, all very different human coronaviruses," the company said.

This underlines the broad spectrum pan-coronavirus activity of NV-CoV-2 and its ability to remain active against coronavirus variants, it added.

The pseudovirion study also showed that NV-CoV-2 neutralizes the virus particles themselves, outside of the cells, validating NanoViricides' design mechanism.

With a few vaccines and treatments available under emergency use authorization against the novel coronavirus, the thrust now is on treatments that can be effective against emerging variants.

NanoViricides' NV-CoV-2 fits in the bill, and if the company can take its candidate into the clinics and successfully prove its efficacy and safety in human trials, it has a promising product in the pipeline.

"We believe that NV-CoV-2 may help end the pandemic if it is shown to be effective in human clinical trials," said Anil Diwan, chairman and president of NanoViricides.

The company said it is now preparing submission documents to enable the initiation of human clinical trials.

https://www.benzinga.com/general/biotech/21/10/23316481/nanoviricides-covid-19-treatment-candidate-found-effective-against-coronavirus-variants-in-lab-st