NIH ‘very concerned’ about serious side effect in AstraZeneca coronavirus vaccine trial

Astra Zenaca is working with Oxford University for Covid 19 vaccine. The Muslim Times has the best collection of articles for the war against Covid 19, especially the vaccines.

Source: CNN

(Kaiser Health News) The Food and Drug Administration is weighing whether to follow British regulators in resuming a coronavirus vaccine trial that was halted when a participant suffered spinal cord damage, even as the National Institutes of Health has launched an investigation of the case.

“The highest levels of NIH are very concerned,” said Dr. Avindra Nath, intramural clinical director and a leader of viral research at the National Institute for Neurological Disorders and Stroke, an NIH division. “Everyone’s hopes are on a vaccine, and if you have a major complication the whole thing could get derailed.”

Here’s why a vaccine will not stop the Covid-19 pandemic right awayA great deal of uncertainty remains about what happened to the unnamed patient, to the frustration of those avidly following the progress of vaccine testing.

AstraZeneca, which is running the global trial of the vaccine it produced with Oxford University, said the trial volunteer recovered from a severe inflammation of the spinal cord and is no longer hospitalized.AstraZeneca has not confirmed that the patient was afflicted with transverse myelitis, but Nath and another neurologist said they understood this to be the case.

Transverse myelitis produces a set of symptoms involving inflammation along the spinal cord that can cause pain, muscle weakness and paralysis. Britain’s regulatory body, the Medicines and Healthcare Products Regulatory Agency, reviewed the case and has allowed the trial to resume in the United Kingdom.

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In this day and age, understanding bacteria and viruses and developing vaccines are national security issues. In my view sizable part of every country’s defense budget should be spent in these pursuits rather than making tanks and other weapons.

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Categories: Vaccine

5 replies

  1. (CNN)Dr. Umair Shah remembers the last mass vaccination campaign the US waged.

    It was in 2009, when the H1N1 “swine” flu broke out in April, right at the end of the regular flu season.
    “That was very challenging,” Shah, who heads the Harris County, Texas, health department, told CNN.
    “There were a lot of moving pieces. It took several weeks to months to not just organize but to implement and to do safely and effectively. And that was a mild pandemic.”
    This is not a mild pandemic. And while vaccine manufacturers, public health experts and the federal government are all confident one or more of the coronavirus vaccines being tested now will be shown to work safely by the end of the year, the US and the world will still be a long way from ending the pandemic.
    The US isn't even close to getting Covid-19 down to where it needs to be by fall, medical experts say
    The US isn’t even close to getting Covid-19 down to where it needs to be by fall, medical experts say
    “I feel cautiously optimistic that we will have a vaccine by the end of this calendar year, as we get into early 2021,” Dr. Anthony Fauci, who, as director of the National Institute of Allergy and Infectious Diseases, is helping lead the medical battle against the virus, told CNN’s Wolf Blitzer Friday.

    https://www.cnn.com/2020/09/15/health/vaccine-not-end-coronavirus-pandemic/index.html

  2. (Reuters) – U.S. drug developer Novavax Inc said on Tuesday it was doubling its potential COVID-19 vaccine manufacturing capacity to two billion doses annually under an agreement with Serum Institute of India, sending its shares up about 7%.

    In August, Novavax signed a deal with Serum Institute, the world’s largest producer of vaccines, to produce a minimum of one billion doses of its vaccine candidate, when approved, for low- and middle-income countries and India.

    As part of the expanded agreement, Serum Institute will also manufacture the antigen component of the vaccine, dubbed NVX‑CoV2373, which Novavax said will bring its manufacturing capacity to over two billion doses by mid-2021.

    Novavax’s vaccine is currently in mid-stage trials after an early-stage study showed it produced high levels of antibodies against the novel coronavirus. The company plans to begin late-stage trials in the third quarter.

    Last month, Novavax said it will supply 60 million doses of its coronavirus vaccine candidate to the UK beginning as early as the first quarter of 2021.

    https://finance.yahoo.com/news/novavax-aims-two-billion-covid-112503651.html

  3. UK researchers are to begin trials of inhaled coronavirus vaccines.

    Delivering doses directly to the lungs might give a better immune response than conventional jabs, they say.

    The Imperial College London team will use two frontrunners already in development – the Oxford one recently paused in trials and one from Imperial that entered human testing in June.

    There are nearly 180 candidates being explored globally – but none has yet reached the end goal.

    How close are we to developing a coronavirus vaccine?
    Oxford University to resume vaccine trial after pause
    About 30 healthy volunteers will be given the vaccines as a mist or aerosol – in the same way asthma drugs are delivered with a nebuliser machine and a mask or mouthpiece.

    The seasonal flu jab can also be given as a nasal spray rather than an injection.

    Lead researcher Dr Chris Chiu said: “The current pandemic is caused by a respiratory virus which primarily infects people through the cells lining the nose, throat and lungs.

    “These surfaces are specialised and produce a different immune response to the rest of the body.

    “So it is critical we explore whether targeting the airways directly can provide an effective response compared to a vaccine injected into muscle.”

    https://www.bbc.com/news/health-54147607

  4. After coming under fire for vaccine safety, AstraZeneca releases trial blueprints.
    AstraZeneca revealed details of its large coronavirus vaccine trial on Saturday, the third in a wave of rare disclosures by drug companies under pressure to be more transparent about how they are testing products that are the world’s best hope for ending the pandemic.

    Polls are finding Americans increasingly wary of accepting a virus vaccine. And scientists inside and outside the government are worried that regulators, pressured by President Trump for results before Election Day on Nov. 3, might release an unproven or unsafe vaccine.

    “The release of these protocols seems to reflect some public pressure to do so,” said Natalie Dean, a biostatistician and expert in clinical trial design for vaccines at the University of Florida. “This is an unprecedented situation, and public confidence is such a huge part of the success of this endeavor.”

    Pfizer and Moderna revealed details of their vaccine trials on Thursday.

    Experts have been particularly concerned about AstraZeneca’s trials because of the company’s refusal to provide details about serious neurological illnesses in two participants, both women, who received its experimental vaccine in Britain, where the company’s trials began in April.

  5. Experts have been particularly concerned about AstraZeneca’s vaccine trials, which began in April in Britain, because of the company’s refusal to provide details about serious neurological illnesses in two participants, both women, who received its experimental vaccine in Britain. Those cases spurred the company to halt its trials twice, the second time earlier this month. The studies have resumed in Britain, Brazil, India and South Africa, but are still on pause in the U.S. About 18,000 people worldwide have received AstraZeneca’s vaccine so far.

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