Yellow and Other Virus and Vaccine Perils

August, 8, 2022 | 18 Comments

Comments

  1. If infants are prevented from learning how to cough in order to expel viruses naturally ,apart from weakening their immune system will the vaccine not be preventing them from developing the muscles , the physiology needed for coughing and for developing t strong lungs necessarily for a healthy active life?

  2. Another Congested Race…Give it to Mum…

    “A big concern for the scientists involved in RSV vaccine development is to make sure we do not repeat the same situation again,” said Polack, who is also affiliated with the INFANT Foundation in Buenos Aires.

    Research shows why 1960s RSV shot sickened children

    https://www.reuters.com/article/us-rsv-shot-idUSTRE4BM4SH20081223

    NEW YORK (Reuters Health) – Researchers from Johns Hopkins have solved the decades-old mystery of why a vaccine developed to prevent a common childhood viral infection wound up making kids sick.

    The findings provide important clues to how to develop a safe, effective vaccine against respiratory syncytial virus (RSV), the main cause of wintertime hospital stays among babies and young children worldwide, Dr. Fernando P. Polack, the lead researcher on the study, told Reuters Health.

    “A big concern for the scientists involved in RSV vaccine development is to make sure we do not repeat the same situation again,” said Polack, who is also affiliated with the INFANT Foundation in Buenos Aires.

    Vaccine failure explained

    Immunologists show how deaths in 1966 could have been avoided.

    https://www.nature.com/articles/news.2008.1302

    “MedImmune has made huge amounts of money on Synagis,” says Openshaw.

    “There are some vaccines that came very easily, but developing a vaccine for RSV is very tricky,” says Polack. But, he adds, a vaccine for the disease is urgently needed.

    https://www.fiercebiotech.com/biotech/gsk-drops-phase-2-viral-vector-rsv-vaccine-pediatric-ages

    The RSV vaccine, GSK3389245A, also known as ChAd155-RSV, is a recombinant chimpanzee adenovirus vector vaccine that GSK developed with the Oxford Vaccine Group—also known for working on AstraZeneca’s COVID-19 jab. The vaccine is based on three RSV viral proteins encoded by the vector and was expected to engage both the humoral and cellular arms of the immune system against the pathogen.

    “GSK remains committed to addressing the burden of RSV disease through our maternal and older adult vaccine candidates, which use different technologies … and are both progressing in phase 3 trials,” a spokesperson said. “We remain confident in the potential of our viral vector technology, and our therapeutic hepatitis B virus development program continues as planned.”

    News of the discontinuation comes months after GSK began a late-stage study of another vaccine for RSV, GSK3888550A. By giving the vaccine to pregnant women, GSK is aiming to protect babies from the virus during their first months of life. 

    Pfizer raises pressure on GSK, J&J with late-stage RSV vaccine trial

    https://pharmaphorum.com/news/pfizer-raises-pressure-on-gsk-jj-with-late-stage-rsv-vaccine-trial/

    Moderna recently started trials of an mRNA-based flu vaccine candidate, and said it intends to move ahead with a plan to combine flu, COVID-19 and RSV into a single shot. Pfizer meanwhile has a partnership with its COVID-19 vaccine compatriot BioNTech that also covers an RSV jab.

    While there is no approved RSV vaccine yet, drugs are available to treat patients at the other end of the age spectrum – infants and very young children – who are also at risk of serious complications from the virus.

    Swedish Orphan Biovitrum (Sobi) currently sells Synagis (palivizumab), a monthly antibody which is the only approved drug to provide passive prophylaxis against the virus in paediatric patients, while another antibody candidate from AstraZeneca and Sanofi is headed for regulatory filings next year.

    GSK meanwhile is also exploring whether its vaccine could impart protection to children if administered to their mothers before birth.

  3. Edward Dowd Reposted

    rwmalonemd
    @rwmalonemd

    Vaccines Are Bringing Back a Nearly Eradicated Deadly Virus

    https://link.theepochtimes.com/mkt_app/vaccine
    Vaccines Are Bringing Back a Nearly Eradicated Deadly Virus

    BY XIAOXU SEAN LIN 

    https://www.theepochtimes.com/mkt_app/vaccines-are-bringing-back-a-nearly-eradicated-deadly-virus_4650115.html

    However, vaccines are not medications, and they don’t function to “kill” a virus. It only help to stop the transmission of the virus in ideal situations.

    We don’t know of any other natural animal reservoirs for the poliovirus to hide, outside human hosts. How could we “eradicate” a certain virus with vaccines when we don’t know where the virus comes from?

    Are we creating more problems with a wrong objective coupled with a wrong approach?

    On the one hand, people want to wipe polio out from the face of the earth, yet on the other hand, the vaccines are “spreading” the viruses all over the world.  The VDPVs are still polio viruses, even though they are not wild type polioviruses.  Delta or Omicron variants are still SARS-CoV-2 viruses, even though they are not the wild type Wuhan strain. Are we fooling ourselves by declaring some regions or countries as polio-free, simply based on not detecting wild type poliovirus, while we clearly know that VDPVs are still circulating, and even spreading faster due to the large OPV campaigns in many developing countries?

    With billions of dollars spent on GEPI globally, with many intensive campaigns to inoculate people, especially children, with OPVs (regardless old or novel versions), we are inoculating the world with more VDPVs in nature as we have no way to contain its existence and spread. Is eradicating polio becoming a delusion that the world just cannot wake up from, as we have invested so much of money, emotion, effort, and dedication to it, even though we know that the train is on the wrong track?

    Children under 10 will get polio boosters as virus returns to UK for first time in 40 years

    https://www.dailymail.co.uk/news/article-11093247/Children-10-polio-boosters-virus-returns-UK-time-40-years.html

    There have been no confirmed cases of polio in patients in Britain so far – but experts have suggested it has been passing from person to person because of the amount of poliovirus samples in sewage.

    The virus was detected at the Beckton sewage treatment works, which covers a population of four million in north and east London.

    It is normal for sampling to detect one-off traces of poliovirus in sewage each year, but officials said a sample identified in April was genetically linked to one first seen in February which persisted and mutated into a ‘vaccine-derived’ poliovirus, which is more like the ‘wild’ type that can cause serious symptoms.

  4. Lyme Disease Vaccine: Pfizer Launches Phase 3 Trial Targeting Kids, Adults

    https://childrenshealthdefense.org/defender/pfizer-valneva-lyme-disease-vaccine-clinical-trial/

    If approved, the vaccine could be the first human vaccine available for Lyme disease in the U.S. in more than two decades after LYMERix, manufactured by GlaxoSmithKline, was withdrawn from the market in 2002, due to lawsuits, safety concerns and dwindling sales.

    Similar to claims Pfizer made about booster doses of the COVID-19 vaccines, the drugmaker said that while the two-dose regimen of VLA15 demonstrated immunity, a third VLA15 dose “increased the level of antibodies against an outer surface protein.”

    According to a press release, Pfizer and French partner Valneva are enlisting 6,000 participants ages 5 and older for a late-stage clinical trial that will test the vaccine, VLA15, against the tick-borne illness.

    According to ClinicalTrials.gov, “18,000 healthy participants 5 years and older” were recruited for the study. In its press release, Pfizer did not explain the discrepancy in the number of trial participants.

    How the LYMErix Lyme Disease Vaccine was Pulled from the Market

    https://www.lymedisease.org/members/lyme-times/special-issues/tick-borne-disease/lymerix-lyme-disease-vaccine/

    “It’s rare that a vaccine be voted on with such ambivalence and a stack of provisos.”…… 

  5. There is a real gap in the market for children aged between age 3½ (MMR (2nd dose) +
    4-in-1 pre-school booster*) and age 11 (HPV vaccine).

    Those UK kids must feel left out.

    * wow: SEVEN antigens in one go! So physiological.

    • The primary factor behind these vaccine schedules appears to be convenience rather than science. There is nothing natural about giving a baby 6 infections along with adjuvants etc all in one go at 6 weeks of age and then repeating the trick and few weeks later.

      A colleague was telling me her doctor musing with her rather than trying to persuade or convert said it was his impression that delaying these early vaccines by some weeks seemed to lead to less bronchiolitis subsequently.

      We also don’t know for instance ssimple things like what makes more sense – sticking to a rigid 6 week after birth schedule when say the baby was born premature or aiming at vaccination 6 weeks after the due date? There is a big difference between the two but it seems most likely that no-one is in a position to offer a physiologically informed view on what might be best.

      DH

  6. ‘Acting at speed ‘
    we believe the public will understand and thank us for this decisive action’. Clap, clap
    .
    Navigation menu MenuSearch GOV.UK
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    Letter to the profession from the UK Chief Medical Officers on the UK COVID-19 vaccination programmes
    Department of Health & Social Care
    31 December 2020

    Dear colleagues,

    Thank you for your remarkable commitment to the health of our nation in the most difficult of circumstances; the COVID-19 pandemic is undoubtedly the biggest health crisis in a generation, and certainly in our professional lifetimes. We are at a critical point in the pandemic as the emergence of a novel variant of SARS-CoV-2 with a markedly higher growth rate is rapidly shifting the epidemiological curve in the wrong direction across much of the UK in the middle of winter.

    Authorisation of first the Pfizer and now the AZ vaccine (AZD1222) for use is incredibly welcome. Both are highly effective vaccines from clinical trial data and are anticipated to have sizeable effects on preventing severe disease and hospitalisation. Getting vaccines deployed as rapidly as possible into as many older, clinically vulnerable patients, and also frontline health and social care workers is essential. The Joint Committee on Vaccination and Immunisation (JCVI) has put forward a prioritisation scheme, attached, of which you will all be aware.

    We wanted to lay out to you the scientific and public health rationale for the dosing schedule for the AZ vaccine and the change to the dosing schedule for the second dose of the Pfizer vaccine. As with all decisions during this pandemic it is about balance of risks and benefits.

    We have to ensure that we maximise the number of eligible people who receive the vaccine. Currently the main barrier to this is vaccine availability, a global issue, and this will remain the case for several months and, importantly, through the critical winter period. The availability of the AZ vaccine reduces, but does not remove, this major problem. Vaccine shortage is a reality that cannot be wished away.

    We are confident that based on publicly available data as well as data available to the JCVI, the statutory independent body, that the first dose of either Pfizer or AZ vaccine provides substantial protection within 2-3 weeks of vaccination for clinical disease, and in particular severe COVID disease. The JCVI has issued a new evidence statement today.

    The second vaccine dose is likely to be very important for duration of protection, and at an appropriate dose interval may further increase vaccine efficacy. In the short term, the additional increase of vaccine efficacy from the second dose is likely to be modest; the great majority of the initial protection from clinical disease is after the first dose of vaccine.

    In terms of protecting priority groups, a model where we can vaccinate twice the number of people in the next 2 to 3 months is obviously much more preferable in public health terms than one where we vaccinate half the number but with only slightly greater protection.
    This is why the JCVI has recommended that first doses of vaccine are prioritised for as many people as possible on the Phase 1 JCVI priority list, in advance of second doses which will subsequently provide more assured longer-term protection. It is a classic public health approach centred on doing as much good for as many people in the shortest possible timeframe, within the available vaccine supplies, against a background of immediate disease activity and still high population sero-susceptibility (despite the disease burden seen).
    The JCVI is confident 12 weeks is a reasonable dosing interval to achieve good longer-term protection.
    The position is strongly supported by the UK Chief Medical Officers on public health grounds of maximising benefit.
    We recognise that the request to re-schedule second appointments is operationally very difficult, especially at short notice, and will distress patients who were looking forward to being fully immunised. However, we are all conscious that for every 1000 people boosted with a second dose of COVID-19 vaccine in January (who will as a result gain marginally on protection from severe disease), 1000 new people can’t have substantial initial protection which is in most cases likely to raise them from 0% protected to at least 70% protected. Whilst the NHS, through all of your work, has so far vaccinated over 1 million UK patients with a first dose,approximately 30 million UK patients and health and social care workers eligible for vaccination in Phase 1 remain totally unprotected and many are distressed or anxious about the wait for their turn. These unvaccinated people are far more likely to end up severely ill, hospitalised on in some cases dying without vaccine. Halving the number vaccinated over the next 2-3 months because of giving two vaccines in quick succession rather than with a delay of 12 weeks does not provide optimal public health impact.

    We have to follow public health principles and act at speed if we are to beat this pandemic which is running rampant in our communities and we believe the public will understand and thank us for this decisive action. We hope this has your support.
    GOV.UK
    Navigation menu MenuSearch GOV.UK

  7. Brook Jackson  
    @IamBrookJackson
    ·
    Aug 13

    The Time of COVID –

    Dr. Phillip Altman There is even more explosive information and documents that will be released in the coming days!

    Please share

    https://8630368.fs1.hubspotusercontent-na1.net/hubfs/8630368/AMPS/Altman%20Report%20Final%20Version%2011-8-22%20(1).pdf?utm_source=hs_email&utm_medium=email&_hsenc=p2ANqtz-9QLZBYAx-iWryax8LzJZbPBhwdHOK0WZCH4DH10l4iSkGPO-AROeYGrSVybiel3ygZuKtL

    Given the statistically or virtually nil risk of serious COVID-19 in general affecting children aged 6 months to 11 or 12 years of age and the clear and significant risk of serious adverse effects including myocarditis, pericarditis and death in this age group – there seems to be little benefit to be gained by vaccinating these children.

    Considerable scientific, clinical and statistical epidemiological data and understanding has been acquired since the introduction (on a provisional basis only) of the investigational COVID-19 gene-based “vaccines”. Many of the initial ambitious claims and assumed perceptions regarding the safety and efficacy of these serious therapeutics have now been invalidated and it is now time to review and reconsider the utility of these products in light of the known unprecedented level of serious adverse reactions and death attributed to their use.

    If we’ve all been jabbed and millions have had the virus at least once – why are so many of us being poleaxed by a bout of Covid?

    13 August 2022

    https://www.dailymail.co.uk/health/article-11108521/Covid-19-weve-jabbed-poleaxed-virus.html

    This all begs the question: why, more than two years after Covid first appeared, are so many of us suddenly being laid so low?

    Experts agree that the decision to offer all adults a third jab last winter, in response to the arrival of the highly transmissible Omicron variant, was a success.

  8. This is very much an important read, had trouble with this link so hope this works –

    The Time of COVID

    A Report by Phillip M. Altman
    BPharm(Hons), MSc, PhD

    Clinical Trial & Pharmaceutical Regulatory Affairs Consultant

    9 August 2022

    https://8630368.fs1.hubspotusercontent-na1.net/hubfs/8630368/AMPS/Altman%20Report%20Final%20Version%2011-8-22%20(1).pdf?utm_source=hs_email&utm_medium=email&_hsenc=p2ANqtz-9QLZBYAx-iWryax8LzJZbPBhwdHOK0WZCH4DH10l4iSkGPO-AROeYGrSVybiel3ygZuKtL

  9. ‘It is also hoping to have a Covid-flu combined vaccine ready by next winter, as well as a triple-threat jab combining Covid and flu with respiratory syncytial virus (RSV) by the winter of 2024-25.’ 

    UK authorises ‘next generation’ omicron booster vaccine in world first

    Joe Pinkstone – 29m ago

    The Telegraph

    https://www.msn.com/en-gb/news/uknews/uk-authorises-next-generation-omicron-booster-vaccine-in-world-first/ar-AA10FJ3i?ocid=msedgdhp&pc=U531&cvid=40f6ba5663e4444ab4ae036b374197c5

    ‘Sharpened tool in our armoury’

    Dr June Raine, the chief executive of the MHRA, said: “I am pleased to announce the approval of the Moderna bivalent booster vaccine, which was found in the clinical trial to provide a strong immune response against the omicron BA.1 variant as well as the original 2020 strain.

    “The first generation of Covid-19 vaccines being used in the UK continue to provide important protection against the disease and save lives. What this bivalent vaccine gives us is a sharpened tool in our armoury to help protect us against this disease as the virus continues to evolve.

    “We have in place a comprehensive safety surveillance strategy for monitoring the safety of all UK-approved Covid-19 vaccines and this will include the vaccine approved today.”

  10. GOV.UK
    Navigation menu MenuSearch GOV.UK
    Home
    Marketing authorisations, variations and licensing guidance
    Decision
    Regulatory approval of Spikevax bivalent Original/Omicron booster vaccine
    Information for healthcare professionals and the public on Moderna’s bivalent vaccine. Information on the original Spikevax COVID-19 vaccine can found on a separate page (link below)

    From:
    Medicines and Healthcare products Regulatory Agency
    Published
    15 August 2022
    Get emails about this page
    Documents

    Summary of Product Characteristics Spikevax bivalent Original/Omicron
    PDF, 476 KB, 21 pages

    Patient Information Leaflet Spikevax bivalent Original/Omicron
    PDF, 245 KB, 8 pages

    Spikevax bivalent Original/Omicron Information for Healthcare Professionals (Regulation 174)
    PDF, 476 KB, 23 pages

    Details
    The 15-minute observation period following vaccination with the mRNA COVID-19 vaccines has been removed for individuals aged 12 years and over who have no history of a severe allergic reaction (as outlined in the Greenbook advice This follows careful review of the safety data by the MHRA and advice from the government’s independent Commission on Human Medicines. A temporary suspension of the 15-minute observation period for children aged 5-11 years remains in place and this will be reviewed on a regular basis.

    The product information for the Spikevax original COVID-19 vaccine (formerly COVID-19 Vaccine Moderna) can be found on a separate page.

    The MHRA has issued a Conditional Marketing Authorisation for Spikevax bivalent Original/Omicron booster vaccine in Great Britain and a temporary Regulation 174 authorisation for Northern Ireland to ensure supply across all of the UK. If the European Medicines Agency grants a CMA for Spikevax bivalent Original/Omicron booster vaccine it would apply in Northern Ireland and the Regulation 174 authorisation would no longer be in place.

    Supply of this product will be subject to the same requirements in Great Britain and Northern Ireland.

    The information for healthcare professionals and UK recipients on using the bivalent vaccine safely will be periodically updated as new data become available and this will continue when the CMA is converted to a MA. Please regularly check this information as it is often updated.

    The Public Assessment Report will be published shortly.

    Summary of Product Characteristics (also referred to as the Information for Healthcare Professionals under R174)
    This is a description of a medicinal product’s properties and the conditions attached to its use. It explains how to use and prescribe a medicine. It is used by healthcare professionals, such as doctors, nurses and pharmacists.

    Patient Information Leaflet
    The Patient Information Leaflet provides information for patients on using the medicine safely. This is based on the Summary of Product Characteristics of the product.

    Public Assessment Report
    The Public Assessment Report is a scientific report, written by the MHRA. It explains how this product was assessed and its authorisation recommended, as well as its conditions of use. It is not intended to provide practical advice on how to use this product.

    Published 15 August 2022
    Get emails about this page

  11. More than Ambivalent about bivalent Spikevax Seems more important to MHRA to be the first to approve it – make it ‘conditional’ and backs are covered. Remember they have made it the publics’ responsibility to look out for serious adverse effects.

    Warnings and precautions
    Talk to your doctor, pharmacist or nurse before you are given Spikevax bivalent Original / Omicron if:
    – you have previously had a severe, life-threatening allergic reaction after any other vaccine
    injection or after you were given Spikevax or Spikevax bivalent Original / Omicron in the past.
    – you have a very weak or compromised immune system
    – you have ever fainted following any needle injection.
    – you have a bleeding disorder
    – you have a high fever or severe infection; however, you can have your vaccination if you have a
    mild fever or upper airway infection like a cold
    – you have any serious illness
    – if you have anxiety related to injections
    Myocarditis/pericarditis
    There is an increased risk of myocarditis (inflammation of the heart muscle) and pericarditis
    (inflammation of the lining outside the heart) after vaccination with Spikevax bivalent Original /
    Omicron (see section 4).
    These conditions can develop within just a few days after vaccination and have primarily occurred
    within 14 days. They have been observed more often after the second dose of Spikevax (original), and
    more often in younger males.
    Following vaccination, you should be alert to signs of myocarditis and pericarditis, such as
    breathlessness, palpitations and chest pain, and seek immediate medical attention should these occur.
    If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or
    nurse before you are given Spikevax bivalent Original / Omicron.
    Capillary leak syndrome (CLS) flare-ups
    A few cases of capillary leak syndrome flare-ups (causing fluid leakage from small blood vessels
    (capillaries) resulting in rapid swelling of the arms and legs, sudden weight gain and feeling faint, low
    blood pressure) have been reported following vaccination with Spikevax. If you have previously had
    episodes of CLS, talk to a doctor before you are given Spikevax bivalent Original / Omicron.
    Duration of protection
    As with any vaccine, a booster dose of Spikevax bivalent Orginal / Omicron may not fully protect all
    those who receive it and it is not known how long you will be protected.
    Children
    Spikevax bivalent Original / Omicron is not recommended for children aged under 18 years.
    Other medicines and Spikevax bivalent Original / Omicron
    Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other
    medicines. Spikevax bivalent Orginal / Omicron may affect the way other medicines work, and other
    medicines may affect how Spikevax bivalent Orginal / Omicron works.
    Immunocompromised individuals
    A booster dose of Spikevax bivalent Orginal / Omicron may not provide full immunity to COVID-19
    in people who are immunocompromised, and you should continue to maintain physical precautions to
    help prevent COVID-19. In addition, your close contacts should be vaccinated as appropriate. Discuss
    appropriate individual recommendations with your doctor.
    Pregnancy and breast-feeding
    Spikevax bivalent Original / Omicron can be used during pregnancy. A large amount of information
    from pregnant women vaccinated with Spikevax during the second and third trimester has not shown
    negative effects on the pregnancy or the newborn baby. While information on effects on pregnancy or
    the newborn baby after vaccination during the first trimester is limited, no change to the risk for
    miscarriage has been seen.
    3
    Spikevax bivalent Original / Omicron can be given during breastfeeding. A large amount of
    information from breastfeeding women vaccinated with Spikevax has not shown negative effects in
    breastfed babies.
    If you are pregnant or think you may be pregnant, and have any questions or concerns, tell your
    doctor, nurse or pharmacist before you receive this vaccine.
    Driving and using machines
    Do not drive or use machines if you are feeling unwell after vaccination. Wait until any effects of the
    vaccine have worn off before you drive or use machines.
    Spikevax contains sodium
    Spikevax bivalent Original / Omicron contains less than 1 mmol (23 mg) sodium per dose and, that is
    to say, essentially ‘sodium-free’.
    3. How you will be given Spikevax bivalent Original / Omicron
    Individuals 18 years of age and older
    A booster dose will be given to you as a single 0.5 mL (50 microgram) injection. This should be at
    least 3 months after a second dose or a booster dose of a COVID-19 vaccine.
    Your doctor, pharmacist or nurse will inject the vaccine into a muscle (intramuscular injection) in your
    upper arm.
    During and after each injection of the vaccine, your doctor, pharmacist or nurse will watch over you
    for at least 15 minutes to monitor for signs of an allergic reaction.
    If you have any further questions on the use of this vaccine, ask your doctor, pharmacist or nurse.
    4. Possible side effects
    Like all medicines, this vaccine can cause side effects, although not everybody gets them. Most side
    effects go away within a few days of appearing. If side effects such as pain and/or fever are
    troublesome, they can be treated by medicines for pain and fever such as paracetamol.
    Get urgent medical attention if you get any of the following signs and symptoms of an allergic
    reaction:
    – feeling faint or light-headed;
    – changes in your heartbeat;
    – shortness of breath;
    – wheezing;
    – swelling of your lips, face, tongue or throat;
    – hives or rash;
    – nausea or vomiting;
    – stomach pain.
    Talk to your doctor or nurse if you develop any other side effects. These can include:
    Very common (may affect more than 1 in 10 people):
    – swelling/tenderness of the underarm glands
    – headache
    – nausea
    – vomiting
    – muscle ache, joint aches, and stiffness
    4
    – pain or swelling at the injection site
    – redness at the injection site (some of which may occur approximately 9 to 11 days after the
    injection)
    – feeling very tired
    – chills
    – fever
    Common (may affect up to 1 in 10 people):
    – diarrhoea
    – rash
    – rash or hives at the injection site (some of which may occur approximately 9 to 11 days after the
    injection)
    Uncommon (may affect up to 1 in 100 people):
    – itchiness at the injection site
    – dizziness
    – stomach pain
    Rare (may affect up to 1 in 1,000 people)
    – temporary one-sided facial drooping (Bell’s palsy)
    – swelling of the face (Swelling of the face may occur in patients who have had facial cosmetic
    injections.)
    – decreased sense of touch or sensation
    – unusual feeling in the skin, such as tingling or a crawling feeling (paraesthesia)
    Very rare (may affect up to 1 in 10,000 people)
    – inflammation of the heart muscle (myocarditis) or inflammation of the lining outside the heart
    (pericarditis) which can result in breathlessness, palpitations or chest pain
    Frequency unknown
    – severe allergic reactions with breathing difficulties (anaphylaxis)
    – reaction of increased sensitivity or intolerance by the immune system (hypersensitivity)
    – a skin reaction that causes red spots or patches on the skin that may look like a target or
    “bulls-eye” with a dark red centre surrounded by paler red rings (erythema multiforme)

  12. PS
    More than Ambivalent about bivalent Spikevax Seems more important to MHRA to be the first to approve it – so made it ‘conditional’ and backs are covered. Remember they have made it the publics’ responsibility to look out for serious adverse effects.

    check under Warnings and precautions

  13. “We’re going to start rolling …..

    https://www.telegraph.co.uk/news/2022/08/16/timing-covid-booster-important-type-insists-deputy-jcvi-chair/

    ‘Timeliness much more important than vaccine type’

    Speaking to the BBC, Professor Harnden said: “The timeliness is much more important than the type of vaccination we believe, though we do welcome this bivalent vaccine approved by the MHRA.

    “At the moment, we’re saying get vaccinated and don’t worry too much about the type of vaccine.

    “There may well be other vaccines in the pipeline – Pfizer I believe are developing a bivalent vaccine which we’ll look at very carefully on JCVI if its approved.

    “And of course, the Government may order, or may have ordered, some more bivalent Moderna vaccines so that there’s going to be a suite of vaccines which are available to use.”

    Alan Bishop7 MIN AGO

    Yet another ‘getcha covid jab’, so that big pharma can continue making lotsa lolly from the gullible punters.
    Yet another jab that will neither stop you catching the pox or passing it on. (The very opposite to the true definition of a vaccine).
    I’m 75, am Type 2 diabetic and also have a damaged kidney- but I have never had any covid jab and no intention of having one.

    “For simplicities sake ….. “

    Today – Radio 4

    https://www.bbc.co.uk/sounds/play/m001b40p

    1.31.40

    “What about AstraZeneca”………………. ‘the beauty’ …

  14. Maybe a dose of Spikevax would help poor Albert

    @AlbertBourla
    ·
    15 Aug
    I would like to let you know that I have tested positive for #COVID19. I am thankful to have received four doses of the Pfizer-BioNTech vaccine, and I am feeling well while experiencing very mild symptoms. I am isolating and have started a course of Paxlovid.
    Albert Bourla
    @AlbertBourla
    We have come so far in our efforts to battle this disease that I am confident I will have a speedy recovery. I am incredibly grateful for the tireless efforts of my Pfizer colleagues who worked to make vaccines and treatments available for me and people around the world.
    12:52 pm · 15 Aug 2022·Twitter Web App

    @AlbertBourla
    ·
    15 Aug
    Replying to
    @AlbertBourla
    Paxlovid is not approved, but is authorized for emergency use by the FDA to treat mild-to-moderate COVID-19 in high-risk patients 12+, weighing at least 40 kg, with positive results of SARS-CoV-2 viral testing. See safety info: http://COVID19oralRx.com.

  15. The chickens are coming home to roost for Pfizer

    16th August 2022 by Nadya Swart

    https://www.biznews.com/health/2022/08/16/chickens-home-roost-pfizer

    Having succeeded in foisting Covid-19 mRNA injections on an initially unsuspecting public, it appears that the chickens have come home to roost for Pfizer. Pfizer’s criminal withholding of vaccine data is particularly reprehensible when it comes to those children who received a Covid-19 vaccine on the basis that it was not only completely safe, but necessary. A study in Thailand conducted during the country’s national Covid-19 vaccination campaign for adolescents showed what one physician described as a “stunning” association between myocarditis and the Pfizer-BioNTech vaccine. Studies of this nature are emerging across the globe, with the most damning evidence of the vaccine’s dangers so far being the report that came from the pharmaceutical behemoth itself. This article was first published on the Daily Friend. – Nadya Swart

    Pfizer gives damning evidence against Pfizer vaccines

    By Andrew Kenny*

    The most damning report I have ever seen on the dangers of Covid-19 vaccines comes from Pfizer Incorporated.

    In it, Pfizer lists the adverse events shortly following its own vaccination, including death, heart damage, disorders of the gastric system and nervous systems, and of the skin and eyes.

    What makes the report more damning is the fact that Pfizer and the US Food and Drug Administration (FDA) tried to suppress it until a US court of law forced them to make it public.

    Maryanne Demasi, PhD
    @MaryanneDemasi
    ·
    Aug 16

    The FDA’s evidentiary standards for drug approvals has significantly declined. Faster approvals based on fewer, smaller & less rigorous trials has led to distrust, not only of the agency, but in the safety & effectiveness of medicines in general

    https://maryannedemasi.substack.com/p/the-declining-standards-of-fda-drug

    The declining standards of FDA drug approvals

    Maryanne Demasi, PhD

    https://maryannedemasi.substack.com/p/the-declining-standards-of-fda-drug

    The US Food and Drug Administration (FDA) has a legal obligation to protect the public and ensure that the benefits of medicines outweigh the harms before being marketed to people.

    But the agency’s increasing reliance on pharmaceutical industry money has seen the FDA’s evidentiary standards for drug approvals significantly decline.

    Independent experts now say the declining evidentiary standards, shortening approval times, and increasing industry involvement in FDA decision-making, has led to distrust, not only of the agency, but in the safety and effectiveness of medicines, in general.

    Pfailing and Pflailing…

  16. Re: Covid-19: Study provides further evidence that mRNA vaccines are safe in pregnancy Jacqui Wise. 378:doi 10.1136/bmj.o2013
    Dear Editor

    Further to my recent response, it would appear the UK Government are now saying singing a different tune.
    Under the heading “Toxicity conclusions.”
    “In the context of supply under Regulation 174, it is considered that sufficient reassurance of safe use of the vaccine in pregnant women cannot be provided at the present time: however, use in women of childbearing potential could be supported provided healthcare professionals are advised to rule out known or suspected pregnancy prior to vaccination. Women who are breastfeeding should also not be vaccinated.”

    https://www.gov.uk/government/publications/regulatory-approval-of-pfizer

    Douglas R Hendrie

  17. Hi

    About the coding tricks for Jaundice and the RSV vax, I suppose that the goal is to split all the events between 3 different SOCs.

    About the statistical significance, if you use a Poisson distribution all of these RR are significant 🙂

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