Report Covid Vaccine Effects to RxISK

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January 11, 2021 | 28 Comments

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  1. Can people who have had the vaccines please also share their experiences with us on the blog The potential for serious adverse effects are already being obscured on the media but it would help if all experiences could be shared It might inform decision making for people further down the vaccination rollout

  2. Just a question – are people going to be given a patient info leaflet for a vaccine ? It’s not the same as picking up a prescription for other drugs which have a leaflet in the box/container.

    • Before HPV vaccines people were given a brief leaflet detailing possible issues and telling 12year old girls they could get in touch with the regulator if they had anything wrong with them – see Shifting Vaccine Confidence on DH.org

      D

  3. GOV.UK
    Search on GOV.UK
    Coronavirus (COVID-19)

    HomeHealth and social careMedicines, medical devicesPharmacyRegulatory approval of COVID-19 Vaccine AstraZeneca
    Medicines & Healthcare products
    Regulatory Agency
    Decision
    Information for UK recipients on COVID 19 Vaccine AstraZeneca
    Updated 7 January 2021

    Contents
    Package leaflet: Information for the recipient
    1. What COVID-19 Vaccine AstraZeneca is and what it is used for
    2. What you need to know before you receive COVID-19 Vaccine AstraZeneca
    3. How COVID-19 Vaccine AstraZeneca is given
    Possible side effects
    5. How to store COVID-19 Vaccine AstraZeneca
    6. Contents of the pack and other information
    Regulation 174 Information for UK recipients

    And
    GOV.UK
    Search on GOV.UK
    Search
    Coronavirus (COVID-19)

    HomeHealth and social careMedicines, medical devicesPharmacyRegulatory approval of Pfizer/BioNTech vaccine for COVID-19
    Medicines & Healthcare products
    Regulatory Agency
    Decision
    Information for UK recipients on Pfizer/BioNTech COVID-19 vaccine
    Updated 31 December 2020

    Contents
    COVID-19 mRNA Vaccine BNT162b2 concentrate for solution for injection
    Package leaflet: Information for the recipient
    1. What COVID-19 mRNA Vaccine BNT162b2 is and what it is used for
    2. What you need to know before you receive COVID-19 mRNA Vaccine BNT162b2
    3. How COVID-19 mRNA Vaccine BNT162b2 is given
    4. Possible side effects
    5. How to store COVID-19 mRNA Vaccine BNT162b2
    6. Contents of the pack and other information
    Regulation 174 Information for UK recipients

  4. Susanne – in answer to your question above about a patient leaflet when given the Covid vaccine. We don’t get one for the flu jab and neither did I get one for the ‘one off’ pneumonia jab so I don’t for one moment expect to have such a thing this time round either. I was monitored for 15 minutes following the pneumonia one but had no reactions whatsoever. Are they monitoring now for the Oxford/ AstraZeneca one ? i know they did for the Pfizer one in the beginning but I don’t know if that’s still true now either.
    Since we in the UK will probably be last to hear about any reactions happening here under our noses, it would be great to have comments on any news that other countries have on what’s happening here in the UK please. Could do with it being pretty quick now as we ‘over 70s’ are due to be queuing up by the middle of next month – or so they say!

  5. Mary – Rhetorical question – what about informed consent !
    I cant find anything specific to Wales but on the Scottish web site they give more detail about potential side effects on above leaflet , Sssh don’t tell them….It’s like wading through treacle trying to find reliable info . Good luck with getting yours when promised . Dr Dai Hickman from a surgery in Llanelli is kicking up about the ‘highly unethical ‘ way the unequal distribution of vaccines is going on.

    Possible side effects
    Like all medicines, this vaccine can cause side effects, although not everybody gets them. In clinical studies with the vaccine, most side effects were mild to moderate in nature and resolved within a few days with some still present a week after vaccination.

    If side effects such as pain and/or fever are troublesome, medicines containing paracetamol can be taken.

    Side effects that occurred during clinical trials with COVID 19 Vaccine AstraZeneca were as follows:

    Very Common (may affect more than 1 in 10 people)
    tenderness, pain, warmth, redness, itching, swelling or bruising where the injection is given
    generally feeling unwell
    feeling tired (fatigue)
    chills or feeling feverish
    headache
    feeling sick (nausea)
    joint pain or muscle ache
    Common (may affect up to 1 in 10 people)
    a lump at the injection site
    fever
    being sick (vomiting)
    flu-like symptoms, such as high temperature, sore throat, runny nose, cough and chills
    Uncommon (may affect up to 1 in 100 people)
    feeling dizzy
    decreased appetite
    abdominal pain
    enlarged lymph nodes
    excessive sweating, itchy skin or rash
    In clinical trials there were very rare reports of events associated with inflammation of the nervous system, which may cause numbness, pins and needles, and/or loss of feeling. However, it is not confirmed whether these events were due to the vaccine.

    If you notice any side effects not mentioned in this leaflet, please inform your doctor, pharmacist or nurse.

    Reporting of side effects
    If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

    If you are concerned about a side-effect it can be reported directly via the Coronavirus Yellow Card reporting site or search for MHRA Yellow Card in the Google Play or Apple App Store and include the vaccine brand and batch/Lot number if available.

    By reporting side effects you can help provide more information on the safety of this vaccine. (To the MHRA – really!)

    4. Possible side effects
    Like all vaccines, COVID-19 mRNA Vaccine BNT162b2 can cause side effects, although not everybody gets them.

    Most side effects are mild or moderate and 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.

    Side effects may occur with following frequencies:
    Very common: may affect more than 1 in 10 people

    pain at injection site
    tiredness
    headache
    muscle pain
    chills
    joint pain
    fever
    Common: may affect up to 1 in 10 people

    injection site swelling
    redness at injection site
    nausea
    Uncommon: may affect up to 1 in 100 people

    enlarged lymph nodes
    feeling unwell
    Rare side effects: may affect up to 1 in 1,000 people

    temporary one sided facial drooping
    Not known (cannot be estimated from the available data)

    severe allergic reaction
    Reporting of side effects
    If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. If you are concerned about an adverse event, it should be reported on a Yellow card. Reporting forms and information can be found at the Coronavirus Yellow Card reporting site or search for MHRA Yellow Card in the Google Play and include the vaccine brand and batch/Lot number if available.

    Alternatively, adverse events of concern in association with Pfizer BioNTech COVID-19 mRNA vaccine BNT 162b2 can be reported to Pfizer Medical Information on 01304 616161 or via Pfizer Safety Reporting.

    Please do not report the same adverse event(s) to both systems as all reports will be shared between Pfizer and MHRA (in an anonymized form) and dual reporting will create unnecessary duplicates. (I would definitely report to both systems)

  6. Hello Suzanne, I felt so queasy when I read the part:

    Side effects may occur with following frequencies:
    Very common: may affect more than 1 in 10 people

    pain at injection site
    tiredness
    headache
    muscle pain
    chills
    joint pain
    fever
    Common: may affect up to 1 in 10 people

    injection site swelling
    redness at injection site
    nausea
    Uncommon: may affect up to 1 in 100 people

    enlarged lymph nodes
    feeling unwell
    Rare side effects: may affect up to 1 in 1,000 people

    temporary one sided facial drooping
    Not known (cannot be estimated from the available data)

    What about the unknown side effects and adverse reactions of those poor people who are medically compromised and ingest medicines? Is this vaccine compatible with other medicines? To me it seems like a game of Russian Roulette. Too many unforeseen risks and complications have not been taken into consideration.

  7. Breach of contract.
    The government and their networks underestimated the anger of older people and their power to act when powerful advocates are using their position and voices.. Lady Boothroyd from House of lords has described them as having pulled a ‘daddy of all U turns’ regarding the change of dosage ‘they as being corralled into accepting a change’ they haven’t signed up for . Joan Bakewell also from H of L and ex spokesperson for older people is taking legal action for what amounts to breach of contract . These women have the clout and crucially the money to fund an action. J B was careful to describe the 4 medical directors as honourable men , (what people say off the record is stronger than that )- but she did question their lack of independance from government policy.
    The Guardian .
    Matthew Weaver coverage
    Joan Bakewell has instructed solicitors at Leigh Day to start proceedings in response to the dosing strategy.
    Tue 12 Jan 2021 18.48 GMT
    The journalist and Labour peer Joan Bakewell is threatening the government with legal action over its policy to delay the second dose of Pfizer/BioNTech’s Covid vaccine.

    Lady Bakewell, 87, said there were grounds to show the decision taken by ministers to widen the gap between doses – from the three weeks recommended by the manufacturer to up to 12 weeks – was unlawful.

    She has instructed the law firm Leigh Day to start proceedings in response to the new dosing strategy, and names the respondent as the health secretary, Matt Hancock.

    In a letter, the firm said Bakewell was “concerned that the government’s instruction to delay the provision of the second dose of the Pfizer vaccine is potentially unlawful and unsafe and would therefore impede rather than advance the pandemic response

    The letter sets out three potential grounds for judicial review, including flouting the conditions of authorisation and breaching legitimate expectations.

    Initially those having the vaccine were told their second dose to secure the best immunity to the virus would be given 21 days after the first.

    However, late last month the joint committee on vaccinations and immunisation (JCVI) decided to stretch the timeline for the second dose of both the Pfizer vaccine and the rival Oxford/AstraZeneca jab to up 84 days or 12 weeks.

    While there is some evidence from clinical trials of the Oxford vaccine that a late second dose, of up to 12 weeks, does not interfere with efficacy, Pfizer released a statement saying there was no evidence from its trials to support a delay beyond 21 days.

    Bakewell, who received her first dose of the Pfizer vaccine in December, said: “Older people are in limbo: they need to know whether delaying the Pfizer vaccine is both safe and legal. I am bringing this case because I believe the government needs to make this clear.”

    The move comes amid growing frustration from those who have been given a first dose, but not yet a second.

    On Tuesday, the government said 2,474,205 people had received a first dose of either the Pfizer or Oxford vaccine, but only 393,925 had received the corresponding second jab.

    The World Health Organization has said there is little empirical data to back the UK’s decision to delay the second Pfizer dose.

    The same concern was echoed by scientists, writing in the British Medical Journal, who said the new policy was “not based on data from the trial, but on an assumption of what would have happened if the second dose hadn’t been given at 21 days”.

    However, England’s chief medical officer, Prof Chris Whitty, has said delaying the second dose is safe and the best way of spreading protection to as many people as possible.

    Addressing BBC viewers’ concerns about delays to the second jab, he said: “The thing which is limiting us at the moment is the amount of vaccine in the country. So for every person who gets a second dose, someone else is not even getting their first dose.

    “It can be delayed by a few weeks, and we do not think there will be a significant reduction in the amount of protection over that period of time.”

  8. It would be simple and sensible to give everyone receiving the various covid19 vaccines a piece of paper with a website on it so they can report any negative vaccine symptoms should they crop up.

    I’ve been having a look into the wearables stuff where you send data to a cloud and AI looks at the data in the cloud.  

    https://www.frontiersin.org/articles/10.3389/fdgth.2020.00008/full

    https://etactics.com/blog/wearable-technology-in-healthcare

    I have seen reports of a biosensor that has been developed based on a jellyfish protein which emits light when a virus binds to it.  Once you have a clever biosensor like that you could really keep track of a virus spreading with a much greater precision.

  9. Thank you Susanne. Have also read your comment on David’s blog regarding claims if damaged by the vaccine. Am now getting to the point of view that maybe the less I know beforehand the better! I don’t really want to think about possible side effects but on the other hand I do wish that someone, somewhere could have seen the raw data and tell us the whole truth about the stuff. Maybe there’s nothing hidden but our trust has been rocked due to other coverups by the MHRA hasn’t it. We know of so many lives that would have been so different if only the data was available and truthfully recorded.
    I totally accept that there is a risk with any medication or injection. I also accept that there is no way of knowing who might have an allergic reaction. However, I cannot accept a haphazard attitude where people are passed through within minutes or even seconds without, it seems to me, anything in place incase of an emergency. That is where I fear the UK is at now. In their rush to meet deadlines, corners may be cut.
    When Shane was about 15 the whole of the UK of his age group was vaccinated against measles. I cannot remember why exactly. Shane had had his earlier jabs without any problems. This one at 15 was run along similar lines to the present Covid one. They were kept for 10 minutes or so to make sure there were no reactions. Shane had an anaphylactic shock and was rushed to hospital. Luckily, an ambulance was on site at the school otherwise the outcome would have been very different. He was the only one to have such a reaction at his school and maybe the only case in the UK but, when it happens without warning that close to home, it is a shock. That shock comes back to mind at the thought of having this jab! He cannot have the Pfizer one because of this. I don’t know what he’ll do about any other. Many months before he is invited for it anyway.
    Another UK response gem. Elderly gent in his 90s given phonecall instructions to attend for vaccination 40 miles away from home. When he explained that he didn’t drive so how would he be able to attend, he was given the reply to travel by train!

  10. I am very worried about this Covid -19 vaccine.
    If it is just sugar and water, we are lucky!
    If it is filled with other nasties that impact many peoples well-being, we should be asking ourselves this question:
    If there is an element of risk for anyone having a jab, should we just take the experts advice as gospel?
    Anything that has an element of risk, already does not cut the mustard for me!

  11. This is another vaccination which was trialled for 2 doses , Moderna ,for 28days I don’t know if there are plans to tinker with dosing as with Pfizer ie extend the dosing period to 12 weeks when no trials for this extention have been carried out .

    As with any new medicine in the UK, this product will be closely monitored to
    allow identification of new safety information. Healthcare professionals are asked to
    1. NAME OF THE MEDICINAL PRODUCT
    COVID-19 Vaccine Moderna dispersion for injection

    For the full list of excipients, see section 6.1.
    Individuals 18 years of age and older
    COVID-19 Vaccine Moderna is a two-dose regimen. Each dose is 0.5 mL. It is recommended to
    administer the second dose 28 days after the first dose (see section 5.1).
    3
    There are no data available on the interchangeability of COVID-19 Vaccine Moderna with
    other COVID-19 vaccines to complete the vaccination series. Individuals who have received one dose
    of COVID-19 Vaccine Moderna should receive a second dose of COVID-19 Vaccine Moderna to
    complete the vaccination series.
    Paediatric population
    The safety and efficacy of COVID-19 Vaccine Moderna in children and adolescents less than 18 years
    of age have not yet been established. No data are available.
    Method of administration

    The vaccine should not be mixed in the same syringe with any other vaccines or medicinal products.

    4.3 Contraindications
    Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
    4.4 Special warnings and precautions for use
    Anaphylactic reactions
    Events of anaphylaxis have been reported. Appropriate medical treatment and supervision to manage
    immediate allergic reactions must always be readily available in case of an acute anaphylactic reaction
    following administration of the COVID-19 Vaccine Moderna.
    Close observation for at least 15 minutes is recommended following vaccination.
    A second dose of COVID-19 Vaccine Moderna should not be given to those who have experienced
    severe allergic reactions (e.g. anaphylaxis, generalised urticaria) to the first dose of COVID-19
    Vaccine Moderna (see section 4.3).
    Traceability
    In order to improve the traceability of biological medicinal products, the name and the batch number
    of the administered product should be clearly recorded.
    Anxiety-related reactions
    Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stress‐related
    reactions may occur in association with vaccination as a psychogenic response to the needle injection.
    It is important that precautions are in place to avoid injury from fainting.
    Immunocompromised individuals
    Efficacy, safety and immunogenicity have not been assessed in immunocompromised individuals,
    including those receiving immunosuppressant therapy. The efficacy of COVID-19 Vaccine Moderna
    may be less in these individuals.
    Coagulation disorders
    As with other intramuscular injections, COVID-19 Vaccine Moderna should be given with caution in
    individuals with bleeding disorders, such as haemophilia, or individuals currently on anticoagulant
    therapy, to avoid the risk of haematoma following the injection.
    4
    Acute illness
    Immunization should be postponed in individuals with severe febrile illness or severe acute infection.
    Individuals with moderate or severe acute illness should be vaccinated as soon as the acute illness has
    improved.
    Limitations of vaccine effectiveness
    Vaccination with COVID-19 Vaccine Moderna may not protect all vaccine recipients. Individuals may
    not be fully protected until 14 days after their second dose. The duration of protection afforded by the
    vaccine is unknown at present. Reference should be made to section 5.1.
    Excipients with known effect
    Sodium
    This vaccine contains less than 1 mmol sodium (23 mg) per 0.5 mL dose and is essentially ‘sodiumfree’.
    4.5 Interaction with other medicinal products and other forms of interaction
    No interaction studies have been performed.
    There are no data to assess the concomitant administration of COVID-19 Vaccine Moderna with other
    vaccines (see section 5.1).
    4.6 Fertility, pregnancy and lactation
    Pregnancy
    There is limited experience with use of COVID-19 Vaccine Moderna in pregnant women. Animal
    studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo/foetal
    development, parturition or post-natal development (see section 5.3). Administration of COVID-19
    Vaccine Moderna in pregnancy should only be considered when the potential benefits outweigh any
    potential risks for the mother and foetus.
    Breast-feeding
    It is unknown whether COVID-19 Vaccine Moderna is excreted in human milk.
    Fertility
    Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity
    (see section 5.3).
    4.7 Effects on ability to drive and use machines
    No studies on the effects of the COVID-19 Vaccine Moderna on the ability to drive and use machines
    have been performed.
    Some of the effects mentioned under section 4.8 “Undesirable Effects” may affect the ability to drive
    or use machines.
    4.8 Undesirable effects
    Summary of the safety profile
    The safety of COVID-19 Vaccine Moderna was evaluated in an ongoing Phase 3 randomized,
    placebo-controlled, observer-blind clinical trial conducted in the United States involving 30,351
    participants 18 years of age and older who received at least one dose of COVID-19 Vaccine Moderna
    (n=15,185) or placebo (n=15,166) (NCT04470427). At the time of vaccination, the mean age of the
    population was 52 years (range 18-95); 22,831 (75.2%) of participants were 18 to 64 years of age and
    7,520 (24.8%) of participants were 65 years of age and older.
    5
    The most frequently reported adverse reactions were injection site pain (92%), fatigue (70%),
    headache (65%), myalgia (62%), arthralgia (46%) chills (46%), nausea/vomiting (23%), axillary
    swelling/tenderness (19.8%), fever (15.5%), injection site swelling (14.7%) and redness
    (10%). Adverse reactions were usually mild or moderate in intensity and resolved within a few days
    after vaccination. A slightly lower frequency of reactogenicity events was associated with greater age.
    Overall, there was a higher incidence of some adverse reactions in younger age groups: the incidence
    of axillary swelling/tenderness, fatigue, headache, myalgia, arthralgia, chills, nausea/vomiting
    and fever was higher in adults aged 18 to < 65 years than in those aged 65 years and above. Local and
    systemic adverse reactions were more frequently reported after the second dose than after the first
    dose. If required, symptomatic treatment with analgesic and/or anti-pyretic medicinal products (e.g.
    paracetamol-containing products) may be used.
    Tabulated list of adverse reactions
    The safety profile presented below is based on data generated in a placebo- controlled clinical
    study of 30,351 adults ≥ 18 years of age.
    Adverse reactions reported are listed according to the following frequency:
    Very common (≥1/10)
    Common (≥1/100 to <1/10)
    Uncommon (≥1/1,000 to <1/100)
    Rare (≥1/10,000 to <1/1,000)
    Very rare (<1/10,000)
    Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
    Table 1 Table of adverse drug reactions (ADRs)
    System Organ Class Frequency Adverse reactions
    Blood and lymphatic system
    disorders
    Very common Lymphadenopathy*
    Immune system disorders Not known (cannot be estimated
    from the available data)
    Anaphylaxis**
    Not known (cannot be estimated
    from the available data)
    Hypersensitivity
    Nervous system disorders Very common Headache
    Rare Facial paralysis***
    Gastrointestinal disorders Very common Nausea
    Vomiting
    Subcutaneous and skin disorders Common Rash
    Musculoskeletal and connective
    tissue disorders
    Very common Myalgia
    Arthralgia
    General disorders
    and administration site conditions
    Very common Injection site pain
    Fatigue
    Chills
    Pyrexia
    Injection site swelling
    Common Injection site erythema
    Injection site urticaria
    Injection site rash
    6
    Uncommon Injection site pruritus
    Rare Swelling face****
    *Lymphadenopathy was captured as axillary swelling/tenderness on the same side as the injection site.
    **Anaphylaxis has been reported in post-marketing setting
    ***Throughout the safety follow-up period, acute peripheral facial paralysis (or palsy) was reported by three participants in
    the COVID-19 mRNA Vaccine group and one participant in the placebo group. Onset in the vaccine group
    participants was 22 days, 28 days, and 32 days after Dose 2.
    **** There were two serious adverse events of facial swelling in vaccine recipients with a history of injection of
    dermatological fillers.

  12. IN THE MIDST OF THE SARS-CoV-2 PANDEMIA, CAUTION IS NEEDED WITH
    COMMONLY USED DRUGS THAT INCREASE THE RISK OF PNEUMONIA.
    Joan-Ramon Laporte, M.D.
    Emeritus Professor of Clinical Pharmacology, Department of Pharmacology, Therapeutics and Toxicology

    jrl@icf.uab.cat
    David Healy MD FRCPsych
    Professor Dept of Family Medicine
    McMaster University
    Hamilton, Canada
    Healyd1@mcmaster.ca
    In the present situation of pandemia by SARS-CoV-2, it is imperative to avoid
    pneumonitis and related risk factors as much as possible. The consumption of various
    commonly used medicines increases the risk of and complications from pneumonia.
    Medicines can increase the risk of pneumonia or pneumonitis by depressing immunity and other
    protective mechanisms (e.g., immunosuppressive agents, antipsychotic agents, some opioid
    analgesics, proton pump inhibitors), by causing sedation, which may increase the risk of
    aspiration, by depressing pulmonary ventilation and favouring the occurrence of atelectasis
    (e.g., opioid analgesics, anticholinergic drugs, psychotropic agents), or by a combination of
    these mechanisms.

    Drugs which increase the risk of pneumonia

    In view of the harms induced by the use of antipsychotic agents (APs) for the symptomatic
    treatment of aggression and psychotic symptoms in elderly patients in residential facilities,
    2008 the European national regulatory agencies recommended limiting their use to patients not
    responding to other interventions, and to reconsider their prescription at every follow up visit,
    with close patient follow up.
    In spite of these warnings, APs are widely prescribed off-label to
    the elderly10 at inappropriate doses and for too long periods.
    In these situations, the
    harms caused are considerable.

    It is important also to remember that metoclopramide, prochlorperazine and a number of other
    drugs given for nausea or other gut disturbances are essentially the same drugs as the APs, and
    can cause tardive and respiratory dyskinesias as well as the other problems linked to these
    medicines.
    Anticholinergic drugs
    The consumption of anticholinergic drugs increases the risk of pneumonia by 1.6 to 2.5-
    fold.

    (e.g., chlorphenamine, diphenhydramine, hydroxyzine), antidepressants (e.g., amitryptiline,
    clomipramine, doxepin, imipramine, paroxetine), urinary antispasmodics (e.g., flavoxate,
    oxibutinin, tolteridone), gastrointestinal antispasmodics (e.g., dicyclomine), medicines for
    vertigo (e.g., meclizine, promethazine), antipsychotics (particularly chlorpromazine, clozapine,
    olanzapine, and quetiapine), antiparkinsonian drugs (e.g., amantadine, biperiden,
    trihexyphenidil), opioid analgesics, antiepileptic drugs (carbamazepine, oxcarbazepine), and
    others.
    Anticholinergic drugs are commonly prescribed to the elderly. with codeine plus paracetamol, antidepressants (amitryptiline, dosulepin, paroxetine)
    and urologicals (predominantly oxibutinin ad tolterodine) generally being those with higher
    prevalence of use.
    Many of these medicines have other mechanisms that can increase sedation and increase the
    risk of pneumonia in this way. Their anticholinergic effects can add to confusion in someone
    who may have respiratory compromise and contribute to aspiration in this way. The
    anticholinergic effect can also contribute to atelectasias in the context of a viral respiratory
    infection.

    Opioid analgesics
    Opioid analgesics cause respiratory depression with the resulting pulmonary hypoventilation;
    some of them (codeine, morphine, fentanyl and methadone) have also immunosuppressive
    effects. They increase the risk of pneumonia and respiratory mortality by 40% to 75%.
    Fentanyl and
    morphine are the most commonly used strong opioids, and more recently oxycodone.
    Tramadol, which is also a serotonin reuptake inhibitor, is the most commonly used mild opioid.

    Hypnotics and sedatives
    Several studies have shown an increase of 20%34 to 54%35 in the risk of pneumonia in people
    consuming hypnotics and sedatives, in particular when they are taken concomitantly with other
    CNS depressants (e.g., opioids, gabapentinoids).

    Antidepressants
    In a cohort study in more than 130,000 patients , a 15% increase of the risk of respiratoryrelated morbidity and a 26% increase in mortality was seen among older adults with chronic
    obstructive pulmonary disease (COPD) exposed to SSRI antidepressants. In other studies, an
    increase in the risk has been seen in patients exposed to antidepressants concomitantly with
    other CNS depressants.
    In part, these findings may stem from extrapyramidal nasopharyngeal disorders these drugs
    can cause, which lead in 5-10% of patients in clinical trials of a selective serotonin reuptake
    inhibitor (SSRI) to be diagnosed with nasopharyngitis when in fact these are dystonic effects. In
    the presence of a coronavirus risk, a misdiagnosis may be problematic.
    In the OECD countries,

    Gabapentin and pregabalin
    In December 2019, the FDA warned about an increased risk of pneumonia and severe
    respiratory insufficiency and death associated with gabapentinoids, particularly when they are
    consumed concomitantly with opioid analgesics, hypnotics and sedatives, antidepressants and
    antihistamines. In 2017 the EMA amended the SPC for gabapentin to include warnings for
    severe respiratory depression, which may affect up to 1 in 1,000 patients.41,42
    The summary of product characteristics (SPC) of gabapentin states that the incidence of viral
    infections in RCTs was “very common” (more than 1 out of 10 treated persons), and that the
    incidence of pneumonia and of respiratory infection was “common” (between one in 10 and 1 in
    100). The SPC of pregabalin warns that in treated patients the incidence of nasopharyngitis is
    “common” (between 1 in 10 and 1 in 100).43
    Gabapentin and pregabalin have limited efficacy in the treatment of neuropathic pain, and they
    are ineffective for their main (off-label) uses in practice, i.e. low back pain with possible
    radiculopathy.

    Proton pump inhibitors (PPIs, omeprazol and analogues)
    The reduction of gastric acidity and the increase in gastric and gut bacterial colonization
    induced by these drugs can also increase the risk of pneumonia.
    A number of studies have shown a skyrocketing increase in the use of PPIs in the last years.
    It is thus essential to identify patients who do not need these drugs but there is also a
    need to be aware of a rebound of gastric and anxiety symptoms that can occur on withdrawal.

    Cancer chemotherapeutic and immunosuppressive agents
    Patients on these drugs are more susceptible to viral and non viral infections, and they should
    generally not abandon the treatment. However, between 20% and 50% of patients with
    incurable cancer receive chemotherapy within 30 days of death. In terminally ill cancer patients,
    the use of palliative chemotherapy a few months before death leads to increased risk of
    undergoing mechanical ventilation and cardiopulmonary resuscitation and dying in an intensive
    care unit. In the midst of a COVID-19 pandemia, patients, caregivers and oncologists should
    have a heightened awareness about the potential risks to them and to others of planning and
    continuing palliative chemotherapy.
    Many patients also receive immunosuppressive agents for inflammatory chronic conditions such
    as psoriasis, inflammatory bowel disease, or rheumatic arthritis of mild and moderate severity,
    even though these drugs are only indicated for patients with severe disease not responding to
    first line treatments. Many of these patients may benefit from stepping down or pausing their
    treatments for a while and monitoring their clinical state.

    Corticosteroids, both systemic, inhaled and occasionally topical or given by eye-drops, have
    immunosuppressive effects and increase the risk of pneumonia in patients with asthma and in
    patients with COPD.64,65 Patients with severe asthma should not abandon corticosteroids, but
    many patients receive inhaled corticosteroids (ICs) for upper respiratory infections.
    . Similarly, a
    proportion of COPD patients do not obtain any benefit from ICs and they can avoid them. In
    one study, withdrawal of ICs was followed by a 37% decrease in the incidence of pneumonia.67

    Ibuprofen or paracetamol for fever?
    Given the effects of non-steroidal anti-inflammatory drugs (NSAIDs), it is biologically plausible
    that respiratory, septic and cardiovascular complications of pneumonia are more frequent and
    severe if fever is treated with an NSAID instead of paracetamol.

    In the absence of specific data regarding COVID-19, paracetamol seems less likely to cause
    complications.
    Concomitant use of various drugs
    In modern health care settings, concomitant consumption of several of the drugs mentioned in
    this report is prevalent, increasing the risk of pneumonia.The concomitant use of multiple
    drugs, particularly in older populations, has also more generally been linked to increased rates
    of hospitalisation and an earlier death.

    Opioids, all antipsychotics, and antidepressants have effects on the heart,
    Azithromycin and hydroxychloroquine also prolong Q-T intervals
    and the addition of these drugs to prior treatment may accordingly cause problems.
    Conclusions
    Several widely used medicines, such as antipsychotics and antidepressants, opioid analgesics,
    anticholinergic drugs, gabapentinoids, proton pump inhibitors, and inhaled corticosteroids can
    increase the risk of pneumonia by 1.2 to 2.7 times.
    Elderly patients are particularly likely to receive one or more of these drugs. These treatments
    are often ineffective, and given for unnecessarily long periods, at wrong doses, or for non
    approved indications.
    With such a high consumption and a high baseline incidence of viral infection and
    pneumonia, they can have a significant negative public health impact, and the number of
    victims can be of the order of hundreds per million inhabitants.
    In the present situation of pandemia, unnecessary and harmful treatments should be reviewed
    and eventually stopped.
    • It is urgent to review and in appropriate cases to pause psychotropic drugs (particularly
    antipsychotics), anticholinergic medicines and opioid analgesics and monitor the effects.
    • It is especially important to review the medication burden of residents in nursing homes.
    • During the present COVID-19 pandemia, all medications should be critically reviewed and
    where possible deprescribed, in order to decrease not only the risk of pneumonia and its
    complications, but also other adverse effects which frequently lead to hospital admission
    (e.g., fractures).

  13. fiona godlee Retweeted
    Jim Reed
    @jim_reed
    Jan 2
    Editor of the BMJ
    @fgodlee
    has written to the New York Times asking for an urgent correction of its article today on ‘vaccine mixing’ in UK saying is seriously misleading. Here’s original article

    Britain Opens Door to Mix-and-Match Vaccinations, Worrying Experts
    If a second dose of one vaccine isn’t available, another may be substituted, according to the guidelines.
    Britain has been moving away from the dosing regimens tested in late-stage clinical trials of the vaccines the country is deploying.

    By Katherine J. Wu
    Jan. 1, 2021
    Amid a sputtering vaccine rollout and fears of a new and potentially more transmissible variant of the coronavirus, Britain has quietly updated its vaccination playbook to allow for a mix-and-match vaccine regimen. If a second dose of the vaccine a patient originally received isn’t available, or if the manufacturer of the first shot isn’t known, another vaccine may be substituted, health officials said.

    The new guidance contradicts guidelines in the United States, where the Centers for Disease Control and Prevention has noted that the authorized Covid-19 vaccines “are not interchangeable,” and that “the safety and efficacy of a mixed-product series have not been evaluated. Both doses of the series should be completed with the same product.”

    Some scientists say Britain is gambling with its new guidance. “There are no data on this idea whatsoever,” said John Moore, a vaccine expert at Cornell University. Officials in Britain “seem to have abandoned science completely now and are just trying to guess their way out of a mess.”

    The country has issued an emergency green light to two vaccines, developed by Pfizer and AstraZeneca. According to Britain’s new guidance, “every effort should be made” to complete a dosing regimen with the same shot first used. But when “the same vaccine is not available, or if the first product received is unknown, it is reasonable to offer one dose of the locally available product” the second time around.

    “This option is preferred if the individual is likely to be at immediate high risk or is considered unlikely to attend again,” the recommendation said. Because both vaccines target the spike protein of the coronavirus, “it is likely the second dose will help to boost the response to the first dose.”

    An official at Public Health England on Saturday noted the similarities between the Pfizer and AstraZeneca vaccines, and said substitutions would occur only on “a very exceptional basis, when the alternative is to leave someone with an incomplete course.”
    An official in Wales said that first and second vaccine doses there would be matched.

    It is far from certain that the vaccines are interchangeable, several researchers said.
    “None of this is being data driven right now,” said Dr. Phyllis Tien, an infectious disease physician at the University of California, San Francisco. “We’re kind of in this Wild West.”

    Steven Danehy, a spokesman for Pfizer, pointed to the company’s late-stage clinical trial findings, which relied on a two-dose schedule of its vaccine that was 95 percent effective at preventing Covid-19.

    “While decisions on alternative dosing regimens reside with health authorities, Pfizer believes it is critical health authorities conduct surveillance efforts on any alternative schedules implemented and to ensure each recipient is afforded the maximum possible protection, which means immunization with two doses of the vaccine,” Mr. Danehy said

    Both vaccines are intended to be doled out in two-shot regimens, delivered three or four weeks apart. While the first shots of each vaccine are thought to be somewhat effective at preventing Covid-19, it’s the second dose — intended as a sort of molecular review session for the immune system — that clinches the protective process.

    While it’s possible that swapping out one vaccine for another may still school the body to recognize the coronavirus, it is still a scientific gamble. With different ingredients in each vaccine, it’s possible people will not benefit as much from a second shot. Mixing and matching could also make it more difficult to collect clear data on vaccine safety.

    Without evidence to back it, the hybrid vaccination approach seems “premature,” said Saad Omer, a vaccine expert at Yale University. Still, it’s not without precedent: Health authorities like the C.D.C. have previously said that if it’s impossible to give doses of a vaccine from the same manufacturer, “providers should administer the vaccine that they have available” to complete an injection schedule.

    In a controversial move, the British government this week also decided to frontload its vaccine rollout, delivering as many first doses to people as possible — a move that could delay second shots up to 12 weeks.
    The speedy deployment might afford more people partial protection against the virus in the short term. But some experts, including Dr. Moore, worry that this, too, might be unwise, and could imperil vulnerable populations.

    A vaccination gap that stretches on too long may hamstring the second shot’s ability to boost the protective powers of the first — or raise the odds that people will forget, or decide against, returning for another injection.
    The whiplash changes in guidance in Britain, many made without public meetings or strong data, may erode trust in vaccination campaigns and public health measures in general, Dr. Tien said.

    “We’re making an assumption that the public is just going to listen and come in and get the vaccine,” she said. “I’m worried that’s not going to happen.”

  14. Covid-19: Norway investigates 23 deaths in frail elderly patients after vaccination
    BMJ 2021; 372 doi: https://doi.org/10.1136/bmj.n149 (Published 15 January 2021)
    Read our latest coverage of the coronavirus outbreak

    Covid-19: Norway investigates 23 deaths in frail elderly patients after vaccination
    BMJ 2021; 372 doi: https://doi.org/10.1136/bmj.n149 (Published 15 January 2021)

    Ingrid Torjesen
    Author affiliations London
    Doctors in Norway have been told to conduct more thorough evaluations of very frail elderly patients in line to receive the Pfizer BioNTec vaccine against covid-19, following the deaths of 23 patients shortly after receiving the vaccine.

    “It may be a coincidence, but we aren’t sure,” Steinar Madsen, medical director of the Norwegian Medicines Agency (NOMA), told The BMJ. “There is no certain connection between these deaths and the vaccine.”

    The agency has investigated 13 of the deaths so far and concluded that common adverse reactions of mRNA vaccines, such as fever, nausea, and diarrhoea, may have contributed to fatal outcomes in some of the frail patients.

    “There is a possibility that these common adverse reactions, that are not dangerous in fitter, younger patients and are not unusual with vaccines, may aggravate underlying disease in the elderly,” Madsen said. “We are not alarmed or worried about this, because these are very rare occurrences and they occurred in very frail patients with very serious disease,” he emphasised. “We are now asking for doctors to continue with the vaccination, but to carry out extra evaluation of very sick people whose underlying condition might be aggravated by it.” This evaluation includes discussing the risks and benefits of vaccination with the patient and their families to decide whether or not vaccination is the best course.

    More than 20 000 doses of the vaccine have been administered over the past few weeks in Norway and around 400 deaths normally occur among care home residents every week.

    The Paul Ehrlich Institute in Germany is also investigating 10 deaths shortly after covid-19 vaccination.1

    Asked if any deaths had occurred in UK patients after vaccination, the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) said that details of all suspected reactions reported in association with approved covid-19 vaccines would be published along with its assessment of the data on a regular basis in the future. Based on the available published reports from the clinical trials, the MHRA said it did not currently anticipate any specific safety concerns.

    In a statement, Pfizer said, “Pfizer and BioNTech are aware of reported deaths following administration of BNT162b2. We are working with NOMA to gather all the relevant information.

    “Norwegian authorities have prioritised the immunisation of residents in nursing homes, most of whom are very elderly with underlying medical conditions and some of whom are terminally ill. NOMA confirm the number of incidents so far is not alarming, and in line with expectations. All reported deaths will be thoroughly evaluated by NOMA to determine if these incidents are related to the vaccine. The Norwegian government will also consider adjusting their vaccination instructions to take the patients’ health into more consideration.

    “Our immediate thoughts are with the bereaved families.”

  15. Weekly report on suspected adverse drug by NOMA (Address for NOMA is post@legemiddelvert.no or Covid19beredskap@legemiddelverket.no or post@noma.co. Just sent a copy of D H and J-R Laporte. publication above which might help to avoid more horrible deaths

    Background for the reported cases:
    reactions to coronavirus vaccines Just sent a copy of D H and J-R Laporte.
    Background for the reported cases:
     In Norway, the vaccination campaign (handled by the National Institute of Public Health)
    have prioritized the elderly in nursing homes and long-term care facilities. So far, this is the
    only group of patients for whom vaccination has taken place (until 15/01/2021 only with
    Comirnaty. Vaccination with Moderna starts /15/01/2021).
     Patients in nursing homes represents a very frail group of elderly, and most of the patients
    have severe underlying diseases.
     In Norway we have a “reporting culture” for vaccines ADRs where the normal procedure is to
    report all suspected adverse reactions for new vaccines. Healthcare professionals have a low
    threshold for reporting possible adverse reactions, even when the causal relationships
    appears very unclear.
     The preferred and most used route of reporting is directly to the health authorities, not via
    the Marketing Authorisation Holders.
     The Norwegian ADR registry is a national health registry, obliged to report statistics to the
    public.
     At the highest political level the public has been promised full transparency of the reported
    ADRs of the covid-19 vaccines. The Norwegian Medicines Agency will publish weekly reports.
     The Norwegian Medicines agency, in close cooperation with the National Institute for Public
    Health will continuously follow the reporting of suspected ADRs and update national advice
    accordingly.
    About the statistics: 
    The Norwegian Medicines Agency is transparent about reports of suspected adverse reactions during
    covid-19 vaccination and publishes weekly updates. These updates provide an overview of reported
    suspected adverse reactions after vaccination in Norway.
    All reports of suspected adverse drug reactions, regardless of whether they are reported by
    healthcare professionals or patients or received from vaccine manufacturers, end up in the
    Norwegian ADR Registry.
    The weekly updates summarize all suspected adverse reactions that have been assessed and
    processed.
    The adverse reaction reports are assessed on a continuous basis. Reports of suspected serious
    adverse reactions are prioritized for assessment. The weekly updates will therefore give a skewed
    picture of the distribution between serious and nonserious reports.
    The adverse reaction statistics for the different covid-19 vaccines are not directly comparable
    because they have not been used in the covid vaccination program for the same length of time, and
    because the vaccines are administered to different numbers of people and to different age groups.
    Adverse reactions are reported on suspicion and the reports describe events that have occurred after
    vaccination. Even though an event has been reported, this does not necessarily imply that a causal
    relationship has been established between the event and the vaccines. The known adverse reactions
    of the vaccines are listed in the product information.
    Gender breakdown
    Gender Female Male
    Number 21 8
    Table 1: Gender breakdown among patients who have experienced adverse reactions following
    coronavirus vaccination
    Age breakdown
    Age group
    18-69 70-79 80-89 90+ Unknown age
    4 4 14 7 0
    Table 2: Age breakdown among patients who have experienced adverse reactions following
    coronavirus vaccination
    Severity
    Total number of
    reports
    Number of reports with
    fatal outcome
    Serious reports
    excluding death
    Non-serious reports
    29 13 9 7
    Table 3: Breakdown between reports with death, serious and non-serious reports
    Adverse reactions broken down according to category
    A single adverse reaction report can include a number of suspected adverse reactions or symptoms.
    Category Number of
    reported adverse
    reactions
    General symptoms and reactions at the vaccine administration site
    E.g. Pain around the injection site, discomfort, fever, fatigue
    24
    Gastrointestinal symptoms
    E.g. Stomach pain, nausea, vomiting, diarrhoea
    11
    Respiratory tract symptoms
    E.g. Difficulty breathing, shortness of breath, hyperventilation, cough, irritation
    of the respiratory tract
    10
    Examinations
    E.g. Abnormal pulse, reduced blood pressure
    7
    Neurological symptoms
    E.g. Headache, dizziness, loss of consciousness, numbness, cramp
    6
    Psychiatric symptoms 5
    E.g. Sleep abnormalities, restlessness, lethargy, anxiety
    Musculoskeletal symptoms
    E.g. Muscle pain, joint pain, muscle stiffness
    4
    Vascular symptoms
    E.g. Flushes, pallor
    3
    Infections
    E.g. Pneumonia
    2
    Kidney and urinary tract symptoms
    E.g. Urinary tract infection
    2
    Immune system symptoms
    E.g. Allergic reaction
    1
    Skin symptoms
    E.g. Rash, itching, redness
    1
    Metabolic and nutrition-related symptoms
    E.g. Loss of appetite
    1
    Cardiac symptoms
    E.g. Abnormal heart rate
    1
    Table 4: Reported adverse reactions broken down according to category for Comirnaty
    The most common reported adverse reactions are general symptoms, such as impaired general
    condition, fever and general malaise, along with injection site reactions. Gastrointestinal symptoms
    such as diarrhoea, nausea and vomiting, as well as respiratory tract symptoms such as shortness of
    breath and cough, are also among the most common reported adverse reactions.

  16. Published: 15 January 2021
    Missing clinical trial data: the evidence gap in primary data for potential COVID-19 drugs
    Florence Rodgers, Toby Pepperrell, Sarai Keestra & Victoria Pilkington -Show fewer authors
    Trials volume 22, Article number: 59 (2021)

    Abstract
    Background
    Several drugs are being repurposed for the treatment of the coronavirus disease 2019 (COVID-19) pandemic based on in vitro or early clinical findings. As these drugs are being used in varied regimens and dosages, it is important to enable synthesis of existing safety data from clinical trials. However, availability of safety information is limited by a lack of timely reporting of overall clinical trial results on public registries or through academic publication. We aimed to analyse the evidence gap in this data by conducting a rapid review of results posting on ClinicalTrials.gov and in academic publications to quantify the number of trials missing results for drugs potentially being repurposed for COVID-19.

    Methods
    ClinicalTrials.gov was searched for 19 drugs that have been identified as potential treatments for COVID-19. Relevant clinical trials for any prior indication were listed by identifier (NCT number) and checked for results and for timely result reporting (within 395 days of the primary completion date). Additionally, PubMed and Google Scholar were searched to identify publications of results not listed on the registry. A second, blinded search of 10% of trials was conducted to assess reviewer concordance.

    Results
    Of 3754 completed trials, 1516 (40.4%) did not post results on ClinicalTrials.gov or in the academic literature. Tabular results were available on ClinicalTrials.gov for 1172 (31.2%) completed trials. A further 1066 (28.4%) had published results in the academic literature, but did not report results on ClinicalTrials.gov. Key drugs missing clinical trial results include hydroxychloroquine (37.0% completed trials unreported), favipiravir (77.8%) and lopinavir (40.5%).

    Conclusions
    There is an important evidence gap for the safety of drugs being repurposed for COVID-19. This uncertainty could cause unnecessary additional morbidity and mortality during the pandemic. We recommend caution in experimental drug use for non-severe disease and urge clinical trial sponsors to report missing results retrospectively.
    https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-021-05024-y

  17. Breaking News

    Texas News Today
    Texas
    Norway cannot rule out that “the side effects of the COVID-19 vaccine were behind the deaths of 23” frail elderly “patients.”
    donalddosman1 day ago

    On Friday, a top doctor from the Norwegian drug regulator suggested that the side effects of the Pfizer / BioNTech coronavirus vaccine could have contributed to the deaths of some older patients.
    Dr. Sigurd Hortemo, the doctor in charge of the Norwegian pharmacy, said in a statement that common side effects such as fever and nausea immediately after vaccination could have led to more serious outcomes and deaths in older, frail patients. .

    As of Thursday, 23 suspected deaths were reported to the Norwegian ADR Health Registry, 13 of which were evaluated by health authorities, according to the Norwegian pharmacy.
    In a statement, the agency said, “Side effects on the vaccine (such as fever and nausea) that occur within the first few days after vaccination contribute to the more serious course and fatal consequences of patients with severe underlying illness. There is a possibility, “he said.

    Estimates of studies in which coronavirus shortens life expectancy in the United States over a year

    The statement states that Pfizer’s large clinical trials did not test the vaccine in patients with severe illness or patients over the age of 85.

    In fact, prior to urgent approval from the U.S. Food and Drug Administration, a committee advising the authorities approved the product and did not find any particular safety concerns in the subgroup analysis, but the duration of immunity. In certain high-risk populations, we have listed some unknowns that need further investigation, such as efficacy, previously infected population, efficacy of asymptomatic infections, long-term effects of COVID-19 disease, SARS. -CoV-2 mortality and infection. This study tested patients up to the age of 85.

    According to Pfizer, Norwegian agencies are not wary of a few incidents.
    “Our immediate thoughts are on the bereaved family,” Pfizer wrote in an email to Fox News. “Pfizer and BioNTech are aware of the deaths reported after administration of BNT162b2. We are working with the Norwegian Pharmacy (NOMA) to collect all relevant information. Norwegian authorities are in the nursing home We prioritize vaccinations for residents of Norway. Some elderly people have underlying illnesses and some have terminal illnesses. “

    “NOMA confirmed that the number of incidents so far was not alarming and was in line with expectations,” the statement continued. “All reported deaths will be thoroughly evaluated by NOMA to determine if they are related to the vaccine. The Norwegian government should adjust vaccination instructions in consideration of patient health. Will also consider. “

    Nonetheless, a medical manager at a Norwegian pharmaceutical company advised frail patients who were vaccinated.
    “If you are very frail, you probably shouldn’t be vaccinated,” Norwegian pharmacy Steiner Madsen told reporters Thursday.

    The COVID-19 vaccine usually takes several weeks for the body to build enough immunity to protect itself from the disease.

    The statement did not identify when deaths occurred after vaccination. Fox News is seeking further comments from Norwegian pharmacies.

    Norway cannot rule out that “the side effects of the COVID-19 vaccine were behind the deaths of 23” frail elderly “patients.”

  18. Suzanne, why would any human being want to have this vaccine knowing what you have so well masterfully articulated here. Too many unforeseen variables which are not part of the clinical research. It brings tears to my eyes not knowing the unfortunate outcomes for many poor souls.

  19. Volunteer children?! Children are already becoming ill enough to be hospitalized but we need better evidence that the risk of vaccines outways potential harms than we are being given Or that elderly people are being given. (I will try to find the ref – there is a proposal that three doses of vaccine are being proposed by phatma co.might be necessary for adults)

    Pfizer began testing its coronavirus vaccine in children up to 12. AstraZeneca, which is now undergoing a new global trial, has also committed to test its vaccine on children.

    From Aljazeera Source John Hopkins Uni
    “If you have rare side effects, you want to find it on adults and not harm children,” Soumya Swaminathan, Chief Scientist at the World Health Organization (WHO), told Al Jazeera.

    Children have a more active immune system and can have a stronger reaction compared with adults. This can trigger the body to over-react to a vaccine and generate an inflammatory response.
    “In the past, the administrations of vaccines for the dengue and the respiratory syncytial virus in children resulted in generating most severe diseases, so rather than protecting them, it had the reverse effect,” she said.

    Referring to Children under 12 yrs — … the posting says the study is “not yet recruiting,” and Colleen Hussey, a spokeswoman for Moderna, said it was not certain when the testing sites would be listed or start accepting volunteers. A link on the website to test centers is not yet working, and Ms. Hussey said she was not sure when it would become active.

    Moderna Plans to Begin Testing Its Coronavirus Vaccine in Children
    The company said the trial would involve children ages 12 through 17.
    The study will include 3,000 children, with half receiving two shots of the vaccine four weeks apart.
    The study will include 3,000 children, with half receiving two shots of the vaccine four weeks apart.Credit…Cody O’Loughlin for The New York Times

    Updated Dec. 18, 2020
    The drugmaker Moderna said on Wednesday that it would soon begin testing its coronavirus vaccine in children ages 12 through 17. The study, listed Wednesday on the website clinicaltrials.gov, is to include 3,000 children, with half receiving two shots of vaccine four weeks apart, and half getting placebo shots of salt water.

    Moderna’s vaccine has not yet been studied in children or pregnant women. In the new clinical trial in adolescents, girls past puberty will be tested before each injection to make sure they are not pregnant.

    Pfizer began testing its coronavirus vaccine in children up to 12. AstraZeneca, which is now undergoing a new global trial, has also committed to test its vaccine on children.

  20. Calling June Raine of UK MHRA to come out and give us a statement She has been all over the media recently but has made no appearances since this scandal has broken Why were very frail and even terminally ill people given these vaccines when there are many serious adverse effects known . Were they being used for research? How many would have declined if they had been warned of potential consequences?

    Norway and Germany have take a lead in publicising this There must be similar deaths and serious effects happening in other countries They need to come out with it .

    Last Updated: 15th January, 2021 09:18 IST
    10 Dead In Germany Within 4 Days Of Covid-19 Vaccine Inoculation; Probe Ordered
    German specialists probe as 10 people died soon after getting inoculated against the novel Coronavirus disease, the deceased were aged between 79 to 93 years.
    Written By
    Astha Singh

    Why were very frail and even terminally ill people given these vaccines. Were they being used for research? How many would have declined if they had been warned of potential consequences?

    After the deaths of 10 people who passed away soon after having been inoculated against the novel coronavirus disease, Specialists from Germany’s Paul Ehrlich Institute are looking into it.

    The deceased were aged between 79 to 93, all with antecedent diseases. The time between vaccination and death ranged from several hours to four days, according to the medical expert.

    … Based on our current data WE ASsume they died from their main diseases, coinciding in time with the vaccination,” Keller-Stanislawski said at a press conference.

    The latest figure adds six to the number of known fatalities in Norway, and lowers the age group thought to be affected to 75 from 80
    Lars Erik Taraldsen | Bloomberg
    Last Updated at January 17, 2021 09:56 IST

    Covid Vaccine
    Until Friday, the vaccine produced by Pfizer and BioNTech SE was the only one available in Norway

    EU to buy up to 300 million doses of Pfizer-BioNTech Covid-19 vaccine

    Norway expressed increasing concern about the safety of the Pfizer Inc. vaccine on elderly people with serious underlying health conditions after raising an estimate of the number who died after receiving inoculations to 29.

    Until Friday, the vaccine produced by Pfizer and BioNTech SE was the only one available in Norway, and “all deaths are thus linked to this vaccine,” the Norwegian Medicines Agency said in a written response to Bloomberg on Saturday.

  21. This not going to be reliable. There is so much pathetic whining and superstitious, self-sabotaging resistence even on undeniable side-effects, and vaccines have become one of the fetishes of hypochondric or paranoid nutjobs of our time. Ultimately, I don’t think this is the right website to undertake that task, there are plenty of other opportunities, this is automatically giving it an appearance of anti-establishment, of someone “trying to hide the truth” and other conspiracy-thinking etc. It will be a mess, I’m sure. But it will probably be irrelevant anyway. Have fun…

  22. Reporters in the media are not clued up enough to be providing adequate information to ‘the public’ They are reporting in simplistic terms that people with illnesses and frailties are dying but not linking at all with the fact that their medications are likely to be a factor as highlighted by D H and J-R L
    What investigations are being carried out by regulators and pharma co’s to find out? They should be contacting all those who have published this information

    IN THE MIDST OF THE SARS-CoV-2 PANDEMIA, CAUTION IS NEEDED WITH
    COMMONLY USED DRUGS THAT INCREASE THE RISK OF PNEUMONIA.
    Joan-Ramon Laporte, M.D.
    Emeritus Professor of Clinical Pharmacology, Department of Pharmacology, Therapeutics and Toxicology
    Universitat Autònoma de Barcelona.
    Fundació Institut Català de Farmacologia. WHO Collaborating Centre for Research and Training in
    Pharmacoepidemiology.
    jrl@icf.uab.cat
    David Healy MD FRCPsych
    Professor Dept of Family Medicine
    McMaster University
    Hamilton, Canada
    Healyd1@mcmaster.ca
    In the present situation of pandemia by SARS-CoV-2, it is imperative to avoid pneumonia/
    pneumonitis and related risk factors as much as possible. The consumption of various
    commonly used medicines increases the risk of and complications from pneumonia.

    D H and J-R L have published that detailed list of medications which cause complications and proven risks to elderly people.
    There is nothing in the public domain which alerts elderly people themselves or those who look after people who are too ill or frail that they should be checking on the possible interactions with medications . All people are not getting a proper consultation, they need to know in order to make considered decisions with the aid of the information held by drug companies and regulators and medics. Some are carrying out research themselves and are clued up but there is nowhere to turn to for reliable advice, including what is not known as yet.On R5 overnight a lady phoned in to say that she had type 2 diabetes and that her GP didn’t know whether it was safe to have a vaccine ,and that she was fobbed off and told it was her own decision whether to go ahead. Other callers advised calling 111 or A and E or the Diabetes Charities. How are people who have previously relied on health workers going to know where to go for info before being persuaded to have the vaccine sometimes against their better judgment . Or not to take it. The quality of life is a factor many elderly as well as other people are weighing up, not just the risk of death and illness, but how to get the most out of the last years of life. How to judge whether or how much it will add to the common good or contribute to their families and friends being reassured by them having had a vaccine. The sadness is immense at a time when older people and others should be at a stage when they can relax and be cared for, their last years are being lived in fear and anxiety and knowing that so many have been needlessly sacrificed by the very groups who have and are exploiting their vulnerability

    Covid and the Market in Research
    April 13, 2020 | 20 Comments
    There are 3 bits to this post – an interview with Joan-Ramon Laporte. An article by Ariane Denoyel and a Q and A with Laporte and Healy. Laporte Interview As part of a series for ROAR Magazine, Frank Barat has run some striking interviews about aspects of the Covid pandemic not usually mentioned. …….

  23. Potential of Selective Serotonin Reuptake Inhibitors in preventing clinical deterioration of COVID-19

    Abstract
    COVID-19 has an unpredictable course with substantial percentage of infected patients developing clinical deterioration and increasing health care burden. With no specific treatment or vaccination, the current search is for drugs that can limit the disease progression. Recently Fluvoxamine has been reported to have disease modifying effects in COVID-19. We suggest the hypothesis that short term routine use of Selective Serotonin Reuptake Inhibitors (SSRIs) can prevent clinical deterioration of asymptomatic or mild COVID-19 cases by the following ways: a) anti-inflammatory actions through sigma-1 agonism and reducing release of pro-inflammatory cytokines, b) anti-coagulant action by reducing platelet aggregation, c) specific antiviral and antibacterial effects, d) Immunomodulation through Serotonin pathway and anti-oxidation. The routine short term use of SSRIs can also alleviate the psychological impact of the disease. We hope our hypothesis will encourage future clinical trials to validate the routine use of SSRIs against COVID-19.

    SSRIs for everyone! to PREVENT no one knows exactly what. ladies and gentlemen the indecency is complete.

    https://www.authorea.com/doi/full/10.22541/au.161047751.18397971

  24. I had Covid Vaccine, Astrazenica flavour at 11am,3.20am now. At 10pm I started to develop flu type symptoms, muscle aches, sore throat and coughing and sore head. Temperature currently elevated at 37.3C(I’ve been tracking it for 5 yrs due to another issue its varies between 36.1-36.6). At present time sore throat and coughing appear to be disappearing although muscle aches and sore head(mild) still present. Fits perfectly with side effects warning on NHS Scotland vaccine leaflet. One thing that I do view as very positive here. The NHS Scotland leaflet does in fact contain the details for the yellow card reporting system on 2nd last page which suggests to myself that government do have concerns on this and are wishing to tightly monitor it. Something a little profound has just hit me-shouldn’t the details of the yellow card adverse drug reaction reporting system be on all Patient Information Leaflets, that would be a major step forward in Patient Safety I would say. I shall submit both a yellow card and risk report once this has passed through myself

  25. I am wondering if anyone on an SSRI and who has had any sort of PWS from one has had effects from the vaccine. I am afraid if I have a vaccine it will make akathisia worse.

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