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MouseDoctor

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  • Long term effects of a previously unused vaccine technology? Totally unknown , because this vaccine has been rushed into circulation they’ll have to strap me down and forceably inject it. But hey its ok if a scientist says so.

  • Cladribine – Vaccinations not recommended until IR has occurred
    But I thought that everyone with MS (cladribine or not) is encouraged to get flu (non-live) vaccine each year?

  • Pfizer recently announced that its covid vaccine was more than 90 percent “effective” at preventing covid-19. Shortly after this announcement, Moderna announced that its covid vaccine was 94.5 percent “effective” at preventing covid-19. Unlike the flu vaccine, which is one shot, both covid vaccines require two shots given three to four weeks apart. Hidden toward the end of both announcements, were the definitions of “effective.”

    Both trials have a treatment group that received the vaccine and a control group that did not. All the trial subjects were covid negative prior to the start of the trial. The analysis for both trials was performed when a target number of “cases” were reached. “Cases” were defined by positive polymerase chain reaction (PCR) testing. There was no information about the cycle number for the PCR tests. There was no information about whether the “cases” had symptoms or not. There was no information about hospitalizations or deaths. The Pfizer study had 43,538 participants and was analyzed after 164 cases. So, roughly 150 out 21,750 participants (less than 0.7 percent) became PCR positive in the control group and about one-tenth that number in the vaccine group became PCR positive. The Moderna trial had 30,000 participants. There were 95 “cases” in the 15,000 control participants (about 0.6 percent) and 5 “cases” in the 15,000 vaccine participants (about one-twentieth of 0.6 percent). The “efficacy” figures quoted in these announcements are odds ratios.

    There is no evidence, yet, that the vaccine prevented any hospitalizations or any deaths. The Moderna announcement claimed that eleven cases in the control group were “severe” disease, but “severe” was not defined. If there were any hospitalizations or deaths in either group, the public has not been told. When the risks of an event are small, odds ratios can be misleading about absolute risk. A more meaningful measure of efficacy would be the number to vaccinate to prevent one hospitalization or one death. Those numbers are not available. An estimate of the number to treat from the Moderna trial to prevent a single “case” would be fifteen thousand vaccinations to prevent ninety “cases” or 167 vaccinations per “case” prevented which does not sound nearly as good as 94.5 percent effective. The publicists working for pharmaceutical companies are very smart people. If there were a reduction in mortality from these vaccines, that information would be in the first paragraph of the announcement.

    There is no information about how long any protective benefit from the vaccine would persist. Antibody response following covid-19 appears to be short lived. Based on what we know, the covid vaccine may require two shots every three to six months to be protective. The more shots required, the greater the risk of side effects from sensitization to the vaccine.

    There is no information about safety. None. Government agencies like the Centers for Disease Control (CDC) appear to have two completely different standards for attributing deaths to covid-19 and attributing side effects to covid vaccines. If these vaccines are approved, as they likely will be, the first group to be vaccinated will be the beta testers. I am employed by a university-based medical center that is a referral center for the West Texas region. My colleagues include resident physicians and faculty physicians who work with covid patients on a daily basis. I have asked a number of my colleagues whether they will be first in line for the new vaccine. I have yet to hear any of my colleagues respond affirmatively. The reasons for hesitancy are that the uncertainties about safety exceed what they perceive to be a small benefit. In other words, my colleagues would prefer to take their chances with covid rather than beta test the vaccine. Many of my colleagues want to see the safety data after a year of use before getting vaccinated; these colleagues are concerned about possible autoimmune side effects that may not appear for months after vaccination.

    These announcements by Pfizer and Moderna are encouraging. I certainly hope that these vaccines protect people from the harm of covid-19. I certainly hope that these vaccines are safe. If both of these conditions are true, nobody will need to be coerced into taking the vaccine. However, you should pay even more attention about what is left out of an announcement than about what is stated. The pharmaceutical companies are more than happy for patients to misunderstand what is meant by efficacy. Caveat emptor (buyer beware)!

      • Really not doing pharma any favours.
        “I think the best way of reflecting the results is in a peer-reviewed scientific journal, not in a newspaper.”
        Wall Street being a well known scientific journal!

        • The vaccine won’t get approved without data being avail able. The EMA and MHRA are transparent and will make the data available to the public when they make a positive ruling.

    • I think many of us with scientific/medical backgrounds are waiting to see the published data before coming to a final decision, and acknowledging what is coming out now is from the press office rather than the scientists. However 90-95% efficiency is a good place to start. The problem with NNT applied to vaccinations (NNV) is that it ignores the effect of herd immunity and the protection of people who either can’t have the vaccine or may not be sufficiently protected if they do have it such as elderly and immune compromised.
      There are many common drugs that have an NNT for their indications greater than 167 (statins are 200-300 depending on specific indication and population)
      I have also seen some recent (as yet unpublished) data about potential long term side-effects of even mild COVID infections such as diabetes and biochemical markers that indicate possible future Parkinson’s-like syndrome. So not sure I really want to beta-test COVID either.

    • Nice reasoning

      “If there were a reduction in mortality from these vaccines, that information would be in the first paragraph of the announcement.”

  • After alemtuzumab treatment I have always been advised to avoid live vaccines & this table confirms this.
    However I can see there being a battle with GP receptionists etc to ensure I do not receive one.
    In a rush to getting as many people as possible vaccinated against Covid-19, will hcps be informed of contraindications to ensure the right person gets the right vaccine? This has been worrying me the last few weeks as the vaccines are now close to reality.

  • If you look carefully at the very small print at the top of the ‘slides’ provided by Dr Saul Reyes it says HPV & MMR 2017, so are these tables only relevant to those vaccines?

  • My suggestion is that we all cross the SARS-CoV-2 vaccine bridge when it is there to cross. There are so many unanswered questions that until the trials are published, we have peer-reviewed data in-hand and the regulators have trawled through the safety data and licensed these vaccines all that we say now will be highly speculative. For example, there seem to be major irregularities reported in how the AstraZeneca-Oxford vaccine trials were run which may affect its approval.

  • Thanks MD and Dr Rayes for providing this info.

    As I presume is true for the vast majority I’m keen to receive a vaccine as soon as one becomes available.

    However the words on the slides that strike me the hardest are: ‘LAVs have not been studied and should therefore be avoided’

    As someone who has received Lemtrada and currently has a lymphocytes level below 1, the idea of proceeding with having the Oxford vaccine (subject to its approval) doesn’t sit easily with me.

    • I suspect the vast majoirty will run a mile but will be embraced by the over 50s and people at risk.

      LAVs not studied and should be avoided is the way to reduce risks to the neuros…The issue is whether the adenoviral replication deficient are LAVS I think they should not cause infection but I believe people will be cautious until proven otherwise. I have asked some people and they view adenovirus as a LAv, so I dont think this will be offered. However with the mess of the trial, I suspect it will be delayed. It is amazing how the story emerged and how can much a mess up occur in the trial.

      However I must admit I dont understand the oxford adenovirus trials. The trials were suposed to use 50 billion viral particles followed by 0.5ml of a boost which has 25-65 billion viral particles. Some people in UK got a half dose (there was a 22 billion particle dose in other studies) which is in same range as the boost dose. They realised the half-dose because lack of injection site reactions…which says the virus verese saline trials will not be properly blinded. Having seen the consent-related information for one of the trials I wonder how easy it is going to be to recruit to a placebo-controlled trial. Once you have one agent approved, non inferiory trials should done so every participant gets a vaccinenow have to be done

      • Thanks MD.
        Reckon I’ll go ahead and speak to my GP from the stance of ‘It’s a No from Me’ to the Oxford vaccine added to a request for the Pfizer or Moderna instead.

        Very interesting what you say about the vaccine trials.
        Guess it’s sensible to hope it is approved as one of the most uplifting aspects to it is A/Z saying they’d roll it out on a not for profits basis.

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