#MSCOVID19: from the horse’s mouth

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Barts-MS rose-tinted-odometer: ★★★★★

The horse’s mouth = the MHRA (Medicines and Healthcare products Regulatory Agency)

I have received several vexatious emails accusing me of subjecting my patients, and people with MS (pwMS) in general, to an experiment by recommending and promoting the COVID-19 vaccines. I want to remind the readers that we need to listen to experts. I was challenged that may be the experts are wrong. So if the experts are wrong which regulators should I challenge first; the FDA, EMA, MHRA, Russian, Swiss, Japanese, Canadian, etc.? Have they all got it wrong?  

Yes, occasionally a single regulatory authority may get things wrong, but they have checks and balances in place to correct their errors. As so many regulatory authorities have approved these vaccines is very telling. In addition, for most of the regulatory authorities above their approvals have been unanimous, i.e. all the experts and representatives on their panels have agreed that the safety and efficacy of the COVID-19 vaccine warrant their emergency marketing authorisations. 

Some of these vexatious commentators state that these vaccines were developed too quickly. Yes, they were developed quickly, but not too quickly. The platforms used for these vaccines were already in place and all that had to be done was to slot in the SARS-CoV-2 spike protein immunogen, tweak the production methods and the vaccines were ready for mass production. For the Oxford-AstraZeneca vaccine, all they had to do was swap out the sequence for the coronavirus that causes MERS for SARS-CoV-2. The latter process happened within a week or two.

Instead of doing trials in series a lot of the clinical development was done in parallel, i.e. phase 1b/2 immunological studies were done as part of phase 2 trials and phase 3 studies were added-on in an adaptive way to phase 2 trials. The reason for this turbocharging or the development pathway was that governments had derisked the development of the vaccines and given money to the companies to develop and test vaccines. In parallel governments also provided capital to build production facilities etc.  

So in summary the vaccine development programme was sped up by capital and contracts by governments for a defined number of orders. In normal times this does not happen, hence the many years it ‘normally takes’ to develop a vaccine. In my opinion, no short-cuts were made in terms of testing these vaccines for safety and efficacy. In fact, one could argue that the COVID-19 spike protein vaccines, as a body, represent the largest safety trial programme in vaccine history. 

Now that the vaccines have been used on millions of people if there were any rare sinister adverse events we would have expected the regulatory agencies to have reported them. And yes they have. The only one that sticks out from the Israeli and UK experiences is Bell’s palsy, as a rare adverse event, with the Pfizer-Biontech and probably the AstraZeneca-Oxford vaccine as well. 

I would like to remind these vexatious commentators that there is no conspiracy theory behind the COVID-19 vaccines and vaccination programmes. What public health officials are doing is simply trying to save lives, protect healthcare services and to stop the pandemic. 

Dare I suggest that the ‘post-truth era’ is coming to an end and that politicians, patients and the public will start to value experts again? As a society, we spend an extraordinary amount of time and money to educate and train experts to manage and run institutions such as the FDA, EMA, MHRA, CDC, WHO, etc. These experts need to be trusted and respected; all they are doing is what they have been asked by us to do. 

We all have a responsibility to act responsibly and to not dismiss COVID-19 vaccines as being ineffective, unsafe and designed to anything else other than what is in their labels. In general, these vaccines are very effective, safe and reduce your chances of getting severe COVID-19 and dying from COVID-19 by well over 95%. Why wouldn’t you want the vaccine? 

Ingrid Torjesen. Covid-19: First UK vaccine safety data are “reassuring,” says regulator. BMJ 2021; 372 doi: https://doi.org/10.1136/bmj.n363 (Published 08 February 2021)

Excerpts:

… The UK’s medicines regulator has described the first safety data related to covid-19 vaccines as “reassuring,” with most side effects reported being mild and in line with those seen with other types of vaccine. “The benefits continue to far outweigh the risks,” said June Raine, chief executive of the Medicines and Healthcare Products Regulatory Agency (MHRA).

… The agency published yellow card data for covid-19 vaccines given between 9 December 2020 and 24 January 2021, which comprise 22 820 reports from 7 164 387 first doses and 474 156 second doses. Most of the reports (16 756) are from people who received the Pfizer-BioNTech vaccine, and these list 49 472 suspected reactions. Administration of the AstraZeneca-Oxford vaccine began later, on 4 January, and 6014 yellow cards were reported up to 24 January, detailing 21 032 suspected reactions. A further 50 yellow card reports did not specify the brand of vaccine.

… By 24 January an estimated 5.4 million first doses of the Pfizer-BioNTech vaccine and 1.5 million doses of the AstraZeneca-Oxford vaccine had been administered, and around 0.5 million second doses, mostly of the Pfizer-BioNTech vaccine. Overall, the data show around three yellow card reports per 1000 doses of the vaccine given—a smaller proportion than the 10% of patients reporting them in clinical trials.

…. Severe allergic reactions were reported after administration of the first doses of the Pfizer-BioNTech vaccine on 9 December. Subsequently, the MHRA advised against its use for people with a history of severe allergic reactions to any ingredients in the vaccine and said that recipients should be monitored for at least 15 minutes.

…. A total of 101 anaphylaxis or anaphylactoid reactions after the Pfizer-BioNTech vaccination (1-2 cases per 100 000 doses) have been reported to the MHRA up to 24 January, and 13 anaphylaxis reactions after the AstraZeneca-Oxford vaccine.

….. Bell’s palsy is listed as a possible side effect of the Pfizer-BioNTech vaccine, and facial paralysis or paresis after this vaccine was mentioned in 69 yellow card reports; facial paralysis was mentioned in six reports after the AstraZeneca-Oxford vaccine. Philip Bryan, vaccine safety lead at the MHRA, said, “Bell’s palsy is something that can also happen naturally, so its association with the vaccine hasn’t been established.” 

… The MHRA received 107 reports of death after the Pfizer-BioNTech vaccine, 34 after the AstraZeneca-Oxford vaccine, and 2 in which the brand of the vaccine was unspecified. Most reports were for older people or people with underlying illness, the MHRA said, and a review of individual reports and patterns of reporting did not indicate that the vaccine played a role in the death. “We know, for instance, based on data from [the Office for National Statistics], that for every 100 000 doses given to people aged 80 or over, around 200 people die of natural causes within a week,” Bryan said.

CoI: multiple

Twitter: @gavinGiovannoni                                              Medium: @gavin_24211

About the author

Prof G

Professor of Neurology, Barts & The London. MS & Preventive Neurology thinker, blogger, runner, vegetable gardener, husband, father, cook and wine & food lover.

18 comments

Leave a Reply to Tony Fonda Cancel reply

  • Have those emailing you benefitted from childhood immunisations I wonder? Or maybe they’ve forgotten about those as the benefit of community immunisation is that many potentially dangerous diseases have been eradicated in the UK and as a result being free from these diseases is taken for granted.

    Would we be having the same discussion if polio and diptheria etc were still prevalent?

  • If covid vaccine were too quick to market, what can we say about the zamboni stuff?
    I would be interested in the results of a survey asking about those 2 respective treatments. Gut feel is that the same cohort of anti-vaxer is (or was at least) anti-establishment/pharma/neuroscience/DMTs and pro-zamboni.

  • The only thing we aren’t sure about (and couldn’t possibly be) are long term effects. Is there some other function carried out by a protein “a bit like” the spike protein? Something that binds in that way that performs a vital role in the body?

    So far the answer seems to be definitively “no” but we are still learning about what bodies “do”.

    Additionally there are efficacy questions for the immune-suppressed but that becomes irrelevant if everyone else is also vaccinated.

    Regardless, if people DO think it’s experimental (it’s not but still) I know that given the choice I’d far rather be a guinea pig than a statistic…

    • The people got their first jabs of RNA about one year ago, how long is long? How long are you going to wait?…the RNA is gone in 2 days and for most people the adenovirus will be gone with a week or two. You buy a new car how long are you going to wait to see if it is a rust bucket or not…if you wait to find out, the new car is out of production as a new model will come along…This will be true for the vaccines as they will no doubt change. Is a base pair change important? The regulators are not going to treat it as a totally new entity. I guess you haven’t had beef for a while? Still waiting for BSE to occur:-)

  • Some of the people who are against vaccines are from within the medical profession, although I wouldn’t trust anyone who says aids doesn’t exist. BBC programme was very interesting this evening. I think part of the reason why people are nervous is that if you look to the past there have been mistakes in medicine, from thalidomide to the contaminated blood scandals, for example. I’ve mentioned a friend before that won’t get the jab, which is her choice. I chose to pay for the flu jab before I got diagnosed with ms and became entitled to it, as my sister died from viral myocardialist, due to the flu 10 years ago.. I’ve explained to my friend that I had to make a choice when deciding on a DMT between potentially becoming very disabled and taking a medicine which could potentially cause death (PML). I weighed up the risks and hope for the best, and hope I’m not that one in whatever that gets it, unfortunately someone will be. I think the thing is to be informed – I never actually knew that vaccines could cause TM before this blog, obviously knew of the sore arm etc. The thing is, some people have genuine reasons to be nervous. Some people don’t trust government, central and regional (no wonder when politicians bend the truth to suit their purposes) or “authority” figures as they believe they have been lied to in the past. Some people just won’t listen or be reasoned with whatever you say. But, if you have put the information out there and answered questions when people ask then you have done what you can.

    • It’s like you write: some people have genuine reasons to be nervous, like their medical past, like RRMS, for instance. For many of them, therapy compliance to DMTs is driven by fear of relaps, and they accept all side-effects that come along with the DMT because of that fear. And in ‘normal’ times, this is considered to be a wise and precautious attitude. But that same fear for relaps or disease activity cannot simply be turned off because there’s a pandemic. I’m not saying this is rational (other variables), but it is understandable. And I’m sure other patients with other disease can have similar fears that make them hesitant to take a vaccine. For those patients, more information, disclosure of adverse events, etc. can be very useful. Even if it may seem for medical professionals like endless repeating.

  • Thank goodness for Darwin’s theories of evolution. Anti-vaxers don’t have the vaccine and increase their risk of death. If you have the vaccine, you’re more likely live and to pass on your ideas and genes. There just needs to be a ceiling of care for vaccine refusers, so that valuable ITU resources are not wasted on them.

    • Unfortunately I don’t think being an anti-Vader is genetically determined. I know several people who should have the genes but seem to struggle with the ideas.

    • I don’t think this kind of us versus them-rhetoric is helpful, unless it’s only meant to make us feel superior. You’re never going to convince someone by insulting him.

    • Not good to be so judgemental. Life is about choices and people should be allowed to make the wrong decision and still be treated and managed in a non-judgemental way.

      • (A bit late on my response, sorry). In most situations, yes, non-judgemental is quite important. But here, we have people who act as if they believe they have the right to infect other people (led by Mr. Bozo). How did we get to 500,000 in The States? It was mentality such as this, where people make up their own science. No good. Yea, Darwin’s theory may not actually apply, but the analogy is still good.

  • I thought maybe a can of worms was being opened here. We’ll see. I’d like to know exactly who the nay-sayer antivaxers were. Doctors? Scientists? or…??? I’m a retired disabled doctoral social scientist, so these past 6 years in The US have been a great case study in mob mentality and other dysfunctions. They would call me the liberal elite. The guy who cuts my lawn (I am not rich, again, just disabled), told me he had the virus in summer ’20 and was cured by his doc with a vitamin infusion. He was not going to do a vaccine because of the computer chips in the “jab” (we don’t use that word- handy though). He seems like a decent guy. So much of it here is identity- “I’m not one of them” (the people with the masks). There is safety in numbers and Avg. Joe doesn’t seem such an idiot (to himself) when he’s surrounded by idiots. Sure, there are some legitimate concerns, but really, not many in my opinion. Education, eduction, education. Oh God, education. You don’t have to be that smart, so it’s also other influences. Sorry Doctor, but talking to them intelligently will not help. As the previous guy said, let evolution take its course.

    • Did hear of a student nurse who had been at an anti-Vax demonstration. Someone suggested she should be thrown off her course but a medical friend thought it would be more “educational” if she was put on Covid wards and ITU for the rest of the year. Think my friend has a point.

      • Just why we’re on the subject of covid vaccines & MS, I had AstraZeneca vaccine a week ago. Had a few sniffles & bit of headache for a few days, but my legs have been so stiff with burning sensations the last 2 days. I’ve also started on eltrombopag for ITP 6 weeks ago. MS well controlled following alemtuzumab 9 & 10 years ago.
        Am hoping this is just an immune response to vaccine & it will ease soon. Has anyone else experienced similar?

      • (My reply a bit old, sorry; still holds water). Can’t actually get the video here in The States, but read various descriptions. Rewind your knowledge base back to late grammar school, high school. For a report, you were told to look things up in the library, and given hints on how to identify credible sources of info. This apparently, with social media, has gone by the wayside. Credible, now, means finding what one wants; that meets their purpose. What do they say? “A little knowledge is a very dangerous thing.” Unless one is open enough or self-aware enough, to admit they are just trying to con you, we are left with those other people who believe what they are saying is true. So if you were to look at each and everyone of these individuals in the Panorama TV show, you would indeed find defects in, or intentional misrepresentation about, what they were saying. ALL of them. I know out here in Amish Land in PA USA, there is a strong “group think” pressure to go along with (whatever). Now you can use your computer to do just that. Perhaps you look or seem smarter? If you are actually knowledgeable about something, you are considered the “liberal elite” and therefore your info is bad. It is a very tenuous situation. You see that we just barely squeezed our way out of doom here in the US, for the time being.

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