#MSCOVID19 MDs Saturday COVID lunch

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Wow what a week

Vaccinations Work…If your DMT lets them

Shah et al. Effect of vaccination on transmission of COVID-19: an observational study in healthcare workers and their households. MedRXiv doi: https://doi.org/10.1101/2021.03.11.21253275

A national study determined documented COVID-19 cases and hospitalizations in unvaccinated household members of vaccinated and unvaccinated healthcare workers. The cohort comprised of 194,362 household members (mean age 31.1 years) and 144,525 healthcare workers (mean age 44.4 years). 113,253 (78.3%) of healthcare workers received at least one dose of the BNT162b2 mRNA or ChAdOx1 nCoV-19 vaccine and 36,227 (25.1%) received a second dose. Household members of vaccinated healthcare workers had a lower risk of COVID-19 case compared to household members of unvaccinated healthcare worker (rate per 100 person-years 9.40 versus 5.93; HR 0.70, 95% confidence interval [CI] 0.63-0.78) = 30% less risk. The rate of per 100 person years was lower in vaccinated compared to unvaccinated healthcare workers for documented (20.13 versus 8.51; HR 0.45 [0.42-0.49]) and hospitalized COVID-19 (0.97 versus 0.14; HR 0.16 [0.09-0.27]). Conclusion: Vaccination of health care workers was associated with a substantial reduction in COVID-19 cases in household contacts consistent with an effect of vaccination on transmission.

Therefore not only vaccinate yourself for your benefit but also for the benefit of your loved ones and other memebers of society

Effect of vaccination on transmission of COVID-19: an observational study in healthcare workers and their households

Blood Clots

The development of safe, effective, affordable vaccines against COVID-19 remains the cornerstone to mitigating this pandemic. Early December 2020, multiple research groups had designed potential vaccines. From 11 March 2021, several European countries temporarily suspended the use of the Oxford-AstraZeneca vaccine amid reports of blood clot events and death of a vaccinated person, despite the European Medicines Agency and the World Health Organization assurance that there was no indication that vaccination was linked. This study aimed to identify and analyse the thrombotic adverse reactions associated with Oxford-AstraZeneca vaccine. This was a retrospective descriptive study using spontaneous reports submitted to the EudraVigilance database in the period from 17 February to 12 March 2021. There were 54,571 adverse reaction reports of which 28 were associated with thrombotic adverse reactions. Three fatalities were related to Pulmonary Embolism and 1 fatality to Thrombosis. With 17 million people having had the AstraZeneca vaccine, these are extremely rare events. In Europe, a rare disease (AE in this scenario) is defined when it affects five in 10,000 people (prevalence: 500/million). Ultra or very rare AE is defined as when it affects one in50,000 people or 20/million.. However it is evident that there have been more blood clots in the people vaccinated with the pfizer vaccine.

The EMA Pharmacovigilance Risk Assessment Committee (18 March 2021) concluded that the vaccine was safe, effective and the benefits outweighed the risks. Conducting further analyses based on more detailed thrombotic adverse event reports, including patients characteristics and comorbidities, may enable assessment of the causality with higher specificity.

However, there may be a very rare thromboitic signal associated with vaccination. The advice is to treat this with intravenous immunoglobulins and non heparin anti-coaggulants

Autoimmune inhibitory drugs have a limited effect on vaccination efficacy…in inflammatory Gut disease

Serological response to COVID-19 vaccination in IBD patients receiving biologics.Serre-Yu Wong, Rebekah Dixon, Vicky Martinez Pazos, ICARUS-IBD, Sacha Gnjatic, Jean-Frederic Colombel, Ken Cadwell MEdRXiv doi: https://doi.org/10.1101/2021.03.17.21253848

Objective The impact of medications on COVID-19 vaccine efficacy in IBD patients is unknown, as patients with immunosuppressed states and/or treated with immunosuppressants were excluded from vaccine trials. To address this, we evaluated serological responses to COVID-19 vaccination with the SARS-CoV-2 spike (S) mRNA BNT162b2 (Pfizer-BioNTech) and mRNA-1273 (NIH-Moderna) vaccines in IBD patients enrolled in an ongoing SARS-CoV-2 sero-survey at the Icahn School of Medicine at Mount Sinai in New York City. Design We obtained sera from 48 patients who had undergone vaccination with one or two vaccine doses. Sera were tested for SARS-CoV-2 anti-RBD total immunoglobulins and IgG (Siemens COV2T and sCOVG assays), anti-Spike IgG (in-house ELISA), and anti-nucleocapsid antibodies (Roche). Results All IBD patients (15/15) who completed two-dose vaccine schedules achieved seroconversion to high levels. Two IBD patients with history of COVID-19 infections and who were seropositive at baseline seroconverted to high levels after the first dose. Concurrent biologic use was 85% (41/48), including 33% of patients (16) on TNF antagonist monotherapy, 42% (17) on vedolizumab monotherapy, 6% (3) on vedolizumab combination therapy with thiopurine, and 8% (4) ustekinumab; 1 patient was receiving guselkumab for psoriasis. Three patients (6%) were on oral steroids at the time of vaccination. Conclusion IBD patients receiving biologics can seroconvert with robust serological responses after complete Pfizer-BioNTech and NIH-Moderna COVID-19 vaccination. In IBD-patients with previous SARS-CoV-2 seroconversion, a single dose of either vaccine can induce high index values, mirroring findings from the general population.

The drugs used here are different from most MS drugs but just because you are on an immunomodulator doesnt mean you can’t respond to vaccination. We now know some MS drugs are as expected problematic

Don’t have the vaccine, catch COVID-19 and you may suffer long-term consequences of long-covid even if young

Objectives: The objective of this study was to establish the long-term effects of Covid-19 following hospitalisation and the impact these may have on patient reported outcome measures.

Design: A multicentre, prospective cohort study with at least 3 months follow-up of participants admitted to hospital between 5th February 2020 and 5th October 2020.

Setting: 31 hospitals in the United Kingdom.

Participants: 327 hospitalised participants discharged alive from hospital with confirmed/high likelihood SARS-CoV-2 infection. Main outcome measures and comparisons: The primary outcome was self-reported recovery at least ninety days after initial Covid-19 symptom onset. Secondary outcomes included new symptoms, new or increased disability (Washington group short scale), breathlessness (MRC Dyspnoea scale) and quality of life (EQ5D-5L). We compared these outcome measures across age, comorbidity status and in-hospital Covid-19 severity to identify groups at highest risk of developing long-term difficulties. Multilevel logistic and linear regression models were built to adjust for the effects of patient and centre level risk factors on these outcomes.

Results: In total 53.7% (443/824) contacted participants responded, yielding 73.8% (327/443) responses with follow-up of 90 days or more from symptom onset. The median time between symptom onset of initial illness and completing the participant questionnaire was 222 days (Interquartile range (IQR) 189 to 269 days). In total, 54.7% (179/327) of participants reported they did not feel fully recovered. Persistent symptoms were reported by 93.3% (305/325) of participants, with fatigue the most common (82.8%, 255/308), followed by breathlessness (53.5%, 175/327). 46.8% (153/327) reported an increase in MRC dyspnoea scale of at least one grade. New or worse disability was reported by 24.2% (79/327) of participants. Overall (EQ5D-5L) summary index was significantly worse at the time of follow-up (median difference 0.1 points on a scale of 0 to 1, IQR: -0.2 to 0.0). Females under the age of 50 years were five times less likely to report feeling recovered (adjusted OR 5.09, 95% CI 1.64 to 15.74), were more likely to have greater disability (adjusted OR 4.22, 95% CI 1.12 to 15.94), twice as likely to report worse fatigue (adjusted OR 2.06, 95% CI 0.81 to 3.31) and seven times more likely to become more breathless (adjusted OR 7.15, 95% CI 2.24 to 22.83) than men of the same age.

Conclusions: Survivors of Covid-19 experienced long-term symptoms, new disability, increased breathlessness, and reduced quality of life. These findings were present even in young, previously healthy working age adults, and were most common in younger females.

Disability is a major risk factor for COVID-19 along with the stand risks of the general population

COVID-19 in multiple sclerosis and neuromyelitis optica spectrum disorder patients in Latin America: COVID-19 in MS and NMOSD patients in LATAM.Alonso R, Silva B, Garcea O, Diaz PEC, Dos Passos GR, Navarro DAR, Valle LAG, Salinas LCR, Negrotto L, Luetic G, Tkachuk VA, Míguez J, de Bedoya FHD, Goiry LG, Sánchez NER, Burgos M, Steinberg J, Balbuena ME, Alvarez PM, López PA, Ysrraelit MC, León RA, Cohen AB, Gracia F, Molina O, Casas M, Deri NH, Pappolla A, Patrucco L, Cristiano E, Tavolini D, Nadur D, Granda AMT, Weiser R, Cassará FP, Sinay V, Rodríguez CC, Lazaro LG, Menichini ML, Piedrabuena R, Escobar GO, Carrá A, Chertcoff A, Pujols BS, Vrech C, Tarulla A, Carvajal R, Mainella C, Becker J, Peeters LM, Walton C, Serena MA, Nuñez S, Rojas JI.Mult Scler Relat Disord. 2021 Mar 7;51:102886.

Background: There is no data regarding COVID-19 in Multiple Sclerosis (MS) and neuromyelitis optica spectrum disorder (NMOSD) patients in Latin America.

Objective: The objective of this study was to describe the clinical characteristics and outcomes of patients included in RELACOEM, a LATAM registry of MS and NMOSD patients infected with COVID-19.

Methods: RELACOEM is a longitudinal, strictly observational registry of MS and NMOSD patients who suffer COVID-19 and Dengue in LATAM. Inclusion criteria to the registry were either: (1) a biologically confirmed COVID-19 diagnosis based on a positive result of a COVID-19 polymerase chain reaction (PCR) test on a nasopharyngeal swab; or (2) COVID-19-typical symptoms (triad of cough, fever, and asthenia) in an epidemic zone of COVID-19. Descriptive statistics were performed on demographic and clinical variables. The cohort was later stratified for MS and NMOSD and univariate and multivariate logistic regression analysis was performed to identify variables associated with hospitalizations/intensive critical units (ICU) admission.

Results: 145 patients were included in the registry from 15 countries and 51 treating physicians. A total of 129 (89%) were MS patients and 16 (11%) NMOSD. 81.4% patients had confirmed COVID-19 and 18.6% were suspected cases. 23 (15.8%) patients were hospitalized, 9 (6.2%) required ICU and 5 (3.4 %) died due to COVID-19. In MS patients, greater age (OR 1.17, 95% CI 1.05 – 1.25) and disease duration (OR 1.39, 95%CI 1.14-1.69) were associated with hospitalization/ICU. In NMOSD patients, a greater age (54.3 vs. 36 years, p=<0.001), increased EDSS (5.5 vs 2.9, p=0.0012) and disease duration (18.5 vs. 10.3 years, p=0.001) were significantly associated with hospitalization/ICU.

Conclusion: we found that in MS patients, age and disease duration was associated with hospitalization and ICU admission requirement, while age, disease duration and EDSS was associated in NMOSD.

You already know this but replication of this is important

Camara et al. Differential effects of the second SARS-CoV-2 mRNA vaccine dose on T cell immunity in naive and COVID-19 recovered individuals. MedRXiv https://doi.org/10.1101/2021.03.22.436441

The rapid development and deployment of mRNA-based vaccines against the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) led to the design of accelerated vaccination schedules that have been extremely effective in naive individuals. While a two-dose immunization regimen with the BNT162b2 (Pfizer) vaccine has been demonstrated to provide a 95% efficacy in naive individuals, the effects of the second vaccine dose in individuals who have previously recovered from natural SARS-CoV-2 infection has been questioned. Here we characterized SARS-CoV-2 spike-specific humoral and cellular immunity in naive and previously infected individuals during full BNT162b2 vaccination. Our results demonstrate that the second dose increases both the humoral and cellular immunity in naive individuals.

T cell response after vaccinations

If you have had a serous COVID19 infection the changes are you get most of your response has been generated by the first jab. This have been repeatedly shown. However, it would mean you need to monitor your levels to know about the merits of not having the second jab, so it is simpler to give every body the jab

Meeces

Finally for the week….Yippie. The Brazilian and South Afrianc variants can now infect mice…The B1.351 and P.1 variants extend SARS-CoV-2 host range to mice. Montagutelli et al. BioRXIV doi: https://doi.org/10.1101/2021.03.18.436013. Now that means a new cottage industry for the mousers, but it is terrible news because it increases the range of infection. So when COVID-19 infected people start snogging Sheep and Cows it could mean bad news in future. Sadly when animals get infected there is no Lockdown for them, it is usually dead in a ditch…Look at the Danish Mink Industry as a good example or Swine Flu in pigs. I’ll make sure the Meeces are a snog-free zone. In fact we work with them in protective hoods which filters their air to remove viruses, keeping the mice clear of our infections.

Head to Head

Seroconversion after the pfizer and zeneca jabs

Quantitative SARS-CoV-2 anti-spike responses to Pfizer-BioNTech and Oxford-AstraZeneca vaccines by previous infection statusEyre, D. W., Lumley, S. F., Wei, J., Cox, S., James, T., Justice, A., Jesuthasan, G., O’Donnell, D., Howarth, A., Hatch, S. B., Marsden, B. D., Jones, E. Y., Stuart, D. I., Ebner, D., Hoosdally, S., Crook, D., Peto, T. E., Walker, T. M., Stoesser, N. E., Matthews, P. C., Pouwels, K. B., Walker, A. S., Jeffery, K.10.1101/2021.03.21.21254061 — Posted: 2021-03-26

Objectives We investigate determinants of SARS-CoV-2 anti-spike IgG responses in healthcare workers (HCWs) following one or two doses of Pfizer-BioNTech or Oxford-AstraZeneca vaccines. Methods HCWs participating in regular SARS-CoV-2 PCR and antibody testing were invited for serological testing prior to first and second vaccination, and 4 weeks post-vaccination if receiving a 12-week dosing interval. Quantitative post-vaccination anti-spike antibody responses were measured using the Abbott SARS-CoV-2 IgG II Quant assay (detection threshold: ≥50 AU/ml). We used multivariable logistic regression to identify predictors of seropositivity and generalised additive models to track antibody responses over time. Results Vaccine uptake was 80%, but less in lower-paid roles and Black, south Asian and minority ethnic groups. 3570/3610(98.9%) HCWs were seropositive >14 days post-first vaccination and prior to second vaccination, 2706/2720(99.5%) after Pfizer-BioNTech and 864/890(97.1%) following OxfordAstraZeneca vaccines. Previously infected and younger HCWs were more likely to test seropositive post-first vaccination, with no evidence of differences by sex or ethnicity. All 470 HCWs tested >14 days after second vaccine were seropositive. Quantitative antibody responses were higher after previous infection: median(IQR) >21 days post-first Pfizer-BioNTech 14,604(7644-22,291) AU/ml vs. 1028(564-1985) AU/ml without prior infection (p<0.001). Oxford-AstraZeneca vaccine recipients had lower readings post-first dose compared to Pfizer-BioNTech, with and without previous infection, 10,095(5354-17,096) and 435(203-962) AU/ml respectively (both p<0.001 vs. Pfizer-BioNTech). Antibody responses post-second vaccination were similar to those after prior infection and one vaccine dose. Conclusions Vaccination leads to detectable anti-spike antibodies in nearly all adult HCWs. Whether differences in response impact vaccine efficacy needs further study.

This shows that the antibody levles are higher with the pfizer ja than the zeneca jab

Lastly and Update the UK Regulators don’t think there are any extra problems for people with MS

Freedom of Information request on Covid Vaccines, Stage 3 results and MS (FOI 20-580)

Published 24 March 2021

Thank you for your email.

MHRA has published information on the populations that have received the vaccine in the clinical trials, including any illnesses and medication they were receiving, and any adverse events experienced since receiving the vaccine. This information is available in the Public Assessment Reports (PARs) for the Pfizer/BioNTech and Oxford/AstraZeneca vaccines, which are accessible via the relevant links below. https://www.gov.uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19 https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-astrazeneca

Additionally, the study results from the Pfizer/BioNTech vaccine (including the patients populations and any adverse events experienced) are available in a peer-reviewed journal, the New England Journal of Medicine. A link to this is provided below: https://www.nejm.org/doi/full/10.1056/NEJMoa2034577?query=featured_home

“So a cop out statement ….the MHRA must have got lessons from the Home Office (They evade the question about why I get stopped every time I enter the UK….I have changed my name by Deed poll as a result..I bet it doesn’t make a difference)…cos I don’t remember MS being mentioned in the about reports”

Based on the data received, advice has been given for use of the vaccines in individual patient groups in the Information for Healthcare Practitioners and Information for Recipients of the Vaccine. The Information for Healthcare Practitioners and Information for Recipients of the Vaccine for the Pfizer/BioNTech, Oxford/AstraZeneca and Moderna vaccines can be accessed via the below links: https://www.gov.uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19 https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-astrazeneca https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-moderna

There is no specific precaution or contraindication on the use of any of the authorised vaccines in patients with multiple sclerosis (MS). The vaccine is safe to administer to patients with MS and patients on immunosuppressants. The only relevant precaution in the Information for Healthcare Practitioners states “Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the vaccine. No data are available about concomitant use of immunosuppressants.”

This says they have perhaps given no thought to this, because it is obvious that some people will have extra issues because of fever and the effect it has on demyelinated nerve. People with MS can expect the usual vaccination signs that occurs in some people like headache, pain at the injection site. Prof Anat Achirion from Israel has presented data that 4-6% of (unntreated individuals) people getting the pfizer jab have worsening of neurological signs

If you have a query about the information provided, please reply to this email.

If you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date you receive this response and addressed to: info@mhra.gov.uk

Please remember to quote the reference number above in any future communications.

If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision. Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review. The Information Commissioner can be contacted at:

Information Commissioner’s Office Wycliffe House Water Lane Wilmslow Cheshire SK9 5AF

Yours sincerely

MHRA Customer Service Centre Medicines and Healthcare products Regulatory Agency 10 South Colonnade, Canary Wharf, London E14 4PU Telephone 0203 080 6000

About the author

MouseDoctor

14 comments

  • Excellent read MD. I am quite enjoying the new format….short bursts of information followed by your insights. Perfect!

    I was also pleased to read the news this week related to cladribine and vaccine responses. I was unable to obtain access to a vaccine prior to initiating clad, which I will be taking my first course next week. Yay!

    However, once I am able to get the vaccine, I do wonder if there are any lingering effects from Ocrelizumab that might still impact my vaccine response. Despite stopping Ocrelizumab over 14 months ago, my circulating CD-19 B cells remain below baseline levels. Most likely a result of Teri than lingering anti CD-20🧐

    Lastly, I was a bit saddened by Prof. G announcing he will be stepping back from the blog, yet also very understandable. I only hope his passion, advocacy, and drive to cure MS can truly be passed down to new generation….Prof. G is one of those influential thinkers/leaders that only come around once in a life time.

    • Self description =”Creative thinker, innovator, entrepreneur and problem solver always open to new consultancy or career opportunities in the field of Vaccines”
      “Always open to new consultancy” Sounds like abit of a pharma whore and a bit of a t**t…and only 5 papers on pubmed…sounds like a bit of an opinionated t**t:-)

      The Canadians were burned with CCSVI and I guess are ready for social media and what do they say….Sounds like they think Dr Geert is abit of a t**t….Can you trust someone with a basin cut?:-)
      https://www.mcgill.ca/oss/article/covid-19-critical-thinking-pseudoscience/doomsday-prophecy-dr-geert-vanden-bossche

      I cant be bothered to read his guff…will vaccines make viral escape mutants…isn’t that called natural selection?

        • I think your bias training is fine! Calling BS for what it is it not bias (especially if they have a basin cut 😉).
          Amazingly enough many viruses make mutants, it is what they do, even without vaccines. It comes from not having a good proof-reading enzyme when they are replicating, and some times they get lucky and randomly make one that confers some kind of advantage, so it becomes a dominant strain. The point is that the more the virus gets to replicate, the greater the chance of a random error and the greater the chance it will be one that coders an advantage. The vaccines help us shut down the viral replication process faster, so less chance of any mutants.

  • Is there work going on in the MS community to look at T cell responses on anti CD20?

    I had a gap of 9 months from ocrelizumab to Pfizer vaccine, and had my two doses 3 weeks apart. Prior to this I had only had my 2 half infusions and my first full.

    What are my chances of a vaccine response? I was feeling hopeful until I read this

    • Thanks we know it works….and it can be done by post and have had positives from stuff stored at room temperature for 3 months

      • Well someone should inform the media outlets. Or at least share the science with one of the greedy…I mean philanthropic, pharmaceutical companies.

        I know all of our donations and efforts (shout out to the warrior Kit) helped with funding Dr. A blood spot tests for the Barts MS population, however, why not offer the test commercially or even privately to all pwms, for a fee. Lack of staffing and resources for that type of scaling I guess…..

        I am willing to consent and pay whatever the cost!!!!

  • ‘Prof Anat Achirion from Israel has presented data that 4-6% of (unntreated individuals) people getting the pfizer jab have worsening of neurological signs’

    I had the Pfizer jab 37 days ago and started relapsing with new symptoms yesterday, but if it’s connected would it take that long?

    • Worsening of symptoms would be Uthoffs which should be quick. In terms of whether it is a relapse, which has occured in a few people in the Achirion group who were untreated. Is this vaccine related or would it occurred anyway, is the harder one to answer

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