CME INDIA Presentation by Dr S K Gupta, MBBS MD (Med), CFM (France), Senior Consultant Physician Hosp, Delhi.
Migraine and Covid vaccine
- Headache is a very common side effect of currently approved Covid Vaccines The leaflet insert of Covishield (AstraZeneca Oxford) lists headache among common adverse events encountered in more than 1 in 10 people after vaccination. Practically speaking incidence is far more than listed, Unpublished reports say headache is being seen in more than 50%people. Pfizer openly admits that ~64.5% people reported headache after the jab.
- Those who have migraine, are concerned about the headache as side effect they experience after getting the shot.
- That worry is totally understandable; most people with migraine know that anything that could cause a headache in someone else — a virus, an infection, not getting adequate sleep, too much caffeine, not enough caffeine stress — is quite often a trigger for them that can cause a migraine attack.
- Hence, it is possible that the current Covid vaccines may precipitate migraine. Usually, it is mild and likely to subside in a day or two with usual medications.
- Rare instance of debilitating and prolonged headaches requiring neurological intervention and imaging studies have been reported in Social Media.
- The physicians as well as patients should be aware and take an informed decision especially in tropical climate of India where incidence of headache is bound to increase in approaching Summers.
- Though no agency has advised deferring the Covid vaccine solely due to migraine. But it may prudent to postpone the same at least till acute attack subsides completely.
The COVID-19 vaccines are safe for people with Multiple Sclerosis MS
- None of the available vaccines contain live virus and the vaccines will not cause COVID-19.
- The vaccines are not likely to trigger an MS relapse or have any impact on long-term disease progression.
- The risk of getting COVID-19 far outweighs any risk of having an MS relapse from the vaccine.
- Any vaccine can cause side effects, including a fever. A fever can make MS symptoms worse temporarily, but they should return to prior levels after the fever is gone.
- Even if one has side effects, it’s important to get the second dose of the vaccine for it to be effective.
- The vaccines are safe to use with MS medications
- Continue disease modifying therapy (DMT) unless one is advised by MS healthcare provider to stop or delay it. Stopping some DMTs abruptly can cause severe increase in disability with new lesions on MRI.
- Based on data from previous studies of other vaccines and DMTs, getting the COVID-19 vaccine while on any DMT is safe.
- Some DMTs may make the vaccine less effective but it will still provide some protection. For those taking Kesimpta, Lemtrada, Ocrevus, or Rituxan— consider coordinating the timing of vaccine with the timing of DMT dose.
Any preferred vaccine for those living with MS
- Any of the authorized vaccines is safe to get. There is no vaccine preference.
Special Note on Methyl prednisolone
- Use of methylprednisolone include
- Medrol 4mg (oral),
- Depo-Medrol (Methyl Prednisolone Acetate 20mg in 1mL) I/M or IV 40 to 80 mg,
- Solu-Medrol Intravenous methylprednisolone Sodium Succinate 1gm vial
- Half-life of Methyl Prednisolone: Mean elimination half-life ranges from 2.4 to 3.5 hours in normal healthy adults and appears to be independent of the route of administration, hence all the drug should get cleared within 13 to 20 hours. (Drug is metabolised in Liver so dose need not be adjusted in Renal patients)
- It takes approximately 5.5 times the elimination half-life for a medicine to be cleared from body which is (5.5 x 2.5 hours) 13.75 hours to (5.5 x 3.5 hours) 19.25 hours
- Hence, the Vaccination should be planned in such a manner that immunosuppressive effects of steroid injection have little chance of interfering with development of Antibodies after a vaccine.
- Do not receive a “live” vaccine while using Methyl Prednisolone. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.
Covid Vaccine in patients of Multiple Sclerosis taking Disease Modifying Treatment (DMTs)
- Evidence on the impact of DMTs in patients of MS on COVID-19 severity
- Interferons (Avonex, Betaseron, Extavia, Plegridy, Rebif) and glatiramer acetate (Copaxone) are unlikely to impact negatively on COVID-19 severity. There is some preliminary evidence that interferons may reduce the need for hospitalization due to COVID-19.
- The evidence available suggests that people with MS taking dimethyl fumarate (Tecfidera), diroximel fumarate (Vumerity), teriflunomide (Aubagio), fingolimod (Gilenya), natalizumab (Tysabri), ozanimod (Zeposia) and siponimod (Mayzent) do not have an increased risk of more severe COVID-19 symptoms.
- There is some evidence that therapies that target CD20 – ocrelizumab (Ocrevus) and rituximab (Rituxan)– may be linked to an increased chance of having a more severe form of COVID-19.
- However, these therapies should still be considered as an option for treating MS during the pandemic.
- People with MS who are taking them or ofatumumab (Kesimpta) that works in the same way, should be particularly vigilant regarding the advice here to reduce their risk of infection.
- More data on the use of alemtuzumab (Lemtrada) and cladribine (Mavenclad) during the COVID-19 pandemic are required to make any assessment of their safety. People with MS who are currently taking these therapies and are living in a community with a COVID-19 outbreak should discuss their current lymphocyte counts with their healthcare professional. If their counts are considered to be low, they should isolate as much as possible to reduce their risk.
- In case of Collagen Vascular Disorders American College of Rheumatology recommends stopping Rituximab and similar drugs 4 weeks after each dose of vaccinations.
- Recommendations on delaying second or further doses of alemtuzumab, cladribine, ocrelizumab and rituximab due to the COVID-19 outbreak differ between countries.
- Second dose of Vaccine: People who take these medications and are due for the next dose should consult their healthcare professional about the risks and benefits of postponing treatment.
- People are strongly encouraged not to stop treatment without the advice of their clinician
COVID-19 Vaccination and Neuropathy especially Guillain Barre Syndrome.
- Anthony Fauci, MD in early December 2020 said “that people who have had Guillain-Barré syndrome (GBS) should avoid the SARS-CoV-2 vaccines because they might trigger a recurrence of the disease”. He faced severe criticism from experts who presented with data on the contrary.
- Later in mid-January he set the record straight saying that he had misspoken. Dr Fauci finally said “I have a sense that people who develop any neurological complications will want to attribute it to the vaccines rather than to serendipity. People have very strong feelings about vaccines.”
- Source of the Trigger Evidence:
- Concerns about the risk of GBS in response to vaccines date back to 1976, when CDC has noted “there was a small increased risk of GBS after swine flu vaccination,”. Later It was found that risk of GBS was no more than 1 additional case per one lakh doses of vaccine. Hence the CDC later corrected itself stating “Studies suggested that it is more likely that a person will get GBS after getting the flu than after vaccination.”
- On June 25, 2020, the New England Journal of Medicine published a letter from Italian physicians reporting five cases of GBS among more than 1000 patients admitted in 3 weeks period from Feb 2020 onwards.
- Counter Evidence:
- On December 14, however, the journal Brain published an epidemiological study which found that the incidence of GBS in the United Kingdom actually fell by 50% during the first wave of COVID-19 between March and May 20 compared to the same period during the past four years.
- During 2nd wave too, in October to December 2020, when UK saw up to 60,000 cases a day of COVID-19 the data for GBS remained entirely flat. If there had been a link of COVID-19 to GBS, one would expect the number of cases of GBS to increase during pandemic. There’s not even a bump.
- With billions of the world’s populations having been immunized one would have got thousands and thousands of cases of GBS associated with the vaccine if both had any correlation. However, not more than one case of post vaccination GBS has been reported to CDC till date.
- CDC is of the view that no instances of GBS were seen during clinical trials of the vaccines, that no published studies suggest any cause for concern, and that neither the CDC nor FDA recommends against the vaccine due to GBS.
- Concerns that COVID vaccination might cause GBS in any significant numbers are therefore almost certainly unfounded. Scientists are studying the risk to benefit ratio of the vaccine in someone who previously developed Guillain Barré syndrome after a vaccination.
Covid-19 Vaccination in Epilepsy
- No study to date has assessed the COVID-19 vaccine in patients with epilepsy.
- Epilepsy does not increase the risk of contracting COVID-19.
- There is currently no evidence to suggest that epilepsy is specifically associated with a higher risk of side effects from a COVID-19 vaccine. There is no evidence that this vaccination results in worsening of the epilepsy, or brain injury.
- For people with epilepsy, the risk of COVID-19 infection and potential complications far outweighs the risk of side effects from a COVID-19 vaccine.
- Are people having Epilepsy at Higher Risk of Side Effects of Vaccine? – There is no evidence that persons with epilepsy are at higher risk of side effects after vaccination. As with any vaccine, some persons may develop a fever which could lower their seizure threshold for the short term, and rarely could result in a break-through seizure.
- Should people with Febrile Seizures Avoid Getting the COVID Vaccine? – Fever is a common side effect after getting a vaccine. And it may precipitate Seizure in some people with epilepsy.
- The available data on safety still support vaccination. If someone has seizures triggered by fever, it may be good to talk to one’s health care provider to assess risk benefit. Presumptive use of Paracetamol for 48 hours following vaccination could be helpful and may be considered on individual basis.
- Further, it is recommended to receive the vaccine, at such as a location where medical staff are available with a Seizure Action Plan including rescue therapies
Covid Vaccine and Zoster
Herpes zoster following COVID‐19 vaccine: Coincidence or reactivation of dormant infection?
- Since the start of Corona Vaccination large number of cases of Zoster (Shingles) are being reported. Is it mare coincidence or real awakening of latent Herpes virus by Vaccine related immunomodulation?
- According to Google Trends, searches for the term “Covid shingles” hit peak popularity on the search engine in Mid Feb. Exact figures may not be available but search Trends on Google is enough indictor for the size of problem.
- Almost 1 out of 3 people will develop shingles in their lifetime. It is not surprising that shingles cases are appearing, since many of the millions of people across the world who have gotten their COVID-19 vaccine are older and risk of getting shingles increases with age. Almost certainly, those who got shingles did not have themselves Shingrix vaccinated. Infact, Vaccine has been out of supply for quite some time.
- Also, in general, the CDC advises that no other vaccines be given within 14 days of getting the COVID-19 vaccine.
- Review of literature doesn’t point to a constant pattern in appearance of Zoster and Covid/ Vaccination. Someone received the first dose of the COVID-19 vaccine, 20 days later, the user developed shingles. Patients however, are bound to think, it is probably not a coincidence. But for scientists, basal rate of disease, chronology of events and age factors are important too.
- Infectious disease specialists, hence disagree that this is cause and effect, but interest in the possible connection remains high.
- We have to differentiate medical events that might be causal from coincidence. So far, we don’t have any other events other than allergic reactions [linked to the vaccine] …is the opinion of a leading virologist from New York.
- Herpes zoster caused by reactivation of VZV may occur spontaneously or be triggered by trauma, stress, fever, or immunosuppression. It is well known that fever, stress are common side effects of current Covid vaccines.
- Also, outbreaks of shingles are also often linked to stress, stressful life events, and depressive symptoms — all of which have been common during the pandemic.
- Anyone who has had chickenpox is at risk for shingles. More than 99% of people born before 1980 have had chickenpox. Shingles happens when the varicella zoster virus, which causes chickenpox, is reactivated after lying dormant in Dorsal Root Ganglion in the body.
- On the other hand, case reports of three different cases of herpes virus reactivation following inactivated influenza, hepatitis A, and rabies with Japanese encephalitis vaccines. And Recently, VZV reactivation in immunocompetent cases during COVID‐19 infection has also been reported
Acyclovir Therapy and Covid-19 Vaccines
Some people on regular Herpes (ophthalmicus) prophylaxis with acyclovir 400mg are in dilemma to go ahead for Covid Vaccination or defer the same
Fears are twofold.
- Firstly, if anti-viral drugs acyclovir / Famciclovir /valacyclovir would render the vaccine less effective. Do these drugs have the potential to inactivate the adenovirus in Astra Zeneca /other vector-based vaccines making the vaccination ineffective.
- Fear appears unfounded as Adeno virus even in immunocompromised settings are managed by cidofovir, ribavirin, ganciclovir, and vidarabine.
- More importantly Adenovirus in vector-based Vaccines is Replication defective. Acyclovir which acts by inhibiting Viral DNA polymerase requires viral replication for its action.
- Expert from American Academy of Allergy, Asthma & Immunology clearly say that such therapy would not be a reason to delay the COVID-19 vaccine dose.
- Bharat Biotech Covaxin which has an inactivated virus or mRNA vaccines could be preferred choices in such settings.
- However, those having active Zoster may defer their vaccination until completion of treatment and recovery as CDC too advises to avoid Covid vaccine during active disease.
Bell’s palsy & Covid Vaccination
- Historical Evidence of Associations between influenza vaccines and Bell’s palsy among recipients of an *inactivated intranasal influenza vaccine was reported in a study conducted in 2000–01.
- Since this vaccine contained the Escherichia coli heat-labile toxin as a mucosal adjuvant, which undergoes retrograde neuronal uptake, it was suspected that heat-labile toxin could affect the seventh cranial nerve through such an interaction.
- However, the association between parenteral influenza vaccines and Bell’s palsy was not reproducible/confirmed.
- Over the decades other vaccines including meningococcal conjugate Vaccines when given with DPT etc have not shown significant association with Bell’s palsy.
- Why Concern for Bell’s Palsy with Covid Vaccine?
- Among nearly 40000 mRNA vaccine arm participants, there were seven Bell’s palsy cases compared with one Bell’s palsy case among placebo arm participants. This estimated rate ratio of roughly 7·0, suggested that mRNA vaccination might be associated with Bell’s palsy (p=0·07).
- Two vaccine recipients in the Johnson & Johnson Phase 3 clinical trial developed Bell’s palsy, as did two people in the placebo group.
- The FDA briefing on the Pfizer-BioNTech trial stated “observed frequency of reported Bell’s palsy in the vaccine group is consistent with the expected background rate in the general population.”
- Indian Scenario: A case of 50-year-old frontline worker developed Bell’s palsy after receiving the vaccine -Tribune 2nd April 2021.No statistically significant increase in Bell’s palsy due to the current COVID-19 vaccines has been shown in India. Had there been any temporal association between Covid vaccination and Bell’s Palsy we could been flooded with cases in view of ongoing number of Covid vaccinations daily.
- Vaccination in Special Situations of Bell’s Palsy.
- Patients with recurrent Bell’s palsy already on valacyclovir for prophylactic antiviral therapy may also be encouraged to take Covid Vaccine as vaccines offer a substantial net benefit to public health.
- Even for patients with a history of Bell’s palsy associated with HSV-1 or the varicella zoster virus, it is recommended to take vaccine against SARS-CoV-2.
- In people who develop COVID-19 there is increased risk of stroke and other neurological complications. By getting the vaccine, any potential risks are outweighed by the known neurologic risks of COVID-19.
- While robust surveillance for potential mRNA vaccine-associated Bell’s palsy should be continued please note that Bell’s palsy is usually self-resolving else can be treated with steroids.
COVID-19 related neurological disorders?
- In some people, response to the coronavirus has been shown to increase the risk of stroke, dementia, muscle and nerve damage encephalitis, and vascular disorders. Some researchers think the unbalanced immune system caused by reacting to the coronavirus may lead to autoimmune diseases, but it’s too early to tell.
- Anecdotal reports of other diseases and conditions that may be triggered by the immune system response to COVID-19 include para-infectious conditions that occur within days to a few weeks after infection:
- Multi-system inflammatory syndrome – which causes inflammation in the body’s blood vessels.
- Transverse myelitis – an inflammation of the spinal cord.
- Guillain-Barré syndrome (sometimes known as acute polyradiculoneuritis) – a rare neurological disorder which can range from brief weakness to nearly devastating paralysis, leaving the person unable to breathe independently.
- Dysautonomia – dysfunction of the autonomic nerve system, which is involved with functions such a breathing, heart rate, and temperature control.
- Acute disseminating encephalomyelitis (ADEM) – an attack on the protective myelin covering of nerve fibres in the brain and spinal cord.
- Acute necrotizing haemorrhagic encephalopathy – a rare type of brain disease that causes lesions in certain parts of the brain and bleeding (haemorrhage) that can cause tissue death (necrosis).
- Facial nerve palsies (lack of function of a facial nerve) such as Bell’s Palsy.
- Parkinson’s disease-like symptoms have been reported in a few individuals who had no family history or early signs of the disease.
- Central Venous Sinus Thrombosis and Astra Zeneca Covid Vaccine.
- In Europe, some patients developed cases of Central venous Sinus Thrombosis (CVST), Pulmonary embolism, Splanchnic Vein thrombosis, DVT etc following Astra Zeneca vaccine AZD1222.
- Most of the patients were women under age 55, and the fatality rate among those who develop clots is as high as 40%.
- Central Venous Sinus Thrombosis typically happens between four and 20 days after getting the Astra Zeneca vaccine and the symptoms mimic a stroke or a heart attack.
- Mechanism is probably AZD1222 vaccine induced prothrombotic state caused by development of platelet-activating antibodies directed against platelet factor 4 (PF4). This prothrombotic disorder clinically resembles heparin-induced thrombocytopenia but showing a different serological profile.
- Though instances of such thrombosis are rare but grave nature of complication makes it matter of concern
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