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New contraindication for Covishield vaccine

M3 India Newsdesk Jul 28, 2021

AstraZeneca's COVID-19 vaccine, Vaxzevria, Covishield's counterpart, authorised in the EU has benefits that outweigh the risks in adults of all age groups. However, there have been some cases of side effects that have presented recently. This article discusses the effect of the vaccine along with the precautions that should be taken into account before administering it to some people.

For our comprehensive coverage and latest updates on COVID-19 click here.


Introduction

The Oxford-AstraZeneca COVID-19 vaccine, which was recently renamed Vaxzevria, is a two-dose vaccination developed in collaboration with the Oxford Vaccine Group and the pharmaceutical firm AstraZeneca. It was designed to protect against the SARS-CoV-2 virus. Covishield, that was developed by the Serum Institute of India, is a local equivalent of the Oxford-AstraZeneca vaccine. AstraZeneca-Covishield is manufactured in a similar manner as AstraZeneca-Vaxzevria (AstraZeneca's vaccine) and have the same components as AstraZeneca-Vaxzevria. 


Capillary leak syndrome & COVID vaccine: What's the connection?

People who have previously suffered capillary leak syndrome should not be vaccinated with Vaxzevria (formerly COVID-19 Vaccine AstraZeneca), according to the European Medicine Agency's EMA's safety committee Pharmacovigilance Risk Assessment Committee (PRAC). The Committee also determined that capillary leak syndrome (CLS) should be listed as a new adverse effect of the vaccination in the product material, along with a warning to increase awareness of the risk among healthcare professionals and patients.


Effects of the vaccine

  1. Six cases of capillary leak syndrome in patients who had taken Vaxzevria were examined in depth by the Committee. The majority of incidents were in women and occurred within four days following immunisation. Three of the people who were afflicted had a history of capillary leak syndrome, and one of them died as a result.
  2. Acute limb oedema, haemoconcentration, hypoalbuminaemia, and hypotension are all symptoms of CLS, which can lead to organ damage. Acute CLS as a result of immunisation needs immediate medical attention and, in most cases, extensive supportive treatment. The signs and symptoms of capillary leak syndrome, as well as the likelihood of recurrence in patients who have previously been diagnosed with the illness, should be known to healthcare providers.
  3. If those who have been vaccinated with Vaxzevria experience sudden swelling of the arms and legs or abrupt weight increase in the days after immunisation, they should seek medical help right away. These symptoms are frequently linked to a sensation of dizziness (due to low blood pressure).
  4. The PRAC will continue to look for cases of the disease and will take any required measures. The PRAC has also requested more information from AstraZeneca, the firm that markets Vaxzevria, concerning a probable mechanism for the development of capillary leak syndrome after immunisation.
  5. According to Health Canada, these vaccinations are contraindicated for persons who have had a prior case of CLS.

Clinical nuggets

  1. The European Medicines Agency (EMA) has looked at cases of capillary leak syndrome in persons who got Vaxzevria (formerly COVID-19 Vaccine AstraZeneca).
  2. Vaxzevria should not be given to anyone who has had a history of capillary leak syndrome.
  3. Capillary leak syndrome is an uncommon but dangerous disease that, if left untreated, can be deadly. It causes fluid leakage from the capillaries, which may lead to oedema, hypotension, haemoconcentration, and hypoalbuminaemia, usually in the limbs.
  4. Healthcare providers should be aware of the possibility of capillary leak syndrome recurrence in patients who have already had it.
  5. Healthcare providers should be aware of capillary leak syndrome's indications and symptoms. Patients who get an acute episode of capillary leak syndrome after immunisation need to be treated very once, and they may need to be monitored by a professional and given extensive supportive care.
  6. Healthcare providers should inform vaccine recipients that they should seek medical assistance if they have any of the following symptoms in the days following immunisation, which might be related to feeling faint (due to low blood pressure):
    1. Oedema (swelling) of the extremities
    2. Unexpected weight increase
  7. The product information will be revised to include a warning for those who have had capillary leak syndrome in the past. Aside from that, the condition will be mentioned as a side effect with an uncertain frequency.

Click here to see references

 

Disclaimer- The views and opinions expressed in this article are those of the author's and do not necessarily reflect the official policy or position of M3 India.

The author is a practising super specialist from New Delhi.

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