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Cancer treatment vaccines are a rapidly evolving field that offers a promising approach to immunotherapy. Unlike traditional vaccines that prevent diseases, cancer treatment vaccines are designed to treat existing cancers by stimulating the immune system to recognize and attack cancer cells.
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Body:In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...
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Covishield India: demystifying myths through an early multicenter study.

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The indigenously prepared Covishield vaccine showed no serious adverse effects in a 7-day follow-up study in India. Mild systemic effects like fatigue and myalgia were common but temporary, boosting vaccine confidence.

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Area of Science:

  • Immunology
  • Public Health
  • Vaccinology

Background:

  • India initiated nationwide COVID-19 vaccination on January 16, 2021, using vaccines like Covishield.
  • Covishield, developed by the Serum Institute of India, is based on the Oxford-AstraZeneca ChAdOx1 vaccine.

Purpose of the Study:

  • To assess the safety of the indigenously prepared Covishield vaccine in India.
  • To evaluate adverse and systemic effects following the first dose of Covishield.

Main Methods:

  • A multicenter observational descriptive study was conducted in northern and eastern India.
  • Participants receiving the first Covishield dose were monitored for 7 days via a participant-administered questionnaire.
  • The primary endpoint was the incidence of adverse or systemic effects within 7 days post-vaccination.

Main Results:

  • No serious adverse or systemic effects were reported within the 7-day follow-up period.
  • Nonserious systemic effects occurred in 42.0% of individuals, with myalgia/fatigue (25.7%) and fever (22.0%) being most common.
  • Systemic effects typically began 6-12 hours post-vaccination and did not appear beyond 48 hours; women and older adults tolerated vaccination better.

Conclusions:

  • The study found no serious adverse effects associated with the Covishield vaccine.
  • These findings can help alleviate concerns regarding vaccine acceptance and support global vaccination efforts.