COVID-19 Vaccines and their Early Use in Healthcare

A vaccine is a biological tool that trains the body’s immune system to defend against a particular pathogen. More than 40 new targeted vaccines are now in human trials to help people fight against and stop the spread of SARS-COV2 (novel coronavirus), which causes COVID-19. Health organizations of several countries provide regular updates on coronavirus vaccine development.

Dr. Hilary Marston (NIAID) presents large-cohort Expanded Access for Ebola

Vaccine Type – Inactivated virus

A form of the coronavirus that creates a targeted immune response but has been modified so that it does not spread or cause coronavirus disease (COVID-19)

Examples in Advanced Clinical Development

  • Sinovac
  • Wuhan Institute
  • Bharat

Vaccine Type – 
Viral vector

A plasmid containing instructions to produce antigens that mimic coronavirus and induce a targeted immune response

Examples in Advanced Clinical Development

  • Oxford/AZ
  • CanSino
  • Janssen
  • Gamaleya
 

Vaccine Type – 
RNA or DNA

Synthetic RNA or DNA designed to produce proteins that induce an immune response

Examples in Advanced Clinical Development

  • Moderna
  • Pfizer/BioNTech
  • CureVac

Vaccine Type – 
Protein

Non-viral protein fragments that create immunity against coronavirus

Examples in Advanced Clinical Development

  • Novavax
  • Sanofi/GSK
vaccines
As of November 2020, Emergency Use Authorization (EUA) in the US reviewed one of these corona vaccines’ status (Pfizer/BioNTech). EUA is a conditional license to market a newly regulated product during a declared health emergency, prior to the completion of the review process, required for regular market approval. EUA is a special form of early access, granted after the establishment of substantial clinical evidence of safety and efficacy. Vaccines for COVID-19 have to go through such processes before marketing the product.

The higher number of these products may currently meet the criteria for Expanded Access programs. Expanded Access programs (EAPs) are large, single-arm trials intended to provide medical options to patients who cannot get into regular clinical trials and face severe disease (or risk of disease) in the absence of the investigational product. One can initiate EAPs earlier in the development process than Emergency Use Authorization. They enroll and treat patients under an approved protocol, and all safety data is captured and reported.

covid 19 vaccine
covid 19 vaccine

In 2013 and 2014, the unlicensed meningococcal-B vaccine Bexsero was used as part of a 16,000 patient Expanded Access program to fight parallel meningitis outbreaks at two U.S. universities.
Internationally, an Expanded Access Program in the Democratic Republic of Congo has identified people with the highest exposure risks to the Ebola virus in that country and has enabled 275,000 individuals to access the rVSV-ZEBOV vaccine in parallel to the product’s ongoing clinical development.

Both examples may serve as models for modern, large-size Expanded Access programs for COVID-19 vaccines that are currently in Phase 2 or Phase 3 of clinical development.

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