The Pfizer/BioNTech vaccine
This week’s experts:
Dr Gary Grohmann, Virologist; Vaccine Manufacturing Expert; Former Director of Immunobiology and WHO ERL at the TGA, Office of Laboratories and Scientific Services
Drawn from Dr David Lim’s interview with Dr Gary Grohmann on the Healthed Podcast, ‘Going Viral’.
– Recent headlines that claim the new Pfizer/BioNTech COVID-19 vaccine has 90% efficacy are based on very early data on only a very small number of trial participants (90)
– Important to wait and see the results of the whole data set, the published findings and peer review
– Also important to distinguish between efficacy (which is determined under ideal conditions) and effectiveness (which are the results under real world conditions)
– Based on the experience with other vaccines eg the influenza vaccine the effectiveness of a vaccine is often significantly less than the reported efficacy. In the case of the Pfizer/BioNTech COVID-19 vaccine, if the current efficacy predictions prove true, it should be expected the effectiveness will be between 50 and 80%.
– The Pfizer/BioNTech vaccine has been developed in the US and Germany, two countries with strong regulatory systems of both research and registration, so we can have confidence in the process of development, approval and production
– If all goes to plan, the new vaccine may get FDA approval around March 2021 but it is unlikely to be manufactured in sufficient numbers until much later in the year.
– The new vaccine is an mRNA vaccine which needs to be stored at -80oC immediately after manufacture. At distribution sites it will need to be kept at -20oC before being thawed to 4oC just prior to being given. This presents logistical challenges that need to be planned for.
– The Australian government has invested in a number of potential COVID-19 vaccines to ensure they are not putting all their eggs in one basket
– Whichever COVID-19 vaccine is delivered here in Australia, there will not be 100% effectiveness so infection control measures such hand-hygiene, social distancing and registering at restaurants will continue to be important.