Speaker Dr. Lilliana Chocarro, is a Rotarian from the Rotary club of Oakville. She has worked in vaccine regulation, development/production & quality control, quality assurance, transition from R&D to production of clinical lots, and regulatory pathways. She has experience as a regulator, as a consultant to industry, to regulatory authorities, the International Vaccine Institute, the Bill and Melinda Gates Foundation [BMGF], and as a Senior staff and expert consultant to the World Health Organization. Established the African Vaccine Regulatory Forum (AVAREF) that created legal frameworks and processes for regulation of clinical trials in Africa. She is now working as an expert consultant to WHO helping coordinate activities related to the assessment of Covid-19 vaccines.
Main theme – FACTS AND FIGURES about the COVID 19 VIRUS
- Treatment vs prevention
Complex in a Public Health emergency where the growth of the virus is relatively unknown and there is less time for observation. This was the complication of COVID 19. See below for the infection rate in herd community when the virus is introduced into the community
See the first Square for an unprotected community. See next slide for the infection rate
Without vaccination the change in the colour represents the spread of infection within the community
Vaccine development cycle:
Phase 1 (safety) – ensuring that there is more good than harm
Phase 2 (efficacy) – Safety is still a focus but emphasis is put on effectiveness
Phase 3 (approval) – look at the other effects plus phase 1 and 2 and heavy review of benefits risk assessment.
The continuation in post vaccine creation monitoring has a high focus on the benefits risk assessment. In the case of COIVD vaccine is even more so because of the compressed release timeline. There are strict monitoring protocols, lots or regulation and enforced reporting requirements. However even with this structure people are still concerned about the following:
The speaker addressed each concern, there were some merit however the focus should be on benefits risk and of course its only with the continuous monitoring that we can see the effectiveness over time. With the variants this is also something that would be revealed over time the effectiveness of the vaccine against the variant.
Questions and answers:
Implication of the Vaccine for people with auto immune disease? – No answer at this time because clinical trials did not specifically look at that… the question returns to a benefit risk analysis and this will be the driver for assessing whether the vaccine should be taken.
Do the antibodies fade over time and will we need a booster? – The evidence must be collected because no one knows how long the vaccine will last. This will happen over time as the test group is observed and tested for antibodies level
Can we use the one dose from one manufacturer and one from another? - No evidence to support the effectiveness exist at this time.
Comparison with Spanish flu – Not sure, there was no vaccine, and the science was not available to support the level of data to do a proper compare. What is known was that it was easily transmissible and even back in 1918 they knew masks would be available
Johnson and Johnson requires only one vaccine can you comment whether this will cause better protection? – not fully sure if it will. The recommendation for use is based testing during the clinical trial.
Do cleaning products assist with killing the virus? – Soap and alcohol destroys the envelope of the virus and are effective in killing it
Is there on vaccine that is preferred over the other? – No response
What is the effectiveness of the lockdown in keeping down the virus? – Speaker spoke of the migrating from locked areas to other hence changes in the peak time. No definite answer
What can be done to stay as safe as possible beside wearing a mask and staying away from people? - Wash your hands and not touch your face , and continue to wear you mask and stay outdoors