The Independent Uganda: You get the Truth we Pay the Price
The road to approval
Though it doesn’t have the full picture, the U.S. FDA has said it will consider authorising the vaccine for emergency use – ahead of full approval – once the trial has collected two months’ worth of safety data on half of the participants. Pfizer expects to have this available by the third week of November.
The trial will also continue for many months to come – in order to reach that reliability threshold of 164 cases of disease – and there will be further follow-ups looking at the vaccine’s safety and the immune responses and protection it elicits in different groups of participants. This should give further transparent information and confidence on how well this vaccine works and in which populations.
If the vaccine’s safety and efficacy are looking good, it will then be submitted to regulatory agencies for full approval. The highest risk groups will then be first in line for immunisation. In the UK, this will likely include care home residents and workers, health and social care workers, and people over 80, assuming the vaccine is shown to be safe and effective in these groups. In Europe, prioritised groups include healthcare and essential workers, those vulnerable to the disease and socioeconomically disadvantaged people.
But even if approved, big challenges remain. Pfizer expects to have 50 million doses ready this year, enough to immunise 25 million people, and 1.3 billion by the end of 2021. Given the size of the world’s population – and the fact the vaccine requires two doses – universal coverage is a long way away.
The other vaccines in development therefore remain just as important. We will need more than one vaccine for global coverage, and to ensure we have the right one for each age and health cohort.
Overall, these results should be celebrated, but with the realisation that this is only one step in the journey. We still have a long way to go in getting the world back to normal – but the compass is pointing in the right direction.
****
Anne Moore is Senior Lecturer in Biochemistry and Cell Biology, University College Cork
Source: the conversation
