We don’t know exactly when a COVID-19 vaccine will be ready for distribution, but a good guess would be mid-2021 – that’s not too far from today.
There have been some very encouraging news from several vaccine candidates and there are a dozen other vaccines now in Phase 3 clinical trials, also known as efficacy trials – the last stage before a developer can apply for regulatory approval or license.
This also means these vaccines have passed certain goalposts in terms of initial evaluations of safety and immune response (Phase 1 and Phase 2) that’s why they are now being evaluated in larger (Phase 3) trials.
We now know that the Pfizer/BioNTech mRNA vaccine and Moderna mRNA COVID-19 vaccine work.
Unfortunately, the results were announced via press releases, leaving many scientific questions unanswered. How well the vaccines work in older people or those with underlying conditions and their efficacy in preventing severe disease are promising but still unclear.
When these results are finally published in a peer-reviewed paper, these issues will be resolved but other questions will not be answerable for some time and that’s not unusual because researchers will continue to monitor the effectiveness and safety of these vaccines even after they become available in the market. The other vaccines still undergoing Phase 3 are also promising, but we still do not know if they are going to work.
That’s what the purpose of an efficacy trial is—as well as to provide a more comprehensive assessment of the safety of the vaccine in a large number of people.
Assuming all these vaccine candidates successfully pass Phase 3 – what next? National Regulatory Agencies (NRAs) like our Philippine Food and Drug Administration (FDA) must review the data for safety, efficacy, quality, and approve the vaccines before they can be given to people.
In parallel, the vaccines must be manufactured in large quantities (millions of doses), which will be a major challenge – all the while continuing to produce all the other important life-saving vaccines already in use. (Several of the COVID-19 vaccine developers are also the same companies manufacturing the vaccines we are already using). As a final step, vaccines will be distributed through a complex logistical process, with rigorous stock management and temperature control (cold chain).
It is thought that 60-70 percent of the global population must be immune (vaccinated or infected and recovered) to stop the virus from spreading easily and wreaking havoc. 2020 has been a year of challenges but it has also been a year of unprecedented scientific achievement. In less than 12 months, researchers have identified a novel disease, characterized a new virus’s genomic sequence, developed diagnostic tests and assays, produced treatment protocols, and established the efficacy of treatments and vaccines in randomized controlled clinical trials. This has never happened before in the history of science and the history of mankind.
If all goes well, the vaccine(s) is/are coming mid-2021 (perhaps even earlier)! In the meantime continue regularly washing your hands with soap and water (or hand sanitizer with at least 60% alcohol), continue keeping your distance from others, and continue wearing a mask properly (and the right kind of mask – no valve please).*
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Dr. Melvin Sanicas (@Vaccinologist) is a physician-scientist specializing in vaccines, infectious diseases, and global health.