Developing a Vaccine for Covid-19. What To Expect?
Yves here. Let us hope the race to get a Covid-19 vaccine out does not give anti-vaxxers new talking points.
By Ignacio Moreno Echanove, an epidemiologist
Given the hype and hysteria about Covid-19 I tried to escape for a while from the tunnel vision we are immersed and have a general vision on what is going on with vaccines for Covid 19. I want to share with you what I have come to see in a long evening.
This won’t be comprehensive but an overall view with a critic eye on the existing possibilities with Covid-19 vaccines and their development timelines. I wonder how much matters who wins the race if there is a winner that takes it all. For instance, if the winner is the fastest but not the safest or simply the best. I also wonder as Dr. Shibo Jiang does in Nature (1, links below) if the run to deploy vaccines against Covid-19 might result in big mistakes. Jiang gives an idea of requirements to be fulfilled (direct quote from the article):
In my view, standard protocols are essential for safeguarding health. Before allowing use of a COVID-19 vaccine in humans, regulators should evaluate safety with a range of virus strains and in more than one animal model. They should also demand strong preclinical evidence that the experimental vaccines prevent infection, even though that will probably mean waiting weeks or even months for the models to become available.
He goes on to mention STANDARD GUIDELINES that should be respected and adds that many problems were found when SARS 1.0 vaccines were tried in ferrets, mice and monkeys. Developing a vaccine is not a straightforward procedure. His conclusion is: beware of hype about Covid-19 and proceed with due caution. I strongly recommend reading his letter to Nature in full. Not a long read.
The WHO provides with a document (2) that lists up to 44 vaccine candidates currently being developed for Covid-19 of which two have just initiated, in record time, clinical assays in humans. These probably prompted Mr. Jiang letter above as it seems these might have found shortcuts on their way to human assays. Interestingly, one is Chinese (3) and the other is American (4). Are both superpowers competing to demonstrate the world who is the fastest? The other 42 candidates listed in the document are being developed by private companies (some sponsored or owned by Big Pharma firms), public institutions and public/private partnerships around the world. It is a complex landscape with many interests involved. At least one of these includes a partnership between an American and a Chinese company. I like that! La crème de la crème au monde is in search for a vaccine and one should be confident that someday in a not distant future this will result in success. The WHO list also gives info on the technological platforms used to develop each vaccine, and in this sense, there is also wide variability: the whole existing vaccine toolbox (DNA, RNA, inactivated/attenuated virus, pseudo-virus and protein subunits of all flavours), is being tried to fight Covid-19. This is encouraging. In a few cases, the candidate uses a strategy that has been shown to work before against other respiratory virus including coronavirus. Even more encouraging! In other cases, the candidates are quite innovative with many associated unknowns.
So, it might be the case that at the end of the clinical selection procedures we have a bunch of candidates that prove protective, though we might miss the highly desirable characteristic of long-lasting protection. Successful candidates will differ on their easiness for en masse production & deployment, their levelized cost, their efficacy (degree and duration of protection), risk assessment of side effects, and very, very, few, if any, will make the final cut. Some technologies come with novel specialized inoculation instruments which imply longer and more expensive deployment time plus training. With more than one candidate available, further selection might depend on economic interests, political influence and, critically, on the speed with which any of these gets the approval. It has occurred before that excellent vaccines arrived too late. This, again, spells that there are strong incentives including political pressure to follow shortcuts that, as Dr. Jiang states could be disastrous. Besides the Chinese and American candidates, the Head of the EU Commission has announced fast-track procedures for a German-made candidate (5). Whether this is safe is highly questionable and I wonder why some projects run the fast track while others not. [This Aussie link (5) is worth a read]
So, human trails are being started just by now and more will come in May, June, July, September… but the WHO says that they wouldn’t expect nothing to be ready until mid-2021. In China several candidates are being tested in animals and at least one is about to enter phase I of clinical trials. With some hype it has been announced that an “emergency vaccine” could be ready by April as they start clinical trials (3). This must be the CanSino Inc. (Pseudovirus or non-replicating virus) vaccine candidate listed by the WHO document. If all goes OK with this candidate, large-scale deployment would lag another year so. In line with WHO timelines. The first candidate to start human trials is from US biotech company Moderna (RNA-based vaccine) in Seattle as has been announced today (4). In the pipeline, another candidate from Inovio Pharmaceutical Inc (DNA-based vaccine) will also start human trials in April in the US (6). To my knowledge none of these companies, including the Chinese one, has ever delivered a working vaccine before, though Invio has a MERS vaccine candidate in Phase III. When you are testing an innovative approach, special care should be taken to analyse their potential risks. Clickbait headlines announcing vaccines around the corner abound these days.
I wouldn’t like to end without mentioning the seemingly favourite EU Commission project (CureVac) that has just received 89M $ funding (7). This latest link merits a read as it highlights how inexistent the international coordination and cooperation so loudly touted in forums is. This project is, again, very innovative and to my knowledge this company has not ever delivered a commercial vaccine. Following the neoliberal playbook a few companies are being heavily financed with public + private funds and these are the first to reach clinical trials. What about some other projects managed by public institutions that have already delivered working vaccines before? Are these receiving similar support?
Conclusions: stay tuned but beware the hype and be cautious. Above all, demand strict risk assessment on vaccines before rushing for it!
(1) Don’t rush to deploy COVID-19 vaccines and drugs without sufficient safety guarantees
(2) DRAFT landscape of COVID-19 candidate vaccines –20March2020.
(3) Covid-19 Vaccine May Be Ready For Emergency Use By Apr, As China Claims Research Is Going Well
(4) First human trial for coronavirus vaccine begins Monday in the US
(5) A coronavirus vaccine trial in humans has begun. When could a COVID-19 shot be available? https://www.abc.net.au/news/2020-03-18/coronavirus-vaccine-human-trial-covid19-immunity-hopes/12067024
(6) Which Companies Are Working On A Covid-19 Vaccine?
(7) Curevac gets $89M funding offer from EU for COVID-19 vaccine, denies U.S. acquisition rumors