There appears to be a consensus opinion among leading public health authorities that a coronavirus vaccine for COVID-19 would take at least 12-18 months to develop, test and be ready for market distribution. The projection assumes that an aggressive development schedule would produce a licensed vaccine proven safe and effective for use in humans no earlier than March-August 2021.
On Feb. 11, 2020, the director general of the World Health Organization (WHO), Dr. Tedros Ghebreyesus, said that the first vaccine for COVID-19 could be ready within 18 months.1 A week earlier Thomas Breuer, MD of British pharmaceutical corporation GlaxoSmithKline plc had noted that even if development of a vaccine for COVID-19 were to be done at an accelerated pace, approval of the vaccine would “take at least 12 to 18 months.”2
At a White House press conference on Feb. 25 Anthony Fauci, MD of the U.S. National Institutes of Health (NIH) estimated it would take “at least a year to a year and a half at best” to develop a vaccine for COVID-19.3 Dr. Fauci has subsequently reiterated this estimate on various occasions.4 5 6
Keep in mind that this time frame of 12 to 18 months is extremely ambitious even with the short cuts that are being taken—the elimination of normal government regulatory procedures designed to ensure the safety of vaccines and other pharmaceutical products. A good example of this “fast-tracking” is the elimination of testing vaccines on animals before proceeding to human trials.
In an article in Live Science, Nicoletta Lanese writes:
The lengthy process [of developing a vaccine] requires that scientists first give the vaccine to animals to determine whether it’s safe and effective at preventing the disease in question. Only after passing through iterative tests in animal models, and being adjusted along the way, can a formulation be tested in human trials.7
It normally takes 15 to 20 years to develop a vaccine, according to Mark Feinberg, president and CEO of the International AIDS Vaccine Initiative. “When you hear predictions about it taking at best a year or a year and a half to have a vaccine available, there’s no way to come close to those timelines unless we take new approaches,” Feinberg said.8
A recent article in The Vaccine Reaction highlighted some of the most advanced programs involved in developing a vaccine for COVID-19. All of those research efforts include skipping over the animal trials phase and going straight to human trials. Moderna, Inc. of Cambridge, Massachusetts began its human trials on Mar. 16, 2020 using an experimental mRNA COVID-19 vaccine. Several other companies will follow over the next few months, but none of them expect to have a final product ready for licensure by the U.S. Food and Drug Administration (FDA) this year.9
That’s why it was surprising to hear European Commission (EC) president Ursula von der Leyen say on Mar. 17 that she was hopeful a vaccine for COVID-19 could be available for use by September 2020. Following conversations with managers of German biotechnology firm CureVac AG, von de Leyen said:
The European Union provided them (CureVac) up to €80 million ($89.4 million), and I hope that, with this support, we can have a vaccine on the market perhaps before autumn.10
She added, “They are highly specialized in this field, and it’s their prediction that they might be able, towards fall, to have the possibility to have a vaccine that is fighting coronavirus.”11
A vaccine for COVID-19 ready to roll out in just six months? It sounds wildly optimistic, particularly when you consider that even if a vaccine were to be approved by September 2020, it would take additional time to mass produce and distribute it. If short cuts for the development of a COVID-19 vaccine are being taken in order to meet a 12-to-18-month schedule, then you have to question what kind of short cuts may be adopted to speed things up even further.
In a cautionary note sounded by Professor Jonathan Kimmelman, PhD, director of biomedical ethics at McGill University, Dr. Kimmelman writes:
Outbreaks and national emergencies often create pressure to suspend rights, standards and/or normal rules of ethical conduct. Often our decision to do so seems unwise in retrospect.8
In response to von de Leyen’s six-month projection, a spokesperson for the European Medicines Agency (EMA) said that it would be at least six months before proposed vaccines could be tested in larger clinical trials and 12 to 18 months before a vaccine for COVID-19 could be ready for approval.11
1 Givas N. Coronavirus vaccine could be ready in 18 months, WHO officials say: ‘We are not defenseless’. Fox News Feb. 11, 2020.
2 O’Donnell C, Erman M. Drugmakers see long road ahead in coronavirus vaccine race. Reuters Feb. 5, 2020.
3 Deese K. RHealth official says coronavirus vaccine will take ‘at least a year to a year and a half’ to develop. The Hill Feb. 26, 2020.
4 Fink J. Coronavirus Vaccine ‘At Least A Year” Away ‘At Best’ From Being Publicly Available, National Health Official Says. Newsweek Feb. 26, 2020.
5 Jackson D. Health officials tell Donald Trump that coronavirus vaccine is at least a year away. USA Today Mar. 11, 2020.
6 Soucheray S.. Fauci: Vaccine at least year away, as COVID-19 death toll rises to 9 in Seattle. CIDRAP News Mar. 3, 2020.
7 Lanese N. Researchers fast-track coronavirus vaccine by skipping key animal testing first. Live Science Mar. 13, 2020.
8 Boodman E. Researchers rush to test coronavirus vaccine in people without knowing how well it works in animals. STAT Mar. 11, 2020.
9 TVR Staff. Bill Gates Says Health Care Workers Will Be First to Get Coronavirus Vaccine. The Vaccine Reaction Mar. 20, 2020.
10 FRANCE 24 English. “I hope we can have a vaccine on the market perhaps before Autumn,” says Von der Leyen. YouTube Mar. 18, 2020.
11 Wheaton S. Von der Leyen hopes for vaccine by ‘autumn,’ defying expert predictions. Politico Mar. 17, 2020.