Prior to the COVID-19 pandemic, the fastest a vaccine had ever been developed was back in the 1960s, to prevent mumps. That took four years. The race to come up with a vaccine against this virus has been hailed as a historical milestone for undergoing development in under a single year. Never before has a vaccine been produced so quickly.
But how was that possible?
- Unprecedented funding – funding is usually a big hurdle that slows down vaccine development. Not so during the coronavirus pandemic.
COVID-19 has crippled the UK and global economy. That has focused the world’s attention to finding a vaccine – and fast. Billions of vaccine doses are going to be required to keep the virus in check over the next several years.
Typically, when you produce or develop a vaccine, at each step along the road, you ask yourself, do we have the money to move forward? Is it worth moving forward?
The UK government pledged £250 million to help develop a vaccine. The funding for the Coalition for Epidemic Preparedness Innovations has helped and will continue to help scientists and researchers on the vaccine front. Billions have been pledged governments around the world.
Usually companies developing vaccines aim to mitigate financial risk by waiting until each phase is complete before moving on to the next one. Companies developing coronavirus vaccines, however, have been able to move more quickly because the financial risk is lower.
“They literally did everything that they would have done over a period of years in 10 months. Think of it as an accordion that’s pushed in, so everything is there, it’s just in a smaller package”.
- “Rolling basis” independent review by the MHRA
The process for developing vaccines is standardised: Normally, an exploratory and design period can take several years before eventually leading to clinical trials, which are held in three phases, followed by regulatory review and large-scale manufacturing.
A helpful visualisation can be found in Nature.
Researchers aim to establish an appropriate dosage level in Phase I trials, moving on to a larger group of human study subjects in Phase II to show — hopefully — that the drug offers some health benefit.
The trial phases and manufacturing overlapped somewhat to save time without compromising safety.
For example, in the case of Pfizer, the MHRA sped things along further by looking at thousands of pages of safety and efficacy documentation on a rolling basis.
A number of problems can crop up at any point along the entire process. Sometimes researchers run into unexpected side effects in humans, or safety and efficacy problems, or trouble with regulatory agencies. A vaccine being developed by Australia’s University of Queensland became the first to be abandoned in December 2020 after researchers discovered that it produced false-positive HIV test results.
In normal times, a company would certainly not get started on large-scale manufacturing during the clinical trial phases, because relatively few drugs actually get approved each year. But that’s what companies have been doing. Pfizer, whose vaccine was the first to secure emergency approval in the UK settled on which facilities it would use to make its drug back in May 2020. By the end of July 2020, the company had agreed to supply millions of doses, even though final clinical trial results were several months away.
- Scientists were not starting from scratch. They had research to build on from past viral outbreaks.
The last two decades have seen two other outbreaks of different coronaviruses. (Technically, the term “coronavirus” refers to a whole family of viruses, but it is often used as shorthand for the specific virus that causes COVID-19 due to its sheer prevalence.)
SARS-CoV (severe acute respiratory syndrome coronavirus) and MERS-CoV (Middle East respiratory syndrome coronavirus) emerged in 2002 and 2012, respectively. Scientists began the process of developing a vaccine for SARS-CoV, and two drugs underwent Phase I trials. Development stopped, though, because the virus had petered out by 2004 and it was no longer worth the cost. A vaccine for MERS-CoV is still being developed, eight years after it first appeared. Neither virus came anywhere near the scale of the current crisis.
SARS-CoV-2 (COVID-19), is related to SARS-CoV and MERS-CoV so researchers had a head start on how to potentially design the vaccine. They already knew which protein to focus on.
- The vaccine effort is global.
Chinese scientists sequenced the virus’s genome back in January 2020, sharing the information with the world soon after. Independent regulatory agencies in the UK and elsewhere have been largely open and collaborative with one another to move the process along more efficiently than ever before. Unprecedented times have called for unprecedented co-operation.