What the world learned from the speedy development of the COVID vaccine

The development of a COVID-19 vaccine in record time was among the most significant global health accomplishments in recent history. Its speedy creation was the result of a potent combination of factors: strong established research, unprecedented global cooperation, substantial funding, and the urgency of responding to an aggressive pandemic.

Developing a new vaccine usually takes more than a decade and can cost up to US$500 million. Previously, the fastest any vaccine had been developed – from viral sampling to approval – was four years, for the mumps vaccine in the 1960s. But the COVID-19 vaccine blew past that record after scientists, regulators, and biotechnology companies worked together to shrink the waiting time between testing phases, streamlining the process while still ensuring the vaccine was safe. The first fully tested vaccination against SARS-Cov-2 was approved less than a year after the virus was first reported to the World Health Organization (WHO).

The steps that researchers, governments, corporations, and non-governmental organizations took to make that happen could serve as a guide for how to quickly and safely produce vaccines in response to future pandemics:

Building on a base of research: Scientists working on the vaccine weren't starting from scratch. COVID belongs to a well- known family of coronaviruses that cause a range of neurological, gastrointestinal, and respiratory illnesses – such as severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS) – and are thought to be behind up to a third of all common colds.

By the time COVID hit, researchers working on vaccines for SARS, MERS, and other common coronaviruses had already identified the characteristic spike protein that allows the virus to bind onto and break through the cell membrane. Researchers in the United States were working on vaccine technology to target that protein, including mRNA – or messenger RNA.

MRNA technology had been used in biotech for decades before COVID-19 came along. It is a common tool in cancer immunotherapy and the development of vaccines against infectious diseases such as Ebola, Zika, and influenza. Vaccines created with mRNA use a fragment of a virus's genetic code to construct the protein that prompts an immune response. They can be produced much faster than traditional vaccines, which rely on having samples of the virus itself.

At the same time, researchers at Oxford University were busy adapting a vaccine they had been working on to protect against a number of diseases. Based on a genetically modified common cold virus, the ChAdOx1 vaccine was engineered to allow scientists to swap in the genetic blueprints for whichever virus they wanted to train the immune system to attack. The ChAdOx1 vaccine for MERS was already designed to trigger an immune response against the coronavirus spike protein – scientists just needed COVID's genetic information to swap in.

They got it in January 2020, when China published the full genetic sequence for SARS-CoV-2. Scientists now had the information they needed to adapt their vaccines to fight COVID-19. The work happening in Oxford resulted in the Oxford- AstraZeneca vaccine and the mRNA research became the Pfizer and Moderna vaccines. By February 2020, the first clinical batch of COVID vaccine was ready for trial.

Removing the red tape: Clinical trials are often the slowest parts of the vaccine creation process. Determining a vaccine's efficacy and safety starts with testing it in cells in the lab, then in animals. After that, researchers move on to human trials, which happen in three phases, from a small group of volunteers to a few hundred and finally tens of thousands – if they even get that far.

As COVID overwhelmed health services and hobbled economies across the globe, regulatory bodies responded by letting researchers overlap the phases. The vaccines were subject to the same rigorous safety checks, but researchers could recruit for phases two and three while phase one was still finishing up, for example, instead of waiting for one phase to end before launching the next one.

Regulators also instituted rolling reviews, so that rather than waiting until the end of the trials to look over all the data at once, they reviewed the results as they became available throughout the trials. That helped compress the review timeline from months to weeks.

And the final approval stage was expedited when regulatory bodies in Europe, the United Kingdom, and the United States granted several vaccines their versions of emergency use authorization (EUA). EUAs are issued temporarily during public health emergencies and only when there are no adequate, approved, and available alternatives. With EUAs in place, manufacturers could start producing vaccines as soon as regulators were confident that the potential benefits outweighed any known and potential risks.

Providing immediate, significant funding: The driving force behind the world's race to find a vaccine was the money that governments, the private sector, and funding bodies like the Coalition for Epidemic Preparedness Innovation (CEPI) poured into the effort. The U.S. government made US$18 billion in funding available to companies, for example, and the United Kingdom invested more than £88 million in the development of the Oxford-AstraZeneca vaccine. Pharmaceutical companies also put money into recruiting scientists and building dedicated labs. The massive investment also allowed manufacturers to take on the risk of starting production on COVID-19 vaccines early, to be ready to go out the door immediately once official approval was received.

On December 8, 2020, a 90-year-old grandmother in United Kingdom, Margaret Keenan, became the first person outside of clinical trials to get an approved COVID vaccination. Studies show that over the following year, vaccines prevented an estimated 19.8 million deaths. COVID-related hospitalizations decreased, economies began to reopen, and on May 5, 2023, the WHO declared COVID-19 was no longer a global health emergency.

But the scars the pandemic has left on the world "serve as a permanent reminder of the potential for new viruses to emerge, with devastating consequences,” said WHO Director-General Dr. Tedros Adhanom Ghebreyesus.

To prepare for the next novel viral threat, researchers and companies are taking lessons from the COVID vaccine process to try to make lightning-fast vaccine development the norm. Infectious disease specialists stress the need to train and maintain a skilled workforce of vaccine experts and call for more funding earlier in the process. Studies suggest some of the tweaks made to streamline the testing and approval of the COVID vaccine – combining phases one and two of human trials, for instance, and instituting rolling reviews – could be applied to the creation of most vaccines without compromising safety.

Technology is also taking on a bigger role in attempts to replicate the speed of the COVID vaccine development process, including the use of artificial intelligence (AI) to help scientists quickly search through, analyze, and make connections between decades of research.

In one example, Pfizer is planning to expand its use of the AI and machine-learning tools it used during the pandemic to do things like help their clinical-development teams decide which trial sites will yield the most useful data by predicting COVID- 19 incidence at the local level.

And in July 2023, CEPI announced it was giving the Houston Methodist Research Institute (HMRI) nearly US$5 million for a project that uses AI to design the potential epitopes – pieces of virus protein that could trigger an immune response – of particularly aggressive viruses and then uses lab testing to identify which of those designs are candidates for developing into vaccines.

This follows several other AI-heavy projects CEPI is investing in as part of its five-year, $3.5 billion plan to shrink vaccine development timelines to 100 days. The research from those projects will go into CEPI's "vaccine library," a globally accessible store of scientific knowledge, data, and prototype versions of vaccines against a range of viruses that pose a risk to public health. If a new outbreak emerges, vaccine developers should be able to pick a vaccine design "off the shelf," adapt it to fight the new virus, and avoid the next pandemic.