Seven months since it began, the coronavirus pandemic has claimed more than 14 million cases, resulting in more than 604,000 deaths. With about a hundred vaccines now in various stages of research across the world, the study that’s leading the way is being conducted by the University of Oxford team headed by noted female scientist Sarah Gilbert.
Gilbert’s work in developing the COVID-19 vaccine is remarkable for a number of reasons. She is a renowned female scientist in a field that continues to be dominated by men. The Women in Science and Engineering campaign says that while women constitute 45.7% of professionals in the science research industry, less than 30% of the world’s researchers are women.
And after 20 years of developing various vaccines, she now heads one of the most high-profile and advanced vaccine candidates against COVID-19, with Phase III, or final-stage, trials under way in several countries.
Gilbert first developed a taste for medicine at Kettering High School, which led to a degree in biological sciences from the University of East Anglia, and a doctoral degree at the University of Hull. After working in Leicester Biocentre for two years, she learned about drug manufacturing at the biotech company Delta.
Gilbert moved to Oxford University in 1994, where she became a reader in vaccinology in 2004. In 2010, she joined the Jenner Institute at Oxford. Headed by Adrian Hill, the Institute was founded in 2005 to develop vaccines for diseases of major global importance.
Traditional vaccines are made with a weakened or inactivated form of the germ that causes infection to stimulate an immune response. The Oxford team sped up the process of producing such vaccines with technology that uses a harmless virus as a kind of Trojan horse, which carries the genetic material of a pathogen into cells to generate an immune response.
For COVID-19, the female scientist inserted genetic material from the surface spike protein of the SARS-CoV-2 virus into a chimpanzee adenovirus (a common cold virus) to trick the immune system to fight back. The chimp adenovirus platform stimulates both antibodies and high levels of killer T-cells, a type of white blood cell that helps the immune system destroy infection.
Oxford’s head start on the COVID-19 vaccine is due to its work on Ebola. In 2014, as part of a rapid response to an outbreak spreading in Guinea, Liberia, and Sierra Leone, the Jenner Institute led the first trial of an Ebola vaccine devised by GlaxoSmithKline Plc. The outbreak ended before a vaccine was developed, but left an important lesson – that speed was critical. The team then began working on the Middle East Respiratory Syndrome (MERS), another pneumonia-causing coronavirus that was first detected in Saudi Arabia in 2012, but only became an outbreak in 2014.
To fund a MERS vaccine crafted using the chimp adenovirus, Gilbert and Hill decided to set up Vaccitech, which then raised more than $37.8 million from various sources and helped fine-tune the viral vector program that initiated MERS vaccine safety trials. However, due to the limited number of cases, the group has yet to prove the effectiveness of the MERS vaccine.
The work on MERS jumpstarted the development of the COVID-19 vaccine as the spike protein of MERS shares a 40% to 50% similarity to the spike of SARS-CoV-2. The acclaimed female scientist immediately set to work as soon as Chinese scientists published the genetic sequence of COVID-19 on Jan. 10.
Gilbert sped up the process by performing several steps at once—testing in animals, applying to regulators for human trials, and talking to manufacturers. The hardworking female scientist said, “It doesn’t need to cure you. We want a vaccine to stop people from going to hospital and dying. If you can do that, I think people will be pretty happy.”
Oxford quickly manufactured the shot for the first phase of human trials and Gilbert and her team began injecting mice with the vaccine on Feb. 17. She also tested the vaccine in rhesus monkeys, to ensure safety for human trials. When test results came out in mid-April, Hill said, “It wasn’t promising—it was fantastic. Not only were the monkeys fine, but as a bonus we saw some protection.”
After crunching a process that usually takes five years into less than four months, Gilbert and her colleagues started a human trial on 1,100 people in April. Her confidence in the safety of the vaccine is evident in three participants – the female scientist’s 21-year-old triplets, all biochemists.
She said, “We didn’t really discuss it as I wasn’t home much at the time. We know the adverse event profile and we know the dose to use, because we’ve done this so many times before. Obviously we’re doing safety testing, but we’re not concerned.”
On the production side, Oxford struck a deal with British pharmaceutical giant AstraZeneca Plc to spearhead global manufacturing and distribution and help run more trials around the world. More importantly, AstraZeneca has agreed to sell the vaccine on a not-for-profit basis, at only a “few dollars” per dose. The company has also lined up deals with multiple manufacturers to produce more than 2 billion doses and make the vaccine available in developing countries.
After getting a green light from an independent scientific panel, Gilbert’s team proceeded to more advanced trials on more than 10,000 people in the U.K. at the end of May.
Again, the female scientist stressed the importance of speed: “In order to determine vaccine efficacy for any novel coronavirus vaccine, the trial has to be set up in the right place at the right time, and that’s very hard to predict. It’s why we’re planning to do multiple trials in multiple countries.”
As U.K. cases began to drop, in early June AstraZeneca set up trials of the vaccine in Brazil and South Africa, where the virus is surging.
At this rate, the female scientist and her team will likely finish vaccinating subjects in its big 10,000-person efficacy trial before other candidates even start testing on that scale.
On the cusp of a life-changing and historic vaccine, Gilbert remains cautiously optimistic. “The best-case scenario is that by the autumn of 2020, we have … the ability to manufacture large amounts of the vaccine. (But) These best-case timeframes are highly ambitious and subject to change.” The female scientist stated that she would know more by September. The outcome will either help end the pandemic, or tell the world to wait a while longer.
Here is the latest update on the vaccine being developed by Oxford team. The vaccine is safe, hasn’t caused unexpected ill-effects and induces early immune reaction, early results suggest.