Jerusalem Post By DONNA RACHEL EDMUNDS APRIL 12, 2020 01:29
“I think there’s a high chance that it will work, based on other things that we have done with this type of vaccine,” Professor Sarah Gilbert said.
A team of scientists in Oxford, England, believe they may have a viable vaccine ready by September.
Sarah Gilbert, professor of vaccinology at Oxford University, has told The Times of London that she is 80% certain that the vaccine her team are working on will be successful in inoculating against COVID-19. The team plans to go to human trials within the next two weeks, and have asked the British government to back the manufacture of tens of millions of doses before the trials are completed so that if they are successful, the vaccine will be available to roll out immediately, worldwide.
As teams around the world, including in Israel, work at break-neck speed to develop a vaccine, Microsoft founder Bill Gates has already pledged to "waste" billions of dollars to build factories to manufacture and test seven possible vaccines.
“Even though we’ll end up picking at most two of them, we’re going to fund factories for all seven just so we don’t waste time in serially saying ‘OK, which vaccine works?’ and then building the factory,” Gates told The Daily Show.
"We don’t think we need facilities built, there are facilities that can be switched over," Gilbert told The Times, but she did welcome investment into manufacturing the vaccine.
“We are talking about a significant amount of money needing to be spent and it will increase over time. We are talking about £50 million or £100 million going through the year in order to get this up and running and then, obviously, if it works... we are talking about not just manufacturing for the UK – we have to think about manufacturing for the world. We want everybody to be able to have access to this vaccine,” she said.
Trialing new vaccines normally takes years, but for COVID-19 the process will be fast-tracked by running as many steps concurrently as possible, Gilbert explained.
“First there is the need to manufacture the vaccine for clinical studies under tightly controlled conditions, certified and qualified – we need ethical approval and regulatory approval. Then the clinical trial can start with 500 people in phase 1.
“This is always in healthy adults aged about 18 to 55, and usually the primary read-out from a phase 1 study is safety,” she says. “Then we can do phase 2 looking at a wider age range, in this case we are going to increase the age range, 55 to 70 plus. We are looking at safety in the older age group, we expect to see weaker immune responses.”
As it is unethical to purposely infect people in the trial with COVID-19, participants will be asked to go about their normal routine in the expectation that some will be exposed to it naturally. This means that studies are unlikely to take places in countries with a lock-down enforced, as the participants are unlikely to come in contact with the virus.
“If we wait too long, a large proportion of people will be immune before we vaccinate them. So it’s vital we go fast before a high proportion become infected. But it also means we are going to need to do studies in different countries because the amount of virus transmission is affected by the lock-downs,” Gilbert said.
The team is planning to run a number of trials in different populations worldwide. “If one of those turns out to have a high rate of virus transmission then we will get our efficacy results very quickly, so that is one strategy for reducing the time. Total lock-downs do make it harder. But we don’t want the herd immunity either. We want them to be susceptible and exposed for the trials purely to test the efficacy. It’s a question of timing, it’s not easy to predict which continents or countries will be the best places to test.”
Talks are already underway between the team and regulators around the world to gain the necessary permissions, Gilbert said, but she emphasized that in the UK “the regulators... are not slowing us down at all, they’re working with us very productively to assess the information that we give them and to allow us to work through the processes at record speed.”
If successful, the vaccine could come this autumn, just in time to prevent a second wave of COVID-19 from taking hold.
“That is just about possible if everything goes perfectly,” she said, adding: “We have to go for that. Nobody can give any guarantees, nobody can promise it’s going to work and nobody can give you a definite date, but we have to do all we can as fast as we can.”