Long read..I copied and pasted an article a British friend emailed me back in April regarding the Oxford vaccine.
surfgirl , the Oxford one has nothing to do with the US. But I'm glad that US has a deal in place to buy millions of doses.
JOHN LAWRENCE/THE GUARDIAN
Alice Thomson, Rachel Sylvester
Saturday April 11 2020, 12.01am, The Times
Everybody has to do what they can in this pandemic, says Sarah Gilbert, professor of vaccinology at Oxford University. “Some people can do the best thing by staying at home and not going out to meet their friends, some people can help their neighbours with shopping and leave it on their doorstep. There are healthcare workers who are working extremely hard, sometimes without proper personal protective equipment.
“What we can do is make a vaccine — so that’s what we’re doing.”
Professor Gilbert and her team of researchers are working around the clock to develop a vaccine that would protect the world against coronavirus. It is, she admits, exciting to be involved in this once-in-a-lifetime scientific endeavour to save lives “but it’s terrible as well when you look at the number of deaths being announced daily. We just have to focus on what we can do to make this work and not agonise too much about what is going on.”
Their progress has been astonishing. A vaccine could, Professor Gilbert says, be available for general use in the human population by the autumn, in time to prevent the impact of a second wave of coronavirus.
“That is just about possible if everything goes perfectly,” she tells us in a very succinct, no-nonsense phone interview. “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.”
The Oxford scientists have already developed a vaccine that is due to go into clinical trials, meaning that it will be tested on humans, within the next two weeks. “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 Gilbert says. “I would go for 80 per cent.”
That is not just a hunch. Professor Gilbert is a woman who neither surmises nor exaggerates and is not prone to hyperbole. “We are gathering data, this is based on evidence.” The results from animal trials are “still only just beginning to come through because it’s all been so rapid, but everything is looking good so far.”
Usually vaccines take years of trials before they can come on to the market but the search for a Covid-19 vaccine will run as many steps as possible in parallel. “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.”
Volunteers will not be deliberately infected. “It would be unethical to manufacture a very controlled lot of the virus. We do it for flu and malaria but there is always a way of treating the people and there isn’t yet for corona.”
Young people may still die from the virus, she says. “We still don’t know the risks, even for younger people. You need to manage the risks if you are giving people a disease. We want both male and female in the studies, but we can’t have pregnant women.”
Instead volunteers will be asked to carry on their lives normally so that some of them will become infected naturally. “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 lockdowns.”
Professor Gilbert’s team is planning a spread of studies 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 lockdowns 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.”
The team is talking to regulators around the world to get as wide a range of volunteers for clinical trials as possible. According to Professor Gilbert “the regulators in this country 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.”
The vaccine could be licensed “under emergency-use legislation . . . It means that in an emergency situation, if the regulators, agree, it’s possible to use a vaccine earlier than in normal circumstances.”
That’s not enough, however. The vaccine also needs to be manufactured at scale and speed. Bill Gates, the founder of Microsoft, has said that he is willing to “waste” billions of dollars to build factories to manufacture and test seven possible coronavirus vaccines.
For the Oxford vaccine to be available for distribution in the autumn, Professor Gilbert says production must begin even before it has been proven to work. She would like to see “tens of millions” of doses manufactured while trials are still going on so that if the vaccine does prove to be effective it will be possible to distribute it right away.
“We don’t want to get to later this year and discover we have a highly effective vaccine and we haven’t got any vaccine to use. We don’t think we need facilities built, there are facilities that can be switched over.”
The government should, she says, invest in manufacturing capacity now. “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.”
Although she says, “we don’t have all the funding in place to do what we need to do as of today” negotiations are taking place and “announcements may be imminent”.
Teams of researchers around the world are working on different vaccines. “I was on a call where about 30 different approaches were being presented,” Professor Gilbert says. “There is an unusual level of collaboration in this pandemic. As soon as we know one vaccine that works, and understand why it’s working, what level of immune response it needs to work, that helps everybody. Because we are a university, not a company, we are working very hard to ensure that we can get this vaccine available to everybody.”
It would, in her view, be wrong for pharmaceutical companies to make a fortune out of Covid-19. “Most pharmaceutical companies are not taking the view that they will make a huge amount of money out of this, certainly in the pandemic period,” she says. “Once the pandemic is finished and controlled, either people are vaccinated or enough people have become immune . . . there’s a question over a continued commercial market for a vaccine.
“They won’t be doing a bad thing if they make vaccine to be used during the pandemic and make it available at a reasonable price but then once the pandemic is over they sustain their business by selling a vaccine that’s still needed.”
Professor Gilbert, 58, never meant to become a vaccine specialist. “I actually came to Oxford to work on a human genetics project,” she says. “That highlighted the role of a particular type of immune response in protection against malaria and so the next thing to move on to was to make a vaccine that would work through that type of immune response and that’s how I got into vaccines.”
Now, though, she hopes everyone will understand the importance of the work. “Vaccines don’t receive enough investment. They’re the most cost-effective healthcare intervention but they’re overlooked. Many of us have been saying for years we need more vaccines against these outbreak pathogens and we need to be able to move faster when there’s a new pandemic. I don’t think there’s any point getting angry about it because we just have to focus on what we can do now, but there’s a feeling of ‘I told you so’.”
She is pleased that ministers who once declared that the British people had had enough of experts have found themselves relying on science. “I think the government needs to take account of experts and also realise that experts’ views cannot always be communicated in a very simple manner.”
The Oxford University scientists are barely resting as they search for the breakthrough the world needs. “It’s very long days at the moment for a lot of us,” Professor Gilbert says. “I work in my office and from home. Other people who are preparing for clinical trials are coming in and working in the lab. We’ve had to look at social distancing, which is helped by the fact that all non-essential work has stopped now, so we can take over more space.
“In the clinic they are screening volunteers ready for vaccination. People are working seven days a week to get this all done.”
Her children, triplets who are 21, are all students and they are living at home at present. “They are all biochemists and they are very interested in what’s happening,” she says. And they have all volunteered to be part of the vaccine trial.