Speaker 1: Hi, I'm Carol Masser and I'm Jason Kelly. It's time
Speaker 1: for this week's cover story. Well, of all the players
Speaker 1: developing a vaccine for COVID nineteen, here's a piece of advice.
Speaker 1: There's one name you should remember. Sarah Gilbert. That's right, Jason.
Speaker 1: The fifty eight year old University of Oxford professor is
Speaker 1: leading one of the most high profile and advanced vaccine
Speaker 1: candidates against COVID nineteen. The Oxford vaccine, a so called
Speaker 1: viral vector type, is already in phase three, or final
Speaker 1: stage trials. That puts Gilbert in her team months ahead
Speaker 1: of the competition. Oxford Well, it's also struck a deal
Speaker 1: with Astra Zeneca to spearhead global manufacturing and distribution. The
Speaker 1: pharma company has lined up agreements to produce two billion
Speaker 1: doses and sell the vaccine on a not for profit
Speaker 1: basis during the crisis. So why the impressive lead Because
Speaker 1: Gilbert's work on a vaccine for ebola and then mirrors
Speaker 1: another coronavirus gave her a running start when COVID nineteen emerged.
Speaker 1: While the big question remains the vaccines efficacy, Gilbert says
Speaker 1: she could have results by September the front on her.
Speaker 1: Oxford's COVID nineteen vaccine, devised by Sarah Gilbert, is in
Speaker 1: human trials. Astra Zenica has lined up agreements to produce
Speaker 1: two billion doses. Now the World waits. By Stephanie Baker.
Speaker 1: In April, Sarah Gilbert's three children, twenty one year old triplets,
Speaker 1: all studying biochemistry, decided to take part in a trial
Speaker 1: for an experimental vaccine against COVID nineteen. It was their
Speaker 1: mother's vaccine. She leads the University of Oxford team that
Speaker 1: developed it. But there wasn't a big family talk. We
Speaker 1: didn't really discuss it as I wasn't home much at
Speaker 1: the time. Gilbert told me recently. She'd been working around
Speaker 1: the clock, as one does while trying to end the pandemic,
Speaker 1: and at any rate, wasn't worried for her kids. We
Speaker 1: know the adverse event profile, and we know the dose
Speaker 1: to use because we've done this so many times before,
Speaker 1: she says. Obviously we're doing safety testing, but we're not
Speaker 1: concerned with safety. Low on her list of worries, her
Speaker 1: triplets are fine. Gilbert is focused on quickly determining how
Speaker 1: effective the vaccine will be and how it will be made.
Speaker 1: In April, Oxford struck a deal with British pharmaceutical giant
Speaker 1: astra Zenica to spearhead global manufacturing and distribution and help
Speaker 1: run more trials around the world. Astrazenica has agreed to
Speaker 1: sell the vaccine on a not for profit basis during
Speaker 1: the crisis if it proves effective, and has lined up
Speaker 1: deals with multiple manufacturers to produce more than two billion doses.
Speaker 1: Gilbert has been all over the British press, but she
Speaker 1: appears to regard public attention as a distraction. For more
Speaker 1: than two decades, she worked anonymously developing vaccines while also
Speaker 1: of necessity turning out endless grant applications. Her research was
Speaker 1: rarely discussed outside scientific circles. Now she's leading one of
Speaker 1: the most high profile and advanced vaccine candidates against COVID nineteen,
Speaker 1: with Phase three, or final stage trials under way involving
Speaker 1: thousands of people in Brazil, South Africa, the UK and
Speaker 1: soon the US. Money is no longer a struggle. At
Speaker 1: the end of April, crunching a process that normally takes
Speaker 1: about five years into less than four months, Gilbert and
Speaker 1: her colleagues at Oxford's Jenner Institute started a human trial
Speaker 1: on people. When Gilbert testified before a parliamentary committee in
Speaker 1: early July, one member compared her effort to going into
Speaker 1: a shed and coming out with the jet engine. Gilbert's
Speaker 1: team has leap frogged other vaccine contenders to the point
Speaker 1: where it will likely finish vaccinating subjects in its big
Speaker 1: ten thousand person efficacy trial before other candidates even start
Speaker 1: testing on that scale. Kate Bingham, chair of the UK
Speaker 1: government's Vaccine Task Force, told the committee in early July
Speaker 1: she's well ahead of the world. Bingham said it's the
Speaker 1: most advanced vaccine anywhere. Anthony Fauci, director of the u
Speaker 1: S National Institute of Allergy and Infectious Disease the in
Speaker 1: I a i D, has sounded a note of caution
Speaker 1: about Oxford's frontrunner status. You've got to be careful if
Speaker 1: you're temporarily leading the way versus having a vaccine that's
Speaker 1: actually going to work, he told the BBC. Recently, most
Speaker 1: vaccines in development failed to get licensed. Unlike drugs to
Speaker 1: treat diseases, vaccines are given to healthy people to prevent illness,
Speaker 1: which means regulators set a high bar for approval and
Speaker 1: usually want to see year's worth of safety data in
Speaker 1: the COVID nineteen pandemic. It's not yet clear what regulators
Speaker 1: will accept as proof of a successful and safe vaccine.
Speaker 1: The US Food and Drug Administration has said a vaccine
Speaker 1: would need to be more effective than a placebo to
Speaker 1: be approved, and would need to show more evidence than
Speaker 1: blood tests indicating an immune response. Regulators in other countries
Speaker 1: haven't spelled out what would be acceptable. Gilbert has voiced
Speaker 1: remarkable confidence in her chances, saying the Oxford vaccine has
Speaker 1: a probability of being effective in stopping people who are
Speaker 1: exposed to the novel coronavirus from developing COVID nineteen. She
Speaker 1: has said she could know by September. Asked by MPs
Speaker 1: in early July whether the world would have to struggle
Speaker 1: through the winter without a vaccine, Gilbert said, I hope
Speaker 1: we can improve on those timelines and come to your rescue. Gilbert,
Speaker 1: who is fifty eight, has the hyper efficient, serious demeanor
Speaker 1: you'd expect from someone who might be on the cusp
Speaker 1: of a breakthrough and hasn't a minute to spare. When
Speaker 1: I first called her in early March, she abruptly ended
Speaker 1: the conversation after ten minutes to speak to someone about
Speaker 1: the technical process of manufacturing the vaccine. It would have
Speaker 1: been crazy to take offense. Gilbert says. She wakes up
Speaker 1: at around four a m. Most days with lots of
Speaker 1: questions in my head, works from home for a few hours,
Speaker 1: then rides her bicycle to the institute, where she works
Speaker 1: into the evening. The Oxford team, just a handful of
Speaker 1: people in January, now comprises roughly two hundred and fifty.
Speaker 1: The vaccine is a so called viral vector type, based
Speaker 1: on years of research by Gilbert and Adrian Hill, the
Speaker 1: head of the Gender Institute. Traditional vaccines are made with
Speaker 1: a weekend or inactivated form of the germ that causes
Speaker 1: infection to stimulate an immune response. They aren't easy to
Speaker 1: develop and produce quickly. The Oxford team has created a
Speaker 1: technology that can speed the process by using a harmless
Speaker 1: virus as a kind of trojan horse to carry the
Speaker 1: genetic material of a pathogen into cells to generate an
Speaker 1: immune response. In the case of COVID nineteen, Gilbert has
Speaker 1: taken a chimpanzee adenavirus, a common cold virus, and inserted
Speaker 1: genetic material from the surface spike protein of the stars
Speaker 1: cove two virus as a way of tricking the immune
Speaker 1: system to fight back. The chimp adenavirus platform stimulates both
Speaker 1: antibodies and high levels of killer T cells, a type
Speaker 1: of white blood cell that helps the immune system destroy infection.
Speaker 1: Gilbert's approach is similar to a viral vector vaccine developed
Speaker 1: by the Chinese company Cancino Biologics that's in phase two
Speaker 1: human trials. The difference between the two is small, but
Speaker 1: maybe crucial. Cancino uses a vector based on a human
Speaker 1: adenovirus that many people have already been infected with. Early
Speaker 1: tests showed that people with pre existing antibodies to the
Speaker 1: adenavirus neutralized the vaccine before it could elicit a strong
Speaker 1: immune response to stars COVI two, the trojan horse is
Speaker 1: destroyed before the troops can get out. Johnson and Johnson
Speaker 1: is developing a similar vaccine based on a human adenovirus.
Speaker 1: It will begin human trials in the second half of July.
Speaker 1: A successful vaccine likely won't be effective no matter who
Speaker 1: wins the race, and success might have different definitions. Not
Speaker 1: all vaccines produce what's called sterilizing immunity, in which the
Speaker 1: body produces neutralizing antibodies that block of virus from getting
Speaker 1: into cells. Some vaccines don't prevent infection, but trigger the
Speaker 1: immune system to protect against illness. Jonas Salk's polio vaccine
Speaker 1: doesn't stop infection, but prevents the disease that crippled millions.
Speaker 1: I asked Gilbert what her definition of a successful vaccine
Speaker 1: would be, but she wouldn't be drawn out on specifics.
Speaker 1: We need a vaccine with a high level of efficacy
Speaker 1: against disease, which also has a significant impact on virus transmission,
Speaker 1: she said. The Oxford team probably wouldn't be so far
Speaker 1: along with its COVID vaccine had it not been for
Speaker 1: another deadly pathogen that threatened to cause a pandemic, Ebola.
Speaker 1: In fourteen, the Gender Institute led the first trial of
Speaker 1: an ebola vaccine devised by Glaxo smith Klein as part
Speaker 1: of the rapid response to an outbreak spreading through Guinea, Liberia,
Speaker 1: and Sierra Leone. The outbreak ended before they were able
Speaker 1: to finish. Merk got there first to test its experimental
Speaker 1: vaccine while cases were still spreading in Guinea. In twenty
Speaker 1: fifteen and one, regulatory approvals in the US and Europe
Speaker 1: at the end of last year. That experience taught the
Speaker 1: Oxford team about the importance of speed. We were horribly
Speaker 1: conscious the whole way through that one week, one way
Speaker 1: or the other might make a difference. Hill says it
Speaker 1: still might. In the wake of the Ebola outbreak, Gilbert
Speaker 1: responded to a call from the World Health Organization for
Speaker 1: researchers to come up with methods to rapidly respond to
Speaker 1: a clutch of emerging pathogens. It meant having a plan
Speaker 1: for disease X, that unknown yet inevitable pathogen lurking around
Speaker 1: the corner before COVID nineteen presented as the nightmare disease
Speaker 1: X scenario. Gilbert began working on Middle East Respiratory Syndrome
Speaker 1: or MIRRORS, another coronavirus that causes pneumonia and had threatened
Speaker 1: to spark a global health crisis. It first emerged in
Speaker 1: twelve in Saudi Arabia, but an outbreak didn't occur until
Speaker 1: MERS is much more deadly than COVID nineteen, killing about
Speaker 1: a third of those infected. Gilbert worked on a Mer's
Speaker 1: vaccine using the chimp adenavirus, in this case fused with
Speaker 1: the genetic material of the MIRRORS virus. She traveled to
Speaker 1: Saudi Arabia in November twenty fifteen for a conference with
Speaker 1: leading vaccinologists, hoping it would result in funding. It didn't.
Speaker 1: She and Hill had government grants to develop a number
Speaker 1: of vaccines, but that could take them only so far,
Speaker 1: and in twenty sixteen they created a private company called Vaxitech.
Speaker 1: It went on to raise more than thirty million pounds
Speaker 1: about thirty seven point eight million dollars from Google Ventures
Speaker 1: now g V, Sequoia Capital China, and Oxford Sciences Innovation,
Speaker 1: a venture capital funds set up to commercialize scientific research
Speaker 1: coming out of Oxford. The company holds the rights to
Speaker 1: several vaccines Gilbert and Hill are developing using the chimpadinavirus platform,
Speaker 1: including a promising prostate cancer therapy. The VC funding, along
Speaker 1: with some government money, helped them fine tune the viral
Speaker 1: vector program and pushed the Mirrors vaccine into a small
Speaker 1: safety trial with twenty four people in the Subjects were
Speaker 1: divided into three groups getting low, intermediate, and high doses.
Speaker 1: The results, published in April twenty twenty, showed the vaccine
Speaker 1: was safe and produced an immune response that persisted for
Speaker 1: a year. It produced high levels of T cells, but
Speaker 1: only forty four percent of people receiving the highest dose
Speaker 1: generated neutralizing antibodies. That raised the question of whether two
Speaker 1: doses might be needed. The Mirror's safety study couldn't prove
Speaker 1: whether the combination of T cells and neutralizing antibodies induced
Speaker 1: by the vaccine worked to prevent the disease because it
Speaker 1: was too small and took place in the UK, which
Speaker 1: has had only a handful of Mirr's cases since twenty twelve.
Speaker 1: In December twenty nineteen, just a few weeks before the
Speaker 1: novel coronavirus emerged in Wuhan, China, Gilbert's team began a
Speaker 1: second trial for the MERS vaccine in Saudi Arabia, where
Speaker 1: most of the world's cases have been reported. Even there,
Speaker 1: only about two hundred cases of MERS are reported annually,
Speaker 1: so proving the vaccine works could take many months. The
Speaker 1: work gave Gilbert a running start when COVID nineteen emerged.
Speaker 1: The spike protein of Mirr's shares a forty percent to
Speaker 1: fifty percent similarity to the spike of stars cove too,
Speaker 1: says Naive al Harby, a sawty scientist who studied under
Speaker 1: Gilbert at Oxford and is running the MIRRORS vaccine trials
Speaker 1: in Riad. We know the chimp adinavirus is safe in humans,
Speaker 1: and it's been tested in humans with the Mirr's spike.
Speaker 1: Given the similarities, the only question with the COVID nineteen
Speaker 1: vaccine is whether it's going to be protective or not.
Speaker 1: The Mirr's study was absolutely critical, says Tom Evans, chief
Speaker 1: scientific officer of Vaxateech. We could say, okay, we can
Speaker 1: start tomorrow. We don't have to make ten different varieties
Speaker 1: of this. We knew it could be manufactured, we knew
Speaker 1: it was immunogenic in humans. When she first heard about
Speaker 1: the cases of pneumonia in China over the new year,
Speaker 1: Gilbert was unsure how quickly it would spread. We didn't
Speaker 1: know what it was. Early on, she says. I was
Speaker 1: talking to colleagues, thinking, yeah, as soon as the sequence
Speaker 1: comes out, we'll make something. We'll test it in mice,
Speaker 1: we'll show what we can do. The moment the Chinese
Speaker 1: scientists published the genetic sequence of the novel coronavirus on
Speaker 1: January tenth, Gilbert got to work. Oxford had an advantage
Speaker 1: unusual for an academic institution, its own vaccine manufacturing facility,
Speaker 1: at which it was able to quickly manufacture the shot
Speaker 1: for the first phase of human trials. Gilbert arranged for
Speaker 1: the next larger batch to come from Italian farmer company Advent,
Speaker 1: and persuaded the university to underwrite the contract until she
Speaker 1: could secure further funding. On February, her team began injecting
Speaker 1: mice with a vaccine to accelerate a process that normally
Speaker 1: takes months. She was performing several steps at once, testing
Speaker 1: in animals, applying to regulators for human trials, and talking
Speaker 1: to manufacturers. Her level of knowledge of the detail is extraordinary,
Speaker 1: says Andrew McLean, who worked with her for years as
Speaker 1: an investor and board member at VACKS attack. It's very
Speaker 1: unusual for a scientist to know the practical parts of
Speaker 1: getting a drug made and be able to talk to
Speaker 1: manufacturers on a toe to toe basis. But in early
Speaker 1: March Gilbert was still scrounging for money. She got a
Speaker 1: small grant from the Coalition for Epidemic Preparedness Innovations or
Speaker 1: c e p I, a foundation set up in twenty
Speaker 1: seventeen with funding from the Bill and Melinda Gates Foundation,
Speaker 1: the governments of Norway in India, and the Welcome Trust,
Speaker 1: a research charity based in London. It was enough to
Speaker 1: keep them going Around this time, there was a debate
Speaker 1: within the Gender Institute about whether to go straight into
Speaker 1: human trials or wait until they got results from a
Speaker 1: study of their vaccine in nine REESUS monkeys at the
Speaker 1: Rocky Mountain Laboratories in Montana, part of the n I
Speaker 1: A I D. They knew that in tests for a
Speaker 1: vaccine against the first Stars virus, which caused an epidemic
Speaker 1: in Asia in two thousand two and three, some vaccinated
Speaker 1: animals became more severely ill after they were challenged with
Speaker 1: the virus than unvaccinated ones did. The phenomenon is known
Speaker 1: as antibody dependent enhancement or a d E. Scientists around
Speaker 1: the world were worried that might happen again with the
Speaker 1: Stars Cove two vaccine, and the Oxford team wanted to
Speaker 1: test it in monkeys to rule it out, but time
Speaker 1: was of the essence. People were dying from COVID nineteen
Speaker 1: and waiting for the monkey results would mean losing crucial weeks.
Speaker 1: We were doing that monkey experiment for safety and to
Speaker 1: convince the pessimists that the vaccine was going to be
Speaker 1: safe after infection. Hill says, the big question was when
Speaker 1: you have a vaccine available, and you have people lined
Speaker 1: up ready to go. Do you wait for the monkey
Speaker 1: results to vaccinate them? They decided to play it safe
Speaker 1: and wait, while pressing ahead with planning the trials, setting
Speaker 1: up manufacturing, and looking for more money. On March twenty third,
Speaker 1: the same day UK Prime Minister Boris Johnson ordered the
Speaker 1: country into lockdown, the government announced a two point two
Speaker 1: million pound grant to Gilbert's team to support testing and manufacturing.
Speaker 1: During the search for money, Bill Gates pushed Gilbert and
Speaker 1: Hill to partner with a big pharmaceutical company, and as
Speaker 1: a C E p I founder, he had leverage. We
Speaker 1: went to Oxford and said, you are doing brilliant work,
Speaker 1: Gates recalled in a call with reporters in early June.
Speaker 1: You really need to team up, and we told them
Speaker 1: a list of people to go and talk to. The
Speaker 1: Oxford team was initially reluctant, Hill says, because they'd run
Speaker 1: plenty of trials on their own. What we struggle against
Speaker 1: all the time is the perception from fonders that we
Speaker 1: can't do this, he says. They held talks with several
Speaker 1: potential partners, whom he declined to name, asking them two questions,
Speaker 1: how much can you manufacture and by when? They didn't
Speaker 1: answer either of those questions, no matter how many times
Speaker 1: we asked, Hill recalls astra Zenica was different. In early April,
Speaker 1: Minne Pangalos, the company's head of research and development for biopharmaceuticals,
Speaker 1: had been hearing positive things about Oxford's work. Although astra
Speaker 1: Zenica isn't a big player in back scenes. It produces
Speaker 1: a nasal flu spray vaccine, but nothing else. He thought
Speaker 1: it was worth calling John Bell, an immunologist and professor
Speaker 1: who directs the university's medical research strategy, to find out more.
Speaker 1: It seemed like they needed a partner, Pangalos recalls. I
Speaker 1: called John up and said, are you interested in working
Speaker 1: with us on this because we think we can help.
Speaker 1: Pangalos negotiated the partnership agreement with Bell and the rest
Speaker 1: of the Oxford team in about ten days through a
Speaker 1: flurry of zoom calls, with Gilbert walking everyone through the data.
Speaker 1: Astra Zeneca agreed to be responsible for worldwide distribution and manufacturing.
Speaker 1: Big money followed the announcement of the deal at the
Speaker 1: end of April. As Pascal Sorrio, astra Zeneca's chief executive
Speaker 1: officer pledged to make the vaccine available at only a
Speaker 1: few dollars per dose. The British government gave sixty five
Speaker 1: million pounds to accelerate the work and order thirty million
Speaker 1: doses for the UK by September, as part of a
Speaker 1: deal to make one million in total, with some reserve
Speaker 1: for de heloping countries. Days later, astra Zeneca announced a
Speaker 1: one point to billion dollar deal with the U s
Speaker 1: Biomedical Advanced Research and Development Authority BARDA to develop and
Speaker 1: produce three hundred million doses, one of the largest deals
Speaker 1: the agency has announced. Astra Zeneca will work with the
Speaker 1: National Institutes of Health to test it in thirty thousand
Speaker 1: people in the US, scheduled to start in August. The
Speaker 1: company later struck a licensing deal with the Serum Institute
Speaker 1: of India to produce a billion doses for developing and
Speaker 1: middle income countries. Because of expected political pressure, any country
Speaker 1: with a role in the production of a vaccine might
Speaker 1: act to secure doses for its own people. Astra Zeneca
Speaker 1: is setting up independent supply chains within countries to prevent
Speaker 1: delays at national borders. As the astro Zenica deal was
Speaker 1: being finalized in mid April, the results of the monkey
Speaker 1: study came through from Montana. It wasn't promising, it was fantastic.
Speaker 1: Hill says. Not only were the monkeys fine, it as
Speaker 1: a bonus we saw some protection. They had vaccinated six
Speaker 1: monkeys and then twenty eight days later, exposed them to
Speaker 1: a massive dose of stars COVID two via multiple roots, eyes, mouth, nose,
Speaker 1: and trachea to expose the lungs. It was much more
Speaker 1: than a person might encounter on public transportation or even
Speaker 1: in a COVID Ward after exposure, the animals showed no
Speaker 1: signs of pneumonia in their lungs by all indications, They
Speaker 1: felt fine. Nasal swabs, however, showed they still had the virus,
Speaker 1: meaning they might be able to infect others. The study's
Speaker 1: aim was to determine safety, not efficacy, so the gender
Speaker 1: team was encouraged to see it provided some protection in
Speaker 1: the face of an overwhelming dose of the virus. The
Speaker 1: day after the preliminary results came in, a team headed
Speaker 1: by Andrew Pollard, a colleague of Gilbert's, running the clinical trials,
Speaker 1: started injecting people. When the full results of the monkey
Speaker 1: trials were published in mid May, critics pounced seeing the
Speaker 1: results as weak. William Hazeltine, a former professor at Harvard
Speaker 1: Medical School who spent years researching HIV, wrote a piece
Speaker 1: in Forbes arguing that the Oxford vaccine looked like it
Speaker 1: would be only partially protective because it didn't generate high
Speaker 1: levels of neutralizing antibodies, which defends cells against infection. What
Speaker 1: happens when you have a vaccine with people running around
Speaker 1: with virus spewing out of their nose. Anyone who is
Speaker 1: not vaccinated or not vaccinated well is going to get infected,
Speaker 1: Hazeltine told me on a zoom call. My guess is
Speaker 1: the Oxford vaccine isn't going to be powerful enough for
Speaker 1: older people, so they will have to boost it up,
Speaker 1: and boosting it up can have side effects. On July fourteenth,
Speaker 1: the U. S. Government released results from the safety trial
Speaker 1: of another vaccine candidate from Maderna. The company's stock rose
Speaker 1: sharply on news that the vaccine produced neutralizing antibodies in
Speaker 1: all patients. It also produced side effects in some Maderna's vaccine,
Speaker 1: produced using a technique called Messenger RNA, will go into
Speaker 1: late stage trials by the end of July. Team Oxford
Speaker 1: Astra Zeneca argues it's not realistic to expect clear nasal
Speaker 1: swabs from monkeys after they got a whopping dose straight
Speaker 1: up their noses. It doesn't need to cure you of
Speaker 1: stars cove too. Astra Zeneca's Pungalow says, I don't know
Speaker 1: if we will completely knock out shedding or people being infectious,
Speaker 1: whether we're going to cure people completely, or whether we
Speaker 1: will just dampen down the illness. We want a vaccine
Speaker 1: to stop people from going to hospital and dying. If
Speaker 1: you can do that, I think people will be pretty happy.
Speaker 1: Neutralizing antibodies is one of the things you'll look at,
Speaker 1: but the T cell response is going to be important.
Speaker 1: Hill says the same thing. Has Alten's focus on neutralizing
Speaker 1: antibodies is misplaced scientific debates aside. I was starting to
Speaker 1: sense a Harvard Oxford American British rivalry playing out. It's
Speaker 1: simpler to measure antibodies, it's less expensive. People do it
Speaker 1: all the time, But often the antibodies are a surrogate
Speaker 1: for the T cell number. Hill says, nobody knows in SARS,
Speaker 1: in mers and in COVID nineteen the relative importance of
Speaker 1: those two A flurry of recent research has shown that
Speaker 1: T cells may play an important role in responses to
Speaker 1: SARS cove two, but the only way to know the
Speaker 1: most effective levels or tighters of antibodies and T cells
Speaker 1: is to test the vaccine in people where the virus
Speaker 1: is circulating. No one knows how strong the immune response
Speaker 1: needs to be to achieve protection in people of any age.
Speaker 1: Gilbert says, if we get a strong T cell response,
Speaker 1: we don't need such a high neutralizing antibody tighter to
Speaker 1: achieve protection. The two arms of the immune response work
Speaker 1: together to give better protection. The Gender Institute team is
Speaker 1: taking blood samples of people in the trials that begin
Speaker 1: in late April and May in the UK to measure
Speaker 1: antibodies and T cell responses several weeks after vaccination, but
Speaker 1: blood results can't prove it will prevent disease. It's a
Speaker 1: numbers game. They're looking for very few cases of COVID
Speaker 1: nineteen in people who have received the vaccine, and a
Speaker 1: significantly higher number in a control group of people who haven't.
Speaker 1: The better the vaccine is, the quicker you get a result,
Speaker 1: and the smaller number you need. Hill says, if they
Speaker 1: reach say twenty cases in the control group and eighteen
Speaker 1: among the vaccinated cohort. That's not a great vaccine, and
Speaker 1: they would need a lot of cases to show a difference.
Speaker 1: But if you have twenty in the control group and
Speaker 1: two among the vaccinated, your home and dry, he says.
Speaker 1: Of course, a quicker way of figuring out if it
Speaker 1: works would be to stage human challenge trials like those
Speaker 1: done with the monkeys. So far, no COVID nineteen vaccine
Speaker 1: developer has used to challenge trials because of ethical concerns
Speaker 1: and the lack of an effective treatment for the disease.
Speaker 1: That hasn't stopped more than thirty thousand people from more
Speaker 1: than forty countries from registering to take part in a
Speaker 1: potential challenge trial through an organization called One Day Sooner.
Speaker 1: When I asked Gilbert in April what was worrying her
Speaker 1: the most, she said it was going to be difficult
Speaker 1: to prove the vaccine works as the virus waxes and
Speaker 1: wanes around the world. In order to determine vaccine efficacy
Speaker 1: for any novel coronavirus vaccine, the trial has to be
Speaker 1: set up in the right place at the right time,
Speaker 1: and that's very hard to predict she said, it's why
Speaker 1: we're planning to do multiple trials in multiple countries. In
Speaker 1: early June, as UK cases began to drop, astra Zenica
Speaker 1: set up trials of the vaccine in Brazil and South Africa,
Speaker 1: where the virus is surging. Producing millions, if not billions,
Speaker 1: of doses of the vaccine may be the biggest challenge
Speaker 1: in the history of the pharmaceutical industry. Astra Zennica is
Speaker 1: signing production agreements with companies worldwide, including Oxford Biomedica, a
Speaker 1: small gene and cell therapy company at ten minute drive
Speaker 1: from the Gender Institute. Oxford Biomedica has agreed to produce
Speaker 1: several million doses, with the potential to scale up into
Speaker 1: the tens of millions if it works. James Miskin, the
Speaker 1: company's chief technical officer, describes a multi step production and
Speaker 1: process that sounds to my lay person's ears like a
Speaker 1: cross between making a sour dough starter and boiling down
Speaker 1: sap to make maple syrup. It begins with nurturing a
Speaker 1: few milliliters of human embryonic kidney cells kept in a
Speaker 1: frozen vial that needs to be gradually defrosted as the
Speaker 1: cells are fed a sugar solution they multiply in a
Speaker 1: controlled atmosphere of oxygen and carbon dioxide. Over the course
Speaker 1: of a week. The mixture is moved into larger and
Speaker 1: larger vessels and eventually into a two stainless steel bioreactor.
Speaker 1: The master seedstock of the vaccine, which contains the adenavirus
Speaker 1: with the spike protein, is added to the soupy mixture,
Speaker 1: which is stirred, purified, concentrated and filtered down. Scaling the
Speaker 1: process up to get to millions of doses is full
Speaker 1: of unknowns, says Matthew du Chars, CEO of the UK
Speaker 1: government funded Vaccines Manufacturing and Innovation Center, which is helping
Speaker 1: coordinate British manufacturers. I asked him about the soured analogy.
Speaker 1: It's like trying to go from making a loaf of
Speaker 1: sour dough in your kitchen to making a hundred thousand
Speaker 1: sour dough pizzas he says, scale up of any process
Speaker 1: is never as simple as you think it will be,
Speaker 1: especially with biological material. At the end of May, Gilbert's
Speaker 1: team pressed ahead with more advanced trials on more than
Speaker 1: ten thousand people in the UK after getting the green
Speaker 1: light from an independent scientific panel that reviewed its progress
Speaker 1: so far. To be ready to go, the Oxford group
Speaker 1: had spent several months working with Advent, the Italian manufacturer,
Speaker 1: to produce the vaccine for the large scale trials. Under
Speaker 1: the eye of Stephania Di Marco, a biochemist and advanced
Speaker 1: scientific director. Advance staff worked into the evenings and over
Speaker 1: weekends to produce thirteen thousand doses of the vaccine at
Speaker 1: a time when Italy was the epicenter of the COVID
Speaker 1: nineteen pandemic. With the seed stock, they made one liters
Speaker 1: of unpurified product and reduced it down to about three
Speaker 1: leaders of vaccine. On May fourth, they'd finally reached the
Speaker 1: stage where they could start filling glass vials with the vaccine.
Speaker 1: DeMarco and about fifteen people from her team of twenty
Speaker 1: five gathered that evening as the filling began, with some
Speaker 1: tears and hugging. We were excited, she says, this is
Speaker 1: precious material. Two weeks later, after extensive checks and documentation,
Speaker 1: the first shipment of the vaccine arrived in Oxford in
Speaker 1: temperature controlled boxes. At the end of May, advanced batch
Speaker 1: of vaccines started going into people over the age of
Speaker 1: fifty five to find out if there's a variation in
Speaker 1: immune responses to the shot in people of different ages.
Speaker 1: How the vaccine performs in this much larger and more
Speaker 1: diverse group, particularly older people, could well determine whether the
Speaker 1: Oxford vaccine will help end the pandemic or whether the
Speaker 1: world must continue to wait. With Vernon Silver and James Patton,
Speaker 1: thanks for listening to this week's cover story. Check out
Speaker 1: this week's magazine for more stories, including one on America's
Speaker 1: richest man opening up about COVID risk and luck the issue.
Speaker 1: Keep in mind it's on news stands right now. You
Speaker 1: can also find it online at Bloomberg dot com and
Speaker 1: always on the Bloomberg terminal. I'm Carol Masser and I'm
Speaker 1: Jason Kelly, and also be sure to check us out
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