Many countries are cautiously emerging from lockdown, but life is unlikely to return to normal until a vaccine for this coronavirus is found.
So far, the virus has infected more than 4.5 million people across the world, killing close to 305,000, according to latest figures from the Johns Hopkins Coronavirus Resource Center, and bringing global economies to a near-standstill.
More than 70 potential vaccines are currently being developed, according to the World Health Organization, all of which are at various different stages as the race to defeat the virus starts to takes shape.
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One project, being developed by clinical research teams at the University of Oxford’s Jenner Institute and Oxford Vaccine Group in the U.K., seems to have taken an early lead. Researchers began working on a vaccine in February, and human trials started at the end of April.
Here’s everything you need to know about the vaccine, known as ChAdOx1 nCoV-19.
How does the vaccine work?
The vaccine is made from a weakened version of a common cold virus (known as an adenovirus) from chimpanzees, which has been modified so it cannot grow in humans. The spike glycoprotein from the virus that causes COVID-19 have then been added. “We are hoping to make the body recognize and develop an immune response to the Spike protein that will help stop the SARS-CoV-2 virus from entering human cells and therefore prevent infection,” the university said.
There will be some side effects. The trial volunteers have been warned that some may get a sore arm, headaches or fevers in the first couple of days after vaccination.
Who is being tested?
Up to 1,102 healthy volunteers between 18 and 55 years of age are being recruited for the trials in study sites across Oxford, Southampton, London and Bristol.
The first two volunteers, dosed by researchers at the University of Oxford on April 23, were a scientist and a cancer researcher. Six more volunteers were injected two days later, before the trial was expanded to include a much larger group.
In the first phase — currently being conducted — 550 participants are given the ChAdOx1 nCoV-19 vaccine and 550 a control vaccine against meningitis and sepsis for comparison.
Participants, including three members of the same family in Oxfordshire, have been recording any symptoms and keeping an “e-diary” of their experiences. Blood samples are taken at a series of follow-up visits — the samples will then be used to assess the immune response to the vaccine. A separate group of 10 volunteers will receive two doses of the vaccine four weeks apart.
In Phase 2 the age of participants will be extended, before 5,000 volunteers take part in Phase 3.
When will it be available to the public?
The university said its best-case scenario is for an efficacy result from Phase 3 by the fall, alongside the ability to manufacture large amounts of the vaccine, but stressed the time frame was “highly ambitious and subject to change.”
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The U.K.’s gradual emergence from lockdown may actually help speed up the process. The university said if transmission was high in the community it may get enough data to see if the vaccine works “in a couple of months,” while transmission dropping could push that back to six months.
Scientists at Oxford have said the aim is to produce a million doses of the vaccine by September.
John Bell, regius professor of medicine at the University of Oxford, told the BBC Radio 4 program “Today” that he hoped to get “some signal” about whether the vaccine is working by the middle of June.
Millions of doses could be ready by September, but the study’s chief investigator, Andrew Pollard, said it was unlikely the vaccine would be available at a “very large scale” before the end of 2020.
Britain’s chief medical adviser, Chris Whitty, has said it is unlikely that a vaccine will be available within the next year.
However, the university struck a potentially crucial partnership with British drug maker AstraZeneca
for the “further development, large-scale manufacture and potential distribution” of the vaccine if it proves successful.
The agreement would see the pharmaceutical giant work with global partners to internationally distribute the vaccine.
The European Medicines Agency said a vaccine could be ready for approval in a year in an “optimistic” scenario on Thursday, according to Reuters. The EMA’s head of vaccines, Marco Cavaleri, said he was skeptical of claims that a vaccine could be ready by September.
Will the vaccine be successful?
The experimental vaccine showed some success in a small animal study involving six monkeys, according to initial findings published online earlier this month.
Some of the monkeys developed antibodies against the virus within 14 days of being injected with the experimental vaccine, while all six had antibodies after 28 days, the findings published on preprint server bioRxiv revealed. After then exposing the monkeys to the virus, scientists said their findings showed the vaccine is “effective in preventing damage of the lungs” and prevents the virus replicating in the lungs.
The virus was still replicating in the nose, they added. “Importantly, no evidence of immune-enhanced disease following viral challenge in vaccinated animals was observed,” scientists said in the findings.
What if the vaccine doesn’t work?
A high proportion of vaccines are found not to be promising even before clinical trials, and a significant proportion of those tested in clinical trials don’t work. “If we are unable to show that the vaccine is protective against the virus, we would review progress, examine alternative approaches, such as using different numbers of doses, and would potentially stop the program,” the university said.
What about the other vaccines? Do we need more than one, and when might they be ready?
The truly global nature of the pandemic means it is likely several vaccines will be needed to beat the coronavirus.
A global fundraising event led by the European Union has pledged $8 billion to develop COVID-19 vaccines and to ensure universal global access. More than 30 countries, along with the World Bank research institutes and philanthropic bodies including the Bill and Melinda Gates Foundation, made donations. Other wealthy contributors included pop singer Madonna, who pledged €1 million ($1.1 million).
The U.S. has refused to contribute to the global effort and has instead launched “Operation Warp Speed” to accelerate the vaccine-development process.
The world’s pharmaceutical companies have also joined the vaccine race. U.S. pharmaceutical giant Pfizer
has teamed up with German company BioNTech
Human trials, which have already begun in Germany, began in the U.S. last week. Pfizer Chief Executive Albert Bourla told CNBC on Tuesday that clinical trials could be expanded to thousands of people by September if one or two versions of its vaccines show progress. Hundreds of millions of doses could be produced in 2021, he said.
Biotech company Moderna
has completed the Phase 1 trial of its COVID-19 vaccine. A Phase 2 study is expected to start this quarter and will follow 600 participants for 12 months. The company announced what appear to be very positive results from interim Phase 1 data on Monday. Not only did the vaccine lead to the creation of antibodies in eight human test subjects, but the vaccine also kept the virus that causes Covid-19 from replicating in the lungs of mice. Significantly, Moderna announced a 10-year manufacturing deal with Swiss company Lonza Group
earlier this month. The deal will enable up to 1 billion doses of the vaccine — if successful — a year. Manufacturing facilities will be set up in Switzerland and the first batch of the vaccine could be produced by July. It could be ready for market in early 2021.
and Britain’s GlaxoSmithKline
— two of the world’s largest vaccine manufacturers — have joined up to produce a vaccine, aiming to begin enrollment in the fourth quarter of 2020 and approval by the second half of 2021 at the earliest — an accelerated 18-month timeline. Sanofi Chief Executive Paul Hudson told Bloomberg News that Americans could be first in line for the vaccine, as the U.S. stepped up to fund the research. The French drugmaker said on Thursday it was working with European regulators to speed up access to the potential vaccine in Europe.
Johnson & Johnson
plans to start human testing on its own potential vaccine in September, with results in December. The vaccine could then be approved for emergency use earlier next year.