US orders 300 million doses of potential COVID-19 vaccine
Operation Warp Speed zeroes in on an October release for an experimental coronavirus vaccine from the University of Oxford; Jonathan Serrie reports.
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A COVID-19 vaccine trial at Oxford University in the U.K. is “progressing very well,” according to researchers involved in the project.
“The clinical studies are progressing very well and we are now initiating studies to evaluate how well the vaccine induces immune responses in older adults, and to test whether it can provide protection in the wider population,” said Professor Andrew Pollard, head of the Oxford Vaccine Group, in a statement released Friday. “We are very grateful to the huge support of the trial volunteers in helping test whether this new vaccine could protect humans against the pandemic coronavirus.”
The same investigational vaccine protected six monkeys from pneumonia caused by the virus. The ChAdOx1 nCoV-19 vaccine is made from the ChAdOx1 virus, a weakened version of the common cold that has been genetically changed so that it is impossible for it to replicate in humans, according to the Oxford researchers.
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Researchers have started recruiting in the next phase of human trials for the COVID-19 vaccine. The Phase I trial in healthy adult volunteers began in April and more than 1,000 immunizations have been completed, the researchers said, noting that follow-up is currently ongoing.
The Medicines and Healthcare products Regulatory Agency, which oversees drug trials in the U.K., told Fox News that data support the trial's progression from phase I. “The MHRA supports the development and expedites authorisation of clinical trials for COVID-19 treatments, whilst maintaining high regulatory standards to ensure the safety of people involved in the trials," a spokeswoman told Fox News, via email. "Emerging data have been reviewed and support enrolment into the phase II/III trial.”
Fox News has also reached out to Oxford University with a request for comment on this story.
“The next study will enroll up to 10,260 adults and children and will involve a number of partner institutions across the country,” said the Oxford Vaccine Group in the statement. Phase II of the study will involve a small number of older adults aged 56 to 59 and over 70, as well as children aged 5 to 12.
“For these groups, researchers will be assessing the immune response to the vaccine in people of different ages, to find out if there is variation in how well the immune system responds in older people or children,” the researchers said. “Adult participants in both the Phase II and Phase III groups will be randomized to receive one or two doses of either the ChAdOx1 nCoV-19 vaccine or a licensed vaccine (MenACWY) that will be used as a ‘control’ for comparison.”
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Phase III of the study will assess how the vaccine works in a large number of people over the age of 18. “This group will assess how well the vaccine works to prevent people from becoming infected and unwell with COVID-19,” they said in the statement.
To assess whether the vaccine works, Oxford’s statisticians will compare the number of infections in the control group to the number of infections in the vaccinated group.
“For this purpose, it is necessary for a small number of study participants to develop COVID-19,” they said. “How quickly we reach the numbers required will depend on the levels of virus transmission in the community. If transmission remains high, we may get enough data in a couple of months to see if the vaccine works, but if transmission levels drop, this could take up to 6 months.”
Earlier this week, the U.K.’s Business Secretary Alok Sharma said that the Oxford vaccine trial, if successful, could deliver 30 million doses by September.
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With 252,246 cases and 36,124 deaths the U.K. is one of the most impacted countries by the coronavirus pandemic.
A number of efforts to develop a coronavirus vaccine are underway around the world. Scientists at Israel’s Tel Aviv University and biopharmaceutical company Neovii, for example, recently announced a project to develop a COVID-19 vaccine.
Experts involved in the effort say that they are targeting the "Achilles heel" of coronavirus.
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As of Friday morning, more than 5.12 million coronavirus cases have been diagnosed worldwide, at least 1,577,785 of which are in the U.S., according to data compiled by Johns Hopkins University. The disease has accounted for at least 333,489 deaths around the world, including at least 94,729 people in the U.S.
Fox News’ Christopher Carbone contributed to this article. Follow James Rogers on Twitter @jamesjrogers
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