September 10, 2020 8:20:36 am
Coronavirus (COVID-19) Vaccine Tracker: The volunteer whose serious ailment halted clinical trials of a coronavirus vaccine candidate being developed by AstraZeneca and Oxford University is a woman who has shown symptoms of a neurological disorder that affects the spinal cord, according to a report in Stat News, the media organisation which first reported that the clinical trials had been paused.
The report said information about the woman was released by AstraZeneca CEO Pascal Soriot during a “private conference call” with company investors. It said the CEO had informed the investors that the woman had symptoms of a rare disease called transverse myelitis, but that her condition was improving and she was likely to be discharged from the hospital soon.
Soriot also said that the woman participant had indeed received a real vaccine and not a placebo, or a dummy. During phase-3 clinical trials, the participants are either given a dose of a real vaccine, or that of a dummy. The participants do not know what they have been injected with. They are then allowed to go about their normal life, and are checked after a few days or weeks to see whether the group which had been injected with the real vaccine had resisted the infection better than the other group.
Incidentally, the report said, Soriot also mentioned that the trials had been halted once earlier as well, in July, after another participant had also developed neurological problems. The patient was later diagnosed with multiple sclerosis, something that was assessed to be unrelated to the vaccine.
Incidents like these are fairly common in clinical trials of drugs and vaccines, scientists say. But this is the first such incident that has been reported from the clinical trials of dozens of coronavirus vaccine candidates that are currently being done.
Meanwhile, India’s drug regulator issued a show-cause notice to the Pune-based Serum Institute of India for failing to share the information about the pause on AstraZeneca vaccine. Serum, the world’s largest manufacturer of vaccines by volume, has an agreement with AstraZeneca to manufacture and market the vaccine in India and other low and middle income countries. Serum is also carrying out phase-2 and phase-3 trials of that vaccine with the approval of the office of the Drug Controller General of India (DCGI).
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One of the conditions for granting of approval for clinical trials in India had been that data generated from trials within the country would be considered along with that from trials going on in other parts of the world. In its show-cause notice, the DCGI asked Serum why it had not submitted information about the England incident.
In response, Serum said it would follow DCGI’s instructions and abide by the standard protocols.
The trials in India, which had begun in the last week of August, have already been on hold for completely different reasons. The trials have so far seen 100 participants injected with the vaccine. The data generated from these 100 participants have to be submitted to an independent expert body, that will assess it for safety and then decide whether further enrolment of more volunteers could be permitted. That expert body is likely to meet on Thursday or Friday to have a look at the data.
The plan is to enroll 1,600 participants for the combined phase-2 and phase-3 trials India.
Head of government medical research in US non-committal on early November deadline for a coronavirus vaccine
Francis Collins, director of the National Institutes of Health, the medical research agency of the United States, suggested that a November deadline for the coronavirus vaccine was unreasonable since no one could be sure about it.
Collins, who was appearing at a US Senate panel hearing, was repeatedly asked about President Donald Trump’s assertions that a coronavirus vaccine could be possible before the November 3 elections.
“Certainly, to try to predict whether it happens on a particular week before or after a particular date in early November is well beyond anything that any scientist right now could tell you, and be confident they know what they are saying,” Collins said in response.
He repeatedly assured the senators that a vaccine would not be authorised unless it had been established to be safe and effective, according to a report in The New York Times.
On Tuesday, Anthony Fauci, an infectious disease expert and one of the most trusted voices in the United States on the coronavirus epidemic, had said a coronavirus vaccine was unlikely to be ready before November 3.
Speaking at a health conference, Fauci said it was more likely that the vaccine would appear on the scene sometime before the end of the year.
HUNT FOR CORONAVIRUS VACCINE: THE STORY SO FAR
- More than 175 vaccine candidates in pre-clinical or clinical trials
- 34 of them in clinical trials
- Eight in final stages, phase-III of human trials
- At least eight candidate vaccines being developed in India. Two of these have entered phase -II trials after completing phase-I.
- The ones most talked about
* AstraZeneca/Oxford University
* Johnson & Johnson
* Russian vaccine, developed by Gamaleya Insttiute in Moscow
Source: WHO Coronavirus vaccine landscape of September 3, 2020
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