US biotechnology company Moderna has said it would know about the effectiveness of its coronavirus vaccine by November. Moderna’s vaccine candidate is one of the three undergoing large-scale phase-3 clinical trials in the United States, in which 30,000 participants are being enrolled.
Company CEO Stephane Bancel has said if the vaccine candidate was found to be at least 50 per cent effective, the minimum bar set by the US Food and Drug Administration for approving a vaccine, it would immediately move to apply for an emergency use authorisation.
Bancel said if everything went well the company could deliver about 100 million doses of vaccine to the US government in the “first few months of 2021”.
The company also released a 135-page note on the ongoing phase-3 trials. According to that note, which is dated August 20 but made public only on Thursday, the company was expecting to know about the effectiveness of the vaccine candidate by December.
Moderna has never made a vaccine that has been approved. For coronavirus, it is using a genetic approach that has never produced a successful vaccine for any disease. But the company enjoys the confidence and backing of the US government which has pumped in more than a billion dollars to help the company accelerate the vaccine development, and pre-booked hundreds of millions of doses, when it becomes available.
Even if Moderna knows about the effectiveness of its vaccine by November, it might be beaten in the race by another US pharmaceutical company Pfizer, which has said it was hoping to be ready with effectiveness data by the end of October. Like Moderna, Pfizer is also carrying out phase-3 trials of its vaccine in the United States. Pfizer has also said it would apply for emergency authorisation once the effectivenss data is available.
Along with AstraZeneca, the third vaccine under phase-3 trials in US, Moderna and Pfizer are currently being considered the likely first ones to produce a coronavirus vaccine.
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More details emerge about woman whose condition had halted AstraZeneca vaccine trial: 37-year-old had confirmed case of transverse myelitis
The woman whose serious illness had stopped the global late-stage trials of a coronavirus vaccine being developed by AstraZeneca and Oxford University was a 37-year-old UK resident who developed serious complications after being administered the second dose of vaccine.
The woman was diagnosed with confirmed case of transverse myelitis, a rare neurological disorder affecting the spinal cord of the person. The woman was hospitalised on September 5.
The details are contained in an “internal safety report” prepared by AstraZeneca, which was obtained by CNN, which said that the report was probably meant for doctors who were involved in the trials. AstraZeneca has officially given no details about the participant apart from saying that she had recovered from her ailment nad been discharged from the hospital.
The AstraZeneca vaccine candidate is considered one of the frontrunners in the global rush to develop a coronavirus vaccine. It was undergoing phase-3 trials in the United States, Brazil and South Africa, and combined phase-2 and phase-3 trials in England and India, when the news of the woman participant taking ill emerged. The trials were stopped at all places.
After a safety evaluation in England, the trials have since resumed. The go-ahead to re-start the trials have been given in India as well. But the United States has ordered an investigation into this entire incident, and it is yet to decide on resuming the trials.
Hunt for coronavirus vaccine: The story so far
- 180 vaccine candidates in pre-clinical or clinical trials
- 35 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
(As on September 15; source: WHO Coronavirus vaccine landscape of September 9, 2020)
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