Coronavirus vaccine tracker: A Pennsylvania-based pharmaceutical company’s planned start to phase-2 and phase-3 clinical trials have been put on hold for the time being after the US Food and Drug Administration raised questions over the technology it is using to deliver the vaccine inside human body.
The vaccine being developed by Inovio Pharmaceuticals is already under phase-1 trials which will continue. According to a report in The New York Times, the FDA had sought more information from the company about the vaccine’s delivery device which uses an electrical pulse to open skin pores in order to more consistently deliver the vaccine dose. It said regulatory questions over a similar device had earlier held up clinical trials for a cancer vaccine developed by the same company in 2016.
The vaccine seeks to use the DNA of the novel coronavirus to trigger the immune response in human bodies. No DNA-based vaccine has ever been produced for any human disease.
The company said it will respond to FDA’s queries by October. The regulatory body will then, within 30 days, decide on the company’s application to start phase-2 and phase-3 trials.
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Group of scientists ask Pfizer not to seek emergency authorisation for its vaccine before November
Pfizer has said that it hoped to find out by October whether a coronavirus vaccine it was developing was effective or not, and if it was, it would immediately apply for an emergency use authorisation from the US FDA. But a group of scientists is now asking Pfizer not to rush to the FDA after getting the initial data, and instead follow up on the trial participants for at least one more month, according to a Bloomberg Law news report.
This group of about 60 scientists and researchers, affiliated to various US universities, have written a letter to Pfizer pointing out that trial participants needed to be monitored for at least two months after they received the second dose of the vaccine to conclusively know whether anyone of them was showing any side-effects, the Bloomberg report said.
“To be successful, the public needs to have utmost trust in the vaccine and the science behind it. Submission of an application for an EUA (emergency use authorisation) before this standard is met would severely erode public trust, and set back efforts to achieve widespread vaccination,” the Bloomberg report quoted the letter as saying.
If Pfizer indeed gets effectiveness data from its ongoing phase-3 trials, and obtains emergency authorisation as well, it could be the first coronavirus vaccine to be available in the US market.
Hunt for coronavirus vaccine: The story so far
- 191 vaccine candidates in pre-clinical or clinical trials
- 40 of them in clinical trials
- Ten 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
* Three Chinese vaccines that have been approved for use in China without phase-3 trials being completed. One of them has been given emergency use authorisation in UAE
(As on September 28; source: WHO Coronavirus vaccine landscape of September 28, 2020)
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