September 11, 2020 7:43:14 am
A hospital worker pauses next to an ambulance outside of Kingsbrook Jewish Medical Center in Brooklyn, May 11, 2020. (Dave Sanders for The New York Times)
Coronavirus (COVID-19) Vaccine Tracker: While an independent group of experts began investigating the severe illness in a participant that led to a halt on clinical trials of AstraZeneca’s coronavirus vaccine, the World Health Organisation said there was nothing to be discouraged about, since these kinds of incidents routinely happen during trials.
Meanwhile, the India trials of the vaccine, being carried out by Pune-based Serum Institute of India, have also been halted. Serum had, on Wednesday, claimed that the India trials would remain unaffected by AstraZeneca’s decision. However, it was issued a show-cause notice by the officer of the Drug Controller General of India, and on Thursday, Serum said it was putting a hold on India trials. Till now, 100 participants have been given the vaccine in India where combined phase-2 and phase-3 trials were approved last month. About 1,600 participants were planned to be enrolled for the complete trial.
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In Geneva, WHO chief scientist Soumya Swaminathan said the AstraZeneca pause was not a setback, and nothing to be discouraged about. She said the incident just demonstrated that the process of vaccine development was not always a “fast and straight road”.
“I think this is good… perhaps a wake-up call or lesson for everyone to recognise that there are ups and downs in research, there are ups and downs in clinical development, and that we have to be prepared for those,” Swaminathan said.
“We need not be discouraged. Such things happen,” she said.
“We hope that things will be able to move on, but again, it depends.. We will have to wait to see the details of what actually happened,” she said.
It happens – scrutiny is key
This is a singular incident, but vaccine timelines have been crunched — and it is critical to scrutinise adverse reactions. Trials have been paused for similar reviews earlier; it does not necessarily mean that the candidate’s efficacy or safety is suspect – or that testing will not resume.
A team of independent experts has got on to its job of finding out what exactly happened, and most importantly, whether the severe illness in the participant was triggered by the vaccine or something else.
AstraZeneca CEO had, on Wednesday, revealed that the woman participant whose severe illness had halted the clinical trials, had indeed been given the real vaccine, and not a dummy which is given to half the participants in a phase-3 trial. As of now, it is not clear whether the illness, which the company said was a neurological disorder affecting the spinal cord, was in any way linked to the vaccine.
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Ivanka Trump responds to TV show host’s taunt: I will come to your show and take the vaccine
US President Donald Trump’s daughter Ivanka Trump said she was ready to get injected with a coronavirus vaccine on live TV, once it was ready, after being taunted by a television show host.
Joy Behar, co-host of television show The View that airs on ABC network, and an outspoken critic of Donald Trump, said Trump was pushing for an early vaccine only to get re-elected.
“And by the way, I will take the vaccine after Ivanka takes it,” she said.
Ivanka took to Twitter to respond to the challenge thrown to her. “Deal @JoyVBehar. I would come on your show to do so. I trust the FDA and so should all Americans. Vanquishing this virus should be our collective priority”.
Deal @JoyVBehar. I would come on your show to do so.
I trust the FDA and so should all Americans. Vanquishing this virus should be our collective top priority. https://t.co/FXb0Dqjdio
— Ivanka Trump (@IvankaTrump) September 10, 2020
Incidentally, to press home the point that a vaccine developed by Moscow’s Gamaleya institute was safe, Russian President Vladimir Putin had said that her daughter had already taken the vaccine.
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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
* Moderna
* Pfizer/BioNTech
* Johnson & Johnson
* Sanofi/GlaxoSmithKline
* Novavax
* Russian vaccine, developed by Gamaleya Insttiute in Moscow
(As on September 10; source: WHO Coronavirus vaccine landscape of September 9, 2020)
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