Coronavirus (COVID-19) Vaccine Tracker: The clinical trials of a coronavirus vaccine being developed by Oxford University and AstraZeneca, which had to be halted last week, will resume in the United Kingdom, the two partners said in separate statements.
Clinical trials for this vaccine candidate, considered one of the most promising, had been paused last Sunday, after one of the trial participants developed a serious ailment, that several news reports described as a neurological disorder affecting the spinal cord. The trials were halted so that an independent expert team could verify whether the illness was caused due to the vaccine, or something else.
On Saturday, Oxford University said both the expert team, as well as the UK drug regulator, had completed their safety review.
“The independent review process has concluded, and following the recommendations of both the independent safety review committee and the UK regulator, the MHRA (Medicine and Healthcare products Regulatory Agency), the trials will recommence in the UK,” the statement from Oxford University said.
It did not say what conclusion the expert body had reached about the cause of the illness. Also, it did not mention the fate of clinical trials happening in other countries – Brazil, South Africa, the United States, and India. Trials had been halted in all these countries.
In Brazil, South Africa and the United States, the clinical trials are in phased-3, while in India and England, phase-2 and phase-3 trials are being conducted simultaneously.
In India, the trials are being conducted by Pune-based Serum Institute of India, the world’s largest manufacturer of vaccines by volume, which has an agreement with AstraZeneca to produce and market the vaccine in the middle and low-income countries, including India.
Serum had initially said the India trials would not be affected because of the incident in the United Kingdom, but it was pulled up by India’s drug regulator. A day later, the India trials were also halted. Serum plans to enrol 1,600 participants for the phase-2 and phase-3 trials in India. So far, about 100 participants have been given the vaccine.
As of now, it is not clear when the India trials would resume. It is a decision that Indian drug regulator would have to make.
Pfizer and BioNTech to try out their vaccine on more people
Pfizer, which is developing a coronavirus vaccine in partnership with its German collaborator BioNTech, has said it would expand the size of the ongoing phase-3 clinical trials of the vaccine, to include people from more diverse population groups.
The company said it now intends to enrol about 44,000 participants for the trials. Its present plan was to test the vaccine in about 30,000 people. A company statement said the trials were expected to complete the target of enrolling 30,000 people by next week.
“The proposed expansion would allow the companies to further increase trial population diversity, and include adolescents as young as 16 years of age, and people with chronic, stable HIV, Hepatitis C, or Hepatitis B infection, as well as provide additional safety and efficacy data,” the statement said.
The company said the expansion would not affect the timeline for completing the trials. “As stated previously, based on current infection rates, the companies continue to expect that a conclusive readout on efficacy is likely by the end of October,” it said.
The October deadline, announced by the companies only recently, had given rise to speculation that this would be the vaccine that might be granted emergency use authorisation in the United States ahead of the November 3 Presidential election in that country. Pfizer had said it would apply for emergency authorisation as soon as the effectiveness data was available in October.
Merck begins human trials
American pharmaceutical company has begun combined phase-1 and phase-2 clinical trials for its coronavirus vaccine. The trials have begun in Belgium.
According to a report in the Wall Street Journal, the trials hope to enrol 260 healthy volunteers, and that the first ones had already been injected.
The full trials, including phase-3, are expected to continue till April 2022, almost two years from now, although the data needed to make the vaccine available to the public might be obtained much earlier.
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US would indeed give emergency authorisation
The United States is preparing to grant emergency use authorisation to a coronavirus vaccine, when one emerges on the scene. In a series of tweets on Friday, Stephen Hahn, commissioner of Food and Drug Administration, said the US drug regulatory was planning to issue a ‘guidance’ emergency use authorisation of coronavirus vaccines.
Hahn has indicated earlier as well that to expedite the availability of a vaccine to the public, the emergency use authorisation route could be considered. Even vaccines that are yet to complete phase-3 trials can be approved for use, if the benefits of doing so outweighed the risks involved, he had said.
Plans to issue a ‘guidance’ in this regard now indicates that a decision had to been taken to grant emergency authorisations to vaccines that are considered safe and effective, without waiting for the complete trials to get over.
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 10; source: WHO Coronavirus vaccine landscape of September 9, 2020)