Updated: September 13, 2020 8:53:31 am
A healthcare worker holds blood samples during clinical trials for a Covid-19 vaccine at the Research Centers of America in Hollywood, Florida. (Photographer: Eva Marie Uzcategui / Bloomberg)
Coronavirus Vaccine Tracker (COVID-19): The clinical trials of a coronavirus vaccine being developed by the University of Oxford and AstraZeneca, which had to be arrested last week, be resume in UKthe two partners said in separate statements.
Clinical trials for this candidate vaccine, considered one of the most promising, had been halted last Sunday after one of the trial participants developed a serious ailment, which various news reports described as a problem. neurological disorder affecting the spinal cord. The trials were stopped so that a team of independent experts could verify whether the disease was caused by the vaccine or something else.
On Saturday, the University of Oxford said both the expert team and the UK medicines regulator had completed their safety review.
“The independent review process has been completed, and following the recommendations of both the independent safety review committee and the UK regulator, the MHRA (Medicines and Healthcare Products Regulatory Agency), trials will resume in the UK.” the Oxford University statement said. .
He did not say what conclusion the expert body had reached about the cause of the disease. In addition, he did not mention the fate of clinical trials that are being carried out in other countries: Brazil, South Africa, the United States and India. Trials have stopped in all of these countries.
In Brazil, South Africa, and the United States, clinical trials are in phase 3, while in India and England, phase 2 and phase 3 trials are conducted simultaneously.
A sign with the AstraZeneca Plc logo stands on the company’s DaVinci building at Melbourn Science Park in Cambridge, UK (Photographer: Jason Alden / Bloomberg)
In India, trials are being conducted by the 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 low and middle income countries, including India.
Serum had initially said that the Indian trials would not be affected due to the incident in the UK, but it was withdrawn by the Indian drug regulator. A day later, the Trials in India were also stopped. Serum plans to enroll 1,600 participants for phase 2 and phase 3 trials in India. So far, about 100 participants have been given the vaccine.
At the moment, it is unclear when the trials in India will resume. It’s a decision that India’s drug regulator would have to make.
Pfizer and BioNTech will test their vaccine in more people
Pfizer, which is developing a coronavirus vaccine in partnership with its German partner BioNTech, has said it would expand the size of the vaccine’s ongoing phase 3 clinical trials to include people from more diverse population groups.
The company said it now intends to enroll about 44,000 participants for the trials. Her current plan was to test the vaccine on about 30,000 people. A company statement said the trials were expected to complete the goal of enrolling 30,000 people by next week.
A pedestrian in a protective mask passing in front of the Pfizer Inc. signage is reflected outside the company’s headquarters in New York.
“The proposed expansion would allow companies to further increase the diversity of the test population to include adolescents up to 16 years of age and people with chronic and stable infection with HIV, hepatitis C or hepatitis B, as well as provide additional safety and efficacy data ”The statement said.
The company said the expansion would not affect the schedule for completing the tests. “As noted above, based on current infection rates, companies continue to hope that a conclusive reading on efficacy is likely to be obtained by the end of October,” he said.
The October deadline, announced by the companies recently, had led to speculation that this would be the vaccine that could be granted emergency use authorization in the United States before the November 3 presidential election there. country. Pfizer had said it would apply for the emergency authorization as soon as the effectiveness data was available in October.
Merck begins human trials
The American pharmaceutical company has begun combined phase 1 and phase 2 clinical trials for its coronavirus vaccine. The trials have started in Belgium.
According to a Wall Street Journal report, the trials hope to enroll 260 healthy volunteers and that the former have already been injected.
Full trials, including phase 3, are expected to continue through April 2022, nearly two years from now, although the data needed to make the vaccine available to the public could be obtained much earlier.
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FILE PHOTO: Vaccine trial volunteers wait to be called by name before testing for coronavirus disease in Johannesburg, South Africa (Reuters)
The United States would actually issue an emergency clearance
The United States prepares to grant emergency use authorization to a coronavirus vaccine, when one emerges on the scene. In a series of tweets on Friday, Stephen Hahn, commissioner of the Food and Drug Administration, said that the US drug regulator planned to issue a “ guidance ” emergency use authorization for anti-virus vaccines. coronavirus.
Hahn has previously also indicated that for speed up the availability of a vaccine to the public, the emergency use authorization path could be considered. Even vaccines that have not yet completed phase 3 trials can be approved for use, if the benefits of doing so outweigh the risks involved, she had said.
Plans to issue a ‘guide’ in this regard now indicate that a decision had to be made to grant emergency authorizations to vaccines that are considered safe and effective, without waiting for full trials to complete.
FILE – In this July 27, 2020, file photo, a nurse prepares an injection as a study of a possible COVID-19 vaccine, developed by the National Institutes of Health and Moderna Inc., which is launched in Binghamton, NY (AP Photo / Hans Pennink, file)
Search for the coronavirus vaccine: the story so far
- 180 candidate vaccines in clinical or preclinical trials
- 35 of them in clinical trials
- Eight in final stages, phase III human trials
- At least eight potential vaccines are under development in India. Two of them have entered phase II trials after completing phase I.
- The most commented:
* AstraZeneca / University of Oxford
* Modern
* Pfizer / BioNTech
* Johnson and Johnson
* Sanofi / GlaxoSmithKline
* Novavax
* Russian vaccine, developed by Gamaleya Insttiute in Moscow
(As of September 10; source: WHO Coronavirus Vaccine Overview of September 9, 2020)
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