Covid-19 Vaccines Summary

Covid-19 Vaccines Summary

Over the course of the year, we have published reports on active Covid-19 clinical trials in Canada and from around the world. This month we are publishing a summary report of promising Covid-19 Vaccines. Researchers are racing to produce a safe and effective coronavirus vaccine against the COVID-19 pandemic.

In this report, we have summarized the status of 11 promising vaccine candidates that have reached phase 3 clinical trials. We have indicated each candidate’s Trial Design, their outcomes and overall status.

 

This report is co-published with the Clinical Consultancy CRO, McDougall Scientific and provided to you in a format that is hopefully useful to digest.

All clinical trial data, summaries, content and references have been referenced directly from clinicaltrials.gov provided by the National Institutes of Health, by the Regulatory Affairs Professionals Society (RAPS),  the New York Times Coronavirus Vaccine Tracker, and by CNN Health.

 

Download the Covid-19 Vaccines report.

Includes promising Vaccines from:

Pfizer, Moderna, AstraZeneca, Johnson & Johnson, Novavax, CansinoBio, Sinovac, Sinopharm, Medicago, Bharat Bio,Gamaleya

Covid-19 Clinical Trials worldwide numbers for October 2020

 

Worldwide Covid-19 Clinical Trials numbers for October 2020

We continue to provide updated reports on Clinical Trials focused on Covid-19. Here is the update representing data from October 2020.  Our reports are co-published with our friends at the Clinical Research Organization, McDougall Scientific. We have taken clinical trial data directly from clinicaltrials.gov provided by the National Institutes of Health and published a summary of the data in a format that is hopefully useful to digest.

We will continue to publish Covid-19 Clinical Trial updates as data of new Trials are made available.

 

Download the Report.

Some of the data provided includes:

  • # of Covid-19 Clinical Trials by Country
  • # of Covid-19 Clinical Trials by Sponsors/Collaborators
  • # of Covid-19 Clinical Trial by Drug Interventions

 

Notice of Compliance with Conditions versus Priority Review

What is the difference between Notice of Compliance with Conditions and Priority Review?

 

WHAT IS THE DIFFERENCE BETWEEN THE NOTICE OF COMPLIANCE WITH CONDITIONS AND THE PRIORITY REVIEW?

These two processes apply to drugs used to treat conditions that are serious, life-threatening or for a severely debilitating disease (such as Alzheimer’s disease, cancer, AIDS, or Parkinson’s Disease).

Priority Review (PR) applies to drugs that shows substantial evidence of clinical effectiveness at the end of the clinical trial phases, that is, once the clinical development is completed. The total review timeline is reduced from 355 days to 215 days.

On the other hand, the Notice of Compliance with condition (NOC/c) applies to drugs with promising evidence of clinical effectiveness throughout the clinical trial phases. In summary, the NOC/c can be granted with less clinical data than usually expected, that is with Phase II study results or interim reports of Phase III studies. Approval would be granted to a manufacturer to market and sell that drug in Canada with the condition that the manufacturer execute additional studies to confirm the drug’s benefit and safety.  The total review timeline is reduced from 355 days to 235 days.

The condition needs to be agreed to with Health Canada. Some of the conditions of the NOC/c may include a requirement to closely monitor the drug for safety and adverse reactions and to provide HPFB with regular updates. Once the conditions are met, the designation of “with condition” is removed from the NOC.

To be considered for PR or NOC/c, the drug considered need to meet specific Health Canada criteria, that can be summarized as follows:

  • Offer effective treatment, prevention or diagnosis of a disease or condition for which no drug is available in Canada; or
  • Offer an improved benefit/risk profile over existing therapies, preventatives or diagnostic agents for a disease or condition, not adequately managed by a drug marketed in Canada.

Again, discussing with a Canadian regulatory expert in the early drug development stages can be an advantage for early input to establish the ideal regulatory strategy, as well as to help navigate through the requirements that are specific to Canada, while keeping in mind the global market strategy.

  

For questions about the Canadian Drug Review & Regulatory approval process that is not covered in this section, please go ahead and contact us directly.

 

Covid-19 Clinical Trials worldwide numbers for September

Worldwide Covid-19 Clinical Trials numbers for September

We continue to provide updated reports on Clinical Trials focused on Covid-19. Here is the update as of October 1st, representing data from September 2020.  Our reports are co-published with our friends at the Clinical Research Organization, McDougall Scientific. We have taken clinical trial data directly from clinicaltrials.gov provided by the National Institutes of Health and published a summary of the data in a format that is hopefully useful to digest.

We will continue to publish Covid-19 Clinical Trial updates as data of new Trials are made available.

 

Download the Report.

Some of the data provided includes:

  • # of Covid-19 Clinical Trials by Country
  • # of Covid-19 Clinical Trials by Sponsors/Collaborators
  • # of Covid-19 Clinical Trial by Drug Interventions

 

Covid-19 Clinical Trials worldwide for August

September update: Worldwide Covid-19 Coronavirus Clinical Trials

We continue to provide updated reports on Clinical Trials focused on Covid-19. Here is the update as of September 1st, representing data from August 2020.  Our reports are co-published with our friends at the Clinical Research Organization, McDougall Scientific. We have taken clinical trial data directly from clinicaltrials.gov provided by the National Institutes of Health and published a summary of the data in a format that is hopefully useful to digest.

We will continue to publish Covid-19 Clinical Trial updates as data of new Trials are made available.

 

Download the Covid-19 Worldwide Clinical Trial report, updated as of September 1st.

Some of the data provided includes:

  • # of Covid-19 Clinical Trials by Country
  • # of Covid-19 Clinical Trials by Sponsors/Collaborators
  • # of Covid-19 Clinical Trial by Drug Interventions

 

Covid-19 Clinical Trials worldwide for July

 

August update: Worldwide Covid-19 Coronavirus Clinical Trials

We continue to provide updated reports on Clinical Trials focused on Covid-19. Here is the update as of August 2nd, representing data from July 2020.  Our reports are co-published with our friends at the Clinical Research Organization, McDougall Scientific. We have taken clinical trial data directly from clinicaltrials.gov provided by the National Institutes of Health and published a summary of the data in a format that is hopefully useful to digest.

We will continue to publish Covid-19 Clinical Trial updates as data of new Trials are made available.

 

Download the Covid-19 Worldwide Clinical Trial report, updated as of August 2nd.

Some of the data provided includes:

  • # of Covid-19 Clinical Trials by Country
  • # of Covid-19 Clinical Trials by Sponsors/Collaborators
  • # of Covid-19 Clinical Trial by Drug Interventions

 

Worldwide Covid-19 Clinical Trials for June

 

July update: Worldwide Covid-19 Coronavirus Clinical Trials

We continue to provide updated reports on Clinical Trials focused on Covid-19. Our reports are co-published with our friends at the Clinical Research Organization, McDougall Scientific. We have taken clinical trial data directly from clinicaltrials.gov provided by the National Institutes of Health and published a summary of the data in a format that is hopefully useful to digest.

We will continue to publish Covid-19 Clinical Trial updates as data of new Trials are made available.

 

Download the Covid-19 Worldwide Clinical Trial report, updated as of July 2nd.

Some of the data provided includes:

  • # of Covid-19 Clinical Trials by Country
  • # of Covid-19 Clinical Trials by Sponsors/Collaborators
  • # of Covid-19 Clinical Trial by Drug Interventions

 

Covid-19 Clinical Trials around the World for May

June update: Worldwide Covid-19 Coronavirus Clinical Trials

We continue to provide updated reports on Clinical Trials focused on Covid-19. Our reports are co-published with our friends at the Clinical Research Organization, McDougall Scientific. We have taken clinical trial data directly from clinicaltrials.gov provided by the National Institutes of Health and published a summary of the data in a format that is hopefully useful to digest.

The number of Covid-19, coronavirus clinical trials has significantly grown since March. In April were about 1134 active Clinical Trials from around the world focused on Covid-19 and in May there were about 1703 trials from around the world, a 50% increase.

We will continue to publish Covid-19 Clinical Trial updates as data of new Trials are made available.

 

Download the Covid-19 Worldwide Clinical Trial report, updated as of June 1st.

Some of the data provided includes:

  • # of Covid-19 Clinical Trials by Country
  • # of Covid-19 Clinical Trials by Sponsors/Collaborators
  • # of Covid-19 Clinical Trial by Drug Interventions

 

Covid-19 Coronavirus Clinical Trials in Canada

 

Covid-19, Coronavirus Clinical Trials in Canada

With the pandemic of Covid-19 continuing across the globe, pharmaceutical companies, scientists, hospitals and health care organizations around the world continue to accelerate clinical research to find a treatment and possible vaccine. In Canada, the number of Covid-19, coronavirus clinical trials has been steadily growing.

As of May 1st, 2020, there were 29 active Clinical Trials operating in Canada focused on Covid-19. (See the report below).

Although Clinical Trials take time, we expect further growth over the next few months in the number of Clinical Trials for Covid-19 in Canada and around the world. We will publish any updates as data of new Clinical Trials are made available.

Health Canada has published certain guidelines as it pertains to the management of clinical trial applications (CTA) during the Covid-19 pandemic. Such guidelines include:

  • Health Canada will prioritize the review of clinical trial applications designed to investigate the diagnosis, treatment and/or prevention of COVID-19.
  • Sponsors may continue to file other CTA and CTA amendments according to Health Canada guidance.
  • During the course of a CTA review, if sponsors are unable to respond to an Information Request (IR) within specified time lines, consider withdrawing the submission without prejudice and refiling when the information is available.

Please visit Health Canada’s information page for further details on their guidelines for clinical trials during the Covid-19 pandemic.

Download the Covid-19 Clinical Trial in Canada summary report

We have co-published a report on Covid-19 Clinical Trials in Canada with our friends at the Clinical Research Organization (CRO) McDougall Scientific. We have taken clinical trial data for Canada directly from clinicaltrials.gov provided by the National Institutes of Health and published a summary of the data in a format that is hopefully useful to digest.

Some of the data provided includes:

  • # of Covid-19 Clinical Trials by Canadian Province
  • # of Covid-19 Clinical Trials by Sponsors/Collaborators
  • # of Covid-19 Clinical Trial by Drug Interventions

 

Covid-19 Coronavirus Clinical Trials around the World

Covid-19, Coronavirus Clinical Trials Worldwide

With the pandemic of Covid-19 continuing across the globe, pharmaceutical companies, scientists, hospitals and health care organizations around the world continue to accelerate clinical research to find a treatment and possible vaccine.

The number of Covid-19, coronavirus clinical trials has been steadily growing since January 2020. As of March 31st, there are 287 active Clinical Trials around the world focused on Covid-19.

These Clinical Trials are being conducted across most regions of the world; Europe has 100 going on, Asia has 79 and North America has 56. Within each of these regions we can also find the number of Covid-19 Clinical Trials by Country.

We expect further growth over the next few months in the number of Clinical Trials for Covid-19 around the world. We will publish any updates as data of new Clinical Trials are made available.

We are actively consulting on how to successfully fast-track market access of health product developed for addressing the current pandemic. Communicate with us to see how we can help.

 

Download a Covid-19 Clinical Trial summary report

We have co-published a report on Covid-19 Clinical Trials with our friends at the Clinical Research Organization, McDougall Scientific. We have taken clinical trial data directly from clinicaltrials.gov provided by the National Institutes of Health and published a summary of the data in a  format that is hopefully useful to digest.

Some of the data provided includes:

  • # of Covid-19 Clinical Trials by Country
  • # of Covid-19 Clinical Trials by Sponsors/Collaborators
  • # of Covid-19 Clinical Trial by Drug Interventions
  • # of Covid-19 Clinical Trials that have been completed