Author: Sam Sun

The CDC can prevent tens of thousands of deaths by prioritizing vulnerable Americans for COVID-19 vaccination

Last week, the UK’s regulatory agency approved Pfizer/BioNTech’s COVID-19 vaccine (BNT162b2) for emergency use. Quietly, the UK’s Joint Committee on Vaccination and Immunization (JCVI) also published priorities for populations to be vaccinated.

Like the United States, the UK is in a unique position. It will be among the first countries to roll out the highly effective Pfizer/BioNTech vaccine. However, it will be unable to vaccinate its entire populace with the first, or even the entirety of its Pfizer/BioNTech supply agreement in 2020-2021. Eventually however, many months from now, with a combination of Pfizer/BioNTech, Moderna, and possibly other vaccines currently undergoing phase 3 trials, the USA and the UK will be able to vaccinate its entire population.

Timelines, Vaccines

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Perspectives on WHO’s SOLIDARITY Trial: Disappointing Findings Limit Remdesivir’s Use in COVID-19 Patients

Last week, the World Health Organization (WHO) published data from its SOLIDARITY trial on a preprint server. The SOLIDARITY trial is a global, pragmatic, adaptive, master protocol trial investigating 4 therapies for hospitalized COVID-19 patients, including remdesivir. Disappointing findings for remdesivir in the SOLIDARITY trial elicited a statement from Gilead Sciences, questioning the validity of SOLIDARITY, and emphasizing its ACTT-1 trial as the “gold standard” regarding remdesivir’s value for COVID-19.

Clinical Trials, Expert Perspectives, Therapeutics

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Projections for “The COVID-19 Vaccines Timeline”

Vaccines against COVID-19 could be available as early as the end of this year, and Russia has already granted full regulatory approval to its vaccine candidate. tracks the clinical development, regulatory milestones, and manufacturing capacity associated with each of the most promising vaccines to show not only when vaccines could be approved but also when they could be rolled out for at-risk populations (e.g. healthcare workers) and the general public. Comments or questions regarding the Vaccines Timeline can be sent anytime to [email protected].

Timelines, Vaccines

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Catalysts for “The COVID-19 Therapeutics Watchlist”

Of the hundreds of agents being tested, selects the drugs most likely to have a significant impact on patients with COVID-19. The Watchlist is dynamic, with new drugs added and current drugs dropping off whenever new data prompts the changes. Selection for the Watchlist is based primarily on clinical trial data, but also on compelling mechanisms of action, signals of efficacy in compassionate use programs, and practical considerations such as manufacturing and distribution capacity to meet worldwide demand. Nominations for the Watchlist or other comments can be sent anytime to [email protected].

Therapeutics, Watchlist

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A Tale of Two Timelines

In the midst of growing public and scientific concern regarding the integrity of clinical trials for COVID-19 vaccines, Moderna publicly released its 135-page clinical study protocol. Of biopharma companies with a COVID-19 vaccine candidate in phase 3 trials, Moderna is the first to publicly release its study protocol. The overall goal or primary endpoint of the Moderna’s phase 3 trial is to show that mRNA-1273 has a vaccine efficacy (VE) of 60% in preventing COVID-19. In biostatistics parlance, the VE is [1-HR], or 1 minus the hazard ratio. That is, the goal is to show that healthy participants who receive Moderna’s vaccine are 40% as likely to develop COVID-19, compared to participants that receive placebo. In the trial, a case of COVID-19 is defined as:

  • At least TWO of the systemic symptoms: fever (at least 100.4 degrees), chills, muscle aches, headache, sore throat, loss of taste or smell;
  • At least ONE of the respiratory symptoms: cough, shortness of breath, difficulty breathing, or pneumonia; AND, 
  • At least ONE nasopharyngeal, nasal, saliva, or respiratory test that’s positive for SARS-CoV-2

Clinical Trials, Vaccines

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