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Publications

Risk in Vaccine Research and Development Quantified – PLOS ONE

Published in 20th March 2013

A database was actively compiled to include all vaccine projects in development from 1998 to 2009 in the pre-clinical development phase, clinical trials phase I, II and III up to Market Registration. The average vaccine, taken from the preclinical phase, requires a development timeline of 10.71 years and has a market entry probability of 6%. Stratification by disease area reveals pandemic influenza vaccine targets as lucrative.

https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0057755

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The four phases of clinical trials – Pfizer

The process of learning about and developing an investigational medicine is divided into four phases. At first, very few people receive the medicine being studied. The number of people participating in clinical studies grows along with our understanding of the investigational medicine, and the research continues as long as the potential benefits outweigh the risks.

https://www.pfizer.com/science/clinical-trials/guide-to-clinical-trials/phases

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News

Healthy children simply do not need a Covid jab – The Telegraph

I won’t have been the only parent concerned by news last week that the Pfizer vaccine may be approved for use on children as early as June and potentially rolled out to school pupils from September. Healthy children are at almost no serious risk from Covid-19 – the recovery rate for this age group has been calculated at over 99.99 per cent. The argument that children should have the vaccine is not based on a belief that they need or benefit from it but on the logic that it would be good for our communities at large if children were jabbed. In short, those advocating it assume that children have an obligation to protect adults.

It’s worth noting that the UK Government has granted immunity from liability for harms to all Covid-19 vaccine manufacturers. Can we really ask children to accept a greater risk than the manufacturers themselves are prepared to live with?

https://www.telegraph.co.uk/news/2021/05/03/healthy-children-simply-do-not-need-covid-jab

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News

The shock and reality of catching COVID after being vaccinated – NPR

Robin Hauser, a pediatrician in Tampa, Florida, got COVID in February. What separates her from the vast majority of the tens of millions of other Americans who have come down with the virus is this: She got sick seven weeks after her second dose of the Pfizer-BioNTech vaccine.

https://www.pbs.org/newshour/health/the-shock-and-reality-of-catching-covid-after-being-vaccinated

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Publications

NIAID Statement on AstraZeneca Vaccine

Late Monday, the Data and Safety Monitoring Board (DSMB) notified NIAID, BARDA, and AstraZeneca that it was concerned by information released by AstraZeneca on initial data from its COVID-19 vaccine clinical trial. The DSMB expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data. We urge the company to work with the DSMB to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible.

https://www.nih.gov/news-events/news-releases/niaid-statement-astrazeneca-vaccine

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Inside the Pfizer/BioNTech COVID-19 vaccine trial: ‘We knew the world was watching and waiting for results’ – BioPharma Reporter

A request for Emergency Use Authorization in the US was submitted the same month; and the vaccine was then authorized in the US on December 11 (shortly after UK authorization on December 2).

The trial is not over, however: as all subjects are monitored for a further two year period. And the next step is to test the vaccine in groups that cannot currently receive the vaccine due to a lack of data – such as pregnant women and children (Pfizer has already started a trial in pregnant women​ and one in children is set to follow later this year).

https://www.biopharma-reporter.com/Article/2021/03/03/Inside-the-Pfizer-BioNTech-COVID-19-vaccine-trial-Insights-on-speed-agility-and-digital-development

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Informed consent disclosure to vaccine trial subjects of risk of COVID-19 vaccines worsening clinical disease – National Center for Biotechnology Information

COVID-19 vaccines designed to elicit neutralising antibodies may sensitise vaccine recipients to more severe disease than if they were not vaccinated. Vaccines for SARS, MERS and RSV have never been approved, and the data generated in the development and testing of these vaccines suggest a serious mechanistic concern: that vaccines designed empirically using the traditional approach (consisting of the unmodified or minimally modified coronavirus viral spike to elicit neutralising antibodies), be they composed of protein, viral vector, DNA or RNA and irrespective of delivery method, may worsen COVID-19 disease via antibody-dependent enhancement (ADE). This risk is sufficiently obscured in clinical trial protocols and consent forms for ongoing COVID-19 vaccine trials that adequate patient comprehension of this risk is unlikely to occur, obviating truly informed consent by subjects in these trials.

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Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals – ClinicalTrials.gov

This is a Phase 1/2/3, randomized, placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection, and efficacy study in healthy individuals.

Actual Study Start Date  :April 29, 2020
Estimated Primary Completion Date  :October 29, 2021
Estimated Study Completion Date  :April 6, 2023

https://clinicaltrials.gov/ct2/show/NCT04368728

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Why Most Clinical Research Is Not Useful – Prof. John Ioannidis

Many clinical research studies, even in the major general medical journals, do not satisfy the identifiable features that make them useful. These features include:

  • problem base;
  • context placement;
  • information gain;
  • pragmatism;
  • patient centeredness;
  • value for money;
  • feasibility;
  • transparency.

Most clinical research findings false. Further, most of the true findings do not result in huge human benefit. Reform and improvement in the clinical research are overdue.

See also: Peer review: a flawed process at the heart of science and journals by Richard Smith at the Journal of the Royal Society of Medicine

Quoted summary points

Blue-sky research cannot be easily judged on the basis of practical impact, but clinical research is different and should be useful. It should make a difference for health and disease outcomes or should be undertaken with that as a realistic prospect.

Many of the features that make clinical research useful can be identified, including those relating to problem base, context placement, information gain, pragmatism, patient centeredness, value for money, feasibility, and transparency.

Many studies, even in the major general medical journals, do not satisfy these features, and very few studies satisfy most or all of them. Most clinical research therefore fails to be useful not because of its findings but because of its design.

The forces driving the production and dissemination of nonuseful clinical research are largely identifiable and modifiable.

Reform is needed. Altering our approach could easily produce more clinical research that is useful, at the same or even at a massively reduced cost.

https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1002049