February 18th 2021
Covid infection shown to provide as much immunity as vaccines
Researchers ‘strongly encouraged’ by findings of reinfection study among UK health workers.
People who have already contracted coronavirus are as protected against reinfection as those who have received the best Covid-19 vaccines, according to a survey of 20,000 UK healthcare workers, the largest study in the world so far.
November 18th 2020
Has Pfizer vaccine been adequately trialled?
Things look promising. 95% effective against ‘catching Covid’.
“To date, the Data Monitoring Committee for the study has not reported any serious safety concerns related to the vaccine. A review of unblinded reactogenicity data from the final analysis which consisted of a randomized subset of at least 8,000 participants 18 years and older in the phase 2/3 study demonstrates that the vaccine was well tolerated, with most solicited adverse events resolving shortly after vaccination. The only Grade 3 (severe) solicited adverse events greater than or equal to 2% in frequency after the first or second dose was fatigue at 3.8% and headache at 2.0% following dose 2. Consistent with earlier shared results, older adults tended to report fewer and milder solicited adverse events following vaccination.”
What is ‘unblinded reactogenicity data’?'
What is ‘unblinded reactogenicity data’?'
Unblinded in the context of clinical trials: (b) “made or done with knowledge of significant facts that may cause bias i.e “unblinded studies of a drug's effectiveness”
Blinded Experiment
In a blind or blinded experiment, information which may influence the participants of the experiment is withheld (masked or blinded) until after the experiment is complete. Good blinding can reduce or eliminate experimental biases that arise from a participants' expectations, observer's effect on the participants, observer bias, confirmation bias, and other sources. A blind can be imposed on any participant of an experiment, including subjects, researchers, technicians, data analysts, and evaluators. In some cases, while blinding would be useful, it is impossible or unethical. For example, it is not possible to blind a patient to their treatment in a physical therapy intervention. A good clinical protocol ensures that blinding is as effective as possible within ethical and practical constraints.
During the course of an experiment, a participant becomes unblinded if they deduce or otherwise obtain information that has been masked to them. For example, a patient who experience a side effect may correctly guess their treatment, becoming unblinded. Unblinding is common in blinded experiments, particularly in pharmacological trials. In particular, trials on pain medication and antidepressants are poorly blinded. Unblinding that occurs before the conclusion of a study is a source of experimental error, as the bias that was eliminated by blinding is re-introduced. The CONSORT reporting guidelines recommend that all studies assess and report unblinding. In practice, very few studies do so.
Bias
A number of biases are present when a study is insufficiently blinded. Patient-reported outcomes can be different if the patient is not blinded to their treatment. Likewise, failure to blind researchers results in observer bias. Unblinded data analysts may favor an analysis that supports their existing beliefs (confirmation bias). These biases are typically the result of subconscious influences, and are present even when study participants believe they are not influenced by them.
“To date, the Data Monitoring Committee for the study has not reported any serious safety concerns related to the vaccine. A review of unblinded reactogenicity data from the final analysis which consisted of a randomized subset of at least 8,000 participants 18 years and older in the phase 2/3 study demonstrates that the vaccine was well tolerated, with most solicited adverse events resolving shortly after vaccination. The only Grade 3 (severe) solicited adverse events greater than or equal to 2% in frequency after the first or second dose was fatigue at 3.8% and headache at 2.0% following dose 2. Consistent with earlier shared results, older adults tended to report fewer and milder solicited adverse events following vaccination.” Pfizer and BioNTech Conclude Phase 3 Study of COVID-19 Vaccine Candidate, Meeting All Primary Efficacy Endpoints
‘Unblinded reactogenicity data’ is therefore ‘highly ambiguous data subject to biases used to produce "expected" adverse reactions (confirmation bias) from information funded, controlled and collected by Pfizer. Furthermore, Pfizer’s own press statement includes these disclosures:
“This release contains forward-looking information about Pfizer’s efforts to combat COVID-19, the collaboration between BioNTech and Pfizer to develop a potential COVID-19 vaccine, the BNT162 mRNA vaccine program, and modRNA candidate BNT162b2 (including qualitative assessments of available data, potential benefits, expectations for clinical trials, anticipated timing of regulatory submissions and anticipated manufacturing, distribution and supply), that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with clinical data (including the Phase 3 data that is the subject of this release), including the possibility of unfavorable new preclinical or clinical trial data and further analyses of existing preclinical or clinical trial data;
It continues:
“whether and when any biologics license and/or emergency use authorization applications may be filed in any jurisdictions for BNT162b2 or any other potential vaccine candidates; whether and when any such applications may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the vaccine candidate’s benefits outweigh its known risks and determination of the vaccine candidate’s efficacy and, if approved, whether it will be commercially successful;
Whether any emergency use authorization applications may be filed?
“the risk that we may not be able to successfully develop non-frozen formulations; the risk that we may not be able to create or scale up manufacturing capacity on a timely basis or have access to logistics or supply channels commensurate with global demand for any potential approved vaccine, which would negatively impact our ability to supply the estimated numbers of doses of our vaccine candidate within the projected time periods indicated; whether and when additional supply agreements will be reached; uncertainties regarding the ability to obtain recommendations from vaccine technical committees and other public health authorities and uncertainties regarding the commercial impact of any such recommendations; uncertainties regarding the impact of COVID-19 on Pfizer’s business, operations and financial results; and competitive developments.”
A rushed vaccine, timed release for maximum financial impact only, trialed using an ambiguous biased tests? Consolidated Standards of Reporting Trials guide lines state terms such as ‘unblinded’ should not be used as they are ambiguous? In a vaccine that is about to be administered to the world’s population? We simply must have more independent studies available for reference as my their own admission, Pfizer have claimed it’s own vaccine is ‘safe’ based on it’s own, ambiguous, biased data.