The Vaccines Don’t Stop Transmission, Even with a Booster By Brian Simpson

There are a number of recent peer-reviewed articles that reach the conclusion that the Covid vaccines do not stop transmission of SARS-CoV-2, even with a booster. As I see it, what follows from this is the mandates are totally pointless, since they are unable to achieve what hey purport to be able to do.

 

https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)02243-1/fulltext 

“In the USA and Germany, high-level officials have used the term pandemic of the unvaccinated, suggesting that people who have been vaccinated are not relevant in the epidemiology of COVID-19. Officials’ use of this phrase might have encouraged one scientist to claim that “the unvaccinated threaten the vaccinated for COVID-19”.

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 But this view is far too simple.

There is increasing evidence that vaccinated individuals continue to have a relevant role in transmission. In Massachusetts, USA, a total of 469 new COVID-19 cases were detected during various events in July, 2021, and 346 (74%) of these cases were in people who were fully or partly vaccinated, 274 (79%) of whom were symptomatic. Cycle threshold values were similarly low between people who were fully vaccinated (median 22·8) and people who were unvaccinated, not fully vaccinated, or whose vaccination status was unknown (median 21·5), indicating a high viral load even among people who were fully vaccinated.

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 In the USA, a total of 10 262 COVID-19 cases were reported in vaccinated people by April 30, 2021, of whom 2725 (26·6%) were asymptomatic, 995 (9·7%) were hospitalised, and 160 (1·6%) died.

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 In Germany, 55·4% of symptomatic COVID-19 cases in patients aged 60 years or older were in fully vaccinated individuals,

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 and this proportion is increasing each week. In Münster, Germany, new cases of COVID-19 occurred in at least 85 (22%) of 380 people who were fully vaccinated or who had recovered from COVID-19 and who attended a nightclub.

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 People who are vaccinated have a lower risk of severe disease but are still a relevant part of the pandemic. It is therefore wrong and dangerous to speak of a pandemic of the unvaccinated. Historically, both the USA and Germany have engendered negative experiences by stigmatising parts of the population for their skin colour or religion. I call on high-level officials and scientists to stop the inappropriate stigmatisation of unvaccinated people, who include our patients, colleagues, and other fellow citizens, and to put extra effort into bringing society together.”

 https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)00090-3/fulltext#sec1 

 

“The most recent SARS-CoV-2 variant of concern to emerge has been named omicron.

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 Its immune evasion potential was predicted by genomic data and has been preliminarily confirmed by observations of an increased incidence of reinfections and breakthrough infections.

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 This has triggered calls to intensify vaccination programmes including provision of vaccine booster doses.

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A group of German visitors who had received three doses of SARS-CoV-2 vaccines, including at least two doses of an mRNA vaccine, experienced breakthrough infections with omicron between late November and early December, 2021, while in Cape Town, South Africa. The group consisted of five White women and two White men) with an average age of 27·7 years (range 25–39) and a mean body-mass index of 22·2 kg/m2 (range 17·9–29·4), with no relevant medical history. Four of the individuals were participating in clinical elective training at different hospitals in Cape Town, whereas the others were on vacation. The individuals were members of two unlinked social groups and participated in regular social life in Cape Town, in compliance with applicable COVID-19 protocols. Upon arrival during the first half of November, 2021, each individual tested negative for SARS-CoV-2 by PCR and provided records of complete vaccination, including booster or third, doses administered via intramuscular injection using homologous (n=5) and heterologous (n=2) vaccination courses.”

 https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(21)00768-4/fulltext 

“Vaccine effectiveness studies have conclusively demonstrated the benefit of COVID-19 vaccines in reducing individual symptomatic and severe disease, resulting in reduced hospitalisations and intensive care unit admissions.

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 However, the impact of vaccination on transmissibility of SARS-CoV-2 needs to be elucidated. A prospective cohort study in the UK by Anika Singanayagam and colleagues

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 regarding community transmission of SARS-CoV-2 among unvaccinated and vaccinated individuals provides important information that needs to be considered in reassessing vaccination policies. This study showed that the impact of vaccination on community transmission of circulating variants of SARS-CoV-2 appeared to be not significantly different from the impact among unvaccinated people.

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 The scientific rationale for mandatory vaccination in the USA relies on the premise that vaccination prevents transmission to others, resulting in a “pandemic of the unvaccinated”.

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 Yet, the demonstration of COVID-19 breakthrough infections among fully vaccinated health-care workers (HCW) in Israel, who in turn may transmit this infection to their patients,

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 requires a reassessment of compulsory vaccination policies leading to the job dismissal of unvaccinated HCW in the USA. Indeed, there is growing evidence that peak viral titres in the upper airways of the lungs and culturable virus are similar in vaccinated and unvaccinated individuals.^2,3,5–7 A recent investigation by the US Centers for Disease Control and Prevention of an outbreak of COVID-19 in a prison in Texas showed the equal presence of infectious virus in the nasopharynx of vaccinated and unvaccinated individuals.

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 Similarly, researchers in California observed no major differences between vaccinated and unvaccinated individuals in terms of SARS-CoV-2 viral loads in the nasopharynx, even in those with proven asymptomatic infection.

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 Thus, the current evidence suggests that current mandatory vaccination policies might need to be reconsidered, and that vaccination status should not replace mitigation practices such as mask wearing, physical distancing, and contact-tracing investigations, even within highly vaccinated populations.

 https://www.bmj.com/content/376/bmj.o102

 

“Pfizer’s pivotal covid vaccine trial was funded by the company and designed, run, analysed, and authored by Pfizer employees. The company and the contract research organisations that carried out the trial hold all the data.17 And Pfizer has indicated that it will not begin entertaining requests for trial data until May 2025, 24 months after the primary study completion date, which is listed on ClinicalTrials.gov as 15 May 2023 (NCT04368728).

The lack of access to data is consistent across vaccine manufacturers.16 Moderna says data “may be available … with publication of the final study results in 2022.”18 Datasets will be available “upon request and subject to review once the trial is complete,” which has an estimated primary completion date of 27 October 2022 (NCT04470427).

As of 31 December 2021, AstraZeneca may be ready to entertain requests for data from several of its large phase III trials.19 But actually obtaining data could be slow going. As its website explains, “timelines vary per request and can take up to a year upon full submission of the request.”20

Underlying data for covid-19 therapeutics are similarly hard to find. Published reports of Regeneron’s phase III trial of its monoclonal antibody therapy REGEN-COV flatly state that participant level data will not be made available to others.21 Should the drug be approved (and not just emergency authorised), sharing “will be considered.” For remdesivir, the US National Institutes of Health, which funded the trial, created a new portal to share data (https://accessclinicaldata.niaid.nih.gov/), but the dataset on offer is limited. An accompanying document explains: “The longitudinal data set only contains a small subset of the protocol and statistical analysis plan objectives.”

We are left with publications but no access to the underlying data on reasonable request. This is worrying for trial participants, researchers, clinicians, journal editors, policy makers, and the public. The journals that have published these primary studies may argue that they faced an awkward dilemma, caught between making the summary findings available quickly and upholding the best ethical values that support timely access to underlying data. In our view, there is no dilemma; the anonymised individual participant data from clinical trials must be made available for independent scrutiny.

Journal editors, systematic reviewers, and the writers of clinical practice guideline generally obtain little beyond a journal publication, but regulatory agencies receive far more granular data as part of the regulatory review process. In the words of the European Medicine Agency’s former executive director and senior medical officer, “relying solely on the publications of clinical trials in scientific journals as the basis of healthcare decisions is not a good idea ... Drug regulators have been aware of this limitation for a long time and routinely obtain and assess the full documentation (rather than just publications).”22

Among regulators, the US Food and Drug Administration is believed to receive the most raw data but does not proactively release them. After a freedom of information request to the agency for Pfizer’s vaccine data, the FDA offered to release 500 pages a month, a process that would take decades to complete, arguing in court that publicly releasing data was slow owing to the need to first redact sensitive information.23 This month, however, a judge rejected the FDA’s offer and ordered the data be released at a rate of 55 000 pages a month. The data are to be made available on the requesting organisation’s website (phmpt.org).

In releasing thousands of pages of clinical trial documents, Health Canada and the EMA have also provided a degree of transparency that deserves acknowledgment.2425 Until recently, however, the data remained of limited utility, with copious redactions aimed at protecting trial blinding. But study reports with fewer redactions have been available since September 2021,2425 and missing appendices may be accessible through freedom of information requests.

Even so, anyone looking for participant level datasets may be disappointed because Health Canada and the EMA do not receive or analyse these data, and it remains to be seen how the FDA responds to the court order. Moreover, the FDA is producing data only for Pfizer’s vaccine; other manufacturers’ data cannot be requested until the vaccines are approved, which the Moderna and Johnson & Johnson vaccines are not. Industry, which holds the raw data, is not legally required to honour requests for access from independent researchers.

Like the FDA, and unlike its Canadian and European counterparts, the UK’s regulator—the Medicines and Healthcare Products Regulatory Agency—does not proactively release clinical trial documents, and it has also stopped posting information released in response to freedom of information requests on its website.”