Covid-19 vaccines: In the rush for regulatory approval, do we need more data?

Doshi, Peter

doi:10.1136/bmj.n1244

Cited by 38 publications

(46 citation statements)

References 8 publications

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“…There is evidence that the mRNA vaccines themselves may distribute widely through the body. In a report by one manufacturer to Japanese regulators the biodistribution of lipid nanoparticles in injected rats showed that up to 75% of the inoculum escaped the injection site and was found circulating in the blood and pooled in the spleen, liver, bone marrow, adrenal glands, ovaries, and other tissues 30 , 31 .…”

Section: Discussionmentioning

confidence: 99%

The histologic and molecular correlates of COVID-19 vaccine-induced changes in the skin

Magro¹,

Crowson²,

Franks³

et al. 2021

Clinics in Dermatology

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Twenty two patients who had developed an adverse cutaneous reaction to the Moderna or Pfizer vaccine underwent biopsies. Each case was assessed light microscopically and in select biopsies spike glycoprotein and cytokine assessment were also conducted. The patients developed self-limited cutaneous reactions often described clinically as urticarial or eczematous within one day to 4 weeks after receiving the first or second dose of the Pfizer or Moderna vaccine. Classic clinical and morphologic depictions of type IV cutaneous hypersensitivity with features of dermatitis, interface dermatitis, granulomatous inflammation and/or lymphocytic vasculitic component were observed. Clinical and/or histologic features of perniosis, pityriasis rosea, pityriasis rubra pilaris and guttate psoriasis were seen in select cases. In two cases the dominant picture was urticarial vasculitis, possibly reflective of an Arthus type III immune complex action. The biopsies of normal skin post-vaccine and skin affected by the post vaccine eruption showed rare deep microvessels positive for spike glycoprotein without complement deposition contrasting with greater vascular deposition of spike protein and complement in skin biopsies from severe COVID-19 patients. It is concluded that self-limited hypersensitivity reactions to the vaccine occur possibly due to a substance found in the vaccine vehicle such as polyethylene glycol. An immune response that is directed against human-manufactured spike has to be considered since some of the reactions clinically and or histologically closely resemble mild COVID-19. Finally, vaccine associated immune enhancement largely attributable to the adjuvant properties of the vaccine may unmask certain inflammatory milieus operational in psoriasis, atopic dermatitis and subclinical hypersensitivity.

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Section: Discussionmentioning

confidence: 99%

The histologic and molecular correlates of COVID-19 vaccine-induced changes in the skin

Magro¹,

Crowson²,

Franks³

et al. 2021

Clinics in Dermatology

View full text Add to dashboard Cite

show abstract

“…(Debates took place regarding the ethics of denying placebo recipients vaccine, and proposals to redesign the trials as cross-over trials were not taken up). 23 In addition to ensuring the public accessibility of follow-up data from continuing trials, greater transparency is necessary into the ongoing deliberations and thinking of regulators who are currently evaluating applications from sponsors seeking to move from emergency use authorisations to actual approval or licensure.…”

Section: General Medicinementioning

confidence: 99%

Transparency of COVID-19 vaccine trials: decisions without data

Tanveer

Rowhani-Farid

Hong

et al. 2021

BMJ EBM

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“…For detailed information on COVID-19 vaccines in clinical development, refer to Table S1 which is adjusted from the WHO document [151]. Although a few claim vaccination is ineffective for limiting contagion, especially considering the vaccine breakthrough by the Delta variant (B.1.617.2) [175][176][177][178][179], vaccination is still recommended for everyone (≥12 years old) to prevent COVID-19 and particularly to avoid hospitalization and death [180].…”

Section: Vaccine Developmentmentioning

confidence: 99%

COVID-19: The Disease, the Immunological Challenges, the Treatment with Pharmaceuticals and Low-Dose Ionizing Radiation

Azzam

Jadhav

et al. 2021

Cells

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The year 2020 will be carved in the history books—with the proliferation of COVID-19 over the globe and with frontline health workers and basic scientists worldwide diligently fighting to alleviate life-threatening symptoms and curb the spread of the disease. Behind the shocking prevalence of death are countless families who lost loved ones. To these families and to humanity as a whole, the tallies are not irrelevant digits, but a motivation to develop effective strategies to save lives. However, at the onset of the pandemic, not many therapeutic choices were available besides supportive oxygen, anti-inflammatory dexamethasone, and antiviral remdesivir. Low-dose radiation (LDR), at a much lower dosage than applied in cancer treatment, re-emerged after a 75-year silence in its use in unresolved pneumonia, as a scientific interest with surprising effects in soothing the cytokine storm and other symptoms in severe COVID-19 patients. Here, we review the epidemiology, symptoms, immunological alterations, mutations, pharmaceuticals, and vaccine development of COVID-19, summarizing the history of X-ray irradiation in non-COVID diseases (especially pneumonia) and the currently registered clinical trials that apply LDR in treating COVID-19 patients. We discuss concerns, advantages, and disadvantages of LDR treatment and potential avenues that may provide empirical evidence supporting its potential use in defending against the pandemic.

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Covid-19 vaccines: In the rush for regulatory approval, do we need more data?

Cited by 38 publications

References 8 publications

The histologic and molecular correlates of COVID-19 vaccine-induced changes in the skin

The histologic and molecular correlates of COVID-19 vaccine-induced changes in the skin

Transparency of COVID-19 vaccine trials: decisions without data

COVID-19: The Disease, the Immunological Challenges, the Treatment with Pharmaceuticals and Low-Dose Ionizing Radiation

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