Commentary: NPF COVID-19 Task Force Guidance Statements

Recently, the Task Force (TF) of the National Psoriasis Foundation (NPF) released a revised version of its COVID-19 statement after an in-depth analysis of publicly available data with two currently approved anti-SARS-CoV-2 vaccines in the US, both mRNA-based.¹ The two additional statements recommend that « patients with psoriatic disease, who do not have contraindications to vaccination, should receive an mRNA-based COVID-19 vaccine as soon as it becomes available, based on local guidance, and that patients who are to receive these vaccines continue their antipsoriatic biologic or oral therapies».¹ Given the gravity and the consequent health emergency related to the global SARS-CoV2 pandemic, which has been ongoing and spreading for about a year, as well as the insufficient impacts of shielding individual and collective measures on the pandemic outcomes, the emergency use authorization (EUA) which allowed early approval by the Food and Drug Administration (FDA) for both Pfizer/BioNTech and Moderna vaccines, as well as the NPF TF updated guidance, appear more than necessary. A similar process was followed by the European Medical Agency (EMA), making these two RNA-based vaccines the first to be used in starting vaccination campaigns in Northern America and in Europe, while a number of other vaccines relying on different vectors have been developed, broadening the immunizing armamentarium. One of these non RNA-based vaccines has been co-developed by Oxford University/AstraZeneca and will be notably available at a very low price during the pandemic in order to make it broadly accessible, including for emerging countries.^2-4 Roughly one year after the SARS-CoV-2 global pandemic blew out, this is a set of extremely positive news, and the excellence and the reactivity of all scientists from the academic and industrial worlds who worked tirelessly on these projects should be celebrated.

The reactivity of the NPF TF in updating its message should also be acknowledged. Indeed, despite overall reassuring data regarding the rate of severe COVID-19 infection in psoriasis patients receiving conventional or biological/small molecule therapies in comparison with the general population in the PsoProtect declarative registry,⁵ the worsening health and economic impacts and threats of the pandemic require clear, rationally phrased guidance towards physicians and patients, in order to make sure that optimal immunisation and protection is urgently delivered to the accepting community. This is a special priority for patients and health care providers (HCP) more prone to develop severe COVID-19 such as the elderly, individuals with one or several comorbid conditions among which obesity, diabetes, and cardiovascular diseases, to name a few. However, it is worth keeping in mind that these latter comorbidities, although being more prevalent in patients with severe psoriasis, have a real but limited impact on the incidence rate of life-threatening COVID-19 and that other determinants are likely to be more influencing this risk. Likewise, the recent identification of inborn errors inhibiting type I Interferon (IFN)-driven immune responses and autoimmune biological abnormalities consisting in the development of anti-IFN𝛼 neutralizing antibodies are the first examples of such highly impacting determinants.^6,7 These immune defects preexisting to the SARS-CoV2 infection might well account for a minority of severe COVID-19. They represent, however, a major advance in the identification of robust biomarkers of the most at risk populations for severe COVID-19. Their prevalence in psoriasis patients is currently unknown, and the efficacy of the Covid vaccine in this subset will need to be tackled.

In the absence of routinely accessible tests able to predict with good sensitivity and specificity the outcome of the COVID-19 in different populations, it appears mandatory to plan a massive vaccination programme in patients with psoriasis and/or psoriatic arthritis, especially as some drugs already on the market or close to it in psoriatic disease, respectively tofacitinib for PsA and tyrosine kinase 2 (Tyk2) inhibitors for moderate-to-severe psoriasis vulgaris, are both known to alter the type I IFN pathway.^8,9

The other key issue is the tolerance of different vaccines, especially for the two mRNA-based ones, which are relying on a disruptive mode of action, although not completely new. So far, phases 1/2/3 of global, randomized clinical trials (RCTs) conducted by BioNTech/Pfizer and Moderna show evidence for high rates of protective immunisation and mild-to-moderate local and/or general reactions, especially in the younger populations, with very low rates of serious adverse events, and no evidence so far for new onset immune-mediated and inflammatory disease (IMIDs).^10,11 However, as data from these pivotal trials are available in the short-term and do not address patients with IMIDs, it is crucial to launch pharmacovigilance cohorts prospectively assessing the efficacy and safety of these vaccines in patients with psoriasis/PsA, especially as RNA-sensing has been advocated to play a pathogenic role in some models of psoriasis.¹²

Ultimately, all decision-makers and HCP should be aware that significant obstacles to a successful anti-COVID-19 mass vaccination remain, fueled by various degrees of defiance towards vaccines and loudly expressed by different social groups. From the precedent of the anti-H1N1 2009 vaccination campaign, we learned that some expressed or silent concerns towards vaccines from targeted populations have long been an issue, especially as they often rely on self-beliefs.¹³ This challenge should not be neglected and requires comprehensive and tailored communication strategies. In this sense, transdisciplinary collaborations with patients and civil associations as well as with experts in behavioral medicine, which are currently ongoing in different countries, will provide significant support to overcome these psychosociological hurdles. Any other quick fixed, imposing strategy might well lead to counterproductive effects on the acceptance of vaccination at the population level.