by Carolyn Chu, MD, MSc, AAHIVS, AAHIVM Chief Medical Officer
January 26, 2021
Featured Literature:
Baden LR, El Sahly HM, Essink B et al. Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine. N Engl J Med. 2020 Dec 30; NEJMoa2035389.doi: 10.1056/NEJMoa2035389. Supplementary materials: https://www.nejm.org/doi/suppl/10.1056/NEJMoa2035389/suppl_file/nejmoa2035389_appendix.pdf
Polack FP, Thomas SJ, Kitchin N et al. Safety and efficacy of the BNT162b2 mRNA Covid-19 Vaccine. N Engl J Med. 2020 Dec 31; 383(27): 2603-2615.doi: 10.1056/NEJMoa2034577. Supplementary appendix: https://www.nejm.org/doi/suppl/10.1056/NEJMoa2034577/suppl_file/nejmoa2034577_appendix.pdf
Phase 3 results of the Moderna mRNA vaccine are described by Baden and colleagues
This trial enrolled over 30,000 at-risk participants 18 years of age or older to receive two injections of mRNA-1273 or placebo 28 days apart. 179 participants were people with well-controlled HIV (this represented 0.6% of the total number of participants included in the full analysis set): 121 of the PWH were ≥ 18 to < 65 years of age, and 31 were ≥ 65 years. Primary safety endpoints included: (a) solicited local and systemic adverse reactions for 7 days after each injection; (b) unsolicited adverse events for 28 days after each injection; (c) adverse events leading to discontinuation from a dose or trial participation (or both); and (d) medically attended adverse events and serious adverse events throughout the entire study period. Overall, serious adverse events were rare among participants receiving mRNA-1273. Mild local and moderate-severe systematic reactions (all transient) were fairly common, namely injection-site pain, headache, fatigue, and myalgias (especially after the second dose). 1.5% of participants who received mRNA-1273 reported hypersensitivity reactions, compared to 1.1% of participants receiving placebo.
Polack and colleagues describe phase 2/3 safety and efficacy findings of the Pfizer-BioNTech vaccine
In this trial, two doses of the BNT162b2 mRNA vaccine were given 21 days apart to over 43,000 participants 16 years of age or older. 196 people with well-controlled HIV infection were included. Primary safety endpoints included: (a) solicited, specific local or systemic adverse events and use of antipyretic or pain medication within 7 days after receipt of each dose among the trial’s reactogenicity subset of ~8100 participants; (b) unsolicited adverse events through 1 month after the second dose; and (c) unsolicited serious adverse events through 6 months after the second dose. Among BNT162b2 recipients, mild-moderate injection site pain was the most commonly reported local reaction and resolved within 1 to 2 days. Fatigue and headache were both relatively common in the reactogenicity subset (especially after the second dose); severe systemic events were reported in less than 2% of vaccine recipients except for fatigue (3.8%) and headache (2%). In both trials, reactions were less common among older participants.
Author’s Commentary:
As U.S. vaccination efforts continue, HIV providers will find themselves engaged in an increasing number of discussions regarding patients’ decisions to receive, defer or altogether decline COVID-19 vaccination. Vaccine hesitancy has fluctuated notably since the pandemic was recognized and is likely multi-factorial. As HIV care providers, we should advise patients about the benefits of vaccination, favorable safety profiles, and encourage people to receive the vaccine as soon as it is made available to them. With HIV, we have seen that combination approaches to both treatment and prevention are necessary to meet the needs of diverse communities and address wide-ranging structural challenges. Similarly, combination approaches for communicating with patients about vaccine decision-making are critical.
Two key actions HIV providers can take now are anticipating patient questions and being aware of common and uncommon side effects. Although no details have been published yet on vaccine efficacy or safety specific to participants with HIV in the two trials above, providers should keep an eye out for such information when it becomes available. The CDC-supported COVID-19 Real-Time Learning Network maintains a resource page dedicated to providing up-to-date, detailed information on vaccine trials and development along with distribution planning: https://www.idsociety.org/covid-19-real-time-learning-network/vaccines/.
The author has no conflicts of interest to disclose.
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