3
views
0
recommends
+1 Recommend
1 collections
    0
    shares
      • Record: found
      • Abstract: found
      • Article: found
      Is Open Access

      The Nanoparticle-Enabled Success of COVID-19 mRNA Vaccines and the Promise of Microneedle Platforms for Pandemic Vaccine Response

      research-article

      Read this article at

      Bookmark
          There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

          Abstract

          The coronavirus disease 2019 (COVID-19) public health crisis has reached critical mass, but interdisciplinary research efforts have provided the global community with the first effective medical intervention to fight the pandemic—COVID-19 vaccines. Two of the vaccines approved for use in the United States and Europe deliver nucleic acid in the form of mRNA, the success of which would not be possible without biomaterials. Lipid nanoparticle (LNP)-based mRNA vaccines, discussed in this perspective, protect nucleic acids from degradation and deliver cargo directly to the intracellular compartment of cells where it is translated into the antigenic severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein that triggers protective immune responses. Despite success of LNP-based mRNA vaccines thus far, the pandemic has highlighted the need for emerging technologies that enable rapid development and increased accessibility to vaccination. Microneedle arrays, also discussed in this study, provide features that could lower barriers to vaccine access in resource-poor regions. The ability to exchange antigens within arrays could also facilitate swift vaccine deployment as public health needs evolve (e.g., in response to SARS-CoV-2 variants or entirely new pathogens). Therefore, the COVID-19 pandemic has spotlighted the readiness and value of biomaterials for the prevention and management of disease outbreaks.

          Related collections

          Most cited references45

          • Record: found
          • Abstract: found
          • Article: not found

          Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine

          Abstract Background Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and the resulting coronavirus disease 2019 (Covid-19) have afflicted tens of millions of people in a worldwide pandemic. Safe and effective vaccines are needed urgently. Methods In an ongoing multinational, placebo-controlled, observer-blinded, pivotal efficacy trial, we randomly assigned persons 16 years of age or older in a 1:1 ratio to receive two doses, 21 days apart, of either placebo or the BNT162b2 vaccine candidate (30 μg per dose). BNT162b2 is a lipid nanoparticle–formulated, nucleoside-modified RNA vaccine that encodes a prefusion stabilized, membrane-anchored SARS-CoV-2 full-length spike protein. The primary end points were efficacy of the vaccine against laboratory-confirmed Covid-19 and safety. Results A total of 43,548 participants underwent randomization, of whom 43,448 received injections: 21,720 with BNT162b2 and 21,728 with placebo. There were 8 cases of Covid-19 with onset at least 7 days after the second dose among participants assigned to receive BNT162b2 and 162 cases among those assigned to placebo; BNT162b2 was 95% effective in preventing Covid-19 (95% credible interval, 90.3 to 97.6). Similar vaccine efficacy (generally 90 to 100%) was observed across subgroups defined by age, sex, race, ethnicity, baseline body-mass index, and the presence of coexisting conditions. Among 10 cases of severe Covid-19 with onset after the first dose, 9 occurred in placebo recipients and 1 in a BNT162b2 recipient. The safety profile of BNT162b2 was characterized by short-term, mild-to-moderate pain at the injection site, fatigue, and headache. The incidence of serious adverse events was low and was similar in the vaccine and placebo groups. Conclusions A two-dose regimen of BNT162b2 conferred 95% protection against Covid-19 in persons 16 years of age or older. Safety over a median of 2 months was similar to that of other viral vaccines. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04368728.)
            Bookmark
            • Record: found
            • Abstract: found
            • Article: not found

            Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine

            Abstract Background Vaccines are needed to prevent coronavirus disease 2019 (Covid-19) and to protect persons who are at high risk for complications. The mRNA-1273 vaccine is a lipid nanoparticle–encapsulated mRNA-based vaccine that encodes the prefusion stabilized full-length spike protein of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes Covid-19. Methods This phase 3 randomized, observer-blinded, placebo-controlled trial was conducted at 99 centers across the United States. Persons at high risk for SARS-CoV-2 infection or its complications were randomly assigned in a 1:1 ratio to receive two intramuscular injections of mRNA-1273 (100 μg) or placebo 28 days apart. The primary end point was prevention of Covid-19 illness with onset at least 14 days after the second injection in participants who had not previously been infected with SARS-CoV-2. Results The trial enrolled 30,420 volunteers who were randomly assigned in a 1:1 ratio to receive either vaccine or placebo (15,210 participants in each group). More than 96% of participants received both injections, and 2.2% had evidence (serologic, virologic, or both) of SARS-CoV-2 infection at baseline. Symptomatic Covid-19 illness was confirmed in 185 participants in the placebo group (56.5 per 1000 person-years; 95% confidence interval [CI], 48.7 to 65.3) and in 11 participants in the mRNA-1273 group (3.3 per 1000 person-years; 95% CI, 1.7 to 6.0); vaccine efficacy was 94.1% (95% CI, 89.3 to 96.8%; P<0.001). Efficacy was similar across key secondary analyses, including assessment 14 days after the first dose, analyses that included participants who had evidence of SARS-CoV-2 infection at baseline, and analyses in participants 65 years of age or older. Severe Covid-19 occurred in 30 participants, with one fatality; all 30 were in the placebo group. Moderate, transient reactogenicity after vaccination occurred more frequently in the mRNA-1273 group. Serious adverse events were rare, and the incidence was similar in the two groups. Conclusions The mRNA-1273 vaccine showed 94.1% efficacy at preventing Covid-19 illness, including severe disease. Aside from transient local and systemic reactions, no safety concerns were identified. (Funded by the Biomedical Advanced Research and Development Authority and the National Institute of Allergy and Infectious Diseases; COVE ClinicalTrials.gov number, NCT04470427.)
              Bookmark
              • Record: found
              • Abstract: found
              • Article: found
              Is Open Access

              Cryo-EM structure of the 2019-nCoV spike in the prefusion conformation

              Structure of the nCoV trimeric spike The World Health Organization has declared the outbreak of a novel coronavirus (2019-nCoV) to be a public health emergency of international concern. The virus binds to host cells through its trimeric spike glycoprotein, making this protein a key target for potential therapies and diagnostics. Wrapp et al. determined a 3.5-angstrom-resolution structure of the 2019-nCoV trimeric spike protein by cryo–electron microscopy. Using biophysical assays, the authors show that this protein binds at least 10 times more tightly than the corresponding spike protein of severe acute respiratory syndrome (SARS)–CoV to their common host cell receptor. They also tested three antibodies known to bind to the SARS-CoV spike protein but did not detect binding to the 2019-nCoV spike protein. These studies provide valuable information to guide the development of medical counter-measures for 2019-nCoV. Science, this issue p. 1260
                Bookmark

                Author and article information

                Journal
                DNA Cell Biol
                DNA Cell Biol
                dna
                DNA and Cell Biology
                Mary Ann Liebert, Inc., publishers (140 Huguenot Street, 3rd Floor New Rochelle, NY 10801 USA )
                1044-5498
                1557-7430
                January 2022
                12 January 2022
                12 January 2022
                : 41
                : 1
                : 25-29
                Affiliations
                [1]Fischell Department of Bioengineering, University of Maryland, College Park, Maryland, USA.
                Author notes
                [*]Address correspondence to: Senta M. Kapnick, MS, PhD, Fischell Department of Bioengineering, University of Maryland, 8278 Paint Branch Drive, College Park, MD, 20742, USA skapnick@ 123456umd.edu
                Author information
                https://orcid.org/0000-0002-2246-7053
                Article
                10.1089/dna.2021.0538
                10.1089/dna.2021.0538
                8787697
                34958232
                e430f5ca-5790-49c7-a018-6f02dfd2013e
                © Senta M. Kapnick 2022; Published by Mary Ann Liebert, Inc.

                This Open Access article is distributed under the terms of the Creative Commons License [CC-BY] ( http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : Received for publication June 21, 2021
                : received in revised form November 18, 2021
                : accepted November 24, 2021
                Page count
                References: 48, Pages: 5
                Categories
                Section B: Infectious Diseases: Pathogenesis, Immune Responses, Vaccines, Diagnostics, and the Broad Impact of Them on Society

                biomaterials,covid-19 vaccines,nanoparticles and covid-19 vaccines,microneedle arrays for vaccination,biomaterials and pandemic readiness

                Comments

                Comment on this article