The mRNA platform used in the Pfizer and Moderna vaccines can be readily tweaked, enabling the companies to produce newer versions within weeks. Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Moderna COVID-19 Vaccine. W911QY-20-C-0100. Single booster dose of 50 µg of mRNA-1273 or mRNA-1273.351 increased neutralizing titers against SARS-CoV-2 and two variants of concern (B.1.351, P.1) in previously vaccinated clinical trial participants Booster dose of mRNA-1273.351, a strain-matched candidate, achieved higher titers against B.1.351 than a booster dose of mRNA-1273 Moderna announced on Wednesday that its booster COVID-19 vaccine will likely be effective against variants of the virus first identified in … On November 30, 2020, the Company also announced that it filed for Emergency Use Authorization with the U.S. FDA and a Conditional Marketing Authorization (CMA) application with the European Medicines Agency. “Our mRNA platform allows for rapid design of vaccine candidates that incorporate key virus mutations, potentially allowing for faster development of future alternative variant-matched vaccines should they be needed. The boosters raised the levels of the antibodies against both variants, although the boosters were still slightly less effective than against the original form of the virus. Do not administer the Moderna COVID-19 Vaccine to individuals with a known history of severe allergic reaction (e.g., anaphylaxis) to any component of the Moderna COVID-19 Vaccine. Moderna has also received authorization for its COVID-19 vaccine from health agencies in Canada, Israel, the European Union, the United Kingdom, Switzerland, Singapore, Qatar, Taiwan and the World Health Organization. (617) 335-1374Colleen.Hussey@modernatx.com, Investors Lavina Talukdar 1 https://www.nejm.org/doi/full/10.1056/NEJMc2102179, View source version on businesswire.com: https://www.businesswire.com/news/home/20210505006025/en/, Media Colleen Hussey There are no data available on the interchangeability of the Moderna COVID-19 Vaccine with other COVID-19 vaccines to complete the vaccination series. The Moderna COVID-19 vaccine being administered at the University of Nevada, Las Vegas last month. The Moderna vaccine was shown to provide protection against virus variants. Following boost, geometric mean titers (GMT) against the wild-type, B.1.351, and P.1 variants increased to levels similar to or higher than the previously reported peak titers against the ancestral (D614G) strain following primary vaccination1. Moderna plans to evaluate three approaches to boosting, including: A variant-specific booster candidate, mRNA-1273.351, based on the B.1.351 variant first identified in the Republic of South Africa, at the 50 µg dose level and lower. In May, researchers showed Moderna was also likely effective against B.1.617.1, the variant that has spread rapidly across India. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. To learn more, visit www.modernatx.com. The initial data is from an ongoing Phase 2 study in which three strategies for boosting neutralizing titers in previously vaccinated participants are being evaluated: mRNA-1273.351, a booster candidate based on the B.1.351 variant first identified in the Republic of South Africa, mRNA-1273.211, a multivalent booster candidate which combines a 50-50 mix of mRNA-1273, Moderna’s authorized vaccine against ancestral strains, and mRNA-1273.351 in a single vaccine, and a 50 µg booster dose of mRNA-1273. Today, 24 development programs are underway across these therapeutic areas, with 13 programs having entered the clinic. Severe allergic reactions, including anaphylaxis, have been reported following administration of the Moderna COVID-19 Vaccine during mass vaccination outside of clinical trials. The Moderna COVID-19 Vaccine is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein, which was co-developed by Moderna and investigators from the National Institute of Allergy and Infectious Diseases’ (NIAID) Vaccine Research Center. Moderna's variant-targeting booster shot appears to be protective against the strain of the virus first identified in South Africa, the company announced Wednesday. Moderna announced Wednesday it was working with the U.S. government to test an experimental booster shot aimed at protecting recipients against a variant that first emerged in South Africa. The Moderna booster shots appear to be effective at neutralizing at least two of the new variants. The most common solicited systemic adverse events after the third dose of mRNA-1273.351 or mRNA-1273 were fatigue, headache, myalgia and arthralgia. Moderna, Pfizer and other vaccine makers are racing to develop booster shots against emerging variant strains. Moderna’s Booster Shots Appear ‘Effective’ at Protecting Against COVID-19 Variants. The company plans to release data from later time points, and from tests of the combination booster, as they become available. Antibodies from the initial vaccination were detectable in 37 of those people, but in about half the participants, the antibodies performed poorly against the variants that have pummeled South Africa and Brazil. A second booster specifically designed to counter B.1.351, the variant identified in South Africa, produced an even stronger immune response against that variant. A third shot of either the original Moderna vaccine or a variant-specific booster improved antibody levels against two major variants, which were first detected in … Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. We are encouraged by these new data, which reinforce our confidence that our booster strategy should be protective against these newly detected variants. There were no Grade 4 solicited local or systemic adverse events. Two weeks after receiving either mRNA-1273 or mRNA-1273.351, PsVN titers were boosted in all participants and all variants tested. Click for Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and Full EUA Prescribing Information for more information. The U.S. government has agreed to purchase supply of mRNA-1273 under U.S. Department of Defense contract no. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. Appropriate medical treatment to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of the Moderna COVID-19 Vaccine. On July 8, 2020, the Phase 2 study completed enrollment. We encourage you to read the Privacy Policy of every website you visit. However, it did show a decrease in the antibody response from the variant … The relative decrease in neutralizing titers between the wild-type (D614G) and B.1.351 assays also improved with mRNA-1273.351 booster, from a 7.7-fold difference prior to boost to a 2.6-fold difference 15 days after boost, suggesting a potentially more balanced immune response against the tested variants. The strong and rapid boost in titers to levels above primary vaccination also clearly demonstrates the ability of mRNA-1273 to induce immune memory,” said Stéphane Bancel, Chief Executive Officer of Moderna. The boosters, tested in 40 participants, were administered as a third shot six to eight months after the two-shot immunization with the current vaccine. Moderna began modifying its vaccine to combat the variant identified in South Africa, after reports emerged that the existing vaccines are slightly less effective against that variant. Adverse reactions reported in a clinical trial following administration of the Moderna COVID-19 Vaccine include pain at the injection site, fatigue, headache, myalgia, arthralgia, chills, nausea/vomiting, axillary swelling/tenderness, fever, swelling at the injection site, and erythema at the injection site. Moderna has been named a top biopharmaceutical employer by Science for the past six years. Moderna Announces Positive Initial Booster Data Against SARS-CoV-2 Variants of Concern, https://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html, Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and Full EUA Prescribing Information, https://www.nejm.org/doi/full/10.1056/NEJMc2102179, https://www.businesswire.com/news/home/20210505006025/en/. In some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “could,” “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The Moderna COVID-19 vaccine being  administered at the University of Nevada, Las Vegas last month. Preclinical results published on the pre-print server Biorxiv on Tuesday show a booster vaccine Moderna has tailored to the B.1.351 variant increases neutralizing antibodies in mice. The National Institutes of Health has started testing a new coronavirus vaccine from Moderna designed to protect against a problematic variant first found in South Africa. The first participant in the NIAID-led Phase 1 study of the Moderna COVID-19 Vaccine was dosed on March 16, 2020, 63 days from sequence selection to Phase 1 study dosing. Moderna is testing three strategies for enhancing the immunity produced by the current vaccine: using the current vaccine as a booster; using the booster designed specifically to combat B.1.351; and a combination of the two in a single vaccine. These risks, uncertainties, and other factors include, among others: the fact that there has never been a commercial product utilizing mRNA technology approved for use; the fact that the rapid response technology in use by Moderna is still being developed and implemented; the safety, tolerability and efficacy profile of the Moderna COVID-19 Vaccine observed to date may change adversely in ongoing analyses of trial data or subsequent to commercialization; the Moderna COVID-19 Vaccine may prove less effective against variants of the SARS-CoV-2 virus, or the Company may be unsuccessful in developing future versions of its vaccine against these variants; despite having ongoing interactions with the FDA or other regulatory agencies, the FDA or such other regulatory agencies may not agree with the Company’s regulatory approval strategies, components of our filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted; Moderna may encounter delays in meeting manufacturing or supply timelines or disruptions in its distribution plans for the Moderna COVID-19 Vaccine; whether and when any biologics license applications and/or additional emergency use authorization applications may be filed in various jurisdictions and ultimately approved by regulatory authorities; potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and clinical trials, supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy; and those other risks and uncertainties described under the heading “Risk Factors” in Moderna’s most recent Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent filings made by Moderna with the SEC, which are available on the SEC’s website at www.sec.gov. The US drug company Moderna has announced that it is developing two new approaches to emerging variants of covid-19 after studies showed that its vaccine had a reduced level of neutralising titres to the South African variant, suggesting that immunity might wane. But Moderna also said it is testing “an additional booster dose” of its vaccine that it hopes will increase the vaccine’s effectiveness against the South African strain. The frequency of any Grade 3 solicited local or systemic adverse events was 15% after the third dose of mRNA-1273 and 10.5% after the third dose of mRNA-1273.351. Moderna COVID-19 Vaccine is authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older. Moderna says early trial results show increased immunity against COVID-19 variants first found in Brazil and South Africa among people who took a booster shot or an experimental new vaccine. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: the Company’s development of a vaccine (mRNA-1273) to protect against the SARS-CoV-2 virus, which causes COVID-19; the Company’s efforts to develop vaccines and boosters against variants of the SARS-CoV-2 virus; the potential for vaccines and boosters, including boosters designed for variants of concern (B.1.351 and P.1) to increase neutralizing antibody titer responses against SARS-CoV-2 and those particular variants; the need for booster vaccines against the SARS-CoV-2 virus and its variants and the potential dosages for those booster vaccines; the conduct of clinical studies for variant-specific boosters; the duration of protection against SARS-CoV-2 from existing vaccines; the safety and tolerability of the Company’s booster candidates; and the ability of the Company’s mRNA platform to facilitate the rapid design of vaccine candidates that incorporate key virus mutations. We look forward to sharing data on our multivalent booster candidate, mRNA-1273.211, which combines mRNA-1273 and mRNA-1273.351 in a single vaccine, when available. A manuscript describing these preliminary results has been submitted as a preprint to medRxiv and will be submitted for peer-reviewed publication upon completion of the multivalent mRNA-1273.211 booster arm. The variant-specific booster candidate – mRNA-1273.351 – encodes for the spike protein of the SARS-CoV-2 variant B.1.351, first discovered in South Africa. Preclinical data on the Company’s variant-specific booster vaccine candidates have been submitted as a preprint to bioRxiv and will be submitted for peer-reviewed publication. Additional authorizations are currently under review in other countries and by the World Health Organization. (617) 209-5834Lavina.Talukdar@modernatx.com. The majority of adverse events were mild or moderate in severity. Available data on Moderna COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy. Moderna’s mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases. The Company’s Phase 2 study to evaluate three approaches to boosting is ongoing. The booster shots, given to volunteers previously inoculated with Moderna's two-dose vaccine regimen, also boosted antibodies against the original version of COVID-19, Moderna … In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. Participants in the Phase 2 study were tested for pseudovirus neutralization (PsVN) titers prior to boosting approximately 6 to 8 months after their primary vaccination series. First, it will study the variant-specific jab, which will be … On May 12, 2020, the U.S. FDA granted the Moderna COVID-19 Vaccine Fast Track designation. The variant vaccine candidate developed by Moderna, mRNA-1273.351, differs from the currently-authorized Moderna vaccine in that it delivers instructions for making the SARS-CoV-2 spike that incorporates key mutations in the B.1.351 virus variant. “As we seek to defeat the ongoing pandemic, we remain committed to being proactive as the virus evolves. The Moderna COVID-19 Vaccine may not protect all vaccine recipients. Individuals. COVID-19 vaccine maker Moderna will make a third booster shot for its two-dose vaccine available to Americans by the fall, CEO Stéphane Bancel said this week. Moderna plans to post the findings to the preprint server bioRxiv, the company said on Wednesday. Monitor Moderna COVID-19 Vaccine recipients for the occurrence of immediate adverse reactions according to the. CAMBRIDGE, Mass.--(BUSINESS WIRE)--May 5, 2021-- Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced initial data from its Phase 2 study showing that a single 50 µg dose of mRNA-1273 or mRNA-1273.351 given as a booster to previously vaccinated individuals increased neutralizing antibody titer responses against SARS-CoV-2 and two variants of concern, B.1.351 (first identified in South Africa) and P.1 (first identified in Brazil). Senior Vice President & Head of Investor Relations During the trial, the investigators observed that a booster dose of mRNA-1273.351, a strain-matched booster Moderna developed for use against the B.1.351 variant, was found to achieve a higher level of neutralizing antibody titers against the B.1.351 variant than a booster dose of mRNA-1273 alone. https://www.nytimes.com/2021/05/05/science/moderna-booster-variants-covid.html. Moderna is voicing confidence in a new version of its coronavirus vaccine tailored to fight variants of the virus. Single booster dose of 50 µg of mRNA-1273 or mRNA-1273.351 increased neutralizing titers against SARS-CoV-2 and two variants of concern (B.1.351, P.1) in previously vaccinated clinical trial participants, Booster dose of mRNA-1273.351, a strain-matched candidate, achieved higher titers against B.1.351 than a booster dose of mRNA-1273, mRNA-1273.351 and mRNA-1273 booster doses were generally well tolerated, Evaluation of a multivalent vaccine booster candidate, mRNA-1273.211, is ongoing; data expected shortly. BARDA is reimbursing Moderna for 100 percent of the allowable costs incurred by the Company for conducting the program described in the BARDA contract. The Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS) is supporting the continued research and development of the Company’s COVID-19 vaccine development efforts with federal funding under contract no. We will continue to make as many updates to our COVID-19 vaccine as necessary to control the pandemic.”. On November 30, 2020, Moderna announced the primary efficacy analysis of the Phase 3 study of the vaccine conducted on 196 cases. The antibodies produced by the booster were effective against the original form of the virus, as well as against the variants of concern first identified in South Africa and Brazil.

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