Australian Therapeutic Goods Administration Issues Preliminary Registration for Moderna’s COVID-19 Vaccine | business
CAMBRIDGE, Mass .– (BUSINESS WIRE) – Nov. August 2021–
Moderna, Inc. (Nasdaq: MRNA), a biotechnology company developing breakthrough messenger RNA (mRNA) therapeutics and vaccines, announced today that the Therapeutic Goods Administration (TGA) has submitted a preliminary registration to the COVID-19 Vaccine Moderna in Australia for an active Immunization for the prevention of COVID-19 caused by the SARS-CoV-2 virus in people over the age of 18 has been granted. Moderna delivery of the COVID-19 vaccine to Australia is slated to begin in the second half of September.
“I would like to thank the Australian Government for their cooperation and the confidence they have shown in making this decision in COVID-19 Vaccine Moderna,” said Stéphane Bancel, Chief Executive Officer of Moderna. “As we try to protect people around the world with our COVID-19 vaccine, we look forward to continuing discussions with the Australian government about possible building local mRNA manufacturing capabilities.”
The Australian government previously secured 10 million doses of the COVID-19 vaccine Moderna for delivery in 2021 through a supply agreement announced on May 12, 2021, as well as an option to source 15 million doses in 2022. Moderna also has an emergency (or other conditional, provisional, or provisional) approval for the use of its COVID-19 vaccine from health authorities in more than 50 countries and an Emergency List (EUL) from the World Health Organization (WHO). The TGA is also considering an application for preliminary registration of Moderna’s COVID-19 vaccine for use in adolescents aged 12-18.
The Therapeutic Goods Administration has granted the COVID-19 Vaccine Moderna in Australia a preliminary registration for active immunization for the prevention of COVID-19, which is caused by the SARS-CoV-2 virus in people aged 18 and over.
IMPORTANT SAFETY INSTRUCTIONS
- Do not give the Moderna COVID-19 vaccine to anyone with a known severe allergic reaction (e.g., anaphylaxis) to any component of the Moderna COVID-19 vaccine.
- In the event that an acute anaphylactic reaction occurs after the administration of the Moderna COVID-19 vaccine, appropriate medical treatment to treat immediate allergic reactions must be available immediately. Monitor recipients of the Moderna COVID-19 vaccine for the occurrence of immediate side effects according to the guidelines of the Centers for Disease Control and Prevention ( https://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html ).
- Reports of adverse events following the use of the Moderna COVID-19 vaccine with EUA suggest an increased risk of myocarditis and pericarditis, especially after the second dose. Typically, symptoms appeared within a few days of receiving the Moderna COVID-19 vaccine. Available short-term follow-up data suggest that symptoms have resolved in most people, but no information is yet available on possible long-term effects. When deciding to give the Moderna COVID-19 vaccine to a person with a history of myocarditis or pericarditis, the person’s clinical circumstances should be considered. The CDC has published clinical considerations on myocarditis and pericarditis related to the administration of the Moderna COVID-19 vaccine ( https://www.cdc.gov/vaccines/covid-19/clinical-considerations/myokarditis.html ).
- Immunocompromised individuals, including those receiving immunosuppressive therapy, may have a decreased response to the Moderna COVID-19 vaccine.
- The Moderna COVID-19 vaccine may not protect all vaccine recipients.
- Side effects reported in a clinical study after administration of the Moderna COVID-19 vaccine include injection site pain, fatigue, headache, myalgia, arthralgia, chills, nausea / vomiting, armpit swelling / tenderness, fever, swelling around the injection site, and erythema at the injection site.
- The following side effects have been reported after administration of the Moderna COVID-19 vaccine during mass vaccination outside of clinical trials:
- Severe allergic reactions, including anaphylaxis
- There is insufficient data available on the Moderna COVID-19 vaccine given to pregnant women to inform about the risks associated with the vaccine in pregnancy. No data are available to evaluate the effects of Moderna COVID-19 vaccine on the breast-fed child or on milk production / excretion.
- To complete the vaccination series, no data are available on the interchangeability of the Moderna COVID-19 vaccine with other COVID-19 vaccines. Individuals who have received a dose of Moderna COVID-19 vaccine should receive a second dose of Moderna COVID-19 vaccine to complete the series of vaccinations.
- Additional side effects, some of which can be serious, may occur with wider use of the Moderna COVID-19 vaccine.
- Vaccination providers must complete reports online and submit them to VAERS at https://vaers.hhs.gov/reportevent.html. For further assistance in reporting to VAERS, call 1-800-822-7967. The reports should include the words “Moderna COVID-19 Vaccine EUA” in the description section of the report.
Click for Leaflet for healthcare providers who deliver vaccines (vaccination providers) and complete information on EUA prescribing for more informations.
In the 10 years since its inception, Moderna has grown from a scientific research company driving messenger RNA (mRNA) programs to a broad portfolio company with a diverse clinical portfolio of vaccines and therapeutics across six modalities intellectual property transformed into areas such as mRNA and lipid nanoparticle formulation and an integrated manufacturing facility that enables both clinical and commercial production on a large scale and at unprecedented rates. Moderna has alliances with a wide range of domestic and foreign government and trade partners that have enabled both the pursuit of breakthrough science and the rapid scale of manufacturing. Recently, Moderna’s capabilities have come together to enable the approved use of one of the earliest and most effective vaccines against the COVID-19 pandemic.
Moderna’s mRNA platform builds on the continuous advances in basic and applied mRNA science, delivery technology and manufacturing and has enabled the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Today there are 23 development programs running in these therapeutic areas, 15 of which have been added to the clinic. Moderna was created by. honored as a top employer in the biopharmaceutical sector science for the past six years. To learn more, visit www.modernatx.com.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including: the Company’s efforts to develop a vaccine for COVID-19 and to supply the vaccine to the Australian Government at that date of this shipment, the potential establishment of mRNA manufacturing capabilities in Australia, the ability for the Australian government to exercise its option to purchase additional doses for shipment in 2022, and the potential extension of TGA approval to use the vaccine to adolescent populations. The forward-looking statements contained in this press release are neither promises nor guarantees and you should not place undue reliance on these forward-looking statements as they involve known and unknown risks, uncertainties and other factors, many of which are outside of Moderna’s control and lead to them actual results could differ materially from those expressed or implied in these forward-looking statements. These risks, uncertainties and other factors include the other risks and uncertainties identified under the heading “Risk Factors” in Moderna’s latest annual report on Form 10-K filed with the SEC and in subsequent filings by Moderna of the SEC, which are available on the SEC’s website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility to update or revise any forward-looking statements contained in this press release as a result of new information, future developments, or otherwise. These forward-looking statements are based on Moderna’s current expectations and speak only as of today.
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SOURCE: Moderna, Inc.
Copyright Business Wire 2021.
PUB: 09/08/2021 10:05 AM / DISC: 09/08/2021 10:06 AM
Copyright Business Wire 2021.