Australian Therapeutic Goods Administration grants provisional registration for Moderna’s COVID-19 vaccine
Australia has obtained 25 million doses of Moderna’s COVID-19 vaccine
Delivery will begin in the second half of September
CAMBRIDGE, Massachusetts, August 9, 2021– (COMMERCIAL THREAD) –Moderna, Inc. (Nasdaq: MRNA), a pioneering biotechnology company in messenger RNA (mRNA) therapies and vaccines, today announced that the Therapeutic Goods Administration (TGA) has granted provisional registration to COVID -19 Vaccine Moderna in Australia for active immunization to prevent COVID-19 caused by SARS-CoV-2 virus in people 18 years of age and older. Delivery of Moderna’s COVID-19 vaccine to Australia is expected to begin in the second half of September.
“I would like to thank the Australian government for its collaboration and for the confidence it has shown in the COVID-19 Moderna vaccine with this decision,” said Stéphane Bancel, CEO of Moderna. “As we seek to protect people around the world with our COVID-19 vaccine, we look forward to continuing discussions with the Australian government on the possibility of establishing local mRNA manufacturing capabilities. “
The Australian government has already secured 10 million doses of Moderna COVID-19 vaccine for delivery in 2021, through a supply agreement announced on May 12, 2021, along with an option to purchase 15 million doses in 2022. Moderna has also received emergency relief (or other conditional, provisional or provisional authorization) for the use of its COVID-19 vaccine from health agencies in more than 50 countries and a list of use of Emergency (EUL) from the World Health Organization (WHO). The TGA continues to assess an application for the provisional registration of Moderna’s COVID-19 vaccine for use in adolescents aged 12 to 18.
The Therapeutic Goods Administration has granted provisional registration to COVID-19 Vaccine Moderna in Australia for active immunization aimed at preventing COVID-19 caused by the SARS-CoV-2 virus in people 18 years of age and older.
IMPORTANT SAFETY INFORMATION
Do not administer the Moderna COVID-19 vaccine to people with a known history of a serious allergic reaction (for example, anaphylaxis) to any component of the Moderna COVID-19 vaccine.
Appropriate medical treatment to manage immediate allergic reactions should be immediately available in the event of an acute anaphylactic reaction following administration of Moderna COVID-19 vaccine. Monitor Moderna COVID-19 vaccine recipients for the onset of immediate adverse reactions as directed by 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 Moderna COVID-19 vaccine in EUA suggest increased risks of myocarditis and pericarditis, especially after the second dose. Typically, the onset of symptoms has occurred within a few days of receiving the Moderna COVID-19 vaccine. Available data from short-term follow-up suggests that most individuals have had resolution of symptoms, but information is not yet available on potential long-term sequelae. The decision to give the Moderna COVID-19 vaccine to a person with a history of myocarditis or pericarditis should take into account the person’s clinical circumstances. The CDC has published clinical considerations for myocarditis and pericarditis associated with the administration of the Moderna COVID-19 vaccine (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/myocarditis.html).
People who are immunocompromised, including people receiving immunosuppressive therapy, may have a decreased response to the Moderna COVID-19 vaccine.
The Moderna COVID-19 vaccine may not protect all vaccinees.
Adverse reactions reported in a clinical trial after administration of Moderna COVID-19 vaccine include pain at the injection site, fatigue, headache, myalgia, arthralgia, chills, nausea / vomiting, axillary swelling / tenderness, fever, injection site swelling, and injection site erythema.
The following adverse reactions have been reported following administration of Moderna COVID-19 vaccine during mass vaccination outside of clinical trials:
There is insufficient data available on the Moderna COVID-19 vaccine given to pregnant women to inform the risks associated with the vaccine during pregnancy. Data are not available to assess the effects of Moderna COVID-19 vaccine on the breastfed infant or on milk production / excretion.
There is no data available on the interchangeability of Moderna COVID-19 vaccine with other COVID-19 vaccines to complete the vaccination series. People who have received a dose of Moderna COVID-19 vaccine must receive a second dose of Moderna COVID-19 vaccine to complete the vaccination series.
Additional side effects, some of which can be serious, may become apparent with more widespread use of the Moderna COVID-19 vaccine.
Immunization providers should complete and submit reports to VAERS online at https://vaers.hhs.gov/reportevent.html. For help with reporting to VAERS, call 1-800-822-7967. Reports should include the words “Moderna COVID-19 Vaccine EUA” in the description section of the report.
In the 10 years since its inception, Moderna has grown from a company in the scientific research stage advancing programs in the field of messenger RNA (mRNA), to a company with a diverse clinical portfolio of vaccines and therapeutic products. through six modalities, a broad portfolio of intellectual property in areas such as the formulation of mRNA and lipid nanoparticles, and an integrated manufacturing facility that enables both clinical and commercial production on a large scale and at low speed. previous. Moderna maintains alliances with a wide range of domestic and foreign government and business collaborators, which has allowed the pursuit of both groundbreaking science and rapid scale-up of manufacturing. More recently, Moderna’s capabilities have come together to enable the licensed use of one of the oldest and most effective vaccines against the COVID-19 pandemic.
Moderna’s mRNA platform builds on continuous advancements in basic and applied mRNA science, delivery technology and manufacturing, and has enabled the development of therapies and vaccines for them. infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Today, 23 development programs are underway in these therapeutic areas, of which 15 programs have entered the clinic. Moderna was named one of the top biopharmaceutical employers by Science for 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 regarding: the Company’s efforts to develop a vaccine against COVID-19 and the supply of the vaccine to the Australian government, the timing of this delivery, the potential establishment of mRNA manufacturing capacity in Australia, the possibility for the Australian government to exercise its option to purchase additional doses for delivery in 2022, and the potential expansion of TGA authorization for use of the vaccine in 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 because they involve risks, uncertainties and other known and unknown 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. These risks, uncertainties and other factors include the other risks and uncertainties described under the heading “Risk Factors” in Moderna’s most recent annual report on Form 10-K filed with the State Securities and Exchange Commission (SEC). United and in subsequent filings by Moderna with 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 in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna’s current expectations and speak only as of the date hereof.
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