Moderna, Inc., provided a supply update for the Moderna’s COVID-19 Vaccine, increasing its base-case global production estimate from 500 to 600 million doses for 2021. According to the information that company published, Moderna plans to invest and add staff to build up to potentially 1 billion doses for 2021.
“With the availability of two vaccines now for the prevention of COVID-19, the FDA has taken another crucial step in the fight against this global pandemic that is causing vast numbers of hospitalizations and deaths in the United States each day,” said FDA Commissioner Stephen M. Hahn, M.D.
“Through the FDA’s open and transparent scientific review process, two COVID-19 vaccines have been authorized in an expedited timeframe while adhering to the rigorous standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization that the American people have come to expect from the FDA.
These standards and our review process, which are the same we have used in reviewing the first COVID-19 vaccine and intend to use for any other COVID-19 vaccines, included input from independent scientific and public health experts as well as a thorough analysis of the data by the agency’s career staff.”
100 Million Doses at First Quarter of 2021
The Company said it expects about 100 million doses to be available in the United States by the end of the first quarter of 2021, with 200 million doses total available by the end of the second quarter. Moderna reported that approximately 18 million doses have been supplied to the U.S. Government to date.
“Our effectiveness in providing early supply to the U.S. and Canadian governments and our ability to increase baseline production estimates for 2021 are both signals that our scale up of mRNA vaccine production is a success,” said Juan Andres, Chief Technical Operations and Quality Officer at Moderna. “I want to thank the many private and government collaborators, contractors and the hundreds of Moderna staff who have been working thoughtfully and tirelessly to accomplish this.”
Moderna’s COVID-19 Vaccine Information
According to the FDA the Moderna’s COVID-19 Vaccine has met the statutory criteria for issuance of an EUA. The Moderna’s COVID-19 Vaccine contains messenger RNA (mRNA), which is genetic material. The vaccine contains a small piece of the SARS-CoV-2 virus’s mRNA that instructs cells in the body to make the virus’s distinctive “spike” protein.
After a person receives this vaccine, their body produces copies of the spike protein, which does not cause disease, but triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2.
“The totality of the available data provides clear evidence that the Moderna’s COVID-19 Vaccine may be effective in preventing COVID-19. The data also show that the known and potential benefits outweigh the known and potential risks—supporting the company’s request for the vaccine’s use in people 18 years of age and older.
In making this determination, the FDA can assure the public and medical community that it has conducted a thorough evaluation of the available safety, effectiveness, and manufacturing quality information,” – The FDA said.
