2020COVID-19 and related vaccine development and research

Paul A. Krieg, Ph.D., Douglas A. Melton, Ph.D., Tom Maniatis, Ph.D., and Michael Green, Ph.D., and colleagues at Harvard University use a synthesized RNA enzyme to make biologically active messenger RNA (mRNA) in a lab. A similar process is still used today to make synthetic mRNA. Drs. Krieg and Melton use synthetic mRNA to study gene function and activity. Other researchers also study RNA.

Robert W. Malone, M.D., M.S., mixes mRNA with fat droplets. He discovers that when human cells are added to this mixture, they absorb the mRNA and make proteins. Dr. Malone also finds that frog embryos absorb mRNA. These experiments are considered early steps in the eventual development of mRNA-based COVID-19 vaccines.

Researchers test mRNA as a treatment in rats and as an influenza and cancer vaccine in mice.

Several researchers study mRNA treatments or vaccines. But since mRNA is easy to damage and expensive to produce, many researchers can’t get funding to pursue this work and so the research often wasn’t pursued.

Katalin Kariko, Ph.D., and Drew Weissman, M.D., Ph.D., discover that modifying synthetic mRNA keeps the immune system from attacking the mRNA. This discovery moves mRNA vaccine research forward.

Many researchers study mRNA treatments or vaccines.

A new coronavirus called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is found in China. The SARS-CoV-2 virus causes coronavirus disease 2019 (COVID-19). WHO will declare the COVID-19 outbreak a pandemic in 2020. WHO and CDC issue recommendations for preventing and treating COVID-19. By January 2021, COVID-19 will cause about 2.5 million deaths worldwide.

Many COVID-19 vaccine clinical trials are in process. Researchers take what was previously learned from vaccine studies of SARS-CoV, MERS-CoV and other viruses to develop vaccines that prevent COVID-19. Researchers also study COVID-19 symptoms, long-term effects, diagnostic tests, antibody tests, treatments and drugs.

Mayo Clinic researchers study and develop a COVID-19 diagnostic test, an antibody test, monoclonal antibody medications, convalescent plasma therapy and vaccines.

COVID-19 vaccines

In the U.S., the Food and Drug Administration (FDA) gives emergency use authorization to two mRNA COVID-19 vaccines, the Pfizer-BioNTech and the Moderna COVID-19 vaccines. Because there is an urgent need for COVID-19 vaccines and the FDA’s vaccine approval process can take months to years, the FDA first gives emergency use authorization to COVID-19 vaccines based on less data than is normally required. However, data must show that the vaccines are safe and effective before the FDA can give emergency use authorization or approval. Vaccines have gone through — and continue to go through — extensive safety monitoring. From December 2020 to December 2025, billions of COVID-19 vaccines are given.

Researchers at Mayo Clinic and other medical centers continue to study more about COVID-19 vaccines.

The FDA gives emergency use authorization to the Janssen/Johnson & Johnson COVID-19 vaccine. The FDA approves the Pfizer-BioNTech COVID-19 vaccine, now called Comirnaty, to prevent COVID-19 in people age 16 and older. The FDA authorizes the Pfizer-BioNTech vaccine for children ages 5 through 15. Researchers continue to study and develop several other COVID-19 vaccines. Many COVID-19 vaccines are in clinical trials. 

The FDA approves the Moderna COVID-19 vaccine, now called Spikevax, to prevent COVID-19 in people age 18 and older. The FDA authorizes the Pfizer-BioNTech vaccine for children ages 6 months to 4 years and the Moderna vaccine for children ages 6 months to 17 years. The Novavax COVID-19 vaccine is authorized for people age 18 and older, and soon it is authorized. The Novavax COVID-19 vaccine is authorized for people age 18 and older, and soon it is authorized for people age 12 and older. 

The FDA approves the Pfizer-BioNTech COVID-19 vaccine, now called Comirnaty, to prevent COVID-19 in people age 12 and older. The FDA authorizes the Pfizer-BioNTech vaccine for people age 6 months to 11 years. The FDA approves the Moderna COVID-19 vaccine, now called Spikevax, to prevent COVID-19 in people age 12 and older. The FDA authorizes the Moderna vaccine for children 6 months to 11 years.

Certain strains of the COVID-19 virus are targeted in the 2024-2025 COVID-19 vaccines based on the virus strains that are spreading. These include the Pfizer- BioNTech, Moderna and Novavax COVID-19 2024-2025 formula vaccines. The Novavax COVID-19 vaccine, adjuvanted, 2024-2025 formula is authorized for people age 12 and older.

The 2025-2026 COVID-19 vaccines available in the United States include Moderna, Pfizer-BioNTech and Novavax. The vaccines are all approved for people age 65 and older. Each vaccine also is approved for younger people with a health condition that raises the risk of serious COVID-19 illness.