{"id":15402,"date":"2020-05-31T08:49:51","date_gmt":"2020-05-31T12:49:51","guid":{"rendered":"http:\/\/stateofthenation.co\/?p=15402"},"modified":"2020-05-31T08:49:51","modified_gmt":"2020-05-31T12:49:51","slug":"it-looks-like-vaccine-maker-moderna-has-been-working-on-a-covid-19-vaccination-forever","status":"publish","type":"post","link":"https:\/\/stateofthenation.co\/?p=15402","title":{"rendered":"It looks like vaccine maker MODERNA has been working on a COVID-19 vaccination forever"},"content":{"rendered":"

\"\"
\n<\/p>\n

\n
\n

Moderna\u2019s Work on a COVID-19 Vaccine Candidate<\/h1>\n<\/div>\n<\/div>\n
\n
\n
\n
\n
\n
\n
\n
\n

Time is of the essence to provide
\na vaccine against this pandemic virus.<\/h2>\n

Moderna is proud to be among the many groups working to respond to this
\ncontinuing global health emergency. This page summarizes key milestones in our
\nwork to advance mRNA-1273, our vaccine candidate against the novel coronavirus.<\/h3>\n<\/div>\n<\/div>\n<\/div>\n
\n
\n
\n
\n
\n
\n
\n
\n
\n
\n
May 18<\/span><\/div>\n<\/div>\n
\n
\n

Moderna announced<\/a> positive interim Phase 1 data for mRNA-1273.<\/p>\n<\/div>\n<\/div>\n<\/div>\n

\n
\n
May 12<\/span><\/div>\n<\/div>\n
\n
\n

Moderna received<\/a> FDA Fast Track designation\u00a0for mRNA-1273.<\/p>\n<\/div>\n<\/div>\n<\/div>\n

\n
\n
May 06<\/span><\/div>\n<\/div>\n
\n
\n

Moderna\u00a0reported<\/a> that Anthony S. Fauci, M.D., Director of NIAID, participated in an interview with National Geographic<\/i><\/a>, which described his assessment of the results of certain preclinical testing related to the ongoing Phase 1 clinical study of mRNA-1273.<\/p>\n<\/div>\n<\/div>\n<\/div>\n

\n
\n
May 01<\/span><\/div>\n<\/div>\n
\n
\n

Moderna and Lonza\u00a0announced<\/a>\u00a0a worldwide strategic collaboration with the goal to enable manufacturing of up to 1 billion doses of mRNA-1273 per year.<\/p>\n<\/div>\n<\/div>\n<\/div>\n

\n
\n
Apr 27<\/span><\/div>\n<\/div>\n
\n
\n

Moderna\u00a0submitted<\/a>\u00a0 an IND to the U.S. FDA for Phase 2 study of mRNA-1273.<\/p>\n<\/div>\n<\/div>\n<\/div>\n

\n
\n
Apr 16<\/span><\/div>\n<\/div>\n
\n
\n

BARDA\u00a0awarded<\/a>\u00a0Moderna up to $483 million to accelerate development of mRNA-1273 to enable large-scale production in 2020 for pandemic response.<\/p>\n

The NIH-led Phase 1 study of mRNA-1273 completed<\/a>\u00a0enrollment of three dose cohorts (25 \u00b5g, 100 \u00b5g and 250 \u00b5g) and expanded to an additional six cohorts: three cohorts of older adults (ages 56 -70) and three cohorts of elderly adults (age 71 and above).<\/p>\n<\/div>\n<\/div>\n<\/div>\n

\n
\n
Mar 27<\/span><\/div>\n<\/div>\n
\n
\n

The NIH\u00a0announced<\/a>\u00a0that Emory University in Atlanta would begin enrolling healthy adult volunteers ages 18 to 55 years in the NIH-led Phase 1 study of mRNA-1273.<\/p>\n<\/div>\n<\/div>\n<\/div>\n

\n
\n
Mar 23<\/span><\/div>\n<\/div>\n
\n
\n

While a commercially-available vaccine is not likely to be available for at least 12-18 months, Moderna reported<\/a> it is possible that under emergency use, a vaccine could be available to some people, possibly including healthcare professionals, in the fall of 2020.1<\/sup><\/p>\n

Moderna confirmed that it is scaling up manufacturing capacity toward the production of millions of doses per month, in the potential form of individual or multi-dose vials.2<\/sup><\/p>\n<\/div>\n<\/div>\n<\/div>\n

\n
\n
Mar 16<\/span><\/div>\n<\/div>\n
\n
\n

The NIH announced<\/a> that the first participant in its Phase 1 study of mRNA-1273 was dosed, a total of 63 days from sequence selection to first human dosing.<\/p>\n<\/div>\n<\/div>\n<\/div>\n

\n
\n
Mar 04<\/span><\/div>\n<\/div>\n
\n
\n

The FDA completed its review of the IND application filed by the NIH for mRNA-1273 and allowed the study to proceed to clinical trials.<\/p>\n<\/div>\n<\/div>\n<\/div>\n

\n
\n
Feb 24<\/span><\/div>\n<\/div>\n
\n
\n

Moderna shipped<\/a> the first clinical batch of mRNA-1273 to the NIH for use in their Phase 1 clinical study.<\/p>\n<\/div>\n<\/div>\n<\/div>\n

\n
\n
Feb 07<\/span><\/div>\n<\/div>\n
\n
\n

The first clinical batch of mRNA-1273 was completed<\/a>, a total of 25 days from sequence selection to vaccine manufacture. The batch then proceeded to analytical testing for release.<\/p>\n<\/div>\n<\/div>\n<\/div>\n

\n
\n
Jan 13<\/span><\/div>\n<\/div>\n
\n
\n

The NIH and Moderna\u2019s infectious disease research team finalized the sequence for mRNA-1273. Moderna mobilized toward clinical manufacture.<\/p>\n

NIAID, part of NIH, disclosed their intent to run a Phase 1 study using mRNA-1273 in response to the coronavirus threat. Manufacture of this batch was funded by the\u00a0Coalition for Epidemic Preparedness Innovations\u00a0(CEPI).<\/p>\n<\/div>\n<\/div>\n<\/div>\n

\n
\n
Jan 11<\/span><\/div>\n<\/div>\n
\n
\n

Chinese authorities shared the genetic sequence of the novel coronavirus.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/section>\n<\/div>\n<\/div>\n<\/div>\n

\n
\n
\n
\n\n\n\n
\n