Online Extra: Coronavirus vaccine trial starts in Seattle
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Researchers are now testing the first vaccine for the new coronavirus, the National Institutes of Health announced March 16. The study will enroll 45 healthy volunteers in Seattle, one of the first U.S. epicenters of COVID-19, as the respiratory illness caused by the virus is known.
The coronavirus continues to spread rapidly. As of March 19, there were more than 227,000 confirmed cases worldwide, more than 9,000 cases in the United States, over 800 cases in California, and just over 400 in the San Francisco Bay Area, where a shelter in place order is now in effect in most counties.
While most people who contract COVID-19 will have mild illness, the virus can cause potentially fatal respiratory disease. There are currently no approved treatments or vaccines.
The new early-stage trial will test an experimental vaccine called mRNA-1273 that is being jointly developed by the National Institutes of Allergy and Infectious Disease, the Cambridge, Mass., biotechnology company Moderna, and the Coalition for Epidemic Preparedness Innovations.
Discussing the trial at a special session at the recent Conference on Retroviruses and Opportunistic Infections — conducted virtually after the in-person meeting was canceled due to the crisis — NIAID director Dr. Anthony Fauci said this has been the fastest-ever production of a vaccine candidate.
"Finding a safe and effective vaccine to prevent infection with SARS-CoV-2 is an urgent public health priority," Fauci said in the NIH statement, referring to the official name of the virus. "This phase 1 study, launched in record speed, is an important first step toward achieving that goal."
Coronaviruses have spikes on their surface that bind to human cells and allow the virus to enter. The new vaccine uses a sequence of genetic material from the virus that researchers hope will elicit a robust immune response. It does not contain the whole virus, so it cannot cause infection.
The first human trial will test different doses of the vaccine to see whether it is safe and whether it stimulates immune responses against the virus. If the results are promising, it will then move into larger trials to determine if it protects against infection. Fauci has estimated that the process could take 12 to 18 months.
This trial is now seeking 45 healthy adults at Kaiser Permanente Washington Health Research Institute in Seattle. Participants will receive two injections of the vaccine in the upper arm about a month apart. The first four will receive a single shot of the lowest dose and the next four will receive the intermediate dose. Researchers will then review preliminary safety data before administering additional injections or vaccinating the rest of the participants.
The study will not enroll people with certain medical or psychiatric conditions, including respiratory disease, cardiovascular disease, cancer, HIV, hepatitis B or C, chronic liver disease, or immune deficiency.
While people in some of these categories are more likely to develop severe COVID-19 disease — and therefore might seem to need a vaccine more urgently — early trials like this focus on evaluating safety in healthy people before moving on those at higher risk for complications.