American biotech company Moderna announced this morning that the first coronavirus vaccine to be tested on people appears to be safe and seems to be able to stimulate an immune response against the virus. In a press release, they said that they received “positive interim clinical data of mRNA-1273.” mRNA-1273 is what they are calling their “vaccine candidate” for the coronavirus.
Their findings are based on results from a study on a group of 45 participants. Each participant received a 25, 100 or 250 microgram dose, with 15 people in each dose group. Participants received two doses of the potential vaccine via intramuscular injection in the upper arm approximately 28 days apart.
The company said that after 43 days into the study, and two weeks after the second dose was given, volunteers who received a 25 microgram dose had “levels of binding antibodies [that] were at the levels seen” in people who have recovered from COVID-19. Meanwhile, on day 43, volunteers who got a 100 microgram dose level had “levels of binding antibodies [that] significantly exceeded the levels seen in” people who have recovered from COVID-19.
In other words, those who got two 25 microgram doses had the same amount of antibodies as those who had recovered from COVID-19. Those who got two 100 microgram doses had “significantly” more antibodies than someone who recovered.
CNBC explains that “Scientists hope the antibodies provide some degree of protection against getting COVID-19, but they can’t say that definitively yet since it hasn’t been studied and some patients appear to have been reinfected after recovering from the virus.”
The only adverse effect at those doses was redness and soreness in one patient’s arm where the shot was given. The New York Times reports that at the highest dose (250 micrograms), three patients had fever, muscle and headaches, adding that the symptoms went away after a day. The 250 microgram dose is being eliminated from their future studies, not because of the side effects, but because the lower doses appeared to work so well that the high dose is not needed, according to the Times.
Moderna also noted that data is only available for the first four participants in the 25 and 100 microgram groups; there are still participants in each group who they haven’t yet gathered data from.
The Times reports that Moderna said that additional tests in mice that were vaccinated and then infected found that the vaccine could prevent the virus from replicating in their lungs, and that the animals had levels of neutralizing antibodies comparable to those in the people who had received the vaccine. It’s worth mentioning, again, that scientists have not yet proved that antibodies can protect people from getting COVID-19.
Moderna mentioned a “phase two” of testing in their press release, but didn’t say when that would take place. They did say that they hope to start “phase three” in July, so phase two will obviously start soon.
Dr. Tal Zaks, Moderna’s chief medical officer, said that if those trials go well, a vaccine could become available for widespread use by the end of this year or in early 2021, according to The New York Times. Dr. Zaks said that the company will work to make as much of the vaccine as possible. CNBC quoted Dr. Zaks as saying, “When combined with the success in preventing viral replication in the lungs of a pre-clinical challenge model at a dose that elicited similar levels of neutralizing antibodies, these data substantiate our belief that mRNA-1273 has the potential to prevent COVID-19 disease and advance our ability to select a dose for pivotal trials.”
Dozens of other companies in the United States, Europe and China are also working to produce vaccines.
Moderna’s stock was up 30 percent following the announcement, according to CNBC.
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