The first coronavirus vaccine we wrote about back on March 17, developed by Massachusetts-based biotech firm Moderna, is already in its second phase of testing and about to enter its third later this month. And a report on the first phase is being called a "triumph" by one Stanford expert.
Dr. Bali Pulendran, a professor of microbiology and immunology at Stanford, tells ABC 7 that a report on the vaccine's first human trial in 45 volunteers in the Seattle area looks to be "a wonderful triumph for vaccinology."
Moderna published the results of the Phase 1 trial in the New England Journal of Medicine Tuesday — results that were hinted at in a press release in May — and not only did the vaccine appear to be completely safe in all 45 volunteers to whom it was given, but it also conferred antibodies in all of them.
As the New York Times reports, the trial involved 45 healthy adults, ages 18 to 55, and each received two doses of the vaccine, 28 days apart. The initial trial also featured three different dosage levels of the vaccine, in an attempt to begin to determine what the lowest effective dose will need to be — the lower the dose, the more each vaccine production phase can be spread out among a population.
Moderna said that it found "rapid and strong immune response" in all 45 subjects, regardless of the differences in dosage. All study participants developed neutralizing antibodies against the virus, all in similar levels to patients who have recovered from severe cases of the virus. The vaccine also produced a promising T-cell response in all the participants.
Dr. Kizzmekia S. Corbett, a viral immunologist who helped lead the vaccine development team, tells the Times that the Phase 1 result "exceeds all expectations."
There were, however, side effects in more than half the volunteers, similar to those experienced from the flu shot. They included fever, fatigue, chills, headaches, muscle aches, and pain a the injection site. As Reuters reports, the reactions were more likely in the participants who received higher-dose infections, and following the second dose.
One study participant, Seattle resident Neal Browning, tells ABC 7 that he only had pain in his upper arm after each of the two injections. But, he added, "honestly, much less so than when I've gotten the flu shots in the past."
What remains unknown is whether the immunity conferred by the vaccine lasts for any length of time — a study released Monday suggested that recovered patients' antibody levels declined significantly within a few months — and whether the vaccine actually protects against virus transmission in a real-world setting, which will be the goal result of the Phase 3 trial beginning July 27. There is also a possibility that the vaccine prevents the virus from becoming severe, but does not necessarily prevent infection completely.
As Dr. Angela Rasmussen, a virologist at Columbia University, tells the Times, "If it’s a choice between a bad cold and being on a ventilator, I’ll take the bad cold."
Moderna and the National Institutes for Health are seeking 27,000 to 30,000 volunteers to participate in the Phase 3 trial, with an emphasis placed on virus "hot spots" and communities that are most vulnerable to contracting the virus.
Moderna is one of the first firms to use a new technology for vaccine production involving mRNA, or messenger RNA, that is meant to speed the creation of vaccines in the future. Older processes, like the one still used to make the flu vaccine, involved using neutralized virus particles that have been grown in chicken egg fluids.
Dr. Anthony Fauci expressed optimism about Moderna's vaccine, noting that there are multiple, simultaneous trials underway across the globe for coronavirus vaccines — including one that the at the Russians were bragging about having completed all clinical trials of this week, though it sounds like they have only completed a Phase 1.
As Fauci put it, "If that's one company with a couple hundred million, another company feels that within a year they could have a few hundred million up to a billion. So right away I'm feeling much better about getting vaccine that's distributed not only within our own country, but that they'll be able to have doses for people throughout the world."
Also, as he said in an interview with Reuters, "If your vaccine can induce a response comparable with natural infection, that’s a winner."