- Moderna’s early coronavirus vaccine results look promising, but they actually lack the crucial data that doctors and physicians working on COVID-19 therapies need.
- The company’s Monday announcement left out key details that will only arrive once a full study is available, but it also sent its stock soaring ahead a new round of public stock offering.
- Moderna did say that eight out of 45 volunteers who were inoculated with the RNA vaccine developed neutralizing antibodies for SARS-CoV-2.
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Moderna is one of the several companies working on a vaccine for the novel coronavirus, and it’s the first company to have started Phase 1 human trials for the drug. It’s also the closest to reaching Phase 2, and emergency use of the vaccine may be approved as soon as this fall if all goes well.
The first patients were inoculated with Moderna’s mRNA-1273 compound several weeks ago, and the company disclosed preliminary results a few days ago saying the drug generates an immune response comparable to the one seen in COVID-19 survivors. That’s the kind of good news the world has been waiting for. A vaccine will be key to stopping the spread of the disease. However, some researchers say that Moderna hasn’t actually shared any data of value to scientists, cherry-picking the information it chose to make public.
Vaccine experts told STAT that Moderna failed to produce actual data from the study. The information the company delivered was tailored to the needs of the media and people waiting for vaccine news. It hardly satisfies the needs of the scientific community involved in studying the novel coronavirus.
STAT also points out that the National Institute of Allergy and Infectious Diseases (NIAID), Moderna’s partner in these trials, did not address these preliminary results from Phase 1 in any way. NIAID did not provide a press release on the matter and made no comments on the news.
Scientists are troubled by the way Moderna shared its findings. The company said that eight of the 45 subjects in Phase 1 showed positive results, without explaining what happened to the other 37. The company said that four people who received two 25-microgram mRNA-1273 doses and four volunteers who got two 100-microgram doses developed neutralizing antibodies. Testing for the other 37 might not be done, but it’s still unclear why Moderna would only share partial results.
Also, STAT notes that Moderna didn’t reveal the ages of the participants who developed neutralizing antibodies either. The volunteers are aged between 18-55, and age is a risk factor in COVID-19.
As for the neutralizing antibodies remark, that’s also puzzling researchers given the way Moderna phrased it:
At this time, neutralizing antibody data are available only for the first four participants in each of the 25 µg and 100 µg dose level cohorts. Consistent with the binding antibody data, mRNA-1273 vaccination elicited neutralizing antibodies in all eight of these participants, as measured by plaque reduction neutralization (PRNT) assays against live SARS-CoV-2. The levels of neutralizing antibodies at day 43 were at or above levels generally seen in convalescent sera.
“I thought: Generally? What does that mean?” Johns Hopkins University researchers Anna Durbin told STAT. She also noted that it’s unclear if those antibodies are durable, as the data comes from blood samples taken two weeks after the subjects received a second dose.
John “Jack” Rose, a vaccine researcher from Yale University, also pointed out that not all patients who recover from COVID-19 develop neutralizing antibodies. “When a company like Moderna with such incredibly vast resources says they have generated SARS-2 neutralizing antibodies in a human trial, I would really like to see numbers from whatever assay they are using,” he said.
We’ll remind you that researchers are already assessing the immune response of patients and looking at neutralizing antibodies. Hospitals that are using plasma therapy on COVID-19 patients test for antibodies as well. Researchers in New York have developed an antibody test to measure the strength of the immune response, to pick the right donors for plasma therapies.
Morgan Stanley analysts who looked at the most promising vaccine candidates for SARS-CoV-2 acknowledged that more data about neutralizing antibodies is needed to assess the efficacy of those candidates. Such data could arrive from NIAID before vaccine studies are published.
“The convalescent sera levels are not being detailed in our data readout, but would be expected in a downstream full data exposition with NIH, and its academic collaborators,” Moderna’s senior manager for corporate communications told STAT. It’s unclear why Moderna chose to announce these early results to begin with.
Moderna’s stock soared almost 20% to $80 as a result of its announcement on Monday, quadrupling compared to January levels. On Monday, Moderna also announced a public offering of shares of common stock priced at $76 several hours after revealing the preliminary vaccine data. Moderna had to file a regulatory filing a few weeks ago after CEO Stephan Bancel told Goldman Sachs that mRNA-1273 could be ready for emergency use by the fall. Moderna’s stock slipped at the time.
Former Harvard Medical School professor William Haseltine noted in an op-ed for The Washington Post that Moderna’s “publication by press release” is “damaging trust in the fundamental methods of science and medicine at a time when we need it most.”
Haseltine likens Moderna’s announcement with NIH’s remdesivir statement last month, which came without actual supporting data, and the study itself has yet to be published. Also, the promising Oxford COVID-19 vaccine that’s in development was labeled as promising well before the actual data was published in a study. The research showed that the subject monkeys were infected by the virus, as the virus was detected in nasal swabs. Haseltine argues that the positive result reported initially was not “protection from infection at all.” But the virus did not replicate inside the lungs and caused no complications
With all that in mind, Moderna’s news is still good. But there’s no guarantee we’ll ever have a COVID-19 vaccine, no matter how promising the preliminary data looks. More data will be needed to prove that mRNA-1273 is both effective and safe for humans.