05/21/2020 / By Franz Walker
On Wednesday, one of America’s top scientists said that the government shouldn’t count on a successful vaccine against the Wuhan coronavirus (COVID-19) being developed anytime soon when making a decision on easing restrictions. The statements by Dr. William Haseltine come after Moderna claimed to have made great strides in developing a vaccine against COVID-19.
Dr. Haseltine, a former professor at the Harvard Medical School, renowned for his groundbreaking work on HIV and the human genome, stated that the better approach to the pandemic would be to manage the disease through careful contact tracing and strict isolation measures when it starts spreading.
While a COVID-19 vaccine could eventually be developed, Haseltine said, “I wouldn’t count on it.”
Haseltine’s statements come after Moderna announced Monday that their COVID-19 candidate — the frontrunner in the U.S. market — seemed to be generating favorable immune responses in Phase 1 trial subjects. (Related: Trump pushes for an accelerated, risky vaccine “by the end of the year,” then says coronavirus will “go away without a vaccine.”)
The seemingly positive news caused the company’s stock valuation to surge, hitting $29 billion. This is an astonishing feat for a company that currently has no products on the market.
However, Moderna’s announcement presented little in the way of actual data. Even what figures the company did release didn’t mean much on their own as other bits of critical information necessary for interpreting this data was withheld.
Moderna’s statement led with the fact that all 45 test subjects who received doses of 35 micrograms, 100 micrograms or 250 micrograms of the vaccine candidate developed binding antibodies. However, their statement later indicated that only eight volunteers — four who received 25 micrograms and four who received 100 micrograms — developed neutralizing antibodies. The data lacks information on the results from the other 37 volunteers.
Neutralizing antibodies are the ones that scientists are hoping to see in these tests — they’re the ones that indicate a subject may be developing immunity. However, testing for these is more time-consuming and needs to be done in specialized laboratories.
In addition, while the report did state that the volunteers were between 18 and 55 years old, it did not state the exact ages of the volunteers who developed neutralizing antibodies.
Haseltine had some less than kind words to share when reflecting on the data, or lack of it, in Moderna’s press release when talking to CNBC Wednesday.
“If a CFO had tried to get away with such an opaque and data-less statement it would have bee treated with derision and possibly an investigation,” he stated.
“We all know it’s an emergency, and in an emergency it’s even more important to be clear on what you know and what you do not know,” he added, pointing out the importance of having exact information at this time.
In addition, Haseltine also expressed disappointment at Dr. Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases, calling the results “encouraging.”
“Whether [Fauci] shaded what should have been done, I think is an important question,” he said. “He’s obviously under enormous pressure for positive results but it was not the right thing to do if you can’t see the data.”
Haseltine isn’t the only scientist who has raised questions about Moderna’s vaccine, or COVID-19 vaccines in general. In a recent article, STAT talked to a number of scientists who also called elements of Moderna’s report into question.
Anna Durbin, a vaccine researcher at Johns Hopkins University, questioned the durability of the neutralizing antibodies detected in the subjects. She pointed out that the blood samples from the volunteers had been taken only two weeks after they received their second dose of the vaccine candidate.
“That’s very early. We don’t know if those antibodies are durable,” stated Durbin.
Others have questioned whether the amount of antibodies produced is actually enough to stave off the coronavirus. Moderna claims that the antibody levels they saw were on par or greater than those seen in people who have recovered from COVID-19.
However, studies have shown that antibody levels in people who have recovered from the disease can vary greatly. Yale University researcher John “Jack” Rose pointed to a study from China that shows that, among 175 recovered COVID-19 patients, 10 had no detectable neutralizing antibodies. Meanwhile, others on the opposite end had really high antibody levels.
Though Moderna claims that the antibody levels produced by their vaccine candidate were as high as those produced by the infection, there’s no real way to know what exactly that comparison means.
When questioned about their information by STAT, Moderna claimed that they would release the full data in the future in an eventual journal article from the National Institute of Allergy and Infectious Diseases. However, this reply seemed to raise more questions.
“My guess is that their numbers are marginal or they would say more,” said Rose.
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