Two of the most watched COVID-19 vaccine trials have already brought some very (very) early results, which is raising hopes that a vaccine genuinely might arrive sooner rather than later. This comes on the heels of a study from South Korea that makes it more likely that a vaccine can be effective. It’s still not absolutely certain that having antibodies to the SARS-CoV-2 virus results in immunity to developing COVID-19. That evidence is unlikely to come until there are more long-term studies of COVID-19 survivors as well as the first results from human subjects in early vaccine trials. However, as of Monday there are two results to examine—one of which is hopeful. The other … less so.
Meanwhile, a team in China has announced that it’s working on something that’s not a COVID-19 vaccine. It’s a COVID-19 “cure.”
The last thing I wrote before heading for the virtual door for a two-week vacation laying floors and mending deck boards was an article on the prospect of vaccines and treatments for COVID-19. But that article only touched on a fraction of the over 80 efforts underway to develop a vaccine, which are taking place on every continent. (Except Antarctica. As far as I’m aware, the penguins are staying out of the race.)
Some of the vaccines under development are still in stealth mode. Some—particularly at least five in development by Chinese firms—are getting little attention in the West. Others—like the vaccine underway from Biontech/Pfizer—already have a commitment to go into production well before the first test results are in.
But of all the vaccines in development, the two that have been media stars up to this point are one coming from nine-year-old U.S. biotech firm Moderna and one being developed under the leadership of Oxford University in the U.K. Both of these vaccines have already done a hyperspeed pass through animal testing. Both of them have already been injected in humans. And this week saw the first reported results.
The information released in a call on Monday afternoon, concerned Moderna’s phase 1 testing. Moderna’s approach is a break from traditional vaccine development in that they are using mRNA (messenger RNA) fragments delivered in specially created liposome spheres. No vaccine of this type has ever been approved for use in humans—not for COVID-19, not for anything. If Moderna’s vaccine is successful, it will not only provide a tool against a devastating disease, it will validate an entirely new approach—one that might be easily adaptable to the next disease, and the one after that. That’s if it works and if it doesn’t have serious side effects. This is a high-risk, big-money gamble on the part of those backing the company.
The first group of people to test Moderna’s vaccine are 45 healthy volunteers between the ages of 18 and 55. The main points of this phase of the test were simple enough: to see whether Moderna’s vaccine would actually generate antibodies, and to start the process of determining the proper dose.
The information Moderna released on Monday was limited. Volunteers received one of three dosages: 25 milligrams, 100 milligrams, or 250 milligrams. The information that was released covered the first four patients in the 25 milligram and 100 milligram groups. Moderna reports that all eight developed “neutralizing antibodies at day 43” that were at or above levels seen in patients recovering from COVID-19. The only side effect noted in this group was one case of redness around the injection site from someone in the 100 milligram group. Earlier, Moderna reported that three volunteers who received the highest dosage (250 mg) reported flu-like symptoms. Going forward into phase 2, Moderna will test 50 milligram and 100 milligram doses.
Considering the stakes for Moderna, it’s not surprising that they rushed to report on these results as soon as the very first numbers were in. Considering the state of the world, it might have been nice to at least wait until results were in for the whole phase 1 group.
Meanwhile, across the pond, first results for the Oxford vaccine are not yet available. That vaccine was the subject of a great deal of hope two weeks ago as the U.K. government announced the beginning of large-scale human trials. However, the university has released more information on the animal trials that were conducted in the last two months, and a second look at those results is making that vaccine seem less than perfectly effective.
In tests on macaque monkeys, it appeared that the vaccine did prevent the test subjects from developing severe symptoms. However, it didn’t appear to block the virus from infecting the monkeys. Swab tests of animals with and without the vaccine suggested similar viral loads. It seems possible that, unlike people who have recovered from COVID-19, those receiving the Oxford vaccine might still be infected, and might still act as a vector for the disease. It’s also unclear whether the vaccine would actually provide protection against serious illness in humans.
Both sets of results are very early. Both sets involve very small sets of volunteers (and not so voluntary monkeys). Do not be surprised if additional results emerge in the next week suggesting contradictory outcomes. This is, after all, a moment of intense opportunity, scrutiny, and pressure. Also expect to see early results being trumpeted by other groups.
Meanwhile in China, Peking University has announced something that’s very much not a vaccine. In an article in the scientific journal Cell, the team there has bypassed the whole giving people a vaccine thing to generate the development of neutralizing antibodies phase. They’ve just filled up a syringe with … neutralizing antibodies. This is essentially the same treatment being used when people receive plasma from recovered patients, but distilled down into a concentrated form. Like plasma treatment, the drug can reportedly confer short-term immunity to SARS-CoV-2. However, the larger use might be as a treatment for those seriously ill with COVID-19.
The particular antibody at the heart of the study, BD-368-2, appears particularly effective at blocking COVID-19. However, it’s unclear whether the researchers can yet produce the antibody in the quantities needed without extracting it from recovering patients. The primary focus of the article is not on BD-368-2 as a treatment, but on how the team used a new technique to rapidly identify and isolate the antibodies to SARS-CoV-2.
Even so, the team states they hope to have millions of doses on hand for a potential second wave next winter. At the moment, this COVID-19 “cure” remains more theoretical than practical, but that could change quickly. Everything else is.