Moderna’s stock jumped today upon great news from the vaccine front. The biotech company just released its first results from an early trial of its COVID-19 vaccine. The results were overwhelmingly positive, with all participants developing antibodies against the coronavirus. The vaccine candidate will now enter a larger scale trial to prove its safety. At this point, both Moderna and Pfizer have entered the next stage of the race.
A Great Day For Investors
In premarket trading this Wednesday, Moderna’s stock surged 17%. The newly-released report confirms claims the company made in May that it had a promising candidate. After weeks of speculation and rumors that the trial would be delayed, Moderna officially announced its great news. Now, stocks are up almost 7% (of $5.18) to $80.22.
Moderna’s Early Trial
The trial involved 45 participants. Each received one of three dosages of the vaccine, called mRNA-1273. The test subjects were all between 18 and 55 years of age. 15 participants received a low dose of 25 micrograms (µg), 15 received a medium dose of 100 µg, and 15 participants received a high dose of 250 µg. Doses were administered via injection.
All participants ended up developing neutralizing antibodies. Neutralizing antibodies work by binding to structures on the edges of an infectious particle. Then, with these structures blocked, the infectious particle can no longer bind to or infect any host cells. Participants actually displayed higher levels of such antibodies than people who had suffered from COVID-19 and recovered. In short, the vaccine looks like a success.
As with Pfizer’s candidate, Moderna’s vaccine caused some side effects. More than half of participants experienced fatigue, headache, chills, and aching at the injection site. But these are all common side-effects of the annual flu shot. Additionally, the high dosage triggered a severe fever in some participants, a symptom also present in the Pfizer trial.
In fact, one participant from Moderna’s high dose group developed a fever of 103 degrees Fahrenheit. The dangerously high temperature was accompanied by nausea, lightheadedness, and fainting. However, the fever broke within a day and a half.
Moving Into Phase 2 Trial
Moderna will not be including the highest dose in its next two trials. Because the drug was shown to be effective at the lower doses, there is no need to include the dose that causes severe side effects. Researchers say Phase 2 will include doses of 50 µg and 100 µg, and the Phase 3 trial will only examine a 100-µg dose.
Moderna will launch the larger trial starting July 27th. This trial will include 30,000 participants, by far the largest sample size yet. It will hopefully prove the safety and efficacy of the drug.
Even before publishing these data, Moderna had already announced it had found a winning candidate. President Stephen Hoge also said in a statement that a vaccine could be available for emergency use if the government allows:
“If we and others build data that show that the vaccine has a potential for benefit, that it’s safe and has a potential for efficacy, then, of course, there are circumstances where the vaccine could be deployed to high-risk populations earlier under something called an Emergency Use Authorization. Really though, that’s a decision that regulators, in particular the FDA, have to make.”
The Race for a Vaccine
The race is narrowing, as only a week ago Pfizer released similar findings. On Monday, Pfizer, Inc. and its collaborator, BioNTech SE, announced that the Food and Drug Administration (FDA) had given two of their COVID-19 vaccine candidates the “fast-track” designation. This means the FDA will decide on approval within 6 months. The U.S. health agency will likely grant the fast-track to Moderna as well.
Meanwhile, British-Swedish biotech firm AstraZeneca released its own positive results this week. With similar designs and results for all the vaccines, competition is heating up.
At this point, the coronavirus has claimed around 580,000 lives. The companies are not only racing each other, but also the growing number of cases. Moderna leadership has said it is working around the clock, as each day wasted equals thousands of new deaths.