On Monday, biotech firm Moderna announced interim data from its Phase 3 clinical trials for its Covid-19 vaccine. The data is encouraging – suggesting the vaccine may be close to 95% effective in preventing Covid-19 infections in vaccinated patients, without any serious safety concerns. The analysis comes from an independent Data Safety Monitoring Board appointed by the National Institutes of Health. The company’s next step is applying for an Emergency Use Authorization for the vaccine from the FDA, which it intends to do in the next few weeks.
This data comes hot on the heels of last week’s announcement from pharmaceutical giant Pfizer, which announced last week that preliminary data for its Covid-19 vaccine showed 90% efficacy against the disease.
Here’s what you need to know.
Moderna’s vaccine is based on a new kind of technology
Moderna’s Covid-19 vaccine is an mRNA vaccine that relies on messenger RNA to deliver instructions to the cells in your body, which then produce small parts of the Covid-19 virus that are just enough to trigger the immune system without getting you sick. “We’ve actually taught a human body to make its own medicine,” Moderna Chief Medical Officer Tal Zaks previously told Forbes. Moderna, which has never yet gotten a vaccine through FDA approval, was working on mRNA vaccines for viruses including Zika virus before the Covid-19 pandemic. But since the pandemic began, the company has thrown all its weight behind its Covid-19 vaccine.
Moderna isn’t the only company using mRNA to its advantage when creating vaccines. Pfizer, which has partnered with German company BioNTech, and Translate Bio, which has partnered with pharma giant Sanofi, are each creating an mRNA vaccine for Covid-19. The benefits of mRNA vaccines is that they are quick to produce, seem to be largely effective, and since they don’t include any of the Covid-19 virus, are unlikely to make people sick with the disease.
The downside is that the technology is still so new that no mRNA vaccine has been approved by the FDA— nor any other global regulatory body. Whether it’s from Pfizer or Moderna, a Covid-19 vaccine will likely be the first time an mRNA vaccine is authorized to distribute to the general population.
Preliminary results suggest mRNA vaccines are very effective
In a press release, Moderna announced that its mRNA vaccine was about 95% effective at preventing Covid-19 in a trial of 30,000 people across the U.S. The actual data from the clinical trial has not yet been released or peer-reviewed, though the company said it plans to do so. In a placebo group, 90 of 95 patients became infected with Covid-19, while only 5 out of 95 who were given the vaccine got infected. No one who was given the vaccine had a severe case of Covid-19, compared to 11 people who got the placebo. That suggests that even if the vaccine doesn’t fully protect you from getting infected, it may prevent the worst forms of the disease.
“When you look at the severe disease, it’s what gets me most excited,” says Moderna CEO Stéphane Bancel. “That’s amazing.”
The outcome is “pretty impressive,” agrees Needham biotech analyst Alan Carr. “There seems to be a pattern with the [Pfizer and Moderna] mRNA vaccines which suggests the technology is pretty helpful for infectious disease.” If the numbers hold up when the vaccine’s released to the general public, that suggests they may be significantly better than seasonal flu vaccines, which typically only have efficacy in the range of 40-60%.
The vaccine still needs to be approved by regulatory authorities
Before any vaccine can be distributed to the public, it first has to be authorized by the appropriate regulatory bodies. To that end, Moderna has said that it plans to submit an application for an Emergency Use Authorization to the Food & Drug Administration “in the coming weeks.” Applications to other regulatory bodies around the world will follow shortly thereafter.
Moderna got a big boost in development cash from the Federal government
As part of the Federal government’s “Operation Warp Speed,” Moderna received nearly $1 billion in support from the Federal government to develop its Covid-19 vaccine, in addition to approval to begin human trials before animal safety testing had completed. That was a big boost to the company, which had posted a net loss of $514 million on revenues of just $60 million last year. (By contrast, Pfizer spent around $1 billion of its own money to develop its vaccine). Moderna has also signed a $1.5 billion agreement with the federal government to purchase 100 million doses of its vaccine once it’s been approved.
If approved, the vaccine should be generally available next year
If the vaccine receives an Emergency Use Authorization from the FDA in the next few weeks, Bancel says that the first doses could be distributed as early as late December of this year. The rollout will be quick because Moderna has already begun manufacturing of the vaccine, and has said that it plans to have 20 million doses by the end of 2020. Next year, the company has said it plans to make between 500 million and 1 billion doses of the vaccine.
However, this doesn’t mean that the average person will be able to get a vaccine next month. Vaccines will most likely be distributed to frontline healthcare workers first, and then people who are most at-risk of severe Covid-19. The exact distribution plans haven’t been disclosed by Moderna or the federal government.
The vaccine faces hurdles in distribution and administration
Moderna’s vaccine still faces a few hurdles. While it doesn’t need to be refrigerated at the ultra-low temperature of Pfizer’s mRNA vaccine (-94° Fahrenheit), it still needs to be kept in long-term storage at -4° Fahrenheit. New data released on Monday, however, says that the vaccine can be kept at normal refrigerator temperatures for up to 30 days, which will make vaccine distribution easier.
While that may not seem like a big deal at first glance, it could potentially benefit Moderna, says William Moss, executive director of the International Vaccine Access Center at Johns Hopkins University. “That’s an important difference between the two vaccines, even though they’re fairly similar in terms of efficacy.”
Another potential issue that could crop up is making sure people get the full dose of the vaccine. Moderna’s vaccine is a two-part injection, with the second dose coming 28 days after the first. While there will eventually be data released about the efficacy of the vaccine after only one dose, Bancel says, right now it is not publicly available.
Finally, the company needs to work with the government to figure out how to efficiently distribute millions of doses of vaccines around the country, and the world. Bancel says that the government is working with McKesson Corporation, which distributes annual flu shots, as well as pharmacies including Walgreens and CVS to develop a plan that will make the vaccine readily available next year.
Other vaccines will be needed to ensure global coverage
Even if Moderna is able to make 1 billion doses of its vaccine in 2021, that won’t come close to covering the world’s susceptible population. Bancel says that no one company will be able to manufacture enough doses on its own, so the success of multiple Covid-19 vaccines is essential. “We need three or four vaccines to make it to the finish line,” he says.
In addition to Moderna and Pfizer, several other companies including AstraZeneca, Johnson & Johnson and Novavax are also in phase three clinical trials. None of these companies have released findings from their trials yet, but preliminary data could come out any day.
It’s not yet clear how often people will need to be vaccinated for Covid-19
There have already been several documented cases of Covid-19 reinfection, though right now this phenomenon seems to be rare. It calls into question, however, how long the immune system can keep memory cells and antibodies that will recognize and fight off SARS-CoV-2, the virus that causes Covid-19. In addition, the virus has already mutated several times, including a new strain recently found to pass from minks to humans in Denmark.
The current Covid-19 vaccine that Moderna is making might not be effective against these new strains, but Bancel is confident that if a new vaccine needs to be made, it can be done in a matter of weeks by using the blueprint of the current vaccine and just swapping out the genetic differences. “mRNA is fantastic because you can just swap a new strain and run with it, so that’s good,” he says.