By We’re getting more information about one of the world’s most anticipated vaccines for COVID-19. The biotech company Moderna recently announced that its vaccine has shown to be 94.1% effective in preventing new transmissions of the deadly virus and 100% effective at preventing serious illness.
Out of a 30,000-person clinical trial, just 11 people developed mild flu-like symptoms after receiving the drug, compared to 185 people in the placebo group. Meanwhile, no one that received the drug developed serious symptoms. The vaccine appears to be working regardless of the person’s age, background, or medical history.
With this new data, the company is getting ready to submit its findings to the Food and Drug Administration for review. If it gets the green light, we could see doses ready to administer in just a few weeks.
On Track for Success
Moderna is doubling down on the fact that its vaccine is working as expected. When the company first made the announcement several weeks ago, it released an interim report that only analyzed 95 cases. New patient safety information expands our understanding of how the drug will work in clinical settings.
Of those in the clinical trial, just 11 people developed mild symptoms, and no one came down with serious illness after receiving the drug and being exposed to the virus. Meanwhile, 30 people developed serious symptoms in the placebo group.
The company was adamant about including as many different types of people in the clinical trial as possible. They say the drug appears to be equally effective across different genders and ethnicities.
Of the 30,000 participants, more than 7,000 were over the age of 65, and 5,000 were under that age, but had preexisting conditions such as diabetes and hypertension that put them at a greater risk of developing serious illness after being exposed to COVID-19.
The study also included 11,000 people of color. The virus has disproportionately affected black and brown Americans; convincing communities of color to take the drug will be vital in the months ahead.
What Happens Next?
Moderna is using this information to shore up support from providers, patients, and the federal government. The company is expected to submit its findings to the FDA in the coming weeks in hopes of receiving an Emergency Use Authorization (EUA).
The pharmaceutical giant Pfizer is in the process of applying for an EUA for its coronavirus vaccine as well, which has shown to be 90% effective in preventing new infections. It submitted a request for an emergency use authorization to the FDA last week.
The government agency announced its vaccine advisory committee will convene on December 10th to discuss the drug. With Moderna reporting similar levels of success, the committee could meet again as soon as Dec. 17th to discuss that company’s drug as well. Once the committee schedules a session, it could approve the drug within 48 to 72 hours, according to Moderna CEO Stéphane Bancel. The company is also looking to get approval from the European Medicines Agency.
Bancel says the safety information should compel the FDA to approve the drug, so those most at risk can get vaccinated as soon as possible. “Give it to healthcare workers, give it to the elderly, give it to people with diabetes, overweight, heart disease,” he said.
The FDA’s vaccine advisory committee is made up of independent professionals across the healthcare industry, including epidemiologists and infectious disease experts. They advise the FDA and CDC in terms of prioritizing certain vaccines, but individual states will need to come up with their own guidelines in terms of distributing the drug. The government recently announced that vaccines will be distributed to the states based on population, not perceived risk.
That means rural states like South Dakota, Idaho, and Iowa will receive fewer doses than major population centers like New York and California, regardless of how many new cases have just been reported.
“I would still like to see all of the actual data, but what we’ve seen so far is absolutely remarkable,” says Paul Offit, a vaccine researcher at the Children’s Hospital of Philadelphia, who is also a member of the FDA’s vaccine advisory committee.
Once approved, Moderna plans to sell the drug for $32 to $37 per dose in developed countries like the U.S. and Europe. It will distribute the drug in developing countries at a lower price. “We want to have this vaccine available at a tiered price for low-income countries,” Bancel added.
The company hopes to release around 20 million doses in the U.S. by the end of the year.
With multiple vaccines in the running, experts say each one will serve its purpose, assuming they are all approved by the FDA. Some drugs may be better suited for use in large hospitals, while others that are easier to transport will likely be used in rural areas.
CEO Bancel agrees that it’s best to have as many working drugs on the market as possible, so the burden doesn’t lay on a single company. “The world needs several manufacturers to make it to the finish line to stop this awful pandemic,” he added.
