The U.S. Food and Drug Administration granted emergency use authorization (EUA) to a coronavirus vaccine from Massachusetts pharmaceutical giant Moderna on Friday, making it the second official American inoculation against the coronavirus pandemic.
The move came after an expert FDA panel voted to endorse the vaccine, called mRNA-1273, on Thursday—one day after the United States shattered virus records with nearly a quarter million new cases and more than 3,600 deaths. To date, more than 300,000 Americans have died from COVID-19 and about 17 million more have been infected.
The much-anticipated emergency-use authorization, which is not the same as full FDA approval, clears the way for a second COVID-19 vaccine to be rolled out to vulnerable populations and frontline workers. The United States has already agreed to purchase 200 million Moderna doses and millions were said to be ready to ship, with federal officials suggesting distribution could start within 24 hours.
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Hospitals and other vaccination sites could start using the Moderna vaccine, previously deemed “highly effective” and safe by career scientists at the FDA, as soon as Monday. And it could quickly fill a massive hole in the emerging national immunization project.
“One of the big things that is really exciting about the Moderna vaccine is that the cold-storage requirements are a lot easier to actually meet across the country than the Pfizer vaccine,” Maimuna Majumder, an epidemiologist at Boston Children’s Hospital and Harvard Medical School, told The Daily Beast.
While a Pfizer vaccine OK’d by the feds last week breaks down at temperatures warmer than about -100 degrees Fahrenheit and must be stored in special freezers, the Moderna vaccine does not require the same level of cold storage—making it more accessible to more rural communities and small facilities.
“My first instinct and biggest concern with the Pfizer vaccine has been the ultra-cold storage issue [which raises] serious concerns about exacerbating health disparities,” Majumder said, noting that areas that can’t afford cold storage are often the places that have been neglected in terms of other health resources and needs.
Earlier this week, the FDA released its analysis of the Moderna vaccine, concluding that the immunization was about 94 percent effective and had a “favorable safety profile" that raised "no specific safety concerns identified that would preclude issuance of an EUA.” The emergency-use authorization green-lit the vaccine for individuals 18 years and older—unlike its predecessor, which has been approved for people as young as 16.
On Dec. 11, Pfizer was the first pharmaceutical company to win emergency-use authorization for a fully tested COVID-19 vaccine in the United States. Like Pfizer’s, the Moderna vaccine is based on “messenger-RNA” (MRNA) technology that has proven very effective in trials, but is being rolled out to the wider public for the first time.
Also like Pfizer’s, the new vaccine requires two doses, though Moderna’s is administered as two 100-microgram shots 28 days apart. Pfizer’s vaccine, on the other hand, is administered as two 30-microgram doses about 21 days apart.
“Even though they’re both messenger RNA vaccines, they’re really different messenger RNA molecules, they have different so-called lipid delivery systems, meaning the sort of fatty droplet in which the messenger RNA is located,” Dr. Paul Offit, a member of the FDA's vaccine advisory committee, told CNN on Monday. “That’s why they have different storage and handling characteristics.”
Established in 2010, the Massachusetts biotech company has never gotten any of its vaccine candidates authorized for use by the FDA. Additionally, it had also never brought a product to phase three of a clinical trial
The vaccine’s apparent success, however, must be attributed at least in part to the company’s collaboration with the National Institute of Allergy and Infectious Diseases and support from the U.S. Biomedical Advance Research and Development Authority.
In March, the FDA green-lit Moderna’s request for COVID-19 vaccine clinical trials—making them the first out the gate. Through its vaccine partnership with the federal government, Moderna also received nearly $1 billion in research funding. Four months later, on July 27, the biotech company started its advanced stage clinical trial and was the first government-funded Phase 3 trial for the coronavirus vaccine.
In the trial, about 15,000 participants were given a placebo—or a shot of saline with no medical effect—and another 15,000 were given the vaccine. Out of the placebo test group, 185 participants were diagnosed with COVID-19 and one died. Of those who received the vaccine, 11 developed COVID-19 and none experienced severe forms of the virus.
The trial also concluded the vaccine was effective across age, racial, and ethnic groups—and genders—according to the FDA briefing document.
The hope among experts was that the vaccination program, which includes other not-yet-authorized candidates like one from Oxford and AstraZeneca, would steadily gain steam, easing supply-chain and other problems. Multiple states reported receiving less of the Pfizer vaccine than originally anticipated this week, though whether that was because they were not available or because of federal logistical problems was not clear.
“Maximizing dose counts is a really big issue right now,” Majumder said. “We want to make sure there is enough vaccine for people who want it… When you distribute the labor a bit, it definitely leaves me feeling a bit more confident.”
Majumder also noted that scientists were excited to learn how vaccine candidates do with transmission—that is, whether immunized people can be carriers even if they do not have symptoms. From that perspective, more candidates rolling out to the public was an added bonus beyond just increasing the number of vaccinated people.
“Every vaccine that’s approved for emergency use in the coming months, I expect it’s not just these two… they’ll be big deals for different reasons,” she said.
