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Law360 (December 17, 2020, 10:25 PM EST ) Moderna's COVID-19 vaccine moved one step closer to obtaining U.S. regulatory approval on Thursday after the U.S. Food and Drug Administration's independent advisory committee found that the vaccine candidate's benefits outweigh its risks for those 18 and older.
At the end of an eight-hour meeting in which the panelists discussed the two-dose vaccine's clinical trial data, 20 panelists voted in favor of the mNRA vaccine candidate, dubbed mRNA-1273, while one panelist abstained and no one voted against it.
The panel based its recommendation on data from Moderna's phase 3 clinical trial, which enrolled more than 30,000 participants in the U.S. who were given either a placebo or the vaccine.
The results of the trial showed the vaccine had a 94.1% efficacy rate, with the most common adverse reactions being pain at the injection site, erythema, swelling, enlarged lymph nodes and a higher rate of severe reactions after the second dose, according to Moderna. Moderna plans to continue to monitor all clinical trial participants for two years.
After the vote, Moderna CEO Stéphane Bancel said in a statement that the Cambridge, Massachusetts-based company is working with the U.S. Centers for Disease Control and Prevention and the federal Operation Warp Speed initiative to prepare for the vaccine's distribution if the FDA signs off on its emergency use.
"We look forward to getting our vaccine to people in the U.S. to help address this ongoing public health emergency," Bancel said.
If approved, Moderna's vaccine candidate would be the second to obtain emergency approval from the FDA. Pfizer and BioNTech's vaccine, called BNT162b2, received emergency FDA approval earlier this month, a day after an independent panel recommended their vaccine, and the U.K.-based AstraZeneca PLC is currently seeking regulatory approval of its vaccine, which it says is 90% effective, in multiple countries.
Although obtaining regulatory approval is a major milestone for the pharmaceutical companies, vaccine distribution poses another challenge, particularly because both Moderna and Pfizer's vaccines use mRNA technology, which relies on a synthetic version of messenger RNA to create proteins that mimic the virus that causes COVID-19, and as a result, they need to be kept cold.
On Thursday, Moderna updated its guidance for handling its vaccine, saying the vaccine can be kept at refrigerator temperatures for up to 30 days, as opposed to the sub-zero temperatures that Pfizer and BioNTech's vaccine requires.
"Recognizing that shipping and handling of [a] product can be a barrier to vaccination, Moderna remains committed to supporting efficient distribution," Moderna said in a statement.
For its part, Pfizer has said the company has "vast experience and expertise" with shipping vaccines similar to BNT162b2, and that it has distribution hubs around the world that can store doses for up to six months.
Meanwhile, AstraZeneca's vaccine, AZD1222, was developed in partnership with the University of Oxford and doesn't use mRNA technology and instead came out of decades of research on adenovirus-based vaccines that are being developed to treat HIV, the Ebola virus and the influenza virus, according to the drugmaker. As a result, it doesn't need to be stored in freezing temperatures.
If approved, AstraZeneca expects to be able to produce up to 3 billion doses in 2021.
Since Pfizer and BioNTech's vaccine was approved for emergency use, Pfizer has begun distributing millions of doses of the vaccine to health care workers, who are first in line. The federal government has said it plans to ship 2.9 million doses within hours of regulatory approval.
Pfizer reportedly has 6.4 million doses on hand for distribution in the U.S. and the company said it's entered a supply deal with the European Union for 200 million doses, with an option for supplying an additional 100 million doses to the EU.
Moderna also recently announced that it has entered a supply agreement with the U.K. to begin distribution in March, pending the vaccine's approval, adding that it's ramping up production to be able to deliver roughly 500 million doses per year and possibly up to 1 billion doses per year starting in 2021.
The race to develop a COVID-19 vaccine and secure regulatory approval comes as the U.S. and other nations around the world are experiencing unprecedented spikes in the number of new coronavirus cases reported daily.
As of Thursday, the U.S. had reported a total of 16.8 million confirmed cases and more than 306,400 deaths due to the virus since January, with more than 1.49 million new COVID-19 cases reported in the U.S. over the past seven days, according to the CDC.
--Additional reporting by Dani Kass, Kevin Stawicki and Hailey Konnath. Editing by Jay Jackson Jr.
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