Moderna expects to have enough safety data on its COVID-19 vaccine to file for emergency use authorization from the FDA in a matter of weeks
As the coronavirus continues its deadly surge in the U.S., breaking daily case records and prompting new lockdowns all over the country, there is some good news on the horizon: Drugmaker Moderna just announced the earliest results from its large-scale clinical trial of an experimental COVID-19 vaccine and says the vaccine is 94.5 percent effective.
This news comes just days after another pharmaceutical company, Pfizer, announced that preliminary data showed its vaccine was 90 percent effective. While there are still many hurdles to overcome before either vaccine can be widely distributed to the public, scientists are cautiously optimistic that these vaccines could bring an end to the pandemic in 2021.
We just announced that mRNA-1273, our COVID-19 vaccine candidate, has met its primary efficacy endpoint in the first interim analysis of the Phase 3 COVE study.
Read more: https://t.co/vYWEy8CKCv pic.twitter.com/YuLubU1tlx
— Moderna (@moderna_tx) November 16, 2020
Moderna Chief Executive Stephane Bancel said in a statement that the results showed “the first clinical validation that our vaccine can prevent Covid-19 disease, including severe disease.” Moderna President Stephen Hoge told Reuters, “We are going to have a vaccine that can stop COVID-19.”
The company still doesn’t have all the safety data required by the FDA to apply for emergency use authorization, but expects to in the next week or so. According to Reuters, the company could seek an EUA by the end of the month. If both Moderna and Pfizer receive emergency use authorization, the U.S. could have two vaccines available before the end of the year. The two companies have said they can produce a combined 60 million doses by January.
More good news on the vaccine front. Moderna's vaccine shows similar efficacy as Pfizer's, and a longer shelf-life at refrigerated temperatures. Small caps rip higher. pic.twitter.com/tbiE7RgdGD
— Lisa Abramowicz (@lisaabramowicz1) November 16, 2020
Both companies announced the results of their studies in press releases. The data hasn’t been peer-reviewed, so it can’t be considered conclusive. Still, Dr. Anthony Fauci, the nation’s leading expert on infectious disease, hasn’t been very able to hide his excitement about all the recent COVID-19 vaccine development news.
“I had been saying I would be satisfied with a 75 percent effective vaccine,” he told the New York Times. Aspirationally, you would like to see 90, 95 percent, but I wasn’t expecting it. I thought we’d be good, but 94.5 percent is very impressive.”
"Doses could be available to high-risk individuals by the end of December," says Dr Fauci of Covid vaccine. "The data are striking, really quite impressive" He doesn't want to get ahead of the FDA – but believes it's likely Moderna will get emergency use authorization
— Chris Jansing (@ChrisJansing) November 16, 2020
What’s even better news is that having two COVID-19 vaccines with high effectiveness proves their development concept for other drugmakers to follow suit.
“The fact that two different vaccines made by two different companies with two different kinds of structures, in a new messenger RNA concept, both worked so effectively confirms the concept once and for all that this is a viable strategy not only for COVID but for future infectious disease threats,” Dr. Barry R. Bloom, a public health professor at Harvard University, told the New York Times.
While this is good news, it does not mean the COVID-19 pandemic is over. No vaccine is likely to be widely available until at least the spring, and for now, we all need to continue to wear our masks, social distance, and do our part to slow the spread and save lives.