Moderna's COVID-19 Vaccine
On Monday, the pharmaceutical company Moderna (NASDAQ: MRNA) applied to the U.S. Food and Drug Administration (FDA) for emergency-use authorization of its COVID-19 vaccine. Obviously, a COVID-19 vaccine would be phenomenal, especially as the U.S. reports over 13 million coronavirus cases and more than 268,000 coronavirus deaths.
Of course, having a vaccine approved doesn’t mean that it will be an instant fix for this major problem, but it is very good news for the public and for the companies involved in supplying that vaccine. Moderna has requested that the FDA review its expanded data set that indicates its vaccine is 94.1% effective at preventing COVID-19 and 100% effective at preventing severe cases of the disease. Dr. Paul Offit, a member of the FDA’s vaccine advisory committee, said, “This is striking. These are amazing data.”
This might be the optimism that Americans need before the year ends. Dr. Tal Zaks, Moderna’s chief medical officer, said, “It was the first time I allowed myself to cry. We have a full expectation to change the course of this pandemic.”
Moderna isn’t the first company to apply to the FDA for emergency-use authorization for a coronavirus vaccine. Pfizer applied on November 20, with data similar to Moderna's. Director of the National Institute of Allergy and Infectious Diseases Dr. Anthony Fauci said that the first vaccinations in the U.S. are expected to take place “towards the latter part of December.” Moderna also mentioned on Monday that it had plans to apply for authorization from the European Medicines Agency.
COVID-19 cases and deaths in the U.S. are expected to rise in the next few weeks since a lot of Americans chose to travel during the U.S. Thanksgiving holiday despite warnings from top health care experts and scientists. The outlook for the virus's spread continues to be extremely grim. Back in July, Moderna gave 30,000 Americans in its clinical trial the vaccine or a placebo (a shot of saline). Of those 30,000 people, about half received the vaccine and the other half received the placebo.
Of the people who received the vaccine, only 11 developed COVID-19, and none of them became severely ill. Of the ones who received the placebo, about 185 developed COVID-19, and 30 of those 185 people became severely ill. Unfortunately, one died. All of this amounts to data that indicate a 94.1% efficacy for Moderna’s vaccine, which uses messenger RNA to elicit an immune response in the human body. The vaccine is given in two doses a few weeks apart. Its side effects can include fever or body aches for a few days.
The FDA's Vaccines and Related Biological Products Advisory Committee will meet on December 17 to review Moderna’s application. There’s a lot that the FDA will need to take into consideration, like why people who were given the vaccine were still able to get the virus. What were the circumstances or characteristics that made those people more susceptible to the virus even though they received the vaccine?
While those details get ironed out, Moderna is expecting to have about 20 million doses of the vaccine available in the U.S. by the end of 2020. It plans to be on track to manufacture 500 million to 1 billion doses globally next year. Dr. Zaks said:
The magnitude of this achievement and the implications of what it means to what’s ahead of us in the context of what’s going on around us is — it’s just overwhelming emotionally.
This vaccine is groundbreaking, and it’s a major milestone for a company that went public almost two years ago (December 7, 2018). Not often do companies like Moderna get a product to market at the rate that it’s been working to get the COVID-19 vaccine to market. Without a doubt, the company stepped up in a big way, spending long hours and working hard to develop this crucial vaccine. Moderna's ability to produce a vaccine in record time gives its management and investors the confidence that it can explore treatments for other diseases — like cancer and autoimmune disorders — in the same manner.
This won’t be the last time you hear from Moderna.
Until next time,