FDA gives green light to Moderna COVID-19 vaccine
The Food and Drug Administration (FDA) on Friday cleared the nation’s second coronavirus vaccine, giving additional hope that the end of the pandemic could be in sight.
The official emergency use authorization for the Moderna vaccine comes after an agency advisory panel voted 20-0 in favor of the vaccine Thursday.
The authorization now allows the Trump administration to begin shipping nearly 6 million doses of the vaccine across the country.
Once a Centers for Disease Control and Prevention (CDC) panel meets and votes this weekend, vaccinations will be allowed to begin.
Between Moderna and the vaccine from Pfizer/BioNTech that has already been approved, health officials said they expect to deliver enough doses to vaccinate 20 million people with the first dose by the end of the year.
Still, it will be a long time before vaccines are widely available. Even under perfect conditions, the general population likely won’t get vaccinated until late spring or summer. Until then, health officials are warning everyone that the coming months will be dire.
Both the Pfizer and Moderna vaccine require two doses, and officials said they intend to hold back the second dose and ship it to states separately to ensure there’s no waste.
Both vaccines are about 95 percent effective for the general population, although Moderna’s was 86 percent effective for people over age 65.
Moderna’s vaccine is anticipated to create fewer logistical challenges, as it does not require the same ultra-cold storage as Pfizer’s vaccine. It can remain stable for up to 30 days at the same temperature as a standard freezer.
Unlike Pfizer, Moderna’s vaccine was developed with significant federal financial support. The administration’s Operation Warp Speed has invested $4.1 billion into the vaccine’s development and distribution, and the National Institutes of Health helped run clinical trials for the company.
Moderna has also contracted the federal government directly to run the distribution, so the administration will have more control over the logistics than it has with Pfizer. The government has contracted with McKesson, one of the world’s largest wholesale drug distributors, for vaccine distribution.
The vaccine will be shipped from the manufacturer to McKesson distribution sites, and then will be sent out to the 64 different jurisdictions that will receive doses. That approach contrasts with Pfizer, which because of the cold storage requirements, ships its vaccines directly to hospitals and health centers.
The Trump administration signed a deal last summer to deliver a total of 100 million doses of the Moderna vaccine in the first quarter of 2021. Earlier this month, Warp Speed officials announced that the administration had purchased another 100 million doses from Moderna for the second quarter.