FDA authorises Moderna’s COVID vaccine for emergency use

The United States Food and Drug Administration (FDA) has approved Moderna Inc’s COVID-19 vaccine for emergency use, paving the way for millions of doses to be shipped across the country as early as this weekend.

The FDA’s announcement on Friday came a day after a committee of outside experts endorsed the Moderna vaccine’s use across the US, saying its benefits outweigh any potential risks in people aged 18 and older.

The move marked the world’s first authorisation for the vaccine from Moderna, a small company based in Massachusetts – and the second COVID-19 vaccine authorisation in the US, after the FDA approved the Pfizer-BioNTech vaccine last week.

“With the availability of two vaccines now for the prevention of COVID-19, the FDA has taken another crucial step in the fight against this global pandemic that is causing vast numbers of hospitalizations and deaths in the United States each day,” FDA Commissioner Stephen M Hahn said in a statement.

Moderna has about 5.9 million doses ready for shipment set to begin during the weekend, according to Operation Warp Speed, the US government’s vaccine development programme.

Healthcare workers and nursing home residents are expected to be inoculated next week, before other essential workers and vulnerable groups have access to the vaccine.

“Authorization of Moderna’s vaccine means we can accelerate the vaccination of frontline healthcare workers and Americans in long-term-care facilities, and, ultimately, bring a faster end to this pandemic,” US Health and Human Services Secretary Alex Azar said in a statement.

First inoculations next week

Al Jazeera’s Kimberly Halkett, reporting from Washington, DC, said the first Moderna vaccines are expected to be administered on Monday.

While there is still a long way to go before most Americans will be inoculated, Halkett said the Moderna vaccine’s authorisation is “a hopeful sign at a time when Americans need it”, as COVID-19 is surging across the country.

Moderna’s vaccine is similar to the one from Pfizer-BioNTech that is now being dispensed to healthcare workers and nursing home residents across the US.

The two work “better than we almost dared to hope”, National Institutes of Health Director Dr Francis Collins told The Associated Press news agency. “Science is working here; science has done something amazing,” Collins said.

Early results of large, still-unfinished studies show both vaccines appear safe and strongly protective although Moderna’s is easier to handle since it does not need to be stored at ultra-low temperatures.

Wafaa El-Sadr, a professor of epidemiology and medicine at Columbia University in New York, said that requirement has meant that the Pfizer-BioNTech vaccine must be restricted to areas that have the necessary infrastructure to store it at those temperatures.

But the Moderna and Pfizer-BioNTech vaccines are similar in several ways, El-Sadr said.

“They’re similar in that they both use the same technology, the same approach to making he vaccine. They both require two doses,” El-Sadr told Al Jazeera, adding that the vaccines are also both about 94 to 95 percent effective.

“These two vaccines work incredibly well,” she said.

Moderna has said it plans to deliver approximately 20 million doses to the US government this year, and it has deals to provide the US with a total of 200 million doses by the end of June 2021.

Virus surging

The US has reported more than 17.4 million COVID-19 cases since the pandemic began and more than 313,000 deaths linked to the novel coronavirus.

Hospitals across the country are stretched to their limits as infections have surged during the second wave, when colder weather is pushing people indoors where the virus can spread more easily.

Health officials are hoping that the COVID-19 vaccine roll-out can help bring the pandemic under control – and top US officials, including Vice President Mike Pence, have publicly received COVID-19 vaccines in an effort to convince Americans that they are safe.

The FDA’s decision also could help pave the way for other countries that are considering the Moderna vaccine. European regulators could authorise its use as soon as January 6.

The United Kingdom, Canada and a few other countries already have cleared the Pfizer-BioNTech shot for use, with a European Union decision due on Monday.