US authorizes Moderna as 2nd COVID-19 vaccine
The United States on Friday authorized Moderna's COVID-19 vaccine for emergency use, paving the way for 6 million doses of a second vaccine to soon begin shipping across the hardest-hit country in the world.
Food and Drug Administration chief Stephen Hahn said: "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."
"Congratulations, the Moderna vaccine is now available!" tweeted President Donald Trump.
The US is the first nation to authorize the two-dose regimen from Moderna, now the second vaccine to be deployed in a Western country after the first, developed by Pfizer and BioNTech.
The Pfizer-BioNTech vaccine was approved by Britain on December 2, followed by several other countries including the US last week. Others shots have also been rolled out in China and Russia.
Meharry Medical College President James Hildreth, who was part of a panel of experts convened by the FDA to discuss approval matters, said on Thursday it was a "remarkable achievement" to have developed and authorized the Pfizer and Moderna vaccines within the space of a year.
Together, they offer a glimmer of light at the end of the pandemic's long tunnel.
The United States alone has seen more than 310,000 people die from coronavirus infections and is in the midst of a brutal winter surge, with nearly 115,000 people hospitalized, according to the COVID-19 Tracking Project.
Millions of doses will now start shipping out as early as this weekend from cold-storage sites outside Memphis and Louisville, overseen by logistics firm McKesson.
From there they will be delivered to sites around the country via partnerships with FedEx and UPS.
Cutting-edge technology
Moderna has several other drugs under development, but has never before seen any authorized.
The decade-old, Massachusetts-based biotech company received US$2.5 billion in federal funding for its efforts and co-developed the vaccine with scientists at the National Institutes of Health.
Both the Pfizer and Moderna vaccines are based on cutting-edge mRNA (messenger ribonucleic acid) technology, and both have been shown to be highly effective, protecting about 95 percent of people against COVID-19 compared to a placebo.
They have also been found to have no serious safety issues in clinical trials involving tens of thousands of people each.
The most commonly reported side effects were pain at the injection site, tiredness, headache, muscle pain, chills, joint pain, swollen lymph nodes in the same arm as the injection, nausea and vomiting, and fever.
But there have now been a handful of people around the world who developed significant allergic reactions after receiving the Pfizer vaccine, and the FDA has said it will remain vigilant in its monitoring.
Both vaccines come with warnings for people who have histories of allergic reactions to their ingredients to avoid having them.
