Over the weekend, the U.S. Food and Drug Administration authorized emergency use of the Moderna COVID-19 vaccine.
Approval followed the FDA’s endorsement.
As of December 18, the U.S. government had ordered 200 million doses, of which 20 million are expected to be delivered by the end of the month. The U.S. has the option to buy an additional 300 million doses.
“It has been a 10-year scientific, entrepreneurial and medical journey and I am thankful to all those who have helped us get here today,” Moderna CEO Stephane Bancel said. “We remain focused on scaling up manufacturing to help us protect as many people as we can from this terrible disease.”
The vaccine itself, from sequence to authorization, took 11 months. Moderna plans to have between 100 and 125 million doses globally available in the first three months of next year, with a majority designated to the U.S.
The Moderna vaccine is recommended for people ages 18 and up. Like the Pfizer vaccine, it is administered in two doses, one month apart. Side effects, such as pain at the injection site or tiredness, were more likely to occur after the second dose, but can happen after either dose. Among Moderna’s clinical trial of nearly 30,000 participants, about half of whom received a placebo, the vaccine was 94.1 percent effective in preventing COVID-19.
“Through the FDA’s open and transparent scientific review process, two COVID-19 vaccines have been authorized in an expedited time frame while adhering to the rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization that the American people have come to expect from the FDA,” FDA Commissioner Stephen M. Hahn said.
The FDA recommends to not get the vaccine if you have had a severe allergic reaction to any of the vaccine’s ingredients (see here) or if you had a severe allergic reaction to the first dose. Before receiving the vaccine, you should have a discussion with your provider if you have any allergies, a fever, a bleeding disorder or received another COVID-19 vaccine, are on a blood thinner, are immunocompromised, are pregnant or planning to be or are breastfeeding. Such conditions do not necessarily mean you should not be vaccinated.
A take-home COIVD-19 test was approved.
Given that wide distribution of either the Pfizer or Moderna vaccine will take some time, it is also important to note the FDA recently approved the first over-the-counter, take-home COVID-19 test. The test received an emergency use authorization by the FDA on December 15.
The Ellume COVID-19 Home Test runs a liquid sample to detect proteins of the SARS-CoV-2 virus via a nasal swab sample. It can be used by any individual age 2 and up. The test is partnered with a smartphone application, which delivers the final results in as little as 20 minutes and sends it to public health authorities to monitor disease prevalence. Ellume is set on producing over 3 million tests next month and will be available in drugstores.
Stimulus relief on the horizon
Looking at the pandemic’s financial implications, Congress leaders finally agreed on a new COVID-19 relief bill last night. The $900 billion aid package will move to the House today and is expected to reach the Senate for final approval by tonight. It includes direct stimulus payments of up to $600, $300 per week for enhanced unemployment benefits, $82 billion for education providers and $25 billion for rental assistance.
The Consolidated Appropriations Act is the only other financial assistance the U.S. government has offered its citizens over a nine-month pandemic, following the CARES Act in March. In light of the $600 stimulus checks, #LetThemEatCake has been trending on Twitter in reference to the infamous quote unofficially attributed to Queen Marie Antoinette. For those eligible for the full amount, $600 will likely make a dent in a list of monthly bills, given that the average rent price for a studio apartment across the country is over $1,600. The lowest average studio rent price is just shy of $600 in Oklahoma City, Oklahoma for $531 a month.