July 14, 2024

U.S. begins shipping out second approved COVID-19 vaccine

Moderna Therapeutics in Cambridge
Moderna Therapeutics in Cambridge

A second coronavirus vaccine authorized in the United States was shipped out from a distribution center on Sunday, adding another glimmer of hope that the deadly respiratory disease, which has killed more than 300,000 Americans and sickened over 16 million others, may gradually begin to come to an end.

Trucks loaded with the Moderna vaccine left a factory in the Memphis area on Sunday morning. The vaccine was developed by Moderna and the U.S. National Institute of Health (NIH).

The first shots are expected to be given from Monday, just three days after the United States Food and Drug Administration (FDA) granted emergency approval on Friday.

An expert committee will debate later on Sunday who should be next in line for early doses of the Moderna vaccine and another one from Pfizer and Germany’s BioNtech.

Pfizer and BioNtech vaccine shipped out a week ago, and has been administered to tens of thousands of people already, including Vice President Mike Pence, House Speaker Nancy Pelosi, House Majority Leader Mitch McConnell. President-elect Joseph R. Biden Jr. announced on Saturday that he will be getting his first shot on Monday.

The Moderna vaccine is the second coronavirus vaccine to receive FDA approval in the United States. Last week, the FDA gave the green light to the Pfizer-BioNtech vaccine to be distributed in the United States.

The FDA’s approval came a day after an advisory panel to the agency voted 20-0 to endorse the vaccine. One committee member abstained.

The Moderna vaccine proved to be more than 90 percent effective in late-stage clinical trials and requires two doses giving few weeks apart.

Unlike the Pfizer-BioNtech vaccine, the Moderna vaccine does not require ultra-cold storage.

The vaccine however elicited non-serious adverse reactions such as muscle pain, joint pain, chills, fatigue and headaches. The side effects were characterized as mild to moderate.

Committee members answered yes to the following question: “Based on the totality of scientific evidence available, do the benefits of the Moderna COVID-19 vaccine outweigh its risk for for use in individuals 18 years of age and older?”

The committee members came from experts outside Moderna and included representatives from the FDA’s Center for Biologics Evaluation and Research advisory committee.

The committee noted that was not enough data to evaluate the duration of protection in relation to the vaccine.

In addition, there was not also enough data on how effective is the Moderna vaccine for high-risk populations such as immunocompromised individuals, or in individuals who have previously been infected with SARS-Cov-2. There was not also enough data on effectiveness in pediatric populations.

Committee members also carefully noted that there was not enough data also for them to evaluate future vaccine effectiveness in relation to changes in the virus, effectiveness against asymptomatic infection, and effectiveness against long-term effects of COVID-19, effectiveness against transmission of coronavirus, and effectiveness against mortality.

The other vaccine from Johnson & Johnson will require just one dose once it is approved. There is also another vaccine candidate from Oxford University and AstraZeneca that may also end up being approved.

The United States would need the combination of these vaccines to end the coronavirus pandemic that is now killing more than 3,000 people a day.

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