Sunday, September 26

FDA Authorizes Modern Coronavirus Vaccine for Emergency Use in the U.S. Coronavirus


The Food and Drug Administration (FDA) has licensed a vaccine developed by Moderna and federal researchers, the second Covid-19 vaccine to receive such approval for emergency use in the US.

The vaccine’s emergency authorization brings the second drug to prevent Covid-19 to the American public in a week, and millions of doses are expected to begin distribution immediately to healthcare workers and long-term care residents. .

Moderna’s vaccine is 94% effective in preventing Covid-19 and is licensed in adults over 18 years of age. The authorization comes after it was recommended by an advisory panel of independent FDA experts.

“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 large numbers of hospitalizations and deaths in the United States every day,” said Stephen Hahn. , the FDA Commissioner, in a sentence announcing emergency clearance.

The vaccine developed by Moderna and the National Institute of Allergy and Infectious Diseases (NIAID) uses messenger RNA technology to introduce the spike proteins that coat the surface of the coronavirus into the body.

“I anticipate that we will probably see injections in the arm early next week,” said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID), to NBC the present day.

Unlike the Pfizer vaccine, the Moderna vaccine deliveries will be managed by the federal government, using funding from Operation Warp Speed, the Trump administration’s program to rapidly develop and disseminate Covid-19 vaccines and treatments.

Pfizer’s vaccine, the first to prevent Covid-19 licensed in the US last week, uses the same technology. Both companies are expected to apply for full approval of the vaccines in the coming months. Federal authorities hope to vaccinate 20 million people before the end of the year.

The authorization comes when the first doses of a vaccine developed by Pfizer are administered to healthcare workers and long-term care residents, after the FDA authorized it last week.

Several high-profile figures have already received the Pfizer vaccine, including Vice President Mike Pence and Speaker of the House, Nancy Pelosi, on Friday. Joe Biden should get his shot on Monday.

Moderna’s vaccine has at least two distinct advantages over the first vaccine. It must be refrigerated, but does not require the ultra-cold -70 ° C (-94 ° F) that Pfizer’s vaccine requires. That means the vaccine could be easier to transport in rural areas and less susceptible to waste. Additionally, Moderna’s data shows that its vaccine appears to protect people against severe Covid-19, when it does not prevent the disease.

The clearance also comes as the virus continues to wreak havoc on Americans. On Thursday he set a new record for daily deaths, when more than 3,500 Americans succumbed to the virus in one day.

A point of view article published in the Journal of the American Medical Association the same week captured the toll: “The daily death rate in the US for deaths from Covid-19 is equivalent to the attacks of September 11, 2001, which claimed 2,988 lives, occurring every 1.5 days, Airbus 320 airliners, each carrying 150 passengers, crash every day, ”wrote Dr. Stephen Woolf and his co-authors.

The authorization, a historic achievement for modern medicine, is also an important achievement for Moderna. Before authorization, the company had no products approved for use by the FDA. Before working on an mRNA vaccine for Covid-19, Moderna scientists were investigating mRNA technology primarily in cancers.

A doctor administers a Pfizer vaccine on Long Island, New York.
A doctor administers a Pfizer vaccine on Long Island, New York. Photograph: Brendan McDermid / Reuters

Moderna’s vaccine brings the number of potential doses to be delivered to high-risk populations to 300 million, 200 million of which Moderna is contracted to provide to the federal government.

Because each vaccine requires a two-dose “booster” regimen, that means the US will have enough doses to immunize 150 million people, if it can effectively implement one of the most ambitious immunization campaigns in the world. the history of medicine. Moderna is mainly based on outsourced manufacturers to produce millions of doses of your vaccine.

Even with the monumental achievement of authorizing a second vaccine, scientists will still need to advance more candidate vaccines to provide the manufacturing capacity to reach millions of other Americans and people around the world.

That means that the authorization of the second vaccine will not immediately bring a return to normalcy, as it will take the better part of a year to immunize and distribute the vaccines to hundreds of millions of Americans.

Both injections will have to overcome high levels of hesitation on the part of a skeptical and tired American public, which for months has been bombarded by misinformation. Moderna’s vaccine may face an even bigger hurdle, as the same White House that has spreading misinformation about Covid-19 played a role in its development.

The Moderna vaccine was found to be more than 94% effective in preventing Covid-19, in a trial of more than 30,000 patients. The Moderna scientists said there were two allergic reactions in their trial, one in the placebo group and one in a vaccine recipient.

In the vaccine arm, the allergic reaction occurred more than 60 days after the participant received the vaccine and was found to be related to a separate medical procedure.


www.theguardian.com

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