Moderna vaccine becomes second authorized for emergency use in US

Coronavirus

WASHINGTON (NewsNation Now) — The U.S. Food and Drug Administration has approved the second COVID-19 vaccine for emergency use in the United States.

The FDA issued an Emergency Use Authorization for the coronavirus vaccine produced by Moderna for ages 18 years of age or older.

Army General Gustave Perna, the chief operating officer of Operation Warp Speed, held a briefing Saturday to acknowledge a “miscommunication” with states about how many doses of Pfizer’s COVID-19 vaccine would be initially available to them.

The briefing was a response to more than 10 states were told this week the number of doses of the vaccine they were expecting to receive next week has been cut. General Perna said the first-dose distribution of the Moderna vaccine will be available 64 jurisdictions and five federal entities.

Perna said the vaccine will be sent to more than 3,700 locations.

The U.S. drugmaker applied for authorization in November with the company citing a 94.1% efficacy rate. A FDA advisory committee endorsed the vaccine Thursday. The first Americans are expected to get their shots Monday.

An advisory panel of the Center for Disease Control, the Advisory Committee on Immunization Practices (ACIP) met Saturday to consider granting its final approval for Moderna’s vaccine.

“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,” said FDA Commissioner Stephen M. Hahn said in a statement.

The FDA found no severe allergic reactions in Moderna’s data but flagged a slightly higher rate of less serious side effects — rash, hives, itching — among participants who got the vaccine, compared with those receiving a dummy shot.

Moderna’s is the second vaccine the FDA has considered, behind one from Pfizer Inc. and Germany’s BioNTech, which was authorized last week.

Thousands of frontline health care workers and long-term care facility residents have already been vaccinated with the Pfizer vaccine. But the two approved vaccines means another logistic challenge for the government. The vaccine will be distributed through the federal government’s Operation Warp Speed project.

Recently, however, Moderna announced the vaccine can be transported in a liquid state at 36 to 46 degrees Fahrenheit. Good news for some areas of the U.S. struggling to receive the fragile Pfizer vaccine.

“In some cases, this may be the only practical means of distribution from clinics and for remote locations. This important update will help facilitate distribution to the final site of administration,” Moderna said in a statement.

The government has purchased 200 million doses of the vaccine from Moderna. 20 million doses will be delivered by the end of the year, 80 million in the first quarter of 2021 and 100 million in the second quarter of 2021.

Like the Pfizer vaccine, Moderna’s requires two doses.

Emergency Use Authorization

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Food and Drug Administration

“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. Through the FDA’s open and transparent scientific review process, two COVID-19 vaccines have been authorized in an expedited timeframe 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. These standards and our review process, which are the same we have used in reviewing the first COVID-19 vaccine and intend to use for any other COVID-19 vaccines, included input from independent scientific and public health experts as well as a thorough analysis of the data by the agency’s career staff.”

FDA Commissioner Stephen M. Hahn, M.D.

“Guided by science and data, the agency’s career staff determined that the vaccine’s known and potential benefits clearly outweigh its known and potential risks, and although not an FDA approval,  the FDA’s expectations described in our June and October guidance documents have been met. Today’s authorization demonstrates our steadfast commitment to the health of the American people, with the assurance that our scientific standards and the integrity of our review process have been maintained. This achievement is yet another testament to the dedication of FDA’s career scientists and physicians, who have been working urgently to conduct comprehensive and rigorous evaluations of the data submitted for vaccines to prevent COVID-19.”

Peter Marks, M.D., Ph.D., Director of the FDA’s Center for Biologics Evaluation and Research

Moderna

“I want to thank the thousands of participants in our clinical trials and the staff at our clinical trial sites who have been on the front lines of the fight against the virus. I want to thank the NIH and NIAID for their scientific leadership and our partners at BARDA and Operation Warp Speed who have been instrumental to accelerating our progress to this point. I also want to thank the Moderna team, our suppliers and our partners for their tireless work across research, development and manufacturing of our vaccine. I am proud of what the Moderna team has achieved in collaboration with our partners. We were able to create and manufacture the Moderna COVID-19 Vaccine in 11 months from sequence to authorization, while advancing clinical development with a Phase 1, Phase 2 and pivotal Phase 3 study of 30,000 participants. 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. We remain focused on scaling up manufacturing to help us protect as many people as we can from this terrible disease.”

Stéphane Bancel, Chief Executive Officer of Moderna

President-elect Joe Biden

At a time when our country is suffering from record high COVID-19 cases, hospitalizations, and deaths, Jill and I share the frustration and grief so many Americans feel right now. Our hearts go out to the families who have lost a loved one or have gotten sick, or are suffering from the disease.

Today’s emergency use authorization by the Food & Drug Administration of the Moderna COVID-19 vaccine is another milestone in our battle to overcome the crisis our country is facing today. The authorization of two vaccines, Pfizer-BioNTech and now Moderna, assures us that brighter days lie ahead. We are grateful to the scientists, medical experts, and trial participants who helped to deliver these vaccines and evaluated their safety and efficacy free from political influence.

The fight against COVID-19 is not yet over. We know the immense challenges ahead, including scaling up manufacturing, distribution, and the monumental task of vaccinating hundreds of millions of Americans. We need to make sure we have the resources to do all of this and to do it quickly. And, we need a coronavirus and economic relief package passed immediately.

This week, health care workers and residents of long-term care facilities around the country began receiving the Pfizer-BioNTech vaccine. Today, the American people saw bipartisan leaders including Vice President Pence, Speaker Pelosi, and Senator McConnell publicly receive the vaccine as well. This is about more than politics. This is about saving lives. I look forward to receiving the vaccine publicly on Monday and continuing to build confidence in the scientific process. Vaccines don’t save lives, vaccinations do. I believe we can administer 100 million vaccine shots in the first 100 days of my administration. My administration will focus on the science and managing a robust and aggressive plan to contain the virus on day one. It will take all of us, continuing to do our part, to slow the spread of the virus including mask wearing and social distancing.

When we come together as Americans, there is nothing we can’t do.

PRESIDENT-ELECT JOE BIDEN

President Donald Trump

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