Updated: March 2, 2021
U.S. President-elect Joseph R. Biden Jr. on Friday expressed frustration that the coronavirus was still killing thousands of Americans every day, and hope that two vaccines have now been approved for emergency use authorization to end the country’s worst health emergency in more than hundred years.
Biden also announced that he will be getting his first vaccine shot on Monday.
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“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,” Biden said in a statement.
“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,” Biden added.
The President-elect warned that the fight against COVID-19 was far from 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,” he said.
He added: “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.”
Biden’s comments came just hours after the United States Food and Drug Administration (FDA) on Friday granted emergency approval for Moderna’s coronavirus vaccine vaccine.
It is the second coronavirus vaccine to receive such 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.