The Food and Drug Administration Approves the First Coronavirus Vaccine for the United States

The Food and Drug Administration has approved the Pfizer vaccine for use against the novel coronavirus causing this pandemic. According to the Washington Post:

“The historic authorization of the vaccine from Pfizer and BioNTech for people age 16 and older, just 336 days after the genetic blueprint of a novel coronavirus was shared online by Chinese scientists, sets in motion a highly choreographed and complex distribution process aimed at speeding vaccines throughout the United States to curb the pandemic.

Federal officials have said distribution of the first 2.9 million doses of the highly effective vaccine would begin within 24 hours of an authorization. Meanwhile, an advisory committee for the Centers for Disease Control and Prevention, which has recommended that health-care workers and nursing home residents be the first recipients, was expected to bless the vaccine on Saturday, paving the way for inoculations to begin early next week.

The vaccine achievement creates a paradigm for vaccine development, proving that fast and flexible technologies paired with a single-minded focus by pharmaceutical companies and government can accomplish in 11 months what typically takes years. And it marks a rare triumph for the Trump administration, which in many other areas — such as ensuring adequate testing supplies and providing consistent guidance on whether to wear masks — has failed to produce a coherent and sustained response to the crisis.

“It’s an all-capital-letters, followed by several exclamation points,” accomplishment, said Howard Markel, a medical historian at the University of Michigan who predicted that the scientists who were responsible will be lionized for ending the pandemic.

THE WASHINGTON POST, DECEMBER 12, 2020

Back in 1954, about 620,000 children in different cities around the United States participated in a field trial of the polio vaccine that summer. The logistical challenge then was to get a vaccine to all the trial locations, recruit the participants, give out the vaccine and then keep track of who got the vaccine and who got a placebo. There were issues of ethics as to how to randomize the participants (by site or by city, or by some other characteristic). There were also issues of social justice on who was going to benefit the most from the vaccine.

All the issues then are the same issues now, amplified by a deadly pandemic, divisive politics, and controversial public health interventions. There will be 2.9 million doses — initially, with millions to come — that will have to be allocated to the priority groups recommended by the Advisory Committee on Immunization Practices and implemented by the state and local governments. In Massachusetts, for example, prisoners in the state correctional facilities are toward the front of the line to getting the vaccine because they are at high risk for outbreaks due to overcrowded, close quarters conditions. The Governor of Massachusetts’ plan calls for police and other first responders to be at the front of the line as well.

The Indian Health Service is also has issued plans for delivering the COVID-19 vaccine to the Native American tribes it serves:

“The federal agency that provides health care to Native Americans said Friday it will receive more than enough vaccines to protect all the people working in hospitals and clinics, including doctors, nurses and support staff.
The Indian Health Service, treated much like a state for distribution purposes, submitted a plan to vaccinate more than 2 million Native Americans and Alaska Natives. The agency expects to receive 22,425 doses of the Pfizer vaccine next week and 46,000 doses of the Moderna vaccine before the end of the year, officials said.

More than 44,000 people work at the 338 facilities that chose to get the vaccines through the Indian Health Service. Other tribal health facilities opted to be covered under states’ allocations.

The ones under the Indian Health Service are encouraged to follow U.S. Centers for Disease Control and Prevention guidelines, which prioritize health care workers, said Rear Adm. Francis Frazier, who is leading the agency’s COVID-19 Vaccine Task Force. Tribes can deviate from the guidelines. For example, a tribe might consider elders as being 55 and older, rather than 65.”

The SALT LAKE TRIBUNE, DECEMBER 11, 2020

Over the next few days, the vaccine will be deployed to healthcare systems, health departments and other points of distribution through a network of public and private logistic companies. Companies like UPS, the US Postal Service and the military have all been recruited into this effort. Local, state and federal public health agencies will begin recording who gets the vaccine, where and when, and they will also begin to analyze data on reported vaccine adverse events to make sure that the vaccines are not causing reactions at a rate higher than expected.

What we are about to experience as a nation — and the world — is going to be one of the biggest public health interventions in history, perhaps only comparable to the effort to eradicate smallpox.

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Author: René F. Najera, DrPH

I am the editor of the History of Vaccines site, an online project by the College of Physicians of Philadelphia. All opinions expressed on these blog posts are not necessarily those of the College or any of my employers. Check out my professional profile on LinkedIn: https://www.linkedin.com/in/renenajera Feel free to follow me on Twitter: @EpiRen