On December 11th, 2020, the United States Food and Drug Administration issued the first EUA or emergency use authorization for a vaccine against COVID-19 (coronavirus disease 2019). COVID-19, caused by the novel coronavirus, is responsible for the death of more than three hundred thousand Americans.
On its website, the FDA said that vaccine authorization for emergency use is a “significant milestone in battling this devastating pandemic.”
FDA deemed the vaccine to the safe and effective because it offered 95% protection against the COIVD-19.
The FDA said that the Pfizer-BioNTech COVID-19 vaccine had fulfilled the statutory requirements for the issuance of a EUA. According to the FDA, the available data shows undisputed evidence that the Pfizer-BioNTech COVID-19 vaccine effectively prevents COVID-19.
The vaccine approval marks a turning point in the ongoing pandemic that has devastated people’s life and the nation’s economy. The virus has claimed over 1.5 million lives globally, making the vaccine’s approval ever more exciting news for the world.
Dr. Eric Wei of New York’s Elmhurst hospital said you could not overstate the vaccine’s importance. New York’s Elmhurst hospital was one of the hardest-hit regions at the beginning of this pandemic.
The vaccine rolled out of Pfizer’s facilities in Michigan within hours of the announcement. A critical care nurse for New York became the first person to get vaccinated with the new Pfizer-BioNTech vaccine after the FDA’s emergency use authorization.
The US FDA approval comes after many countries, including the UK, Mexico, and Canada, have already authorized the Pfizer-BioNTech COVID-19 vaccine for public use.
The decision for emergency use authorization comes after While House chief of staff, Mark Meadows, reportedly asked Hahn to push forward with approval on Friday evening.
Peter Mark, the director of the Center for Biologics Evaluation and Research (FDA), said that the FDA’s emergency use authorization of this vaccine could alter the course of the COVID-19 pandemic in the United States. He also stated that the vaccine’s available safety and effectiveness data is concrete enough for authorizing the emergency use of the Pfizer-BioNTech COVID-19 vaccine because its potential benefits outweigh all known potential risks.
The FDA approved this vaccine’s emergency use, called BNT162B2 after it completed a trial involving 43,000 people. The trial concluded that this vaccine is effective at preventing COVID-19 95% of the time. The vaccine implements a messenger RNA technology to introduce the spike protein on the coronavirus surface. The researchers have published the results of the trial in the New England Journal of Medicine.
How Does Pfizer-BioNTech COVID-19 Vaccine Work?
The Pfizer-BioNTech COVID-19 vaccine is of a new type called mRNA vaccine. It uses a microscopic fragment of genetic code from the coronavirus to teach the body how to fight against it and build immunity.
The FDA stated that this vaccine contains a small segment of the COVID-19 virus’s mRNA that teaches the body to make the virus’s unique “spike” protein.
When a person gets vaccinated with the Pfizer-BioNTech COVID-19 vaccine, their body copies the spike protein and produces it, triggering the immune system to learn to react defensively. The production of the virus’s unique spike protein does not cause disease. Instead, it results in an immune response capable of fighting against COVID-19.
People will receive this vaccine as two injections 21 days apart, with the second shot being a booster. While the immunity begins to develop after the first dose, it will not reach the full potential till seven days after the 2nd dose.
Experts are still looking at how long the immune system will let the vaccine last in the body, called the “duration” of immunity. They monitor the vaccine’s effects on the rate of asymptomatic disease among people and whether it can prevent COVID-19 transmission.
FDA has currently authorized the Pfizer-BioNTech COVID-19 vaccine for people aged 16 and above in the United States. Pfizer is still studying the vaccine’s effects on children aged 12-15.
States will get the initial 2.9 million doses within the first few days of authorization. These vaccines will make their way to the healthcare workers and long-term care residents, whom the CDC has deemed the highest priority for vaccination.
Pfizer will then roll out a 2nd 2.9 million units (booster shots) of this vaccine a few weeks later, for the same people who have gotten their first dose. Taking the vaccine’s booster shot is crucial to achieving 95% efficacy. Authorities aim to vaccinate about 20 million healthcare workers and residents of a long-term care home before the end of 2020.
The most challenging part of the vaccination process is the logistics involved in transporting it to various places. The vaccines need a storage temperature of -94F or -70C to remain viable, and so far, Congress has not provided the necessary funding to advance the effort. The lack of funding leaves stretched public health authorities in a difficult position when distributing the vaccine.
Expert warns that the emergency use authorization does not mean the immediate return to normalcy. The initial supply will be constrained, with some experts predicting that it might take until mid to late 2021 for the vaccine to reach lower-risk individuals.
Experts suggest that individuals need to continue wearing masks, practice social distancing, and handwash while vaccinating the most vulnerable. Meanwhile, health agencies will continue to test and contact trace to bring this pandemic to an end eventually.
Federal health authorities plan on vaccinating 20 million people before the year’s end. However, this number does not fully cover all the 21 million of the nation’s healthcare workers and more than three million long-term care residents.
An FDA advisory panel will be looking into the evidence on a second vaccine in the coming weeks. The pharmaceutical company – Moderna and the National Institute of Allergy and Infectious Diseases are behind this new vaccine called mRNA-1273.
The White House had issued another indication of support for the mRNA-1273 vaccine on Friday evening when it announced that the government had procured an additional 100 million doses.
This new purchase brings the total available doses to 200m, allowing for the continuous vaccine supply through June 2021.